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OBG Management is a leading publication in the ObGyn specialty addressing patient care and practice management under one cover.
gambling
compulsive behaviors
ammunition
assault rifle
black jack
Boko Haram
bondage
child abuse
cocaine
Daech
drug paraphernalia
explosion
gun
human trafficking
ISIL
ISIS
Islamic caliphate
Islamic state
mixed martial arts
MMA
molestation
national rifle association
NRA
nsfw
pedophile
pedophilia
poker
porn
pornography
psychedelic drug
recreational drug
sex slave rings
slot machine
terrorism
terrorist
Texas hold 'em
UFC
substance abuse
abuseed
abuseer
abusees
abuseing
abusely
abuses
aeolus
aeolused
aeoluser
aeoluses
aeolusing
aeolusly
aeoluss
ahole
aholeed
aholeer
aholees
aholeing
aholely
aholes
alcohol
alcoholed
alcoholer
alcoholes
alcoholing
alcoholly
alcohols
allman
allmaned
allmaner
allmanes
allmaning
allmanly
allmans
alted
altes
alting
altly
alts
analed
analer
anales
analing
anally
analprobe
analprobeed
analprobeer
analprobees
analprobeing
analprobely
analprobes
anals
anilingus
anilingused
anilinguser
anilinguses
anilingusing
anilingusly
anilinguss
anus
anused
anuser
anuses
anusing
anusly
anuss
areola
areolaed
areolaer
areolaes
areolaing
areolaly
areolas
areole
areoleed
areoleer
areolees
areoleing
areolely
areoles
arian
arianed
arianer
arianes
arianing
arianly
arians
aryan
aryaned
aryaner
aryanes
aryaning
aryanly
aryans
asiaed
asiaer
asiaes
asiaing
asialy
asias
ass
ass hole
ass lick
ass licked
ass licker
ass lickes
ass licking
ass lickly
ass licks
assbang
assbanged
assbangeded
assbangeder
assbangedes
assbangeding
assbangedly
assbangeds
assbanger
assbanges
assbanging
assbangly
assbangs
assbangsed
assbangser
assbangses
assbangsing
assbangsly
assbangss
assed
asser
asses
assesed
asseser
asseses
assesing
assesly
assess
assfuck
assfucked
assfucker
assfuckered
assfuckerer
assfuckeres
assfuckering
assfuckerly
assfuckers
assfuckes
assfucking
assfuckly
assfucks
asshat
asshated
asshater
asshates
asshating
asshatly
asshats
assholeed
assholeer
assholees
assholeing
assholely
assholes
assholesed
assholeser
assholeses
assholesing
assholesly
assholess
assing
assly
assmaster
assmastered
assmasterer
assmasteres
assmastering
assmasterly
assmasters
assmunch
assmunched
assmuncher
assmunches
assmunching
assmunchly
assmunchs
asss
asswipe
asswipeed
asswipeer
asswipees
asswipeing
asswipely
asswipes
asswipesed
asswipeser
asswipeses
asswipesing
asswipesly
asswipess
azz
azzed
azzer
azzes
azzing
azzly
azzs
babeed
babeer
babees
babeing
babely
babes
babesed
babeser
babeses
babesing
babesly
babess
ballsac
ballsaced
ballsacer
ballsaces
ballsacing
ballsack
ballsacked
ballsacker
ballsackes
ballsacking
ballsackly
ballsacks
ballsacly
ballsacs
ballsed
ballser
ballses
ballsing
ballsly
ballss
barf
barfed
barfer
barfes
barfing
barfly
barfs
bastard
bastarded
bastarder
bastardes
bastarding
bastardly
bastards
bastardsed
bastardser
bastardses
bastardsing
bastardsly
bastardss
bawdy
bawdyed
bawdyer
bawdyes
bawdying
bawdyly
bawdys
beaner
beanered
beanerer
beaneres
beanering
beanerly
beaners
beardedclam
beardedclamed
beardedclamer
beardedclames
beardedclaming
beardedclamly
beardedclams
beastiality
beastialityed
beastialityer
beastialityes
beastialitying
beastialityly
beastialitys
beatch
beatched
beatcher
beatches
beatching
beatchly
beatchs
beater
beatered
beaterer
beateres
beatering
beaterly
beaters
beered
beerer
beeres
beering
beerly
beeyotch
beeyotched
beeyotcher
beeyotches
beeyotching
beeyotchly
beeyotchs
beotch
beotched
beotcher
beotches
beotching
beotchly
beotchs
biatch
biatched
biatcher
biatches
biatching
biatchly
biatchs
big tits
big titsed
big titser
big titses
big titsing
big titsly
big titss
bigtits
bigtitsed
bigtitser
bigtitses
bigtitsing
bigtitsly
bigtitss
bimbo
bimboed
bimboer
bimboes
bimboing
bimboly
bimbos
bisexualed
bisexualer
bisexuales
bisexualing
bisexually
bisexuals
bitch
bitched
bitcheded
bitcheder
bitchedes
bitcheding
bitchedly
bitcheds
bitcher
bitches
bitchesed
bitcheser
bitcheses
bitchesing
bitchesly
bitchess
bitching
bitchly
bitchs
bitchy
bitchyed
bitchyer
bitchyes
bitchying
bitchyly
bitchys
bleached
bleacher
bleaches
bleaching
bleachly
bleachs
blow job
blow jobed
blow jober
blow jobes
blow jobing
blow jobly
blow jobs
blowed
blower
blowes
blowing
blowjob
blowjobed
blowjober
blowjobes
blowjobing
blowjobly
blowjobs
blowjobsed
blowjobser
blowjobses
blowjobsing
blowjobsly
blowjobss
blowly
blows
boink
boinked
boinker
boinkes
boinking
boinkly
boinks
bollock
bollocked
bollocker
bollockes
bollocking
bollockly
bollocks
bollocksed
bollockser
bollockses
bollocksing
bollocksly
bollockss
bollok
bolloked
bolloker
bollokes
bolloking
bollokly
bolloks
boner
bonered
bonerer
boneres
bonering
bonerly
boners
bonersed
bonerser
bonerses
bonersing
bonersly
bonerss
bong
bonged
bonger
bonges
bonging
bongly
bongs
boob
boobed
boober
boobes
boobies
boobiesed
boobieser
boobieses
boobiesing
boobiesly
boobiess
boobing
boobly
boobs
boobsed
boobser
boobses
boobsing
boobsly
boobss
booby
boobyed
boobyer
boobyes
boobying
boobyly
boobys
booger
boogered
boogerer
boogeres
boogering
boogerly
boogers
bookie
bookieed
bookieer
bookiees
bookieing
bookiely
bookies
bootee
booteeed
booteeer
booteees
booteeing
booteely
bootees
bootie
bootieed
bootieer
bootiees
bootieing
bootiely
booties
booty
bootyed
bootyer
bootyes
bootying
bootyly
bootys
boozeed
boozeer
boozees
boozeing
boozely
boozer
boozered
boozerer
boozeres
boozering
boozerly
boozers
boozes
boozy
boozyed
boozyer
boozyes
boozying
boozyly
boozys
bosomed
bosomer
bosomes
bosoming
bosomly
bosoms
bosomy
bosomyed
bosomyer
bosomyes
bosomying
bosomyly
bosomys
bugger
buggered
buggerer
buggeres
buggering
buggerly
buggers
bukkake
bukkakeed
bukkakeer
bukkakees
bukkakeing
bukkakely
bukkakes
bull shit
bull shited
bull shiter
bull shites
bull shiting
bull shitly
bull shits
bullshit
bullshited
bullshiter
bullshites
bullshiting
bullshitly
bullshits
bullshitsed
bullshitser
bullshitses
bullshitsing
bullshitsly
bullshitss
bullshitted
bullshitteded
bullshitteder
bullshittedes
bullshitteding
bullshittedly
bullshitteds
bullturds
bullturdsed
bullturdser
bullturdses
bullturdsing
bullturdsly
bullturdss
bung
bunged
bunger
bunges
bunging
bungly
bungs
busty
bustyed
bustyer
bustyes
bustying
bustyly
bustys
butt
butt fuck
butt fucked
butt fucker
butt fuckes
butt fucking
butt fuckly
butt fucks
butted
buttes
buttfuck
buttfucked
buttfucker
buttfuckered
buttfuckerer
buttfuckeres
buttfuckering
buttfuckerly
buttfuckers
buttfuckes
buttfucking
buttfuckly
buttfucks
butting
buttly
buttplug
buttpluged
buttpluger
buttpluges
buttpluging
buttplugly
buttplugs
butts
caca
cacaed
cacaer
cacaes
cacaing
cacaly
cacas
cahone
cahoneed
cahoneer
cahonees
cahoneing
cahonely
cahones
cameltoe
cameltoeed
cameltoeer
cameltoees
cameltoeing
cameltoely
cameltoes
carpetmuncher
carpetmunchered
carpetmuncherer
carpetmuncheres
carpetmunchering
carpetmuncherly
carpetmunchers
cawk
cawked
cawker
cawkes
cawking
cawkly
cawks
chinc
chinced
chincer
chinces
chincing
chincly
chincs
chincsed
chincser
chincses
chincsing
chincsly
chincss
chink
chinked
chinker
chinkes
chinking
chinkly
chinks
chode
chodeed
chodeer
chodees
chodeing
chodely
chodes
chodesed
chodeser
chodeses
chodesing
chodesly
chodess
clit
clited
cliter
clites
cliting
clitly
clitoris
clitorised
clitoriser
clitorises
clitorising
clitorisly
clitoriss
clitorus
clitorused
clitoruser
clitoruses
clitorusing
clitorusly
clitoruss
clits
clitsed
clitser
clitses
clitsing
clitsly
clitss
clitty
clittyed
clittyer
clittyes
clittying
clittyly
clittys
cocain
cocaine
cocained
cocaineed
cocaineer
cocainees
cocaineing
cocainely
cocainer
cocaines
cocaining
cocainly
cocains
cock
cock sucker
cock suckered
cock suckerer
cock suckeres
cock suckering
cock suckerly
cock suckers
cockblock
cockblocked
cockblocker
cockblockes
cockblocking
cockblockly
cockblocks
cocked
cocker
cockes
cockholster
cockholstered
cockholsterer
cockholsteres
cockholstering
cockholsterly
cockholsters
cocking
cockknocker
cockknockered
cockknockerer
cockknockeres
cockknockering
cockknockerly
cockknockers
cockly
cocks
cocksed
cockser
cockses
cocksing
cocksly
cocksmoker
cocksmokered
cocksmokerer
cocksmokeres
cocksmokering
cocksmokerly
cocksmokers
cockss
cocksucker
cocksuckered
cocksuckerer
cocksuckeres
cocksuckering
cocksuckerly
cocksuckers
coital
coitaled
coitaler
coitales
coitaling
coitally
coitals
commie
commieed
commieer
commiees
commieing
commiely
commies
condomed
condomer
condomes
condoming
condomly
condoms
coon
cooned
cooner
coones
cooning
coonly
coons
coonsed
coonser
coonses
coonsing
coonsly
coonss
corksucker
corksuckered
corksuckerer
corksuckeres
corksuckering
corksuckerly
corksuckers
cracked
crackwhore
crackwhoreed
crackwhoreer
crackwhorees
crackwhoreing
crackwhorely
crackwhores
crap
craped
craper
crapes
craping
craply
crappy
crappyed
crappyer
crappyes
crappying
crappyly
crappys
cum
cumed
cumer
cumes
cuming
cumly
cummin
cummined
cumminer
cummines
cumming
cumminged
cumminger
cumminges
cumminging
cummingly
cummings
cummining
cumminly
cummins
cums
cumshot
cumshoted
cumshoter
cumshotes
cumshoting
cumshotly
cumshots
cumshotsed
cumshotser
cumshotses
cumshotsing
cumshotsly
cumshotss
cumslut
cumsluted
cumsluter
cumslutes
cumsluting
cumslutly
cumsluts
cumstain
cumstained
cumstainer
cumstaines
cumstaining
cumstainly
cumstains
cunilingus
cunilingused
cunilinguser
cunilinguses
cunilingusing
cunilingusly
cunilinguss
cunnilingus
cunnilingused
cunnilinguser
cunnilinguses
cunnilingusing
cunnilingusly
cunnilinguss
cunny
cunnyed
cunnyer
cunnyes
cunnying
cunnyly
cunnys
cunt
cunted
cunter
cuntes
cuntface
cuntfaceed
cuntfaceer
cuntfacees
cuntfaceing
cuntfacely
cuntfaces
cunthunter
cunthuntered
cunthunterer
cunthunteres
cunthuntering
cunthunterly
cunthunters
cunting
cuntlick
cuntlicked
cuntlicker
cuntlickered
cuntlickerer
cuntlickeres
cuntlickering
cuntlickerly
cuntlickers
cuntlickes
cuntlicking
cuntlickly
cuntlicks
cuntly
cunts
cuntsed
cuntser
cuntses
cuntsing
cuntsly
cuntss
dago
dagoed
dagoer
dagoes
dagoing
dagoly
dagos
dagosed
dagoser
dagoses
dagosing
dagosly
dagoss
dammit
dammited
dammiter
dammites
dammiting
dammitly
dammits
damn
damned
damneded
damneder
damnedes
damneding
damnedly
damneds
damner
damnes
damning
damnit
damnited
damniter
damnites
damniting
damnitly
damnits
damnly
damns
dick
dickbag
dickbaged
dickbager
dickbages
dickbaging
dickbagly
dickbags
dickdipper
dickdippered
dickdipperer
dickdipperes
dickdippering
dickdipperly
dickdippers
dicked
dicker
dickes
dickface
dickfaceed
dickfaceer
dickfacees
dickfaceing
dickfacely
dickfaces
dickflipper
dickflippered
dickflipperer
dickflipperes
dickflippering
dickflipperly
dickflippers
dickhead
dickheaded
dickheader
dickheades
dickheading
dickheadly
dickheads
dickheadsed
dickheadser
dickheadses
dickheadsing
dickheadsly
dickheadss
dicking
dickish
dickished
dickisher
dickishes
dickishing
dickishly
dickishs
dickly
dickripper
dickrippered
dickripperer
dickripperes
dickrippering
dickripperly
dickrippers
dicks
dicksipper
dicksippered
dicksipperer
dicksipperes
dicksippering
dicksipperly
dicksippers
dickweed
dickweeded
dickweeder
dickweedes
dickweeding
dickweedly
dickweeds
dickwhipper
dickwhippered
dickwhipperer
dickwhipperes
dickwhippering
dickwhipperly
dickwhippers
dickzipper
dickzippered
dickzipperer
dickzipperes
dickzippering
dickzipperly
dickzippers
diddle
diddleed
diddleer
diddlees
diddleing
diddlely
diddles
dike
dikeed
dikeer
dikees
dikeing
dikely
dikes
dildo
dildoed
dildoer
dildoes
dildoing
dildoly
dildos
dildosed
dildoser
dildoses
dildosing
dildosly
dildoss
diligaf
diligafed
diligafer
diligafes
diligafing
diligafly
diligafs
dillweed
dillweeded
dillweeder
dillweedes
dillweeding
dillweedly
dillweeds
dimwit
dimwited
dimwiter
dimwites
dimwiting
dimwitly
dimwits
dingle
dingleed
dingleer
dinglees
dingleing
dinglely
dingles
dipship
dipshiped
dipshiper
dipshipes
dipshiping
dipshiply
dipships
dizzyed
dizzyer
dizzyes
dizzying
dizzyly
dizzys
doggiestyleed
doggiestyleer
doggiestylees
doggiestyleing
doggiestylely
doggiestyles
doggystyleed
doggystyleer
doggystylees
doggystyleing
doggystylely
doggystyles
dong
donged
donger
donges
donging
dongly
dongs
doofus
doofused
doofuser
doofuses
doofusing
doofusly
doofuss
doosh
dooshed
doosher
dooshes
dooshing
dooshly
dooshs
dopeyed
dopeyer
dopeyes
dopeying
dopeyly
dopeys
douchebag
douchebaged
douchebager
douchebages
douchebaging
douchebagly
douchebags
douchebagsed
douchebagser
douchebagses
douchebagsing
douchebagsly
douchebagss
doucheed
doucheer
douchees
doucheing
douchely
douches
douchey
doucheyed
doucheyer
doucheyes
doucheying
doucheyly
doucheys
drunk
drunked
drunker
drunkes
drunking
drunkly
drunks
dumass
dumassed
dumasser
dumasses
dumassing
dumassly
dumasss
dumbass
dumbassed
dumbasser
dumbasses
dumbassesed
dumbasseser
dumbasseses
dumbassesing
dumbassesly
dumbassess
dumbassing
dumbassly
dumbasss
dummy
dummyed
dummyer
dummyes
dummying
dummyly
dummys
dyke
dykeed
dykeer
dykees
dykeing
dykely
dykes
dykesed
dykeser
dykeses
dykesing
dykesly
dykess
erotic
eroticed
eroticer
erotices
eroticing
eroticly
erotics
extacy
extacyed
extacyer
extacyes
extacying
extacyly
extacys
extasy
extasyed
extasyer
extasyes
extasying
extasyly
extasys
fack
facked
facker
fackes
facking
fackly
facks
fag
faged
fager
fages
fagg
fagged
faggeded
faggeder
faggedes
faggeding
faggedly
faggeds
fagger
fagges
fagging
faggit
faggited
faggiter
faggites
faggiting
faggitly
faggits
faggly
faggot
faggoted
faggoter
faggotes
faggoting
faggotly
faggots
faggs
faging
fagly
fagot
fagoted
fagoter
fagotes
fagoting
fagotly
fagots
fags
fagsed
fagser
fagses
fagsing
fagsly
fagss
faig
faiged
faiger
faiges
faiging
faigly
faigs
faigt
faigted
faigter
faigtes
faigting
faigtly
faigts
fannybandit
fannybandited
fannybanditer
fannybandites
fannybanditing
fannybanditly
fannybandits
farted
farter
fartes
farting
fartknocker
fartknockered
fartknockerer
fartknockeres
fartknockering
fartknockerly
fartknockers
fartly
farts
felch
felched
felcher
felchered
felcherer
felcheres
felchering
felcherly
felchers
felches
felching
felchinged
felchinger
felchinges
felchinging
felchingly
felchings
felchly
felchs
fellate
fellateed
fellateer
fellatees
fellateing
fellately
fellates
fellatio
fellatioed
fellatioer
fellatioes
fellatioing
fellatioly
fellatios
feltch
feltched
feltcher
feltchered
feltcherer
feltcheres
feltchering
feltcherly
feltchers
feltches
feltching
feltchly
feltchs
feom
feomed
feomer
feomes
feoming
feomly
feoms
fisted
fisteded
fisteder
fistedes
fisteding
fistedly
fisteds
fisting
fistinged
fistinger
fistinges
fistinging
fistingly
fistings
fisty
fistyed
fistyer
fistyes
fistying
fistyly
fistys
floozy
floozyed
floozyer
floozyes
floozying
floozyly
floozys
foad
foaded
foader
foades
foading
foadly
foads
fondleed
fondleer
fondlees
fondleing
fondlely
fondles
foobar
foobared
foobarer
foobares
foobaring
foobarly
foobars
freex
freexed
freexer
freexes
freexing
freexly
freexs
frigg
frigga
friggaed
friggaer
friggaes
friggaing
friggaly
friggas
frigged
frigger
frigges
frigging
friggly
friggs
fubar
fubared
fubarer
fubares
fubaring
fubarly
fubars
fuck
fuckass
fuckassed
fuckasser
fuckasses
fuckassing
fuckassly
fuckasss
fucked
fuckeded
fuckeder
fuckedes
fuckeding
fuckedly
fuckeds
fucker
fuckered
fuckerer
fuckeres
fuckering
fuckerly
fuckers
fuckes
fuckface
fuckfaceed
fuckfaceer
fuckfacees
fuckfaceing
fuckfacely
fuckfaces
fuckin
fuckined
fuckiner
fuckines
fucking
fuckinged
fuckinger
fuckinges
fuckinging
fuckingly
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humira AND expensive
illegal
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texarkana
Endometrial cancer after unopposed estrogen: $7.5M
Endometrial cancer after unopposed estrogen: $7.5M
A 42-year-old woman took unopposed estrogen as treatment for reported perimenopausal symptoms from October 2010 through October 2012, although she still had her uterus.
In December 2013, the patient was diagnosed with Stage 3 endometrial cancer. She underwent a radical hysterectomy followed by several rounds of chemotherapy. Despite treatment, the cancer metastasized, leaving the patient with a decreased life expectancy.
Patient’s claim Use of unopposed estrogens by a woman who still has her uterus significantly increases her risk of developing endometrial cancer. The gynecologist was negligent for prescribing the drug.
Physician’s defense The case was settled during the trial.
Verdict A $7.5 million Illinois settlement was reached
Preeclampsia treatment delayed because BP machine failed: $5M
At 31 4/7 weeks’ gestation, a woman went to the hospital. She reported burning pain in her chest, headache, and vomiting.
Two nurses cared for the mother: one who was completing her shift (Nurse A) and another who was beginning her shift (Nurse B). Nurse A stated that the blood pressure (BP) machine was not working correctly when she attempted to assess the patient at admission. When Nurse B took the patient’s BP, it indicated preeclampsia. Shortly thereafter, fetal heart-rate monitoring showed a concerning pattern. Nurse B notified the ObGyn 75 minutes after the mother’s arrival. The ObGyn ordered intervention to treat the baby’s concerning heart rate and, when those efforts failed, an emergency cesarean delivery was performed. The baby was found to have brain damage caused by hypoxia.
Parents’ claim Because the BP machine was not working properly when the mother arrived at the hospital, intervention for preeclampsia was delayed. Preeclampsia caused the baby’s injuries. An earlier cesarean delivery should have been performed.
Defendant’s defense The patient was adequately treated. The injury likely occurred before the mother arrived at the hospital. The case was settled during the trial.
Verdict A $5 million Massachusetts settlement was reached with the hospital and ObGyn.
Standard prenatal scan missed congenital syndrome: $3.75M
A woman receiving prenatal care at a medical center requested an ultrasonographic anatomical fetal scan. A limited ultrasound (US) was performed, and no abnormalities were detected.
Upon birth, the child was found to have Dandy Walker syndrome, a malformation of the brain affecting mobility. The child requires full-time nursing care.
Parents’ claim If a complete prenatal anatomical survey had been performed when requested, the abnormality would have been detected. The mother would have terminated the pregnancy.
Defendant’s defense It is the medical center’s policy to perform complete anatomical surveys only on women with high-risk pregnancies, which this was not. The woman switched health care providers during her pregnancy. A subsequent US performed by the new health care provider did not show a fetal abnormality. The case was settled during the trial.
Verdict A $3.75 million New Jersey settlement was reached with the medical center.
Should mother have been discharged? $700,000 settlement
Due to elevated fetal heart rate, a woman was admitted to the hospital for fetal heart-rate monitoring and then discharged a few hours later. After 2 days, the mother was readmitted for induction of labor, but she was discharged the following day. The next day, she was readmitted when she noticed lack of fetal movement. The infant was stillborn.
Parents’ claim The mother and fetus were not properly monitored; she should not have been sent home after induction of labor. The hospital was negligent for not properly monitoring labor, for not assigning an ObGyn to care for the mother, and for not performing cesarean delivery.
Hospital’s defense The case was settled during the trial.
Verdict A $700,000 Illinois settlement was reached with the hospital.
Endometrial cancer after unopposed estrogen: $7.5M
A 42-year-old woman took unopposed estrogen as treatment for reported perimenopausal symptoms from October 2010 through October 2012, although she still had her uterus.
In December 2013, the patient was diagnosed with Stage 3 endometrial cancer. She underwent a radical hysterectomy followed by several rounds of chemotherapy. Despite treatment, the cancer metastasized, leaving the patient with a decreased life expectancy.
Patient’s claim Use of unopposed estrogens by a woman who still has her uterus significantly increases her risk of developing endometrial cancer. The gynecologist was negligent for prescribing the drug.
Physician’s defense The case was settled during the trial.
Verdict A $7.5 million Illinois settlement was reached
Preeclampsia treatment delayed because BP machine failed: $5M
At 31 4/7 weeks’ gestation, a woman went to the hospital. She reported burning pain in her chest, headache, and vomiting.
Two nurses cared for the mother: one who was completing her shift (Nurse A) and another who was beginning her shift (Nurse B). Nurse A stated that the blood pressure (BP) machine was not working correctly when she attempted to assess the patient at admission. When Nurse B took the patient’s BP, it indicated preeclampsia. Shortly thereafter, fetal heart-rate monitoring showed a concerning pattern. Nurse B notified the ObGyn 75 minutes after the mother’s arrival. The ObGyn ordered intervention to treat the baby’s concerning heart rate and, when those efforts failed, an emergency cesarean delivery was performed. The baby was found to have brain damage caused by hypoxia.
Parents’ claim Because the BP machine was not working properly when the mother arrived at the hospital, intervention for preeclampsia was delayed. Preeclampsia caused the baby’s injuries. An earlier cesarean delivery should have been performed.
Defendant’s defense The patient was adequately treated. The injury likely occurred before the mother arrived at the hospital. The case was settled during the trial.
Verdict A $5 million Massachusetts settlement was reached with the hospital and ObGyn.
Standard prenatal scan missed congenital syndrome: $3.75M
A woman receiving prenatal care at a medical center requested an ultrasonographic anatomical fetal scan. A limited ultrasound (US) was performed, and no abnormalities were detected.
Upon birth, the child was found to have Dandy Walker syndrome, a malformation of the brain affecting mobility. The child requires full-time nursing care.
Parents’ claim If a complete prenatal anatomical survey had been performed when requested, the abnormality would have been detected. The mother would have terminated the pregnancy.
Defendant’s defense It is the medical center’s policy to perform complete anatomical surveys only on women with high-risk pregnancies, which this was not. The woman switched health care providers during her pregnancy. A subsequent US performed by the new health care provider did not show a fetal abnormality. The case was settled during the trial.
Verdict A $3.75 million New Jersey settlement was reached with the medical center.
Should mother have been discharged? $700,000 settlement
Due to elevated fetal heart rate, a woman was admitted to the hospital for fetal heart-rate monitoring and then discharged a few hours later. After 2 days, the mother was readmitted for induction of labor, but she was discharged the following day. The next day, she was readmitted when she noticed lack of fetal movement. The infant was stillborn.
Parents’ claim The mother and fetus were not properly monitored; she should not have been sent home after induction of labor. The hospital was negligent for not properly monitoring labor, for not assigning an ObGyn to care for the mother, and for not performing cesarean delivery.
Hospital’s defense The case was settled during the trial.
Verdict A $700,000 Illinois settlement was reached with the hospital.
Endometrial cancer after unopposed estrogen: $7.5M
A 42-year-old woman took unopposed estrogen as treatment for reported perimenopausal symptoms from October 2010 through October 2012, although she still had her uterus.
In December 2013, the patient was diagnosed with Stage 3 endometrial cancer. She underwent a radical hysterectomy followed by several rounds of chemotherapy. Despite treatment, the cancer metastasized, leaving the patient with a decreased life expectancy.
Patient’s claim Use of unopposed estrogens by a woman who still has her uterus significantly increases her risk of developing endometrial cancer. The gynecologist was negligent for prescribing the drug.
Physician’s defense The case was settled during the trial.
Verdict A $7.5 million Illinois settlement was reached
Preeclampsia treatment delayed because BP machine failed: $5M
At 31 4/7 weeks’ gestation, a woman went to the hospital. She reported burning pain in her chest, headache, and vomiting.
Two nurses cared for the mother: one who was completing her shift (Nurse A) and another who was beginning her shift (Nurse B). Nurse A stated that the blood pressure (BP) machine was not working correctly when she attempted to assess the patient at admission. When Nurse B took the patient’s BP, it indicated preeclampsia. Shortly thereafter, fetal heart-rate monitoring showed a concerning pattern. Nurse B notified the ObGyn 75 minutes after the mother’s arrival. The ObGyn ordered intervention to treat the baby’s concerning heart rate and, when those efforts failed, an emergency cesarean delivery was performed. The baby was found to have brain damage caused by hypoxia.
Parents’ claim Because the BP machine was not working properly when the mother arrived at the hospital, intervention for preeclampsia was delayed. Preeclampsia caused the baby’s injuries. An earlier cesarean delivery should have been performed.
Defendant’s defense The patient was adequately treated. The injury likely occurred before the mother arrived at the hospital. The case was settled during the trial.
Verdict A $5 million Massachusetts settlement was reached with the hospital and ObGyn.
Standard prenatal scan missed congenital syndrome: $3.75M
A woman receiving prenatal care at a medical center requested an ultrasonographic anatomical fetal scan. A limited ultrasound (US) was performed, and no abnormalities were detected.
Upon birth, the child was found to have Dandy Walker syndrome, a malformation of the brain affecting mobility. The child requires full-time nursing care.
Parents’ claim If a complete prenatal anatomical survey had been performed when requested, the abnormality would have been detected. The mother would have terminated the pregnancy.
Defendant’s defense It is the medical center’s policy to perform complete anatomical surveys only on women with high-risk pregnancies, which this was not. The woman switched health care providers during her pregnancy. A subsequent US performed by the new health care provider did not show a fetal abnormality. The case was settled during the trial.
Verdict A $3.75 million New Jersey settlement was reached with the medical center.
Should mother have been discharged? $700,000 settlement
Due to elevated fetal heart rate, a woman was admitted to the hospital for fetal heart-rate monitoring and then discharged a few hours later. After 2 days, the mother was readmitted for induction of labor, but she was discharged the following day. The next day, she was readmitted when she noticed lack of fetal movement. The infant was stillborn.
Parents’ claim The mother and fetus were not properly monitored; she should not have been sent home after induction of labor. The hospital was negligent for not properly monitoring labor, for not assigning an ObGyn to care for the mother, and for not performing cesarean delivery.
Hospital’s defense The case was settled during the trial.
Verdict A $700,000 Illinois settlement was reached with the hospital.
ADDITIONAL MEDICAL VERDICTS CASES:
Stroke during delivery: $35.4M verdict: OBG Manag. 2016;28(2):46.
Failure to find breast cancer; later diagnosed at Stage 3: OBG Manag. 2016;28(2):48.
No surprises from the USPSTF with new guidance on screening mammography
In 2009, the US Preventive Services Task Force (USPSTF) recommended that biennial mammography screening in average-risk women begin at age 50.1 New guidelines, that take into account reviews and modeling studies, clarify the earlier USPSTF recommendations, paying particular attention to individualized screening for women aged 40 to 49, use of tomosynthesis, and supplemental evaluation for women with radiologically dense breasts.
The new guidance only applies to women at average risk for breast cancer (not to those at substantially higher-than-average risk), including those with prior breast cancer or biopsy-confirmed high-risk lesions (eg, atypical hyperplasia), certain genetic conditions (such as BRCA1 or BRCA2 mutation), or histories of chest irradiation (eg, Hodgkin lymphoma).
Major statements:
- Biennial screening is recommended for women aged 50 to 74 (B recommendation; definitions of USPSTF grades are available online at ).
- Initiation of screening before age 50 should be individualized depending on patient preferences (C recommendation).
- For women aged ≥75, current evidence is insufficient to assess benefits and harms of screening (I statement).
- Current evidence is insufficient to assess the benefits and harms of adding tomosynthesis to conventional screening mammography (I statement).
- For women with radiologically dense breasts, current evidence is insufficient to assess the benefits and harms of adjunctive ultrasound, magnetic resonance imaging (MRI), or tomosynthesis (I statement).2
The Task Force generated controversy with its 2009 recommendation that screening begin at age 50 in average-risk women. The current guidance clarifies that repetitive screening of women through 10 years reduces breast cancer deaths by 4 (aged 40–49), 8 (aged 50–59), and 21 (aged 60–69) per 10,000 women, respectively.2
The term “overdiagnosis” refers to detection and treatment of invasive and noninvasive (usually ductal carcinoma in situ) lesions that would have gone undetected without screening and would not have caused health problems. The USPSTF acknowledges that, while overdiagnosis represents the principal harm from screening, estimating overdiagnosis rates is challenging (best estimates range from 1 in 5 to 1 in 8 breast cancers diagnosed in screened women).2–4 False-positive results, which lead to unnecessary additional imaging and biopsies,3,4 can represent an additional harm of screening mammography.
The rationale for recommending that average-risk women begin screening at age 50 is based on the relatively smaller benefits and greater harms incurred when younger women are screened;3,4 however, in noting that most of the screening benefits for women in their 40s are realized starting at age 45, the USPSTF guidance opens the door to average-risk women to begin screening at that age (congruent with the November 2015 American Cancer Society recommendations5). Also, women with a first-degree relative with breast cancer may want to initiate screening at age 40.
Regarding screening frequency, annual screening generates minimal if any benefit while increasing the potential for harm3,4; thus, for most women at average risk for breast cancer, biennial screening provides the best benefit–harm balance.
What about use of tomosynthesis and women with dense breasts?
Tomosynthesis, which can be performed along with conventional digital screening mammography, seems to diminish the need for follow-up imaging while also increasing cancer detection rates.6 However, whether these additional cancers represent overdiagnosis remains unknown. Furthermore, tomosynthesis can expose women to about twice the radiation as conventional digital screening.7
Twenty-four states currently mandate that patients with dense breasts identified at screening be notified. Although increased breast density is a common independent risk factor for breast cancer, the degree of radiographic density can vary substantially from one screen to the next in the same woman. Evidence for or against adjunctive imaging is very limited in women found to have dense breasts in an otherwise negative mammogram, and suggests that ultrasonography and MRI (as well as tomosynthesis) can detect additional breast cancers while also generating more false-positive results.8 Thus, the USPSTF does not recommend specific screening strategies for women with dense breasts.
How I counsel my patients
I plan to continue recommending screening based on USPSTF guidance. However, I also will continue to support the preferences of many of my patients to:
- initiate screening before age 50
- undergo screening annually
- continue screening after age 74.
You and your patients alike may find the USPSTF’s Summary for Patients9 (http://annals.org/article.aspx?articleid=2480981&resultClick=3) to be helpful when navigating this territory.
Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.
- US Preventive Services Task Force. Screening for breast cancer: US Preventive Services Task Force recommendation statement. Ann Intern Med. 2009;151(10):716−726.
- Siu AL; US Preventive Services Task Force. Screening for breast cancer: US Preventive Services Task Force recommendation statement [published online ahead of print January 12, 2016]. Ann Intern Med. doi:10.7326/M15-2886.
- Nelson HD, Pappas M, Cantor A, Griffin J, Daeges M, Humphrey L. Harms of breast cancer screening: systematic review to update the 2009 US Preventive Services Task Force recommendation [published online ahead of print January 12, 2016]. Ann Intern Med. doi: 10.7326/M15-0970.
- Mandelblatt JS, Stout NK, Schechter CB, et al. Collaborative modeling of the benefits and harms associated with different US breast cancer screening strategies [published online ahead of print January 12, 2016]. Ann Intern Med. doi: 10.7326 /M15-1536.
- Oeffinger KC, Fontham ET, Etzioni R, et al; American Cancer Society. Breast cancer screening for women at average risk: 2015 guideline update from the American Cancer Society. JAMA. 2015;314(15):1599−1614.
- Nelson HD, OMeara ES, Kerlikowski K, Balch S, Miglioretti D. Factors associated with rates of false-positive and false-negative results from digital mammography screening: an analysis of registry data [published online ahead of print January 12, 2016]. Ann Intern Med. doi: 10.7326/M15-0971.
- Miglioretti DL, Lange J, van den Broek JJ, et al. Radiation-induced breast cancer incidence and mortality from digital mammography screening: a modeling study [published online ahead of print January 12, 2016]. Ann Intern Med. doi: 10.7326 /M15-1241.
- Melnikow J, Fenton JJ, Whitlock EP, et al. Supplemental screening for breast cancer in women with dense breasts: a systematic review for the US Preventive Services Task Force [published online ahead of print January 12, 2016]. Ann Intern Med. doi: 10.7326/M15-1789.
- Siu AL; US Preventive Services Task Force. Screening for breast cancer: US Preventive Services Task Force Recommendation Statement (Summary for Patients). Ann Intern Med. 2016:164:279–296. http://annals.org/article.aspx?articleid=2480981&resultClick=3. Published January 12, 2016. Accessed January 25, 2016.
In 2009, the US Preventive Services Task Force (USPSTF) recommended that biennial mammography screening in average-risk women begin at age 50.1 New guidelines, that take into account reviews and modeling studies, clarify the earlier USPSTF recommendations, paying particular attention to individualized screening for women aged 40 to 49, use of tomosynthesis, and supplemental evaluation for women with radiologically dense breasts.
The new guidance only applies to women at average risk for breast cancer (not to those at substantially higher-than-average risk), including those with prior breast cancer or biopsy-confirmed high-risk lesions (eg, atypical hyperplasia), certain genetic conditions (such as BRCA1 or BRCA2 mutation), or histories of chest irradiation (eg, Hodgkin lymphoma).
Major statements:
- Biennial screening is recommended for women aged 50 to 74 (B recommendation; definitions of USPSTF grades are available online at ).
- Initiation of screening before age 50 should be individualized depending on patient preferences (C recommendation).
- For women aged ≥75, current evidence is insufficient to assess benefits and harms of screening (I statement).
- Current evidence is insufficient to assess the benefits and harms of adding tomosynthesis to conventional screening mammography (I statement).
- For women with radiologically dense breasts, current evidence is insufficient to assess the benefits and harms of adjunctive ultrasound, magnetic resonance imaging (MRI), or tomosynthesis (I statement).2
The Task Force generated controversy with its 2009 recommendation that screening begin at age 50 in average-risk women. The current guidance clarifies that repetitive screening of women through 10 years reduces breast cancer deaths by 4 (aged 40–49), 8 (aged 50–59), and 21 (aged 60–69) per 10,000 women, respectively.2
The term “overdiagnosis” refers to detection and treatment of invasive and noninvasive (usually ductal carcinoma in situ) lesions that would have gone undetected without screening and would not have caused health problems. The USPSTF acknowledges that, while overdiagnosis represents the principal harm from screening, estimating overdiagnosis rates is challenging (best estimates range from 1 in 5 to 1 in 8 breast cancers diagnosed in screened women).2–4 False-positive results, which lead to unnecessary additional imaging and biopsies,3,4 can represent an additional harm of screening mammography.
The rationale for recommending that average-risk women begin screening at age 50 is based on the relatively smaller benefits and greater harms incurred when younger women are screened;3,4 however, in noting that most of the screening benefits for women in their 40s are realized starting at age 45, the USPSTF guidance opens the door to average-risk women to begin screening at that age (congruent with the November 2015 American Cancer Society recommendations5). Also, women with a first-degree relative with breast cancer may want to initiate screening at age 40.
Regarding screening frequency, annual screening generates minimal if any benefit while increasing the potential for harm3,4; thus, for most women at average risk for breast cancer, biennial screening provides the best benefit–harm balance.
What about use of tomosynthesis and women with dense breasts?
Tomosynthesis, which can be performed along with conventional digital screening mammography, seems to diminish the need for follow-up imaging while also increasing cancer detection rates.6 However, whether these additional cancers represent overdiagnosis remains unknown. Furthermore, tomosynthesis can expose women to about twice the radiation as conventional digital screening.7
Twenty-four states currently mandate that patients with dense breasts identified at screening be notified. Although increased breast density is a common independent risk factor for breast cancer, the degree of radiographic density can vary substantially from one screen to the next in the same woman. Evidence for or against adjunctive imaging is very limited in women found to have dense breasts in an otherwise negative mammogram, and suggests that ultrasonography and MRI (as well as tomosynthesis) can detect additional breast cancers while also generating more false-positive results.8 Thus, the USPSTF does not recommend specific screening strategies for women with dense breasts.
How I counsel my patients
I plan to continue recommending screening based on USPSTF guidance. However, I also will continue to support the preferences of many of my patients to:
- initiate screening before age 50
- undergo screening annually
- continue screening after age 74.
You and your patients alike may find the USPSTF’s Summary for Patients9 (http://annals.org/article.aspx?articleid=2480981&resultClick=3) to be helpful when navigating this territory.
Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.
In 2009, the US Preventive Services Task Force (USPSTF) recommended that biennial mammography screening in average-risk women begin at age 50.1 New guidelines, that take into account reviews and modeling studies, clarify the earlier USPSTF recommendations, paying particular attention to individualized screening for women aged 40 to 49, use of tomosynthesis, and supplemental evaluation for women with radiologically dense breasts.
The new guidance only applies to women at average risk for breast cancer (not to those at substantially higher-than-average risk), including those with prior breast cancer or biopsy-confirmed high-risk lesions (eg, atypical hyperplasia), certain genetic conditions (such as BRCA1 or BRCA2 mutation), or histories of chest irradiation (eg, Hodgkin lymphoma).
Major statements:
- Biennial screening is recommended for women aged 50 to 74 (B recommendation; definitions of USPSTF grades are available online at ).
- Initiation of screening before age 50 should be individualized depending on patient preferences (C recommendation).
- For women aged ≥75, current evidence is insufficient to assess benefits and harms of screening (I statement).
- Current evidence is insufficient to assess the benefits and harms of adding tomosynthesis to conventional screening mammography (I statement).
- For women with radiologically dense breasts, current evidence is insufficient to assess the benefits and harms of adjunctive ultrasound, magnetic resonance imaging (MRI), or tomosynthesis (I statement).2
The Task Force generated controversy with its 2009 recommendation that screening begin at age 50 in average-risk women. The current guidance clarifies that repetitive screening of women through 10 years reduces breast cancer deaths by 4 (aged 40–49), 8 (aged 50–59), and 21 (aged 60–69) per 10,000 women, respectively.2
The term “overdiagnosis” refers to detection and treatment of invasive and noninvasive (usually ductal carcinoma in situ) lesions that would have gone undetected without screening and would not have caused health problems. The USPSTF acknowledges that, while overdiagnosis represents the principal harm from screening, estimating overdiagnosis rates is challenging (best estimates range from 1 in 5 to 1 in 8 breast cancers diagnosed in screened women).2–4 False-positive results, which lead to unnecessary additional imaging and biopsies,3,4 can represent an additional harm of screening mammography.
The rationale for recommending that average-risk women begin screening at age 50 is based on the relatively smaller benefits and greater harms incurred when younger women are screened;3,4 however, in noting that most of the screening benefits for women in their 40s are realized starting at age 45, the USPSTF guidance opens the door to average-risk women to begin screening at that age (congruent with the November 2015 American Cancer Society recommendations5). Also, women with a first-degree relative with breast cancer may want to initiate screening at age 40.
Regarding screening frequency, annual screening generates minimal if any benefit while increasing the potential for harm3,4; thus, for most women at average risk for breast cancer, biennial screening provides the best benefit–harm balance.
What about use of tomosynthesis and women with dense breasts?
Tomosynthesis, which can be performed along with conventional digital screening mammography, seems to diminish the need for follow-up imaging while also increasing cancer detection rates.6 However, whether these additional cancers represent overdiagnosis remains unknown. Furthermore, tomosynthesis can expose women to about twice the radiation as conventional digital screening.7
Twenty-four states currently mandate that patients with dense breasts identified at screening be notified. Although increased breast density is a common independent risk factor for breast cancer, the degree of radiographic density can vary substantially from one screen to the next in the same woman. Evidence for or against adjunctive imaging is very limited in women found to have dense breasts in an otherwise negative mammogram, and suggests that ultrasonography and MRI (as well as tomosynthesis) can detect additional breast cancers while also generating more false-positive results.8 Thus, the USPSTF does not recommend specific screening strategies for women with dense breasts.
How I counsel my patients
I plan to continue recommending screening based on USPSTF guidance. However, I also will continue to support the preferences of many of my patients to:
- initiate screening before age 50
- undergo screening annually
- continue screening after age 74.
You and your patients alike may find the USPSTF’s Summary for Patients9 (http://annals.org/article.aspx?articleid=2480981&resultClick=3) to be helpful when navigating this territory.
Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.
- US Preventive Services Task Force. Screening for breast cancer: US Preventive Services Task Force recommendation statement. Ann Intern Med. 2009;151(10):716−726.
- Siu AL; US Preventive Services Task Force. Screening for breast cancer: US Preventive Services Task Force recommendation statement [published online ahead of print January 12, 2016]. Ann Intern Med. doi:10.7326/M15-2886.
- Nelson HD, Pappas M, Cantor A, Griffin J, Daeges M, Humphrey L. Harms of breast cancer screening: systematic review to update the 2009 US Preventive Services Task Force recommendation [published online ahead of print January 12, 2016]. Ann Intern Med. doi: 10.7326/M15-0970.
- Mandelblatt JS, Stout NK, Schechter CB, et al. Collaborative modeling of the benefits and harms associated with different US breast cancer screening strategies [published online ahead of print January 12, 2016]. Ann Intern Med. doi: 10.7326 /M15-1536.
- Oeffinger KC, Fontham ET, Etzioni R, et al; American Cancer Society. Breast cancer screening for women at average risk: 2015 guideline update from the American Cancer Society. JAMA. 2015;314(15):1599−1614.
- Nelson HD, OMeara ES, Kerlikowski K, Balch S, Miglioretti D. Factors associated with rates of false-positive and false-negative results from digital mammography screening: an analysis of registry data [published online ahead of print January 12, 2016]. Ann Intern Med. doi: 10.7326/M15-0971.
- Miglioretti DL, Lange J, van den Broek JJ, et al. Radiation-induced breast cancer incidence and mortality from digital mammography screening: a modeling study [published online ahead of print January 12, 2016]. Ann Intern Med. doi: 10.7326 /M15-1241.
- Melnikow J, Fenton JJ, Whitlock EP, et al. Supplemental screening for breast cancer in women with dense breasts: a systematic review for the US Preventive Services Task Force [published online ahead of print January 12, 2016]. Ann Intern Med. doi: 10.7326/M15-1789.
- Siu AL; US Preventive Services Task Force. Screening for breast cancer: US Preventive Services Task Force Recommendation Statement (Summary for Patients). Ann Intern Med. 2016:164:279–296. http://annals.org/article.aspx?articleid=2480981&resultClick=3. Published January 12, 2016. Accessed January 25, 2016.
- US Preventive Services Task Force. Screening for breast cancer: US Preventive Services Task Force recommendation statement. Ann Intern Med. 2009;151(10):716−726.
- Siu AL; US Preventive Services Task Force. Screening for breast cancer: US Preventive Services Task Force recommendation statement [published online ahead of print January 12, 2016]. Ann Intern Med. doi:10.7326/M15-2886.
- Nelson HD, Pappas M, Cantor A, Griffin J, Daeges M, Humphrey L. Harms of breast cancer screening: systematic review to update the 2009 US Preventive Services Task Force recommendation [published online ahead of print January 12, 2016]. Ann Intern Med. doi: 10.7326/M15-0970.
- Mandelblatt JS, Stout NK, Schechter CB, et al. Collaborative modeling of the benefits and harms associated with different US breast cancer screening strategies [published online ahead of print January 12, 2016]. Ann Intern Med. doi: 10.7326 /M15-1536.
- Oeffinger KC, Fontham ET, Etzioni R, et al; American Cancer Society. Breast cancer screening for women at average risk: 2015 guideline update from the American Cancer Society. JAMA. 2015;314(15):1599−1614.
- Nelson HD, OMeara ES, Kerlikowski K, Balch S, Miglioretti D. Factors associated with rates of false-positive and false-negative results from digital mammography screening: an analysis of registry data [published online ahead of print January 12, 2016]. Ann Intern Med. doi: 10.7326/M15-0971.
- Miglioretti DL, Lange J, van den Broek JJ, et al. Radiation-induced breast cancer incidence and mortality from digital mammography screening: a modeling study [published online ahead of print January 12, 2016]. Ann Intern Med. doi: 10.7326 /M15-1241.
- Melnikow J, Fenton JJ, Whitlock EP, et al. Supplemental screening for breast cancer in women with dense breasts: a systematic review for the US Preventive Services Task Force [published online ahead of print January 12, 2016]. Ann Intern Med. doi: 10.7326/M15-1789.
- Siu AL; US Preventive Services Task Force. Screening for breast cancer: US Preventive Services Task Force Recommendation Statement (Summary for Patients). Ann Intern Med. 2016:164:279–296. http://annals.org/article.aspx?articleid=2480981&resultClick=3. Published January 12, 2016. Accessed January 25, 2016.
Webcast: Obesity and contraceptive efficacy and risks
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channelAccess Dr. Burkman's Webcasts on contraception: Helpful resources for your practice: |
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channelAccess Dr. Burkman's Webcasts on contraception: Helpful resources for your practice: |
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channelAccess Dr. Burkman's Webcasts on contraception: Helpful resources for your practice: |
2016 Update on obstetrics
Some areas of obstetric care are not as clearcut as others in this time of rapid medical evolution. In this Update, we discuss 3 of them:
- management of twin gestations
- management of chronic hypertension in pregnancy
- cell-free DNA screening for fetal aneuploidy.
To our benefit, both the American College of Obstetricians and Gynecologists (ACOG) and the Society for Maternal-Fetal Medicine (SMFM) have weighed in on important aspects of these areas of obstetric care.
Society for Maternal-Fetal Medicine, Simpson LL. Twin-twin transfusion syndrome. Am J Obstet Gynecol. 2013;208(1):3–18.
Society for Maternal-Fetal Medicine. Checklists and Safety Bundles. https://www.smfm.org/mfm-practice/checklists-and-safety-bundles. Published March 2015. Accessed December 7, 2015.
American College of Obstetricians and Gynecologists. Practice bulletin No. 144. Multifetal gestations: twin, triplet, and higher-order multifetal pregnancies. Obstet Gynecol. 2014;123(5):1118–1132.
From the maternal perspective, twin pregnancies are known to have higher risks than their singleton counterparts for such complications as hypertension, preeclampsia, diabetes, hemorrhage, cesarean delivery, postpartum depression, and anemia. These complications are managed essentially the same way regardless of the number of fetuses.
From the fetal/neonatal perspective, twin gestations may carry increased risks of congenital anomalies, preterm birth, and aneuploidy, which are managed similarly to singleton gestations overall, with certain adjustments as necessary.
Twin pregnancies do have unique risks, however, that are managed differently from the time chorionicity is established until delivery. The level of risk increases as the number of chorions and amnions decreases.
A basic management plan for twin gestations consists of a number of components, elucidated below.
1. Determine chorionicity and amnionicityThis determination is most reliably performed late in the first trimester and must be done using ultrasound. The inter-twin membrane should be identified. At 11 to 14 weeks, the presence of the “lambda sign,” a triangular projection of tissue that extends from the chorionic surface, is indicative of a dichorionic pregnancy, while a “T sign” suggests a monochorionic pregnancy (sensitivities 97%–100%; specificities 98%–100%). Alternatively, demonstration of discordant genders or separate placentas may be used later in pregnancy.
2. Monitor growth every 4 weeks in dichorionic twinsDichorionic twins are, by default, diamniotic. After the anatomic survey, growth surveillance should be conducted approximately every 4 weeks.
Discordant growth usually is defined as a difference of 20% or more in weight between the twins, based on the weight of the larger twin. As an isolated finding with both fetuses of normal weight, this discordance has not been demonstrated to increase adverse outcomes. Routine antenatal surveillance is not necessarily indicated.
Fetal growth restriction of one twin or a coexisting abnormality should prompt antenatal testing and/or earlier delivery. Any maternal comorbidities such as hypertension or diabetes also would be indications for testing. Otherwise, delivery is recommended at 38 weeks’ to 38-6/7 weeks’ gestation.
After 32 weeks, the mode of delivery may be vaginal if the presenting twin is vertex and the delivery provider can perform breech extraction or internal podalic version, if necessary.
3. Monochorionic/diamniotic twins also warrant regular surveillanceThe shared placenta places these pregnancies at increased risk for twin-to-twin transfusion syndrome (TTTS), a fetal-placental imbalance in which one twin “transfuses” the other. Ten percent to 15% of monochorionic pregnancies develop TTTS, which is associated with high rates of morbidity and mortality, even when treated.
Antenatal surveillance of these pregnancies involves ultrasonography assessment every 2 weeks, starting at 16 weeks. At each examination, the deepest vertical pocket (DVP) of fluid and presence of each fetal bladder are documented. This limited assessment alternates with a growth assessment every 2 weeks. SMFM recommends this biweekly assessment until 28 weeks, then every 2 to 3 weeks until delivery.
Stage 1 TTTS is defined by the polyhydramnios/oligohydramnios sequence (DVP of one fetus <2 cm, with DVP of the other >8 cm).
Evaluation for treatment of TTTS with laser coagulation (preferred) or amnio‑reduction should take place after the diagnosis is made, along with increased fetal surveillance.
SMFM also recommends fetal echocardiography due to the 9-fold increased risk of cardiac anomalies in monochorionic pregnancies.
Other complications of monochorionic/diamniotic twins include selective fetal growth restriction (due to unequal sharing of the placenta), twin reversed arterial perfusion (TRAP) sequence, and twin anemia-polycythemia sequence (TAPS).
Antenatal surveillance of all monochorionic twins is recommended, given the increased risk of stillbirth; many centers start testing at 32 weeks’ gestation. According to ACOG, uncomplicated monochorionic/diamniotic twins should be delivered at 34 weeks’ to 37-6/7 weeks’ gestation. Fetal growth restriction or other comorbidities may prompt delivery as early as 32 weeks.
4. Know the risks of monoamniotic twin gestationsThese twins are at increased risk for intrauterine fetal death due to cord entanglement, as well as TTTS, TAPS, and fetal growth restriction. Routine growth assessment and evaluation for TTTS are similar to those for monochorionic/diamniotic twins (without the option of polyhydramnios/oligohydramnios measurement), but the overall management of these pregnancies is unknown.
Protocols may range from outpatient antenatal testing to hospitalization to 24 to 28 weeks’ gestation with daily antenatal testing or attempted continuous monitoring. Delivery by cesarean delivery is recommended at 32 to 34 weeks’ gestation.
What this EVIDENCE means for practice Monochorionic twins need specific and frequent monitoring due to significantly increased risk for both fetal and placental complications. They justify late preterm or early term delivery.
Management of chronic hypertension in pregnancy: Reserve therapy for severe hypertension
Cell-free DNA screening for fetal aneuploidy: Strengths and limitations
Some areas of obstetric care are not as clearcut as others in this time of rapid medical evolution. In this Update, we discuss 3 of them:
- management of twin gestations
- management of chronic hypertension in pregnancy
- cell-free DNA screening for fetal aneuploidy.
To our benefit, both the American College of Obstetricians and Gynecologists (ACOG) and the Society for Maternal-Fetal Medicine (SMFM) have weighed in on important aspects of these areas of obstetric care.
Society for Maternal-Fetal Medicine, Simpson LL. Twin-twin transfusion syndrome. Am J Obstet Gynecol. 2013;208(1):3–18.
Society for Maternal-Fetal Medicine. Checklists and Safety Bundles. https://www.smfm.org/mfm-practice/checklists-and-safety-bundles. Published March 2015. Accessed December 7, 2015.
American College of Obstetricians and Gynecologists. Practice bulletin No. 144. Multifetal gestations: twin, triplet, and higher-order multifetal pregnancies. Obstet Gynecol. 2014;123(5):1118–1132.
From the maternal perspective, twin pregnancies are known to have higher risks than their singleton counterparts for such complications as hypertension, preeclampsia, diabetes, hemorrhage, cesarean delivery, postpartum depression, and anemia. These complications are managed essentially the same way regardless of the number of fetuses.
From the fetal/neonatal perspective, twin gestations may carry increased risks of congenital anomalies, preterm birth, and aneuploidy, which are managed similarly to singleton gestations overall, with certain adjustments as necessary.
Twin pregnancies do have unique risks, however, that are managed differently from the time chorionicity is established until delivery. The level of risk increases as the number of chorions and amnions decreases.
A basic management plan for twin gestations consists of a number of components, elucidated below.
1. Determine chorionicity and amnionicityThis determination is most reliably performed late in the first trimester and must be done using ultrasound. The inter-twin membrane should be identified. At 11 to 14 weeks, the presence of the “lambda sign,” a triangular projection of tissue that extends from the chorionic surface, is indicative of a dichorionic pregnancy, while a “T sign” suggests a monochorionic pregnancy (sensitivities 97%–100%; specificities 98%–100%). Alternatively, demonstration of discordant genders or separate placentas may be used later in pregnancy.
2. Monitor growth every 4 weeks in dichorionic twinsDichorionic twins are, by default, diamniotic. After the anatomic survey, growth surveillance should be conducted approximately every 4 weeks.
Discordant growth usually is defined as a difference of 20% or more in weight between the twins, based on the weight of the larger twin. As an isolated finding with both fetuses of normal weight, this discordance has not been demonstrated to increase adverse outcomes. Routine antenatal surveillance is not necessarily indicated.
Fetal growth restriction of one twin or a coexisting abnormality should prompt antenatal testing and/or earlier delivery. Any maternal comorbidities such as hypertension or diabetes also would be indications for testing. Otherwise, delivery is recommended at 38 weeks’ to 38-6/7 weeks’ gestation.
After 32 weeks, the mode of delivery may be vaginal if the presenting twin is vertex and the delivery provider can perform breech extraction or internal podalic version, if necessary.
3. Monochorionic/diamniotic twins also warrant regular surveillanceThe shared placenta places these pregnancies at increased risk for twin-to-twin transfusion syndrome (TTTS), a fetal-placental imbalance in which one twin “transfuses” the other. Ten percent to 15% of monochorionic pregnancies develop TTTS, which is associated with high rates of morbidity and mortality, even when treated.
Antenatal surveillance of these pregnancies involves ultrasonography assessment every 2 weeks, starting at 16 weeks. At each examination, the deepest vertical pocket (DVP) of fluid and presence of each fetal bladder are documented. This limited assessment alternates with a growth assessment every 2 weeks. SMFM recommends this biweekly assessment until 28 weeks, then every 2 to 3 weeks until delivery.
Stage 1 TTTS is defined by the polyhydramnios/oligohydramnios sequence (DVP of one fetus <2 cm, with DVP of the other >8 cm).
Evaluation for treatment of TTTS with laser coagulation (preferred) or amnio‑reduction should take place after the diagnosis is made, along with increased fetal surveillance.
SMFM also recommends fetal echocardiography due to the 9-fold increased risk of cardiac anomalies in monochorionic pregnancies.
Other complications of monochorionic/diamniotic twins include selective fetal growth restriction (due to unequal sharing of the placenta), twin reversed arterial perfusion (TRAP) sequence, and twin anemia-polycythemia sequence (TAPS).
Antenatal surveillance of all monochorionic twins is recommended, given the increased risk of stillbirth; many centers start testing at 32 weeks’ gestation. According to ACOG, uncomplicated monochorionic/diamniotic twins should be delivered at 34 weeks’ to 37-6/7 weeks’ gestation. Fetal growth restriction or other comorbidities may prompt delivery as early as 32 weeks.
4. Know the risks of monoamniotic twin gestationsThese twins are at increased risk for intrauterine fetal death due to cord entanglement, as well as TTTS, TAPS, and fetal growth restriction. Routine growth assessment and evaluation for TTTS are similar to those for monochorionic/diamniotic twins (without the option of polyhydramnios/oligohydramnios measurement), but the overall management of these pregnancies is unknown.
Protocols may range from outpatient antenatal testing to hospitalization to 24 to 28 weeks’ gestation with daily antenatal testing or attempted continuous monitoring. Delivery by cesarean delivery is recommended at 32 to 34 weeks’ gestation.
What this EVIDENCE means for practice Monochorionic twins need specific and frequent monitoring due to significantly increased risk for both fetal and placental complications. They justify late preterm or early term delivery.
Management of chronic hypertension in pregnancy: Reserve therapy for severe hypertension
Cell-free DNA screening for fetal aneuploidy: Strengths and limitations
Some areas of obstetric care are not as clearcut as others in this time of rapid medical evolution. In this Update, we discuss 3 of them:
- management of twin gestations
- management of chronic hypertension in pregnancy
- cell-free DNA screening for fetal aneuploidy.
To our benefit, both the American College of Obstetricians and Gynecologists (ACOG) and the Society for Maternal-Fetal Medicine (SMFM) have weighed in on important aspects of these areas of obstetric care.
Society for Maternal-Fetal Medicine, Simpson LL. Twin-twin transfusion syndrome. Am J Obstet Gynecol. 2013;208(1):3–18.
Society for Maternal-Fetal Medicine. Checklists and Safety Bundles. https://www.smfm.org/mfm-practice/checklists-and-safety-bundles. Published March 2015. Accessed December 7, 2015.
American College of Obstetricians and Gynecologists. Practice bulletin No. 144. Multifetal gestations: twin, triplet, and higher-order multifetal pregnancies. Obstet Gynecol. 2014;123(5):1118–1132.
From the maternal perspective, twin pregnancies are known to have higher risks than their singleton counterparts for such complications as hypertension, preeclampsia, diabetes, hemorrhage, cesarean delivery, postpartum depression, and anemia. These complications are managed essentially the same way regardless of the number of fetuses.
From the fetal/neonatal perspective, twin gestations may carry increased risks of congenital anomalies, preterm birth, and aneuploidy, which are managed similarly to singleton gestations overall, with certain adjustments as necessary.
Twin pregnancies do have unique risks, however, that are managed differently from the time chorionicity is established until delivery. The level of risk increases as the number of chorions and amnions decreases.
A basic management plan for twin gestations consists of a number of components, elucidated below.
1. Determine chorionicity and amnionicityThis determination is most reliably performed late in the first trimester and must be done using ultrasound. The inter-twin membrane should be identified. At 11 to 14 weeks, the presence of the “lambda sign,” a triangular projection of tissue that extends from the chorionic surface, is indicative of a dichorionic pregnancy, while a “T sign” suggests a monochorionic pregnancy (sensitivities 97%–100%; specificities 98%–100%). Alternatively, demonstration of discordant genders or separate placentas may be used later in pregnancy.
2. Monitor growth every 4 weeks in dichorionic twinsDichorionic twins are, by default, diamniotic. After the anatomic survey, growth surveillance should be conducted approximately every 4 weeks.
Discordant growth usually is defined as a difference of 20% or more in weight between the twins, based on the weight of the larger twin. As an isolated finding with both fetuses of normal weight, this discordance has not been demonstrated to increase adverse outcomes. Routine antenatal surveillance is not necessarily indicated.
Fetal growth restriction of one twin or a coexisting abnormality should prompt antenatal testing and/or earlier delivery. Any maternal comorbidities such as hypertension or diabetes also would be indications for testing. Otherwise, delivery is recommended at 38 weeks’ to 38-6/7 weeks’ gestation.
After 32 weeks, the mode of delivery may be vaginal if the presenting twin is vertex and the delivery provider can perform breech extraction or internal podalic version, if necessary.
3. Monochorionic/diamniotic twins also warrant regular surveillanceThe shared placenta places these pregnancies at increased risk for twin-to-twin transfusion syndrome (TTTS), a fetal-placental imbalance in which one twin “transfuses” the other. Ten percent to 15% of monochorionic pregnancies develop TTTS, which is associated with high rates of morbidity and mortality, even when treated.
Antenatal surveillance of these pregnancies involves ultrasonography assessment every 2 weeks, starting at 16 weeks. At each examination, the deepest vertical pocket (DVP) of fluid and presence of each fetal bladder are documented. This limited assessment alternates with a growth assessment every 2 weeks. SMFM recommends this biweekly assessment until 28 weeks, then every 2 to 3 weeks until delivery.
Stage 1 TTTS is defined by the polyhydramnios/oligohydramnios sequence (DVP of one fetus <2 cm, with DVP of the other >8 cm).
Evaluation for treatment of TTTS with laser coagulation (preferred) or amnio‑reduction should take place after the diagnosis is made, along with increased fetal surveillance.
SMFM also recommends fetal echocardiography due to the 9-fold increased risk of cardiac anomalies in monochorionic pregnancies.
Other complications of monochorionic/diamniotic twins include selective fetal growth restriction (due to unequal sharing of the placenta), twin reversed arterial perfusion (TRAP) sequence, and twin anemia-polycythemia sequence (TAPS).
Antenatal surveillance of all monochorionic twins is recommended, given the increased risk of stillbirth; many centers start testing at 32 weeks’ gestation. According to ACOG, uncomplicated monochorionic/diamniotic twins should be delivered at 34 weeks’ to 37-6/7 weeks’ gestation. Fetal growth restriction or other comorbidities may prompt delivery as early as 32 weeks.
4. Know the risks of monoamniotic twin gestationsThese twins are at increased risk for intrauterine fetal death due to cord entanglement, as well as TTTS, TAPS, and fetal growth restriction. Routine growth assessment and evaluation for TTTS are similar to those for monochorionic/diamniotic twins (without the option of polyhydramnios/oligohydramnios measurement), but the overall management of these pregnancies is unknown.
Protocols may range from outpatient antenatal testing to hospitalization to 24 to 28 weeks’ gestation with daily antenatal testing or attempted continuous monitoring. Delivery by cesarean delivery is recommended at 32 to 34 weeks’ gestation.
What this EVIDENCE means for practice Monochorionic twins need specific and frequent monitoring due to significantly increased risk for both fetal and placental complications. They justify late preterm or early term delivery.
Management of chronic hypertension in pregnancy: Reserve therapy for severe hypertension
Cell-free DNA screening for fetal aneuploidy: Strengths and limitations
In this article
- Know the risks of monoamniotic twin gestations
- “Less tight” versus “tight” BP control
- Cell-free DNA screening for aneuploidy
The well-woman visit comes of age: What it offers, how we got here
When the Affordable Care Act (ACA) was passed in 2010, it represented an intended shift from reactive medicine, with its focus on acute and urgent needs, to a model focused on disease prevention.
OBG Management readers know about the important women’s health services ensured by the ACA, including well-woman care, as well as the key role played by the American Congress of Obstetricians and Gynecologists (ACOG) in winning this coverage. ACOG worked closely with the Institute of Medicine (IOM) to help define this set of services. And the ACA ensured that women have access to these services, often without copays and deductibles.
ACOG and the National Women’s Law Center (NWLC) work closely on many issues. At first independently and then together, the 2 organizations set out to explore some fundamental issues:
- How does a woman experience the new well-woman benefit when she visits her doctor?
- Does she receive a consistent care set?
- Do some patients have copays while patients in other clinics do not for the same services?
- What does well-woman care mean from one doctor to another, from an ObGyn to an internist to a family physician?
This article explores these issues.
2 initiatives focused on components of women’s health care
During her tenure as president of ACOG, Jeanne Conry, MD, PhD, decided to tackle clinical issues associated with well-woman care. She convened a Well-Woman Task Force, led by Haywood Brown, MD, and included the NWLC among other partner organizations (TABLE).
Table. Partipating organizations of the ACOG Well-Woman Task Force
• American Academy of Family Physicians
• American Academy of Pediatrics
• American Academy of Physician Assistants
• American College of Nurse–Midwives
• American College of Osteopathic Obstetricians and Gynecologists
• Association of Reproductive Health Professionals
• Association of Women’s Health, Obstetric, and Neonatal Nurses
• National Association of Nurse Practitioners in Women’s Health
• National Medical Association
• National Women’s Law Center
• Planned Parenthood Federation of America
• Society for Maternal-Fetal Medicine
• Society of Academic Specialists in General Obstetrics and Gynecology
• Society of Gynecologic Oncology
The NWLC and Brigham and Women’s Hospital also partnered with ACOG and others to help ensure a consistent patient experience. These 2 closely related initiatives were designed to work together to help patients and physicians understand and benefit from new coverage under the ACA.
1. How does a woman experience well-woman care?
Experts associated with these 2 initiatives recognized that well-woman care includes attention to the history, physical examination, counseling, and screening intended to maintain physical, mental, and social wellbeing and general health throughout a woman’s lifespan. Experts also recognized that the ACA guarantees coverage of at least one annual well-woman visit, although not all of the recommended components necessarily would be performed at the same visit or by the same provider.
For many women who have gained insurance coverage under the ACA, the well-woman visit represents their entry into the insured health care system. These women may have limited understanding of the services they should receive during this visit.
To address this issue, the NWLC invited ACOG to participate in its initiative with Brigham and Women’s Hospital to understand the well-woman visit from the patient’s point of view. This effort yielded patient education materials in English and Spanish that help women understand:
- that their health insurance now covers a well-woman visit
- what care is included in that visit
- that there is no deductible or copay for this visit
- how to prepare for this visit
- what questions to ask during the visit.
These materials help women understand that the purpose of the well-woman visit is to provide them with a chance to:
- “receive care and counseling that is appropriate, based on age, cognitive development, and life experience
- review their current health and risks to their health with their health care professional
- ask any questions they may have about their health or risk factors
- talk about what they can do to prevent future health problems
- build a trusting relationship with their health care provider, with an emphasis on confidentiality
- receive appropriate preventive screenings and immunizations and make sure they know which screenings and immunizations they should receive in the future
- review their reproductive plan and contraceptive choices.”1
The materials also advise patients that they may be asked about:
- current health concerns
- current medications, both prescription and over the counter
- family history on both the mother’s and father’s sides
- life management, including family relationships, work, and stress
- substance use habits, including alcohol and tobacco
- sexual activity
- eating habits and physical activity
- past reproductive health experience and any pregnancy complications
- any memory problems (older women)
- screening for depression, anxiety, substance use disorders, and interpersonal violence.
To view some of these materials, visit http://www.nwlc.org/sites/default/files/final_well-womanbrochure.pdf.
2. Does each woman receive consistent well-woman care?
ACOG’s Well-Woman Task Force was shaped by an awareness that many medical societies and government agencies provide recommendations and guidelines about the basic elements of women’s health. While these recommendations and guidelines all may be based on evidence and expert opinion, the recommendations vary. A goal of the task force was to work with providers across the women’s health spectrum to find consensus and provide guidance to women and clinicians with age-appropriate recommendations for a well-woman visit.
In the fall of 2015, the task force’s findings were published in an article entitled “Components of the well-woman visit” in the journal Obstetrics & Gynecology.2 Those findings outline a core set of well-woman care practices across a woman’s lifespan, from adolescence through the reproductive years and into maturity, and they are usable by any provider who cares for adolescent girls or women.
ACOG has summarized its well-woman recommendations, by age, on its website,3 at http://www.acog.org/About-ACOG/ACOG-Departments/Annual-Womens-Health-Care/Well-Woman-Recommendations.
3. Do all women have a copay for the well-woman visit?
Because research has revealed that any type of copay or deductible for preventive care significantly lessens the likelihood that patients will seek out such care, the ACA sought to make basic preventive care available without cost sharing.4
The US Department of Health and Human Services notes that: “The Affordable Care Act requires most health plans to cover recommended preventive services without cost sharing. In 2011 and 2012, 71 million Americans with private health insurance gained access to preventive services with no cost sharing because of the law.”4
Grandfathered plans (those created or sold before March 23, 2010) are exempt from this requirement, as are Medicare, TRICARE, and traditional Medicaid plans.
4. What does well-woman care mean from one doctor to another?
Under the ACA, well-woman care can be provided by a “wide range of providers, including family physicians, internists, nurse–midwives, nurse practitioners, obstetrician-gynecologists, pediatricians, and physician assistants,” depending on the age of the patient, her particular needs and preferences, and access to health services.2
The ACOG Well-Woman Task Force “focused on delineating the well-woman visit throughout the lifespan, across all providers and health plans.”2
In determining the components of well-woman care, ACOG’s task force compiled existing guidelines from many sources, including the Department of Health and Human Services, the IOM, the US Preventive Services Task Force, and each member organization.
Members categorized guidelines as:
- single source (eg, abdominal examination)
- no agreement (breast cancer/mammography screening)
- limited agreement (pelvic examination)
- general agreement (hypertension, osteoporosis)
- sound agreement (screening for sexually transmitted infections)
The task force also agreed that final recommendations would rely on evidence-based guidelines, evidence-informed guidelines, and uniform expert agreement. Recommendations were considered “strong” if they relied primarily on evidence-based or evidence-informed guidelines and “qualified” if they relied primarily on expert consensus.
Guidelines were further separated into age bands:
- adolescents (13–18 years)
- reproductive-aged women (19–45 years)
- mature women (46–64 years)
- women older than 64 years.
The task force recommended that, during the well-woman visit, health care professionals educate patients about:
- healthy eating habits and maintenance of healthy weight
- exercise and physical activity
- seat belt use
- risk factors for certain types of cancer
- heart health
- breast health
- bone health
- safer sex practices and prevention of sexually transmitted infections
- healthy interpersonal relationships
- prevention and management of chronic disease
- resources for the patient (online, written, community, patient groups)
- medication use
- fall prevention.
Health care providers also should counsel patients regarding:
- recommended preventive screenings and immunizations
- any concerns about mood, such as prolonged periods of sadness, a failure to enjoy what they usually find pleasant, or anxiety or irritability that seems out of proportion to events
- what to expect in terms of effects on mood and anxiety at reproductive life transitions, including menarche, pregnancy, the postpartum period, and perimenopause
- body image issues
- what to expect in terms of the menstrual cycle during perimenopause and menopause
- reproductive health or fertility concerns
- reproductive life planning (contraception appropriate for life stage, reproductive plans, and risk factors, including risk factors for breast and ovarian cancer and cardiovascular disease)
- pregnancy planning, including attaining and maintaining a healthy weight and managing any chronic conditions before or during pregnancy
- what to expect during menopause, including signs and symptoms and options for addressing symptoms (midlife and older women)
- symptoms of cardiovascular disease
- urinary incontinence.
The task force acknowledged that not all of these recommendations can be carried out at a single well-woman visit or by a single provider.
See, again, ACOG’s specific well-woman recommendations, by age range, at http://www.acog.org/About-ACOG/ACOG-Departments/Annual-Womens-Health-Care/Well-Woman-Recommendations.3
How to winnow a long list of recommendations to determine the most pressing issues for a specific patient
In an editorial accompanying the ACOG Well-Woman Task Force report, entitled “Re-envisioning the annual well-woman visit: the task forward,” George F. Sawaya, MD, of the University of California, San Francisco, devised a plan to determine the most pressing well-woman needs for a specific patient.1 He chose as an example a 41-year-old sexually active woman who does not smoke.
While Dr. Sawaya praised the Well-Woman Task Force recommendations for their “comprehensive scope,” he also noted that the sheer number of recommendations might be “overwhelming and difficult to navigate.”1 One tool for winnowing the recommendations comes from the Agency for Healthcare Research and Quality, which offers an Electronic Preventive Services Selector (http://epss.ahrq.gov/PDA/index.jsp), available both online and as a smartphone app. Once the clinician plugs in the patient’s age and a few risk factors, the tool generates a list of recommended preventive services. This list of services has been evaluated by the US Preventive Services Task Force, with each recommendation graded “A” through “D,” based on benefits versus harms.
Back to that 41-year-old sexually active woman: Using the Electronic Preventive Services Selector, a list of as many as 20 grade A and B recommendations would be generated. However, only 3 of them would be grade A (screening for cervical cancer, HIV, and high blood pressure). An additional 2 grade B recommendations might apply to an average-risk patient such as this: screening for alcohol misuse and depression. All 5 services fall within the Well-Woman Task Force’s recommendations. They also have “good face validity with clinicians as being important, so it seems reasonable that these be prioritized above the others, at least at the first visit,” Dr. Sawaya says.1
Clinicians can use a similar strategy for patients of various ages and risk factors.
Reference
1. Sawaya GF. Re-envisioning the annual well-woman visit: the task forward [editorial]. Obstet Gynecol. 2015;126(4):695–696.
The bottom line
By defining and implementing the foundational elements of women’s health, we can improve care for all women and ensure, as Dr. Conry emphasized during her tenure as ACOG president, “that every woman gets the care she needs, every time.”
Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.
- National Women’s Law Center, Brigham and Women’s Hospital. Your Guide to Well-Woman Visits. http://www.nwlc.org/sites/default/files/final_well-womanbrochure.pdf. Accessed December 8, 2015.
- Conry JA, Brown H. Well-Woman Task Force: Components of the well-woman visit. Obstet Gynecol. 2015;126(4):697–701.
- American College of Obstetricians and Gynecologists. Well-Woman Recommendations. http://www.acog.org/About-ACOG/ACOG-Departments/Annual-Womens-Health-Care/Well-Woman-Recommendations. Accessed December 4, 2015.
- US Department of Health and Human Services. Affordable Care Act Rules on Expanding Access to Preventive Services for Women. http://www.hhs.gov/healthcare/facts-and-features/fact-sheets/aca-rules-on-expanding-access-to-preventive-services-for-women/index.html. Updated June 28, 2013. Accessed December 4, 2015.
When the Affordable Care Act (ACA) was passed in 2010, it represented an intended shift from reactive medicine, with its focus on acute and urgent needs, to a model focused on disease prevention.
OBG Management readers know about the important women’s health services ensured by the ACA, including well-woman care, as well as the key role played by the American Congress of Obstetricians and Gynecologists (ACOG) in winning this coverage. ACOG worked closely with the Institute of Medicine (IOM) to help define this set of services. And the ACA ensured that women have access to these services, often without copays and deductibles.
ACOG and the National Women’s Law Center (NWLC) work closely on many issues. At first independently and then together, the 2 organizations set out to explore some fundamental issues:
- How does a woman experience the new well-woman benefit when she visits her doctor?
- Does she receive a consistent care set?
- Do some patients have copays while patients in other clinics do not for the same services?
- What does well-woman care mean from one doctor to another, from an ObGyn to an internist to a family physician?
This article explores these issues.
2 initiatives focused on components of women’s health care
During her tenure as president of ACOG, Jeanne Conry, MD, PhD, decided to tackle clinical issues associated with well-woman care. She convened a Well-Woman Task Force, led by Haywood Brown, MD, and included the NWLC among other partner organizations (TABLE).
Table. Partipating organizations of the ACOG Well-Woman Task Force
• American Academy of Family Physicians
• American Academy of Pediatrics
• American Academy of Physician Assistants
• American College of Nurse–Midwives
• American College of Osteopathic Obstetricians and Gynecologists
• Association of Reproductive Health Professionals
• Association of Women’s Health, Obstetric, and Neonatal Nurses
• National Association of Nurse Practitioners in Women’s Health
• National Medical Association
• National Women’s Law Center
• Planned Parenthood Federation of America
• Society for Maternal-Fetal Medicine
• Society of Academic Specialists in General Obstetrics and Gynecology
• Society of Gynecologic Oncology
The NWLC and Brigham and Women’s Hospital also partnered with ACOG and others to help ensure a consistent patient experience. These 2 closely related initiatives were designed to work together to help patients and physicians understand and benefit from new coverage under the ACA.
1. How does a woman experience well-woman care?
Experts associated with these 2 initiatives recognized that well-woman care includes attention to the history, physical examination, counseling, and screening intended to maintain physical, mental, and social wellbeing and general health throughout a woman’s lifespan. Experts also recognized that the ACA guarantees coverage of at least one annual well-woman visit, although not all of the recommended components necessarily would be performed at the same visit or by the same provider.
For many women who have gained insurance coverage under the ACA, the well-woman visit represents their entry into the insured health care system. These women may have limited understanding of the services they should receive during this visit.
To address this issue, the NWLC invited ACOG to participate in its initiative with Brigham and Women’s Hospital to understand the well-woman visit from the patient’s point of view. This effort yielded patient education materials in English and Spanish that help women understand:
- that their health insurance now covers a well-woman visit
- what care is included in that visit
- that there is no deductible or copay for this visit
- how to prepare for this visit
- what questions to ask during the visit.
These materials help women understand that the purpose of the well-woman visit is to provide them with a chance to:
- “receive care and counseling that is appropriate, based on age, cognitive development, and life experience
- review their current health and risks to their health with their health care professional
- ask any questions they may have about their health or risk factors
- talk about what they can do to prevent future health problems
- build a trusting relationship with their health care provider, with an emphasis on confidentiality
- receive appropriate preventive screenings and immunizations and make sure they know which screenings and immunizations they should receive in the future
- review their reproductive plan and contraceptive choices.”1
The materials also advise patients that they may be asked about:
- current health concerns
- current medications, both prescription and over the counter
- family history on both the mother’s and father’s sides
- life management, including family relationships, work, and stress
- substance use habits, including alcohol and tobacco
- sexual activity
- eating habits and physical activity
- past reproductive health experience and any pregnancy complications
- any memory problems (older women)
- screening for depression, anxiety, substance use disorders, and interpersonal violence.
To view some of these materials, visit http://www.nwlc.org/sites/default/files/final_well-womanbrochure.pdf.
2. Does each woman receive consistent well-woman care?
ACOG’s Well-Woman Task Force was shaped by an awareness that many medical societies and government agencies provide recommendations and guidelines about the basic elements of women’s health. While these recommendations and guidelines all may be based on evidence and expert opinion, the recommendations vary. A goal of the task force was to work with providers across the women’s health spectrum to find consensus and provide guidance to women and clinicians with age-appropriate recommendations for a well-woman visit.
In the fall of 2015, the task force’s findings were published in an article entitled “Components of the well-woman visit” in the journal Obstetrics & Gynecology.2 Those findings outline a core set of well-woman care practices across a woman’s lifespan, from adolescence through the reproductive years and into maturity, and they are usable by any provider who cares for adolescent girls or women.
ACOG has summarized its well-woman recommendations, by age, on its website,3 at http://www.acog.org/About-ACOG/ACOG-Departments/Annual-Womens-Health-Care/Well-Woman-Recommendations.
3. Do all women have a copay for the well-woman visit?
Because research has revealed that any type of copay or deductible for preventive care significantly lessens the likelihood that patients will seek out such care, the ACA sought to make basic preventive care available without cost sharing.4
The US Department of Health and Human Services notes that: “The Affordable Care Act requires most health plans to cover recommended preventive services without cost sharing. In 2011 and 2012, 71 million Americans with private health insurance gained access to preventive services with no cost sharing because of the law.”4
Grandfathered plans (those created or sold before March 23, 2010) are exempt from this requirement, as are Medicare, TRICARE, and traditional Medicaid plans.
4. What does well-woman care mean from one doctor to another?
Under the ACA, well-woman care can be provided by a “wide range of providers, including family physicians, internists, nurse–midwives, nurse practitioners, obstetrician-gynecologists, pediatricians, and physician assistants,” depending on the age of the patient, her particular needs and preferences, and access to health services.2
The ACOG Well-Woman Task Force “focused on delineating the well-woman visit throughout the lifespan, across all providers and health plans.”2
In determining the components of well-woman care, ACOG’s task force compiled existing guidelines from many sources, including the Department of Health and Human Services, the IOM, the US Preventive Services Task Force, and each member organization.
Members categorized guidelines as:
- single source (eg, abdominal examination)
- no agreement (breast cancer/mammography screening)
- limited agreement (pelvic examination)
- general agreement (hypertension, osteoporosis)
- sound agreement (screening for sexually transmitted infections)
The task force also agreed that final recommendations would rely on evidence-based guidelines, evidence-informed guidelines, and uniform expert agreement. Recommendations were considered “strong” if they relied primarily on evidence-based or evidence-informed guidelines and “qualified” if they relied primarily on expert consensus.
Guidelines were further separated into age bands:
- adolescents (13–18 years)
- reproductive-aged women (19–45 years)
- mature women (46–64 years)
- women older than 64 years.
The task force recommended that, during the well-woman visit, health care professionals educate patients about:
- healthy eating habits and maintenance of healthy weight
- exercise and physical activity
- seat belt use
- risk factors for certain types of cancer
- heart health
- breast health
- bone health
- safer sex practices and prevention of sexually transmitted infections
- healthy interpersonal relationships
- prevention and management of chronic disease
- resources for the patient (online, written, community, patient groups)
- medication use
- fall prevention.
Health care providers also should counsel patients regarding:
- recommended preventive screenings and immunizations
- any concerns about mood, such as prolonged periods of sadness, a failure to enjoy what they usually find pleasant, or anxiety or irritability that seems out of proportion to events
- what to expect in terms of effects on mood and anxiety at reproductive life transitions, including menarche, pregnancy, the postpartum period, and perimenopause
- body image issues
- what to expect in terms of the menstrual cycle during perimenopause and menopause
- reproductive health or fertility concerns
- reproductive life planning (contraception appropriate for life stage, reproductive plans, and risk factors, including risk factors for breast and ovarian cancer and cardiovascular disease)
- pregnancy planning, including attaining and maintaining a healthy weight and managing any chronic conditions before or during pregnancy
- what to expect during menopause, including signs and symptoms and options for addressing symptoms (midlife and older women)
- symptoms of cardiovascular disease
- urinary incontinence.
The task force acknowledged that not all of these recommendations can be carried out at a single well-woman visit or by a single provider.
See, again, ACOG’s specific well-woman recommendations, by age range, at http://www.acog.org/About-ACOG/ACOG-Departments/Annual-Womens-Health-Care/Well-Woman-Recommendations.3
How to winnow a long list of recommendations to determine the most pressing issues for a specific patient
In an editorial accompanying the ACOG Well-Woman Task Force report, entitled “Re-envisioning the annual well-woman visit: the task forward,” George F. Sawaya, MD, of the University of California, San Francisco, devised a plan to determine the most pressing well-woman needs for a specific patient.1 He chose as an example a 41-year-old sexually active woman who does not smoke.
While Dr. Sawaya praised the Well-Woman Task Force recommendations for their “comprehensive scope,” he also noted that the sheer number of recommendations might be “overwhelming and difficult to navigate.”1 One tool for winnowing the recommendations comes from the Agency for Healthcare Research and Quality, which offers an Electronic Preventive Services Selector (http://epss.ahrq.gov/PDA/index.jsp), available both online and as a smartphone app. Once the clinician plugs in the patient’s age and a few risk factors, the tool generates a list of recommended preventive services. This list of services has been evaluated by the US Preventive Services Task Force, with each recommendation graded “A” through “D,” based on benefits versus harms.
Back to that 41-year-old sexually active woman: Using the Electronic Preventive Services Selector, a list of as many as 20 grade A and B recommendations would be generated. However, only 3 of them would be grade A (screening for cervical cancer, HIV, and high blood pressure). An additional 2 grade B recommendations might apply to an average-risk patient such as this: screening for alcohol misuse and depression. All 5 services fall within the Well-Woman Task Force’s recommendations. They also have “good face validity with clinicians as being important, so it seems reasonable that these be prioritized above the others, at least at the first visit,” Dr. Sawaya says.1
Clinicians can use a similar strategy for patients of various ages and risk factors.
Reference
1. Sawaya GF. Re-envisioning the annual well-woman visit: the task forward [editorial]. Obstet Gynecol. 2015;126(4):695–696.
The bottom line
By defining and implementing the foundational elements of women’s health, we can improve care for all women and ensure, as Dr. Conry emphasized during her tenure as ACOG president, “that every woman gets the care she needs, every time.”
Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.
When the Affordable Care Act (ACA) was passed in 2010, it represented an intended shift from reactive medicine, with its focus on acute and urgent needs, to a model focused on disease prevention.
OBG Management readers know about the important women’s health services ensured by the ACA, including well-woman care, as well as the key role played by the American Congress of Obstetricians and Gynecologists (ACOG) in winning this coverage. ACOG worked closely with the Institute of Medicine (IOM) to help define this set of services. And the ACA ensured that women have access to these services, often without copays and deductibles.
ACOG and the National Women’s Law Center (NWLC) work closely on many issues. At first independently and then together, the 2 organizations set out to explore some fundamental issues:
- How does a woman experience the new well-woman benefit when she visits her doctor?
- Does she receive a consistent care set?
- Do some patients have copays while patients in other clinics do not for the same services?
- What does well-woman care mean from one doctor to another, from an ObGyn to an internist to a family physician?
This article explores these issues.
2 initiatives focused on components of women’s health care
During her tenure as president of ACOG, Jeanne Conry, MD, PhD, decided to tackle clinical issues associated with well-woman care. She convened a Well-Woman Task Force, led by Haywood Brown, MD, and included the NWLC among other partner organizations (TABLE).
Table. Partipating organizations of the ACOG Well-Woman Task Force
• American Academy of Family Physicians
• American Academy of Pediatrics
• American Academy of Physician Assistants
• American College of Nurse–Midwives
• American College of Osteopathic Obstetricians and Gynecologists
• Association of Reproductive Health Professionals
• Association of Women’s Health, Obstetric, and Neonatal Nurses
• National Association of Nurse Practitioners in Women’s Health
• National Medical Association
• National Women’s Law Center
• Planned Parenthood Federation of America
• Society for Maternal-Fetal Medicine
• Society of Academic Specialists in General Obstetrics and Gynecology
• Society of Gynecologic Oncology
The NWLC and Brigham and Women’s Hospital also partnered with ACOG and others to help ensure a consistent patient experience. These 2 closely related initiatives were designed to work together to help patients and physicians understand and benefit from new coverage under the ACA.
1. How does a woman experience well-woman care?
Experts associated with these 2 initiatives recognized that well-woman care includes attention to the history, physical examination, counseling, and screening intended to maintain physical, mental, and social wellbeing and general health throughout a woman’s lifespan. Experts also recognized that the ACA guarantees coverage of at least one annual well-woman visit, although not all of the recommended components necessarily would be performed at the same visit or by the same provider.
For many women who have gained insurance coverage under the ACA, the well-woman visit represents their entry into the insured health care system. These women may have limited understanding of the services they should receive during this visit.
To address this issue, the NWLC invited ACOG to participate in its initiative with Brigham and Women’s Hospital to understand the well-woman visit from the patient’s point of view. This effort yielded patient education materials in English and Spanish that help women understand:
- that their health insurance now covers a well-woman visit
- what care is included in that visit
- that there is no deductible or copay for this visit
- how to prepare for this visit
- what questions to ask during the visit.
These materials help women understand that the purpose of the well-woman visit is to provide them with a chance to:
- “receive care and counseling that is appropriate, based on age, cognitive development, and life experience
- review their current health and risks to their health with their health care professional
- ask any questions they may have about their health or risk factors
- talk about what they can do to prevent future health problems
- build a trusting relationship with their health care provider, with an emphasis on confidentiality
- receive appropriate preventive screenings and immunizations and make sure they know which screenings and immunizations they should receive in the future
- review their reproductive plan and contraceptive choices.”1
The materials also advise patients that they may be asked about:
- current health concerns
- current medications, both prescription and over the counter
- family history on both the mother’s and father’s sides
- life management, including family relationships, work, and stress
- substance use habits, including alcohol and tobacco
- sexual activity
- eating habits and physical activity
- past reproductive health experience and any pregnancy complications
- any memory problems (older women)
- screening for depression, anxiety, substance use disorders, and interpersonal violence.
To view some of these materials, visit http://www.nwlc.org/sites/default/files/final_well-womanbrochure.pdf.
2. Does each woman receive consistent well-woman care?
ACOG’s Well-Woman Task Force was shaped by an awareness that many medical societies and government agencies provide recommendations and guidelines about the basic elements of women’s health. While these recommendations and guidelines all may be based on evidence and expert opinion, the recommendations vary. A goal of the task force was to work with providers across the women’s health spectrum to find consensus and provide guidance to women and clinicians with age-appropriate recommendations for a well-woman visit.
In the fall of 2015, the task force’s findings were published in an article entitled “Components of the well-woman visit” in the journal Obstetrics & Gynecology.2 Those findings outline a core set of well-woman care practices across a woman’s lifespan, from adolescence through the reproductive years and into maturity, and they are usable by any provider who cares for adolescent girls or women.
ACOG has summarized its well-woman recommendations, by age, on its website,3 at http://www.acog.org/About-ACOG/ACOG-Departments/Annual-Womens-Health-Care/Well-Woman-Recommendations.
3. Do all women have a copay for the well-woman visit?
Because research has revealed that any type of copay or deductible for preventive care significantly lessens the likelihood that patients will seek out such care, the ACA sought to make basic preventive care available without cost sharing.4
The US Department of Health and Human Services notes that: “The Affordable Care Act requires most health plans to cover recommended preventive services without cost sharing. In 2011 and 2012, 71 million Americans with private health insurance gained access to preventive services with no cost sharing because of the law.”4
Grandfathered plans (those created or sold before March 23, 2010) are exempt from this requirement, as are Medicare, TRICARE, and traditional Medicaid plans.
4. What does well-woman care mean from one doctor to another?
Under the ACA, well-woman care can be provided by a “wide range of providers, including family physicians, internists, nurse–midwives, nurse practitioners, obstetrician-gynecologists, pediatricians, and physician assistants,” depending on the age of the patient, her particular needs and preferences, and access to health services.2
The ACOG Well-Woman Task Force “focused on delineating the well-woman visit throughout the lifespan, across all providers and health plans.”2
In determining the components of well-woman care, ACOG’s task force compiled existing guidelines from many sources, including the Department of Health and Human Services, the IOM, the US Preventive Services Task Force, and each member organization.
Members categorized guidelines as:
- single source (eg, abdominal examination)
- no agreement (breast cancer/mammography screening)
- limited agreement (pelvic examination)
- general agreement (hypertension, osteoporosis)
- sound agreement (screening for sexually transmitted infections)
The task force also agreed that final recommendations would rely on evidence-based guidelines, evidence-informed guidelines, and uniform expert agreement. Recommendations were considered “strong” if they relied primarily on evidence-based or evidence-informed guidelines and “qualified” if they relied primarily on expert consensus.
Guidelines were further separated into age bands:
- adolescents (13–18 years)
- reproductive-aged women (19–45 years)
- mature women (46–64 years)
- women older than 64 years.
The task force recommended that, during the well-woman visit, health care professionals educate patients about:
- healthy eating habits and maintenance of healthy weight
- exercise and physical activity
- seat belt use
- risk factors for certain types of cancer
- heart health
- breast health
- bone health
- safer sex practices and prevention of sexually transmitted infections
- healthy interpersonal relationships
- prevention and management of chronic disease
- resources for the patient (online, written, community, patient groups)
- medication use
- fall prevention.
Health care providers also should counsel patients regarding:
- recommended preventive screenings and immunizations
- any concerns about mood, such as prolonged periods of sadness, a failure to enjoy what they usually find pleasant, or anxiety or irritability that seems out of proportion to events
- what to expect in terms of effects on mood and anxiety at reproductive life transitions, including menarche, pregnancy, the postpartum period, and perimenopause
- body image issues
- what to expect in terms of the menstrual cycle during perimenopause and menopause
- reproductive health or fertility concerns
- reproductive life planning (contraception appropriate for life stage, reproductive plans, and risk factors, including risk factors for breast and ovarian cancer and cardiovascular disease)
- pregnancy planning, including attaining and maintaining a healthy weight and managing any chronic conditions before or during pregnancy
- what to expect during menopause, including signs and symptoms and options for addressing symptoms (midlife and older women)
- symptoms of cardiovascular disease
- urinary incontinence.
The task force acknowledged that not all of these recommendations can be carried out at a single well-woman visit or by a single provider.
See, again, ACOG’s specific well-woman recommendations, by age range, at http://www.acog.org/About-ACOG/ACOG-Departments/Annual-Womens-Health-Care/Well-Woman-Recommendations.3
How to winnow a long list of recommendations to determine the most pressing issues for a specific patient
In an editorial accompanying the ACOG Well-Woman Task Force report, entitled “Re-envisioning the annual well-woman visit: the task forward,” George F. Sawaya, MD, of the University of California, San Francisco, devised a plan to determine the most pressing well-woman needs for a specific patient.1 He chose as an example a 41-year-old sexually active woman who does not smoke.
While Dr. Sawaya praised the Well-Woman Task Force recommendations for their “comprehensive scope,” he also noted that the sheer number of recommendations might be “overwhelming and difficult to navigate.”1 One tool for winnowing the recommendations comes from the Agency for Healthcare Research and Quality, which offers an Electronic Preventive Services Selector (http://epss.ahrq.gov/PDA/index.jsp), available both online and as a smartphone app. Once the clinician plugs in the patient’s age and a few risk factors, the tool generates a list of recommended preventive services. This list of services has been evaluated by the US Preventive Services Task Force, with each recommendation graded “A” through “D,” based on benefits versus harms.
Back to that 41-year-old sexually active woman: Using the Electronic Preventive Services Selector, a list of as many as 20 grade A and B recommendations would be generated. However, only 3 of them would be grade A (screening for cervical cancer, HIV, and high blood pressure). An additional 2 grade B recommendations might apply to an average-risk patient such as this: screening for alcohol misuse and depression. All 5 services fall within the Well-Woman Task Force’s recommendations. They also have “good face validity with clinicians as being important, so it seems reasonable that these be prioritized above the others, at least at the first visit,” Dr. Sawaya says.1
Clinicians can use a similar strategy for patients of various ages and risk factors.
Reference
1. Sawaya GF. Re-envisioning the annual well-woman visit: the task forward [editorial]. Obstet Gynecol. 2015;126(4):695–696.
The bottom line
By defining and implementing the foundational elements of women’s health, we can improve care for all women and ensure, as Dr. Conry emphasized during her tenure as ACOG president, “that every woman gets the care she needs, every time.”
Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.
- National Women’s Law Center, Brigham and Women’s Hospital. Your Guide to Well-Woman Visits. http://www.nwlc.org/sites/default/files/final_well-womanbrochure.pdf. Accessed December 8, 2015.
- Conry JA, Brown H. Well-Woman Task Force: Components of the well-woman visit. Obstet Gynecol. 2015;126(4):697–701.
- American College of Obstetricians and Gynecologists. Well-Woman Recommendations. http://www.acog.org/About-ACOG/ACOG-Departments/Annual-Womens-Health-Care/Well-Woman-Recommendations. Accessed December 4, 2015.
- US Department of Health and Human Services. Affordable Care Act Rules on Expanding Access to Preventive Services for Women. http://www.hhs.gov/healthcare/facts-and-features/fact-sheets/aca-rules-on-expanding-access-to-preventive-services-for-women/index.html. Updated June 28, 2013. Accessed December 4, 2015.
- National Women’s Law Center, Brigham and Women’s Hospital. Your Guide to Well-Woman Visits. http://www.nwlc.org/sites/default/files/final_well-womanbrochure.pdf. Accessed December 8, 2015.
- Conry JA, Brown H. Well-Woman Task Force: Components of the well-woman visit. Obstet Gynecol. 2015;126(4):697–701.
- American College of Obstetricians and Gynecologists. Well-Woman Recommendations. http://www.acog.org/About-ACOG/ACOG-Departments/Annual-Womens-Health-Care/Well-Woman-Recommendations. Accessed December 4, 2015.
- US Department of Health and Human Services. Affordable Care Act Rules on Expanding Access to Preventive Services for Women. http://www.hhs.gov/healthcare/facts-and-features/fact-sheets/aca-rules-on-expanding-access-to-preventive-services-for-women/index.html. Updated June 28, 2013. Accessed December 4, 2015.
Cell-free DNA screening for women at low risk for fetal aneuploidy
CASE: Low-risk patient requests cell-free DNA screening
Ms. Smith is a 25-year-old woman (G1P0) presenting at 10 weeks’ gestation for her first prenatal visit. She requests cell-free DNA (cfDNA) screening to test for fetal aneuploidy. You explain that the current recommendations are for traditional screening, and inform her that her insurance may not cover the cost of cfDNA screening. She is anxious to learn the sex of her fetus as early as possible, and indicates that she would like to pursue cfDNA. After further discussion of the pros and cons, you order the test.
Prenatal screening is currently recommended in pregnancy for a number of genetic disorders, chromosomal aneuploidy, and structural birth defects in the fetus, regardless of maternal age or family history. There is a broad range of sonographic and maternal serum-based options available for carrying out aneuploidy risk assessment in the first and/or second trimester.
In addition, cfDNA screening for fetal aneuploidy has been clinically available since 2011 and has seen tremendous uptake, particularly in the high-risk population. Recent data indicate that cfDNA screening likewise has very high sensitivity and specificity for trisomy 21 in the low-risk population.1,2
Many low-risk patients are asking providers about the pros and cons of cfDNA screening, and the appropriateness of this test as a primary screen, including in low-risk patients, is the focus of this article.
What is cfDNA?
cfDNA consists of small (<200 base pairs) fragments of DNA that are present in the maternal serum. After 10 weeks of gestation, about 10% of the total circulating cfDNA in the maternal serum is derived from the placenta and can therefore be used to test for fetal disorders (FIGURE).3
Although cfDNA screening has been reported to be possible for many different types of genetic conditions, such as RhD type and single-gene disorders such as achondroplasia,4 most clinical testing is done for fetal chromosomal disorders, including trisomies 13, 18, and 21 and the sex chromosomes. In addition, some laboratories provide testing for other trisomies (16 and 22), as well as some of the microdeletion syndromes (22q11.2, 1p36, Prader Willi syndrome, and others).5
Analysis of cfDNA to assess the risk for aneuploidy is done using a number of different approaches; these generally all include next-generation sequencing with advanced bioinformatics analyses.3,6–9 Although the laboratories use somewhat different techniques, all of them share very high sensitivity and specificity for detection of trisomy 21 (TABLE 1).10
Sensitivities for trisomy 13 and sex chromosomal abnormalities are somewhat lower, but the specificity is greater than 99% for each condition, meaning that false-positive rates are very low.
The accuracy of cfDNA in identifying chromosomal aneuploidy depends on several factors, including the relative amount of fetal to maternal DNA, the chance that a chromosome abnormality is present (that is, the risk based on maternal age or results of other screening), and other factors such as the presence of twins or a nonviable second fetus, or the presence of placental mosaicism.
Because of these variables, both false-positive and false-negative results can occur, and the test is not diagnostic but rather is considered a screening test. A positive result does not mean that the fetus is definitely affected with aneuploidy.
What are the advantages of cfDNA screening for low-risk patients?
There are several benefits of cfDNA screening versus traditional screening or diagnostic testing, which are the other options available (TABLE 2). For Down syndrome, the detection rate is higher and the false-positive rate is lower than that seen with traditional aneuploidy screening using serum analytes and nuchal translucency ultrasonography.1,2
TABLE 2 Pros and cons of cfDNA screening in low-risk patients
Pros
- High detection rate and very low false-positive rate
- Can be performed any time after 10 weeks’ gestation
- Requires a single blood test at any gestational age
- Results presented in simple “Yes” or “No” format
- As with other screening tests, cfDNA provides a noninvasive determination of risk
Cons
- Tests for a limited range of conditions, which are rare in low-risk patients
- Is not as comprehensive or definitive as diagnostic testing with amniocentesis or chorionic villus sampling
- Results do not adjust for patient’s prior risk
- Positive results require calculation and interpretation of positive predictive value by provider
- Low fetal DNA and other factors can lead to test failure in some cases
- Cannot be used with vanishing twin
- Can reveal unsuspected maternal conditions of uncertain significance
The test can be done any time after 10 weeks’ gestation without the narrow gestational-age windows required or the need for accurate gestational age determination using traditional screening to accurately interpret results. cfDNA screening involves a single blood test that does not require integration with multiple serum markers or ultrasound findings. Finally, results are generally presented in a simple “Yes” or “No” format that is easy for providers and patients to understand.
CASE Continued
Your patient’s results are positive for trisomy 13. Her understanding is that the test is more than 99% accurate, and she interprets this to mean that the chance of trisomy 13 in her fetus is more than 99%. She is distraught and asks about pregnancy termination.
What are the limitations of cfDNA screening?
Similar to other noninvasive screening tests, cfDNA screening does not carry direct risk to the pregnancy. However, there are limitations to this testing. As a result, the American College of Obstetricians and Gynecologists (ACOG) and the Society for Maternal-Fetal Medicine (SMFM) recently have stated that traditional screening is the most appropriate option for most women.11,12
One reason that cfDNA screening may not be the best choice for low-risk women is that Down syndrome is quite uncommon in this group, so cfDNA screening is a very precise test for a rare condition. Traditional multiple marker screening, on the other hand, is more effective at signaling risk for the broad range of adverse perinatal outcomes that can affect a pregnancy, including other structural birth defects, as well as such obstetric complications as preterm birth, preeclampsia, and fetal growth restriction.13,14
Many women who undergo cfDNA screening are under the impression that they have had a definitive test for all birth defects when, in fact, the coverage of cfDNA for all possible birth defects in a low-risk woman is very limited; her residual risk for a birth defect is little changed by a normal cfDNA result.
The ease of obtaining a blood sample for cfDNA screening is an advantage of the test. However, because it is simple to perform, it often is done with inadequate pretest counseling or consideration. Just because the test is easily obtained does not negate the need for adequate discussion to assure that each woman understands what the test can and cannot measure, and the possible outcomes of testing.
Another perceived benefit of cfDNA screening is the simple presentation of results. While reports vary, they generally provide very dichotomized results. Aneuploidy risk is reported as “Positive” or “Negative,” or as “Detected” or “Not detected.”
Some laboratories report the chance of aneuploidy; this is almost always stated to be more than 99% in patients at increased risk, and less than 1 in 10,000 in patients at low risk.
All of these results suggest a near diagnostic certainty. However, this reporting is oversimplified and misleading, as it does not account for each patient’s prior or background risk. The chance that a positive result is a true positive is very different in a 20-year-old versus a 35-year-old woman, yet the reports do not reflect this difference in positive predictive value (PPV). See TABLE 1.
Accurate interpretation of risk for the individual patient, therefore, requires calculation by the provider; this can be done through an online calculator available through the Perinatal Quality Foundation (www.perina talquality.org).
CASE Continued
You explain to your patient that the chance her fetus has trisomy 13 is far lower than 99%, based in part on the very low prior risk given her age. You calculate the PPV using an online calculator, which estimates that there is only a 7% chance that this is a true positive result.
As mentioned earlier, there has been a tremendously rapid uptake of cfDNA screening. Given wider use by practitioners not as familiar with the complexities of genetic testing and statistical analysis, misunderstanding of the test characteristics carries risks if inappropriate recommendations or decisions are made or actions taken.
Most low-risk patients do not request or desire diagnostic testing. It is important during pretest counseling to explain that cfDNA cannot detect all significant chromosomal aneuploidies. Some serious abnormalities will be undetected; therefore, some women may prefer more comprehensive prenatal testing (TABLE 3).
TABLE 3 Checklist for pretest counseling for cfDNA28
- cfDNA screening is the most accurate screening test for trisomy 21
- cfDNA is a screening test, and false-positive and false-negative results can and do occur
- Diagnostic confirmation with chorionic villus sampling or amniocentesis is recommended for women with abnormal cfDNA results
- A negative cfDNA result decreases risk but does not rule out trisomy 21 and other chromosomal conditions
- cfDNA does not test for all chromosomal conditions
- Women who desire definitive information about chromosome conditions in the pregnancy should consider diagnostic testing with chorionic villus sampling or amniocentesis
- All genetic testing is optional. Whether a woman chooses to have a screening test, a diagnostic test, or no testing is a personal decision; any are reasonable options for any pregnant woman.
ACOG recommends that diagnostic testing should be available to all pregnant women, regardless of age.15 In prenatal series, trisomies 13, 18, and 21 make up approximately two-thirds of all clinically significant aneuploidies.16,17 Given that cfDNA detects only these aneuploidies, the other third will not be identified prenatally in patients who choose cfDNA. Traditional aneuploidy screening has been demonstrated to detect a broader range of these less common but clinically important chromosomal abnormalities.18
In one study of women found to be at increased risk based on traditional multiple marker screening, if cfDNA were chosen instead of diagnostic testing, 17% of the aneuploidies present in this group would not have been detected.18 Of all high-risk women in this study, 2%, or 1 in 50, had a chromosomal abnormality detectable by amniocentesis but not with cfDNA.
Successful tests require adequate placental DNA
Accurate interpretation of cfDNA screening also requires that an adequate quantity of placental DNA be present; this is often referred to as the “fetal fraction.” In some cases, the placental DNA volume is too low for accurate analysis, particularly in obese patients and women with specific chromosomal abnormalities.
Some laboratories measure this and do not report a result if the fetal fraction is below a specific cut-off, typically about 4%. Other laboratories do not measure or exclude cases with too little fetal DNA, raising concern that this could result in missing cases of aneuploidy. It has been noted that a placental DNA fraction of less than 8% is associated with less accurate test results, even if results are returned.8
Low fetal fraction also has been associated with maternal obesity, and in one study cfDNA failed to provide a result in 20% of women weighing more than 250 lb and 50% of women weighing more than 350 lb.19 Therefore, cfDNA is not the best option for obese women (TABLE 4).
TABLE 4 Appropriateness of cfDNA screeningin specific clinical circumstances
Optimal candidates for cfDNA screening
- High risk for trisomy based on maternal age (≥35 years)
- Ultrasound findings suggesting trisomy 13, 18, or 21
- History of prior pregnancy with trisomy 13, 18, or 21
- Positive traditional screening test
- Parental balanced Robertsonian translocation associated with risk for trisomy 13 or 21
Less optimal candidates
- Low risk for trisomy based on age and/or low risk traditional screening
- Ultrasound structural anomalies other than those specifically suggesting trisomy 13, 18, or 21
- High risk for nonchromosomal genetic disorder
- Comprehensive genetic diagnosis desired
- Maternal malignancy
- Maternal organ transplant
- Maternal sex chromosomal mosaicism or other chromosomal abnormality
- Maternal obesity
- Gestational age <10 weeks
While the free fraction is relatively constant from 10 to 22 weeks’ gestation, it is lower earlier than 10 weeks’ gestation and less likely to provide a result. For this reason, the test should not be attempted before 10 weeks’ gestation.
Recent evidence indicates that low fetal DNA fraction is associated with some chromosome abnormalities. Given this association, women with failed cfDNA results should be counseled and offered appropriate follow-up. As the association appears to be greater for trisomies 13 and 18, and triploidy, a careful ultrasound is likely to detect abnormalities in many such cases. However, it also is appropriate to offer the option of diagnostic testing, given the very high risk.
A repeat cfDNA test will be successful in some cases. Whether the patient chooses to attempt cfDNA again may depend in part on maternal body mass index (BMI), as well as gestational age—a patient at a more advanced gestation may not wish to delay obtaining definitive information given the high risk.
cfDNA screening has a low false-positive rate
One of the greatest benefits of cfDNA screening is a lower false-positive rate than is reported with traditional screening. However, when “no results” cases are also considered, the percentage of patients who require follow-up after cfDNA is close to that of traditional screening.
The chance of test failure is reported to be 0.9% to 8.1%,7,9,10 and varies in part by whether the laboratory measures fetal fraction and requires a minimum concentration.
A recent meta-analysis estimated the overall test failure rate at 3%.10 When comparing cfDNA to traditional screening, if “no results” cases are included with the “screen positive” group, the benefits of cfDNA over traditional screening are much less clear, particularly in a low-risk population.
ACOG: Offer traditional multiple-marker screening first
While multiple marker and cfDNA screening have differing performance characteristics, there are no data to support doing both tests concurrently. In fact, in a recent survey of nearly 200 women presented with different testing scenarios, women found it preferable and more reassuring to have a positive traditional screen followed by normal cfDNA results, rather that discrepant results of the 2 tests done concurrently.20
For many reasons, the approach recommended by ACOG and SMFM is to offer traditional multiple-marker screening first, and cfDNA screening or diagnostic testing as a follow-up for patients that screen positive. In that scenario, the benefits and limitations of diagnostic testing versus follow-up with cfDNA screening should be explained carefully.
In all patients who have a positive cfDNA result, diagnostic testing for confirmation should be offered and strongly recommended prior to pregnancy termination if that is considered. Even if a structural abnormality is present and a true positive result is highly likely, karyotyping is important to determine if there may be an inherited translocation putting subsequent pregnancies at higher risk.
Components of pretest counseling
A woman of any age can have a fetus with trisomy or another chromosomal abnormality, and some women prefer diagnostic testing or no testing regardless of age. It is therefore appropriate to offer diagnostic testing, screening, or the option of no testing to all women.
Recent studies have demonstrated that providing well-informed access to all prenatal tests results in more informed choices and no increase in uptake of invasive testing.22 However, the offer of prenatal testing requires discussion of the pros and cons of all test options, including the detection rates of all significant abnormalities, the screen positive rates, and recommended follow-up if an abnormal result is obtained. See TABLE 4.
Cost-effectiveness
Although the detection rate of cfDNA for trisomy 21 is higher than that of traditional screening, the detection rate of traditional screening is also quite high at lower cost. For low-risk women, therefore, traditional screening provides a less expensive alternative to cfDNA. Because aneuploidy is rare in low-risk patients, the residual chance of aneuploidy after a normal traditional screen is very low, and the cost per additional case of Down syndrome detected by cfDNA is very high.
In one study, this was estimated at $3.6 million.23 These authors suggested that, at present, cfDNA is optimally used as a secondary screen for high-risk women. Other cost analyses also have demonstrated that the most cost-effective strategy is a model in which cfDNA is used as a follow-up test in patients found to be screen positive by traditional screening.15,24 A recent cost utility analysis compared outcomes of 6 approaches to prenatal screening, including sequential screening, cfDNA screening, nuchal translucency only, and diagnostic testing with microarray (alone, in combination, or in sequence).
The clinical outcomes included fetal abnormalities detected, taking into account all chromosomal abnormalities, as well as failed cfDNA tests. For younger women (<40 yr), traditional sequential screening provided the highest detection of all abnormalities and was the optimal testing strategy, while cfDNA was preferable for women aged 40 or older, given the higher prevalence of trisomy 21.20
Incidental findings
Given that the cfDNA in maternal serum is a mixture of maternal and placental DNA, a number of biologic phenomena can cause a false-positive cfDNA result. In many cases, these false-positives reveal unanticipated or unexpected maternal conditions and information that the woman may have preferred not to know. A few cases of maternal malignancies with chromosomal abnormalities within the tumor have been reported in patients with false-positive cfDNA results.26
These case reports have raised the question about the need for further evaluation for maternal malignancy in women with false-positive results. Maternal genetic disorders also can cause false-positive results, and may lead to unanticipated detection of adult-onset conditions. In some cases, positive results for sex chromosomal aneuploidy can occur in pregnant women who themselves have a sex chromosomal abnormality, often in mosaic form and previously undiagnosed.27
Again, this has led to discussion of the possible health benefit of karyotyping women who have a false-positive cfDNA result to rule out a mosaic chromosomal abnormality in the mother.
At this time, the clinical utility of such investigations is unknown and there are no recommendations regarding appropriate follow-up for such cases.
CASE Resolved
Given the results of her cfDNA screening, your patient opts to undergo diagnostic testing. In that testing, trisomy 13 is ruled out and she goes on to have a healthy daughter.
Share your thoughts on this article! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.
- Bianchi DW, Parker RL, Wentworth J, et al. DNA sequencing versus standard prenatal aneuploidy screening. N Engl J Med. 2014;370(9):799–808.
- Norton ME, Jacobsson B, Swamy GK, et al. Cell-free DNA analysis for noninvasive examination of trisomy. N Engl J Med. 2015;372(17):1589–1597.
- Norton ME, Brar H, Weiss J, et al. Non-Invasive Chromosomal Evaluation (NICE) study: results of a multicenter prospective cohort study for detection of fetal trisomy 21 and trisomy 18. Am J Obstet Gynecol. 2012;207(2):137.e1–e8.
- Chitty LS, Mason S, Barrett AN, et al. Non-invasive prenatal diagnosis of achondroplasia and thanatophoric dysplasia: next-generation sequencing allows for a safer, more accurate, and comprehensive approach. Prenat Diagn. 2015;35(7):656–662.
- Wapner RJ, Babiarz JE, Levy B, et al. Expanding the scope of noninvasive prenatal testing: detection of fetal microdeletion syndromes. Am J Obstet Gynecol. 2015;212(3):332.e1–e9.
- Bianchi DW, Platt LD, Goldberg JD, Abuhamad AZ, Sehnert AJ, Rava RP. Genome-wide fetal aneuploidy detection by maternal plasma DNA sequencing. Obstet Gynecol. 2012;119(5):890–901.
- Palomaki GE, Kloza EM, Lambert-Messerlian GM, et al. DNA sequencing of maternal plasma to detect Down syndrome: an international clinical validation study. Genet Med. 2011;13(11):913–920.
- Sparks AB, Wang ET, Struble CA, et al. DNA sequencing of maternal plasma to detect Down syndrome: an international clinical validation study [abstract]. Proceedings of the ISPD 16th International Conference on Prenatal Diagnosis and Therapy; Miami, Florida; June 3–6, 2012. Prenat Diagn. 2012;32(suppl 1):s3–s9.
- Zimmermann B, Hill M, Gemelos G, et al. Noninvasive prenatal aneuploidy testing of chromosomes 13, 18, 21, X, and Y, using targeted sequencing of polymorphic loci. Prenat Diagn. 2012;32(13):1233–1241.
- Gil MM, Quezada MS, Revello R, Akolekar R, Niclaides KH. Analysis of cell-free DNA in maternal blood in screening for fetal aneuploidies: updated meta-analysis. Ultrasound Obstet Gynecol. 2015;45(3):249–266.
- American College of Obstetricians and Gynecologists. Committee Opinion No. 640: cell-free DNA screening for fetal aneuploidy. Obstet Gynecol. 2015;126(3):e31–e37.
- Society for Maternal-Fetal Medicine (SMFM) Publications Committee. Prenatal aneuploidy screening using cell-free DNA. Am J Obstet Gynecol. 2015;212(6):711–716.
- Baer RJ, Currier RJ, Norton ME, et al. Obstetric, perinatal, and fetal outcomes in pregnancies with false-positive integrated screening results. Obstet Gynecol. 2014;123(3):603–609.
- Dugoff L; Society for Maternal-Fetal Medicine. First- and second-trimester maternal serum markers for aneuploidy and adverse obstetric outcomes. Obstet Gynecol. 2010;115(5):1052–1061.
- American College of Obstetricians and Gynecologists. Practice bulletin No. 88: invasive prenatal testing for aneuploidy. Obstet Gynecol. 2007;110(6):1459–1467.
- Alamillo CM, Krantz D, Evans M, Fiddler M, Pergament E. Nearly a third of abnormalities found after first-trimester screening are different than expected: 10-year experience from a single center. Prenat Diagn. 2013;33(3):251–256.
- Wellesley D, Dolk H, Boyd PA, et al. Rare chromosome abnormalities, prevalence and prenatal diagnosis rates from population-based congenital anomaly registers in Europe. Eur J Hum Genet. 2012;20(5):521–526.
- Norton ME, Jelliffe-Pawlowski LL, Currier RJ. Chromosome abnormalities detected by current prenatal screening and noninvasive prenatal testing. Obstet Gynecol. 2014;124(5):979–986.
- Ashoor G, Syngelaki A, Poon LC, Rezende JC, Nicolaides KH. Fetal fraction in maternal plasma cell-free DNA at 11-13 weeks’ gestation: relation to maternal and fetal characteristics. Ultrasound Obstet Gynecol. 2013;41(1):26–32.
- Kaimal AJ, Norton ME, Kuppermann M. Prenatal testing in the genomic age: clinical outcomes, quality of life, and costs. Obstet Gynecol. 2015;126(4):737–746.
- Wapner RJ, Martin CL, Levy B, et al. Chromosomal microarray versus karyotyping for prenatal diagnosis. N Engl J Med. 2012;367(23):2175–2184.
- Kuppermann M, Pena S, Bishop JT, et al. Effect of enhanced information, values clarification, and removal of financial barriers on use of prenatal genetic testing: a randomized clinical trial. JAMA. 2014;312(12):1210–1217.
- Cuckle H, Benn P, Pergament E. Maternal cfDNA screening for Down syndrome—a cost sensitivity analysis. Prenat Diagn. 2013;33(7):636–642.
- Beulen L, Grutters JPC, Faas BH, Feenstra I, van Vugt JMG, Bekker MN. The consequences of implementing non-invasive prenatal testing in Dutch national health care: a cost-effectiveness analysis. Eur J Obstet Gynecol Reprod Biol. 2014;182:53–61.
- Okun N, Teitelbaum M, Huang T, Dewa CS, Hoch JS. The price of performance: a cost and performance analysis of the implementation of cell-free fetal DNA testing for Down syndrome in Ontario, Canada: Cost and performance analysis of cfDNA testing for Down syndrome in Ontario. Prenat Diagn. 2014;34(4):350–356.
- Bianchi DW, Chudova D, Sehnert AJ, et al. Noninvasive prenatal testing and incidental detection of occult maternal malignancies. JAMA. 2015;314(2):162–169.
- Wang Y, Chen Y, Tian F, et al. Maternal mosaicism is a significant contributor to discordant sex chromosomal aneuploidies associated with noninvasive prenatal testing. Clin Chem. 2014;60(1):251–259.
- Norton ME, Jelliffe-Pawlowski LL, Currier RJ. Chromosome abnormalities detected by current prenatal screening and noninvasive prenatal testing. Obstet Gynecol. 2014;124(5):979–986Society for Maternal-Fetal Medicine (SMFM) Publications Committee. Prenatal aneuploidy screening using cell-free DNA. Am J Obstet Gynecol. 2015;212(6):711–716.
CASE: Low-risk patient requests cell-free DNA screening
Ms. Smith is a 25-year-old woman (G1P0) presenting at 10 weeks’ gestation for her first prenatal visit. She requests cell-free DNA (cfDNA) screening to test for fetal aneuploidy. You explain that the current recommendations are for traditional screening, and inform her that her insurance may not cover the cost of cfDNA screening. She is anxious to learn the sex of her fetus as early as possible, and indicates that she would like to pursue cfDNA. After further discussion of the pros and cons, you order the test.
Prenatal screening is currently recommended in pregnancy for a number of genetic disorders, chromosomal aneuploidy, and structural birth defects in the fetus, regardless of maternal age or family history. There is a broad range of sonographic and maternal serum-based options available for carrying out aneuploidy risk assessment in the first and/or second trimester.
In addition, cfDNA screening for fetal aneuploidy has been clinically available since 2011 and has seen tremendous uptake, particularly in the high-risk population. Recent data indicate that cfDNA screening likewise has very high sensitivity and specificity for trisomy 21 in the low-risk population.1,2
Many low-risk patients are asking providers about the pros and cons of cfDNA screening, and the appropriateness of this test as a primary screen, including in low-risk patients, is the focus of this article.
What is cfDNA?
cfDNA consists of small (<200 base pairs) fragments of DNA that are present in the maternal serum. After 10 weeks of gestation, about 10% of the total circulating cfDNA in the maternal serum is derived from the placenta and can therefore be used to test for fetal disorders (FIGURE).3
Although cfDNA screening has been reported to be possible for many different types of genetic conditions, such as RhD type and single-gene disorders such as achondroplasia,4 most clinical testing is done for fetal chromosomal disorders, including trisomies 13, 18, and 21 and the sex chromosomes. In addition, some laboratories provide testing for other trisomies (16 and 22), as well as some of the microdeletion syndromes (22q11.2, 1p36, Prader Willi syndrome, and others).5
Analysis of cfDNA to assess the risk for aneuploidy is done using a number of different approaches; these generally all include next-generation sequencing with advanced bioinformatics analyses.3,6–9 Although the laboratories use somewhat different techniques, all of them share very high sensitivity and specificity for detection of trisomy 21 (TABLE 1).10
Sensitivities for trisomy 13 and sex chromosomal abnormalities are somewhat lower, but the specificity is greater than 99% for each condition, meaning that false-positive rates are very low.
The accuracy of cfDNA in identifying chromosomal aneuploidy depends on several factors, including the relative amount of fetal to maternal DNA, the chance that a chromosome abnormality is present (that is, the risk based on maternal age or results of other screening), and other factors such as the presence of twins or a nonviable second fetus, or the presence of placental mosaicism.
Because of these variables, both false-positive and false-negative results can occur, and the test is not diagnostic but rather is considered a screening test. A positive result does not mean that the fetus is definitely affected with aneuploidy.
What are the advantages of cfDNA screening for low-risk patients?
There are several benefits of cfDNA screening versus traditional screening or diagnostic testing, which are the other options available (TABLE 2). For Down syndrome, the detection rate is higher and the false-positive rate is lower than that seen with traditional aneuploidy screening using serum analytes and nuchal translucency ultrasonography.1,2
TABLE 2 Pros and cons of cfDNA screening in low-risk patients
Pros
- High detection rate and very low false-positive rate
- Can be performed any time after 10 weeks’ gestation
- Requires a single blood test at any gestational age
- Results presented in simple “Yes” or “No” format
- As with other screening tests, cfDNA provides a noninvasive determination of risk
Cons
- Tests for a limited range of conditions, which are rare in low-risk patients
- Is not as comprehensive or definitive as diagnostic testing with amniocentesis or chorionic villus sampling
- Results do not adjust for patient’s prior risk
- Positive results require calculation and interpretation of positive predictive value by provider
- Low fetal DNA and other factors can lead to test failure in some cases
- Cannot be used with vanishing twin
- Can reveal unsuspected maternal conditions of uncertain significance
The test can be done any time after 10 weeks’ gestation without the narrow gestational-age windows required or the need for accurate gestational age determination using traditional screening to accurately interpret results. cfDNA screening involves a single blood test that does not require integration with multiple serum markers or ultrasound findings. Finally, results are generally presented in a simple “Yes” or “No” format that is easy for providers and patients to understand.
CASE Continued
Your patient’s results are positive for trisomy 13. Her understanding is that the test is more than 99% accurate, and she interprets this to mean that the chance of trisomy 13 in her fetus is more than 99%. She is distraught and asks about pregnancy termination.
What are the limitations of cfDNA screening?
Similar to other noninvasive screening tests, cfDNA screening does not carry direct risk to the pregnancy. However, there are limitations to this testing. As a result, the American College of Obstetricians and Gynecologists (ACOG) and the Society for Maternal-Fetal Medicine (SMFM) recently have stated that traditional screening is the most appropriate option for most women.11,12
One reason that cfDNA screening may not be the best choice for low-risk women is that Down syndrome is quite uncommon in this group, so cfDNA screening is a very precise test for a rare condition. Traditional multiple marker screening, on the other hand, is more effective at signaling risk for the broad range of adverse perinatal outcomes that can affect a pregnancy, including other structural birth defects, as well as such obstetric complications as preterm birth, preeclampsia, and fetal growth restriction.13,14
Many women who undergo cfDNA screening are under the impression that they have had a definitive test for all birth defects when, in fact, the coverage of cfDNA for all possible birth defects in a low-risk woman is very limited; her residual risk for a birth defect is little changed by a normal cfDNA result.
The ease of obtaining a blood sample for cfDNA screening is an advantage of the test. However, because it is simple to perform, it often is done with inadequate pretest counseling or consideration. Just because the test is easily obtained does not negate the need for adequate discussion to assure that each woman understands what the test can and cannot measure, and the possible outcomes of testing.
Another perceived benefit of cfDNA screening is the simple presentation of results. While reports vary, they generally provide very dichotomized results. Aneuploidy risk is reported as “Positive” or “Negative,” or as “Detected” or “Not detected.”
Some laboratories report the chance of aneuploidy; this is almost always stated to be more than 99% in patients at increased risk, and less than 1 in 10,000 in patients at low risk.
All of these results suggest a near diagnostic certainty. However, this reporting is oversimplified and misleading, as it does not account for each patient’s prior or background risk. The chance that a positive result is a true positive is very different in a 20-year-old versus a 35-year-old woman, yet the reports do not reflect this difference in positive predictive value (PPV). See TABLE 1.
Accurate interpretation of risk for the individual patient, therefore, requires calculation by the provider; this can be done through an online calculator available through the Perinatal Quality Foundation (www.perina talquality.org).
CASE Continued
You explain to your patient that the chance her fetus has trisomy 13 is far lower than 99%, based in part on the very low prior risk given her age. You calculate the PPV using an online calculator, which estimates that there is only a 7% chance that this is a true positive result.
As mentioned earlier, there has been a tremendously rapid uptake of cfDNA screening. Given wider use by practitioners not as familiar with the complexities of genetic testing and statistical analysis, misunderstanding of the test characteristics carries risks if inappropriate recommendations or decisions are made or actions taken.
Most low-risk patients do not request or desire diagnostic testing. It is important during pretest counseling to explain that cfDNA cannot detect all significant chromosomal aneuploidies. Some serious abnormalities will be undetected; therefore, some women may prefer more comprehensive prenatal testing (TABLE 3).
TABLE 3 Checklist for pretest counseling for cfDNA28
- cfDNA screening is the most accurate screening test for trisomy 21
- cfDNA is a screening test, and false-positive and false-negative results can and do occur
- Diagnostic confirmation with chorionic villus sampling or amniocentesis is recommended for women with abnormal cfDNA results
- A negative cfDNA result decreases risk but does not rule out trisomy 21 and other chromosomal conditions
- cfDNA does not test for all chromosomal conditions
- Women who desire definitive information about chromosome conditions in the pregnancy should consider diagnostic testing with chorionic villus sampling or amniocentesis
- All genetic testing is optional. Whether a woman chooses to have a screening test, a diagnostic test, or no testing is a personal decision; any are reasonable options for any pregnant woman.
ACOG recommends that diagnostic testing should be available to all pregnant women, regardless of age.15 In prenatal series, trisomies 13, 18, and 21 make up approximately two-thirds of all clinically significant aneuploidies.16,17 Given that cfDNA detects only these aneuploidies, the other third will not be identified prenatally in patients who choose cfDNA. Traditional aneuploidy screening has been demonstrated to detect a broader range of these less common but clinically important chromosomal abnormalities.18
In one study of women found to be at increased risk based on traditional multiple marker screening, if cfDNA were chosen instead of diagnostic testing, 17% of the aneuploidies present in this group would not have been detected.18 Of all high-risk women in this study, 2%, or 1 in 50, had a chromosomal abnormality detectable by amniocentesis but not with cfDNA.
Successful tests require adequate placental DNA
Accurate interpretation of cfDNA screening also requires that an adequate quantity of placental DNA be present; this is often referred to as the “fetal fraction.” In some cases, the placental DNA volume is too low for accurate analysis, particularly in obese patients and women with specific chromosomal abnormalities.
Some laboratories measure this and do not report a result if the fetal fraction is below a specific cut-off, typically about 4%. Other laboratories do not measure or exclude cases with too little fetal DNA, raising concern that this could result in missing cases of aneuploidy. It has been noted that a placental DNA fraction of less than 8% is associated with less accurate test results, even if results are returned.8
Low fetal fraction also has been associated with maternal obesity, and in one study cfDNA failed to provide a result in 20% of women weighing more than 250 lb and 50% of women weighing more than 350 lb.19 Therefore, cfDNA is not the best option for obese women (TABLE 4).
TABLE 4 Appropriateness of cfDNA screeningin specific clinical circumstances
Optimal candidates for cfDNA screening
- High risk for trisomy based on maternal age (≥35 years)
- Ultrasound findings suggesting trisomy 13, 18, or 21
- History of prior pregnancy with trisomy 13, 18, or 21
- Positive traditional screening test
- Parental balanced Robertsonian translocation associated with risk for trisomy 13 or 21
Less optimal candidates
- Low risk for trisomy based on age and/or low risk traditional screening
- Ultrasound structural anomalies other than those specifically suggesting trisomy 13, 18, or 21
- High risk for nonchromosomal genetic disorder
- Comprehensive genetic diagnosis desired
- Maternal malignancy
- Maternal organ transplant
- Maternal sex chromosomal mosaicism or other chromosomal abnormality
- Maternal obesity
- Gestational age <10 weeks
While the free fraction is relatively constant from 10 to 22 weeks’ gestation, it is lower earlier than 10 weeks’ gestation and less likely to provide a result. For this reason, the test should not be attempted before 10 weeks’ gestation.
Recent evidence indicates that low fetal DNA fraction is associated with some chromosome abnormalities. Given this association, women with failed cfDNA results should be counseled and offered appropriate follow-up. As the association appears to be greater for trisomies 13 and 18, and triploidy, a careful ultrasound is likely to detect abnormalities in many such cases. However, it also is appropriate to offer the option of diagnostic testing, given the very high risk.
A repeat cfDNA test will be successful in some cases. Whether the patient chooses to attempt cfDNA again may depend in part on maternal body mass index (BMI), as well as gestational age—a patient at a more advanced gestation may not wish to delay obtaining definitive information given the high risk.
cfDNA screening has a low false-positive rate
One of the greatest benefits of cfDNA screening is a lower false-positive rate than is reported with traditional screening. However, when “no results” cases are also considered, the percentage of patients who require follow-up after cfDNA is close to that of traditional screening.
The chance of test failure is reported to be 0.9% to 8.1%,7,9,10 and varies in part by whether the laboratory measures fetal fraction and requires a minimum concentration.
A recent meta-analysis estimated the overall test failure rate at 3%.10 When comparing cfDNA to traditional screening, if “no results” cases are included with the “screen positive” group, the benefits of cfDNA over traditional screening are much less clear, particularly in a low-risk population.
ACOG: Offer traditional multiple-marker screening first
While multiple marker and cfDNA screening have differing performance characteristics, there are no data to support doing both tests concurrently. In fact, in a recent survey of nearly 200 women presented with different testing scenarios, women found it preferable and more reassuring to have a positive traditional screen followed by normal cfDNA results, rather that discrepant results of the 2 tests done concurrently.20
For many reasons, the approach recommended by ACOG and SMFM is to offer traditional multiple-marker screening first, and cfDNA screening or diagnostic testing as a follow-up for patients that screen positive. In that scenario, the benefits and limitations of diagnostic testing versus follow-up with cfDNA screening should be explained carefully.
In all patients who have a positive cfDNA result, diagnostic testing for confirmation should be offered and strongly recommended prior to pregnancy termination if that is considered. Even if a structural abnormality is present and a true positive result is highly likely, karyotyping is important to determine if there may be an inherited translocation putting subsequent pregnancies at higher risk.
Components of pretest counseling
A woman of any age can have a fetus with trisomy or another chromosomal abnormality, and some women prefer diagnostic testing or no testing regardless of age. It is therefore appropriate to offer diagnostic testing, screening, or the option of no testing to all women.
Recent studies have demonstrated that providing well-informed access to all prenatal tests results in more informed choices and no increase in uptake of invasive testing.22 However, the offer of prenatal testing requires discussion of the pros and cons of all test options, including the detection rates of all significant abnormalities, the screen positive rates, and recommended follow-up if an abnormal result is obtained. See TABLE 4.
Cost-effectiveness
Although the detection rate of cfDNA for trisomy 21 is higher than that of traditional screening, the detection rate of traditional screening is also quite high at lower cost. For low-risk women, therefore, traditional screening provides a less expensive alternative to cfDNA. Because aneuploidy is rare in low-risk patients, the residual chance of aneuploidy after a normal traditional screen is very low, and the cost per additional case of Down syndrome detected by cfDNA is very high.
In one study, this was estimated at $3.6 million.23 These authors suggested that, at present, cfDNA is optimally used as a secondary screen for high-risk women. Other cost analyses also have demonstrated that the most cost-effective strategy is a model in which cfDNA is used as a follow-up test in patients found to be screen positive by traditional screening.15,24 A recent cost utility analysis compared outcomes of 6 approaches to prenatal screening, including sequential screening, cfDNA screening, nuchal translucency only, and diagnostic testing with microarray (alone, in combination, or in sequence).
The clinical outcomes included fetal abnormalities detected, taking into account all chromosomal abnormalities, as well as failed cfDNA tests. For younger women (<40 yr), traditional sequential screening provided the highest detection of all abnormalities and was the optimal testing strategy, while cfDNA was preferable for women aged 40 or older, given the higher prevalence of trisomy 21.20
Incidental findings
Given that the cfDNA in maternal serum is a mixture of maternal and placental DNA, a number of biologic phenomena can cause a false-positive cfDNA result. In many cases, these false-positives reveal unanticipated or unexpected maternal conditions and information that the woman may have preferred not to know. A few cases of maternal malignancies with chromosomal abnormalities within the tumor have been reported in patients with false-positive cfDNA results.26
These case reports have raised the question about the need for further evaluation for maternal malignancy in women with false-positive results. Maternal genetic disorders also can cause false-positive results, and may lead to unanticipated detection of adult-onset conditions. In some cases, positive results for sex chromosomal aneuploidy can occur in pregnant women who themselves have a sex chromosomal abnormality, often in mosaic form and previously undiagnosed.27
Again, this has led to discussion of the possible health benefit of karyotyping women who have a false-positive cfDNA result to rule out a mosaic chromosomal abnormality in the mother.
At this time, the clinical utility of such investigations is unknown and there are no recommendations regarding appropriate follow-up for such cases.
CASE Resolved
Given the results of her cfDNA screening, your patient opts to undergo diagnostic testing. In that testing, trisomy 13 is ruled out and she goes on to have a healthy daughter.
Share your thoughts on this article! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.
CASE: Low-risk patient requests cell-free DNA screening
Ms. Smith is a 25-year-old woman (G1P0) presenting at 10 weeks’ gestation for her first prenatal visit. She requests cell-free DNA (cfDNA) screening to test for fetal aneuploidy. You explain that the current recommendations are for traditional screening, and inform her that her insurance may not cover the cost of cfDNA screening. She is anxious to learn the sex of her fetus as early as possible, and indicates that she would like to pursue cfDNA. After further discussion of the pros and cons, you order the test.
Prenatal screening is currently recommended in pregnancy for a number of genetic disorders, chromosomal aneuploidy, and structural birth defects in the fetus, regardless of maternal age or family history. There is a broad range of sonographic and maternal serum-based options available for carrying out aneuploidy risk assessment in the first and/or second trimester.
In addition, cfDNA screening for fetal aneuploidy has been clinically available since 2011 and has seen tremendous uptake, particularly in the high-risk population. Recent data indicate that cfDNA screening likewise has very high sensitivity and specificity for trisomy 21 in the low-risk population.1,2
Many low-risk patients are asking providers about the pros and cons of cfDNA screening, and the appropriateness of this test as a primary screen, including in low-risk patients, is the focus of this article.
What is cfDNA?
cfDNA consists of small (<200 base pairs) fragments of DNA that are present in the maternal serum. After 10 weeks of gestation, about 10% of the total circulating cfDNA in the maternal serum is derived from the placenta and can therefore be used to test for fetal disorders (FIGURE).3
Although cfDNA screening has been reported to be possible for many different types of genetic conditions, such as RhD type and single-gene disorders such as achondroplasia,4 most clinical testing is done for fetal chromosomal disorders, including trisomies 13, 18, and 21 and the sex chromosomes. In addition, some laboratories provide testing for other trisomies (16 and 22), as well as some of the microdeletion syndromes (22q11.2, 1p36, Prader Willi syndrome, and others).5
Analysis of cfDNA to assess the risk for aneuploidy is done using a number of different approaches; these generally all include next-generation sequencing with advanced bioinformatics analyses.3,6–9 Although the laboratories use somewhat different techniques, all of them share very high sensitivity and specificity for detection of trisomy 21 (TABLE 1).10
Sensitivities for trisomy 13 and sex chromosomal abnormalities are somewhat lower, but the specificity is greater than 99% for each condition, meaning that false-positive rates are very low.
The accuracy of cfDNA in identifying chromosomal aneuploidy depends on several factors, including the relative amount of fetal to maternal DNA, the chance that a chromosome abnormality is present (that is, the risk based on maternal age or results of other screening), and other factors such as the presence of twins or a nonviable second fetus, or the presence of placental mosaicism.
Because of these variables, both false-positive and false-negative results can occur, and the test is not diagnostic but rather is considered a screening test. A positive result does not mean that the fetus is definitely affected with aneuploidy.
What are the advantages of cfDNA screening for low-risk patients?
There are several benefits of cfDNA screening versus traditional screening or diagnostic testing, which are the other options available (TABLE 2). For Down syndrome, the detection rate is higher and the false-positive rate is lower than that seen with traditional aneuploidy screening using serum analytes and nuchal translucency ultrasonography.1,2
TABLE 2 Pros and cons of cfDNA screening in low-risk patients
Pros
- High detection rate and very low false-positive rate
- Can be performed any time after 10 weeks’ gestation
- Requires a single blood test at any gestational age
- Results presented in simple “Yes” or “No” format
- As with other screening tests, cfDNA provides a noninvasive determination of risk
Cons
- Tests for a limited range of conditions, which are rare in low-risk patients
- Is not as comprehensive or definitive as diagnostic testing with amniocentesis or chorionic villus sampling
- Results do not adjust for patient’s prior risk
- Positive results require calculation and interpretation of positive predictive value by provider
- Low fetal DNA and other factors can lead to test failure in some cases
- Cannot be used with vanishing twin
- Can reveal unsuspected maternal conditions of uncertain significance
The test can be done any time after 10 weeks’ gestation without the narrow gestational-age windows required or the need for accurate gestational age determination using traditional screening to accurately interpret results. cfDNA screening involves a single blood test that does not require integration with multiple serum markers or ultrasound findings. Finally, results are generally presented in a simple “Yes” or “No” format that is easy for providers and patients to understand.
CASE Continued
Your patient’s results are positive for trisomy 13. Her understanding is that the test is more than 99% accurate, and she interprets this to mean that the chance of trisomy 13 in her fetus is more than 99%. She is distraught and asks about pregnancy termination.
What are the limitations of cfDNA screening?
Similar to other noninvasive screening tests, cfDNA screening does not carry direct risk to the pregnancy. However, there are limitations to this testing. As a result, the American College of Obstetricians and Gynecologists (ACOG) and the Society for Maternal-Fetal Medicine (SMFM) recently have stated that traditional screening is the most appropriate option for most women.11,12
One reason that cfDNA screening may not be the best choice for low-risk women is that Down syndrome is quite uncommon in this group, so cfDNA screening is a very precise test for a rare condition. Traditional multiple marker screening, on the other hand, is more effective at signaling risk for the broad range of adverse perinatal outcomes that can affect a pregnancy, including other structural birth defects, as well as such obstetric complications as preterm birth, preeclampsia, and fetal growth restriction.13,14
Many women who undergo cfDNA screening are under the impression that they have had a definitive test for all birth defects when, in fact, the coverage of cfDNA for all possible birth defects in a low-risk woman is very limited; her residual risk for a birth defect is little changed by a normal cfDNA result.
The ease of obtaining a blood sample for cfDNA screening is an advantage of the test. However, because it is simple to perform, it often is done with inadequate pretest counseling or consideration. Just because the test is easily obtained does not negate the need for adequate discussion to assure that each woman understands what the test can and cannot measure, and the possible outcomes of testing.
Another perceived benefit of cfDNA screening is the simple presentation of results. While reports vary, they generally provide very dichotomized results. Aneuploidy risk is reported as “Positive” or “Negative,” or as “Detected” or “Not detected.”
Some laboratories report the chance of aneuploidy; this is almost always stated to be more than 99% in patients at increased risk, and less than 1 in 10,000 in patients at low risk.
All of these results suggest a near diagnostic certainty. However, this reporting is oversimplified and misleading, as it does not account for each patient’s prior or background risk. The chance that a positive result is a true positive is very different in a 20-year-old versus a 35-year-old woman, yet the reports do not reflect this difference in positive predictive value (PPV). See TABLE 1.
Accurate interpretation of risk for the individual patient, therefore, requires calculation by the provider; this can be done through an online calculator available through the Perinatal Quality Foundation (www.perina talquality.org).
CASE Continued
You explain to your patient that the chance her fetus has trisomy 13 is far lower than 99%, based in part on the very low prior risk given her age. You calculate the PPV using an online calculator, which estimates that there is only a 7% chance that this is a true positive result.
As mentioned earlier, there has been a tremendously rapid uptake of cfDNA screening. Given wider use by practitioners not as familiar with the complexities of genetic testing and statistical analysis, misunderstanding of the test characteristics carries risks if inappropriate recommendations or decisions are made or actions taken.
Most low-risk patients do not request or desire diagnostic testing. It is important during pretest counseling to explain that cfDNA cannot detect all significant chromosomal aneuploidies. Some serious abnormalities will be undetected; therefore, some women may prefer more comprehensive prenatal testing (TABLE 3).
TABLE 3 Checklist for pretest counseling for cfDNA28
- cfDNA screening is the most accurate screening test for trisomy 21
- cfDNA is a screening test, and false-positive and false-negative results can and do occur
- Diagnostic confirmation with chorionic villus sampling or amniocentesis is recommended for women with abnormal cfDNA results
- A negative cfDNA result decreases risk but does not rule out trisomy 21 and other chromosomal conditions
- cfDNA does not test for all chromosomal conditions
- Women who desire definitive information about chromosome conditions in the pregnancy should consider diagnostic testing with chorionic villus sampling or amniocentesis
- All genetic testing is optional. Whether a woman chooses to have a screening test, a diagnostic test, or no testing is a personal decision; any are reasonable options for any pregnant woman.
ACOG recommends that diagnostic testing should be available to all pregnant women, regardless of age.15 In prenatal series, trisomies 13, 18, and 21 make up approximately two-thirds of all clinically significant aneuploidies.16,17 Given that cfDNA detects only these aneuploidies, the other third will not be identified prenatally in patients who choose cfDNA. Traditional aneuploidy screening has been demonstrated to detect a broader range of these less common but clinically important chromosomal abnormalities.18
In one study of women found to be at increased risk based on traditional multiple marker screening, if cfDNA were chosen instead of diagnostic testing, 17% of the aneuploidies present in this group would not have been detected.18 Of all high-risk women in this study, 2%, or 1 in 50, had a chromosomal abnormality detectable by amniocentesis but not with cfDNA.
Successful tests require adequate placental DNA
Accurate interpretation of cfDNA screening also requires that an adequate quantity of placental DNA be present; this is often referred to as the “fetal fraction.” In some cases, the placental DNA volume is too low for accurate analysis, particularly in obese patients and women with specific chromosomal abnormalities.
Some laboratories measure this and do not report a result if the fetal fraction is below a specific cut-off, typically about 4%. Other laboratories do not measure or exclude cases with too little fetal DNA, raising concern that this could result in missing cases of aneuploidy. It has been noted that a placental DNA fraction of less than 8% is associated with less accurate test results, even if results are returned.8
Low fetal fraction also has been associated with maternal obesity, and in one study cfDNA failed to provide a result in 20% of women weighing more than 250 lb and 50% of women weighing more than 350 lb.19 Therefore, cfDNA is not the best option for obese women (TABLE 4).
TABLE 4 Appropriateness of cfDNA screeningin specific clinical circumstances
Optimal candidates for cfDNA screening
- High risk for trisomy based on maternal age (≥35 years)
- Ultrasound findings suggesting trisomy 13, 18, or 21
- History of prior pregnancy with trisomy 13, 18, or 21
- Positive traditional screening test
- Parental balanced Robertsonian translocation associated with risk for trisomy 13 or 21
Less optimal candidates
- Low risk for trisomy based on age and/or low risk traditional screening
- Ultrasound structural anomalies other than those specifically suggesting trisomy 13, 18, or 21
- High risk for nonchromosomal genetic disorder
- Comprehensive genetic diagnosis desired
- Maternal malignancy
- Maternal organ transplant
- Maternal sex chromosomal mosaicism or other chromosomal abnormality
- Maternal obesity
- Gestational age <10 weeks
While the free fraction is relatively constant from 10 to 22 weeks’ gestation, it is lower earlier than 10 weeks’ gestation and less likely to provide a result. For this reason, the test should not be attempted before 10 weeks’ gestation.
Recent evidence indicates that low fetal DNA fraction is associated with some chromosome abnormalities. Given this association, women with failed cfDNA results should be counseled and offered appropriate follow-up. As the association appears to be greater for trisomies 13 and 18, and triploidy, a careful ultrasound is likely to detect abnormalities in many such cases. However, it also is appropriate to offer the option of diagnostic testing, given the very high risk.
A repeat cfDNA test will be successful in some cases. Whether the patient chooses to attempt cfDNA again may depend in part on maternal body mass index (BMI), as well as gestational age—a patient at a more advanced gestation may not wish to delay obtaining definitive information given the high risk.
cfDNA screening has a low false-positive rate
One of the greatest benefits of cfDNA screening is a lower false-positive rate than is reported with traditional screening. However, when “no results” cases are also considered, the percentage of patients who require follow-up after cfDNA is close to that of traditional screening.
The chance of test failure is reported to be 0.9% to 8.1%,7,9,10 and varies in part by whether the laboratory measures fetal fraction and requires a minimum concentration.
A recent meta-analysis estimated the overall test failure rate at 3%.10 When comparing cfDNA to traditional screening, if “no results” cases are included with the “screen positive” group, the benefits of cfDNA over traditional screening are much less clear, particularly in a low-risk population.
ACOG: Offer traditional multiple-marker screening first
While multiple marker and cfDNA screening have differing performance characteristics, there are no data to support doing both tests concurrently. In fact, in a recent survey of nearly 200 women presented with different testing scenarios, women found it preferable and more reassuring to have a positive traditional screen followed by normal cfDNA results, rather that discrepant results of the 2 tests done concurrently.20
For many reasons, the approach recommended by ACOG and SMFM is to offer traditional multiple-marker screening first, and cfDNA screening or diagnostic testing as a follow-up for patients that screen positive. In that scenario, the benefits and limitations of diagnostic testing versus follow-up with cfDNA screening should be explained carefully.
In all patients who have a positive cfDNA result, diagnostic testing for confirmation should be offered and strongly recommended prior to pregnancy termination if that is considered. Even if a structural abnormality is present and a true positive result is highly likely, karyotyping is important to determine if there may be an inherited translocation putting subsequent pregnancies at higher risk.
Components of pretest counseling
A woman of any age can have a fetus with trisomy or another chromosomal abnormality, and some women prefer diagnostic testing or no testing regardless of age. It is therefore appropriate to offer diagnostic testing, screening, or the option of no testing to all women.
Recent studies have demonstrated that providing well-informed access to all prenatal tests results in more informed choices and no increase in uptake of invasive testing.22 However, the offer of prenatal testing requires discussion of the pros and cons of all test options, including the detection rates of all significant abnormalities, the screen positive rates, and recommended follow-up if an abnormal result is obtained. See TABLE 4.
Cost-effectiveness
Although the detection rate of cfDNA for trisomy 21 is higher than that of traditional screening, the detection rate of traditional screening is also quite high at lower cost. For low-risk women, therefore, traditional screening provides a less expensive alternative to cfDNA. Because aneuploidy is rare in low-risk patients, the residual chance of aneuploidy after a normal traditional screen is very low, and the cost per additional case of Down syndrome detected by cfDNA is very high.
In one study, this was estimated at $3.6 million.23 These authors suggested that, at present, cfDNA is optimally used as a secondary screen for high-risk women. Other cost analyses also have demonstrated that the most cost-effective strategy is a model in which cfDNA is used as a follow-up test in patients found to be screen positive by traditional screening.15,24 A recent cost utility analysis compared outcomes of 6 approaches to prenatal screening, including sequential screening, cfDNA screening, nuchal translucency only, and diagnostic testing with microarray (alone, in combination, or in sequence).
The clinical outcomes included fetal abnormalities detected, taking into account all chromosomal abnormalities, as well as failed cfDNA tests. For younger women (<40 yr), traditional sequential screening provided the highest detection of all abnormalities and was the optimal testing strategy, while cfDNA was preferable for women aged 40 or older, given the higher prevalence of trisomy 21.20
Incidental findings
Given that the cfDNA in maternal serum is a mixture of maternal and placental DNA, a number of biologic phenomena can cause a false-positive cfDNA result. In many cases, these false-positives reveal unanticipated or unexpected maternal conditions and information that the woman may have preferred not to know. A few cases of maternal malignancies with chromosomal abnormalities within the tumor have been reported in patients with false-positive cfDNA results.26
These case reports have raised the question about the need for further evaluation for maternal malignancy in women with false-positive results. Maternal genetic disorders also can cause false-positive results, and may lead to unanticipated detection of adult-onset conditions. In some cases, positive results for sex chromosomal aneuploidy can occur in pregnant women who themselves have a sex chromosomal abnormality, often in mosaic form and previously undiagnosed.27
Again, this has led to discussion of the possible health benefit of karyotyping women who have a false-positive cfDNA result to rule out a mosaic chromosomal abnormality in the mother.
At this time, the clinical utility of such investigations is unknown and there are no recommendations regarding appropriate follow-up for such cases.
CASE Resolved
Given the results of her cfDNA screening, your patient opts to undergo diagnostic testing. In that testing, trisomy 13 is ruled out and she goes on to have a healthy daughter.
Share your thoughts on this article! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.
- Bianchi DW, Parker RL, Wentworth J, et al. DNA sequencing versus standard prenatal aneuploidy screening. N Engl J Med. 2014;370(9):799–808.
- Norton ME, Jacobsson B, Swamy GK, et al. Cell-free DNA analysis for noninvasive examination of trisomy. N Engl J Med. 2015;372(17):1589–1597.
- Norton ME, Brar H, Weiss J, et al. Non-Invasive Chromosomal Evaluation (NICE) study: results of a multicenter prospective cohort study for detection of fetal trisomy 21 and trisomy 18. Am J Obstet Gynecol. 2012;207(2):137.e1–e8.
- Chitty LS, Mason S, Barrett AN, et al. Non-invasive prenatal diagnosis of achondroplasia and thanatophoric dysplasia: next-generation sequencing allows for a safer, more accurate, and comprehensive approach. Prenat Diagn. 2015;35(7):656–662.
- Wapner RJ, Babiarz JE, Levy B, et al. Expanding the scope of noninvasive prenatal testing: detection of fetal microdeletion syndromes. Am J Obstet Gynecol. 2015;212(3):332.e1–e9.
- Bianchi DW, Platt LD, Goldberg JD, Abuhamad AZ, Sehnert AJ, Rava RP. Genome-wide fetal aneuploidy detection by maternal plasma DNA sequencing. Obstet Gynecol. 2012;119(5):890–901.
- Palomaki GE, Kloza EM, Lambert-Messerlian GM, et al. DNA sequencing of maternal plasma to detect Down syndrome: an international clinical validation study. Genet Med. 2011;13(11):913–920.
- Sparks AB, Wang ET, Struble CA, et al. DNA sequencing of maternal plasma to detect Down syndrome: an international clinical validation study [abstract]. Proceedings of the ISPD 16th International Conference on Prenatal Diagnosis and Therapy; Miami, Florida; June 3–6, 2012. Prenat Diagn. 2012;32(suppl 1):s3–s9.
- Zimmermann B, Hill M, Gemelos G, et al. Noninvasive prenatal aneuploidy testing of chromosomes 13, 18, 21, X, and Y, using targeted sequencing of polymorphic loci. Prenat Diagn. 2012;32(13):1233–1241.
- Gil MM, Quezada MS, Revello R, Akolekar R, Niclaides KH. Analysis of cell-free DNA in maternal blood in screening for fetal aneuploidies: updated meta-analysis. Ultrasound Obstet Gynecol. 2015;45(3):249–266.
- American College of Obstetricians and Gynecologists. Committee Opinion No. 640: cell-free DNA screening for fetal aneuploidy. Obstet Gynecol. 2015;126(3):e31–e37.
- Society for Maternal-Fetal Medicine (SMFM) Publications Committee. Prenatal aneuploidy screening using cell-free DNA. Am J Obstet Gynecol. 2015;212(6):711–716.
- Baer RJ, Currier RJ, Norton ME, et al. Obstetric, perinatal, and fetal outcomes in pregnancies with false-positive integrated screening results. Obstet Gynecol. 2014;123(3):603–609.
- Dugoff L; Society for Maternal-Fetal Medicine. First- and second-trimester maternal serum markers for aneuploidy and adverse obstetric outcomes. Obstet Gynecol. 2010;115(5):1052–1061.
- American College of Obstetricians and Gynecologists. Practice bulletin No. 88: invasive prenatal testing for aneuploidy. Obstet Gynecol. 2007;110(6):1459–1467.
- Alamillo CM, Krantz D, Evans M, Fiddler M, Pergament E. Nearly a third of abnormalities found after first-trimester screening are different than expected: 10-year experience from a single center. Prenat Diagn. 2013;33(3):251–256.
- Wellesley D, Dolk H, Boyd PA, et al. Rare chromosome abnormalities, prevalence and prenatal diagnosis rates from population-based congenital anomaly registers in Europe. Eur J Hum Genet. 2012;20(5):521–526.
- Norton ME, Jelliffe-Pawlowski LL, Currier RJ. Chromosome abnormalities detected by current prenatal screening and noninvasive prenatal testing. Obstet Gynecol. 2014;124(5):979–986.
- Ashoor G, Syngelaki A, Poon LC, Rezende JC, Nicolaides KH. Fetal fraction in maternal plasma cell-free DNA at 11-13 weeks’ gestation: relation to maternal and fetal characteristics. Ultrasound Obstet Gynecol. 2013;41(1):26–32.
- Kaimal AJ, Norton ME, Kuppermann M. Prenatal testing in the genomic age: clinical outcomes, quality of life, and costs. Obstet Gynecol. 2015;126(4):737–746.
- Wapner RJ, Martin CL, Levy B, et al. Chromosomal microarray versus karyotyping for prenatal diagnosis. N Engl J Med. 2012;367(23):2175–2184.
- Kuppermann M, Pena S, Bishop JT, et al. Effect of enhanced information, values clarification, and removal of financial barriers on use of prenatal genetic testing: a randomized clinical trial. JAMA. 2014;312(12):1210–1217.
- Cuckle H, Benn P, Pergament E. Maternal cfDNA screening for Down syndrome—a cost sensitivity analysis. Prenat Diagn. 2013;33(7):636–642.
- Beulen L, Grutters JPC, Faas BH, Feenstra I, van Vugt JMG, Bekker MN. The consequences of implementing non-invasive prenatal testing in Dutch national health care: a cost-effectiveness analysis. Eur J Obstet Gynecol Reprod Biol. 2014;182:53–61.
- Okun N, Teitelbaum M, Huang T, Dewa CS, Hoch JS. The price of performance: a cost and performance analysis of the implementation of cell-free fetal DNA testing for Down syndrome in Ontario, Canada: Cost and performance analysis of cfDNA testing for Down syndrome in Ontario. Prenat Diagn. 2014;34(4):350–356.
- Bianchi DW, Chudova D, Sehnert AJ, et al. Noninvasive prenatal testing and incidental detection of occult maternal malignancies. JAMA. 2015;314(2):162–169.
- Wang Y, Chen Y, Tian F, et al. Maternal mosaicism is a significant contributor to discordant sex chromosomal aneuploidies associated with noninvasive prenatal testing. Clin Chem. 2014;60(1):251–259.
- Norton ME, Jelliffe-Pawlowski LL, Currier RJ. Chromosome abnormalities detected by current prenatal screening and noninvasive prenatal testing. Obstet Gynecol. 2014;124(5):979–986Society for Maternal-Fetal Medicine (SMFM) Publications Committee. Prenatal aneuploidy screening using cell-free DNA. Am J Obstet Gynecol. 2015;212(6):711–716.
- Bianchi DW, Parker RL, Wentworth J, et al. DNA sequencing versus standard prenatal aneuploidy screening. N Engl J Med. 2014;370(9):799–808.
- Norton ME, Jacobsson B, Swamy GK, et al. Cell-free DNA analysis for noninvasive examination of trisomy. N Engl J Med. 2015;372(17):1589–1597.
- Norton ME, Brar H, Weiss J, et al. Non-Invasive Chromosomal Evaluation (NICE) study: results of a multicenter prospective cohort study for detection of fetal trisomy 21 and trisomy 18. Am J Obstet Gynecol. 2012;207(2):137.e1–e8.
- Chitty LS, Mason S, Barrett AN, et al. Non-invasive prenatal diagnosis of achondroplasia and thanatophoric dysplasia: next-generation sequencing allows for a safer, more accurate, and comprehensive approach. Prenat Diagn. 2015;35(7):656–662.
- Wapner RJ, Babiarz JE, Levy B, et al. Expanding the scope of noninvasive prenatal testing: detection of fetal microdeletion syndromes. Am J Obstet Gynecol. 2015;212(3):332.e1–e9.
- Bianchi DW, Platt LD, Goldberg JD, Abuhamad AZ, Sehnert AJ, Rava RP. Genome-wide fetal aneuploidy detection by maternal plasma DNA sequencing. Obstet Gynecol. 2012;119(5):890–901.
- Palomaki GE, Kloza EM, Lambert-Messerlian GM, et al. DNA sequencing of maternal plasma to detect Down syndrome: an international clinical validation study. Genet Med. 2011;13(11):913–920.
- Sparks AB, Wang ET, Struble CA, et al. DNA sequencing of maternal plasma to detect Down syndrome: an international clinical validation study [abstract]. Proceedings of the ISPD 16th International Conference on Prenatal Diagnosis and Therapy; Miami, Florida; June 3–6, 2012. Prenat Diagn. 2012;32(suppl 1):s3–s9.
- Zimmermann B, Hill M, Gemelos G, et al. Noninvasive prenatal aneuploidy testing of chromosomes 13, 18, 21, X, and Y, using targeted sequencing of polymorphic loci. Prenat Diagn. 2012;32(13):1233–1241.
- Gil MM, Quezada MS, Revello R, Akolekar R, Niclaides KH. Analysis of cell-free DNA in maternal blood in screening for fetal aneuploidies: updated meta-analysis. Ultrasound Obstet Gynecol. 2015;45(3):249–266.
- American College of Obstetricians and Gynecologists. Committee Opinion No. 640: cell-free DNA screening for fetal aneuploidy. Obstet Gynecol. 2015;126(3):e31–e37.
- Society for Maternal-Fetal Medicine (SMFM) Publications Committee. Prenatal aneuploidy screening using cell-free DNA. Am J Obstet Gynecol. 2015;212(6):711–716.
- Baer RJ, Currier RJ, Norton ME, et al. Obstetric, perinatal, and fetal outcomes in pregnancies with false-positive integrated screening results. Obstet Gynecol. 2014;123(3):603–609.
- Dugoff L; Society for Maternal-Fetal Medicine. First- and second-trimester maternal serum markers for aneuploidy and adverse obstetric outcomes. Obstet Gynecol. 2010;115(5):1052–1061.
- American College of Obstetricians and Gynecologists. Practice bulletin No. 88: invasive prenatal testing for aneuploidy. Obstet Gynecol. 2007;110(6):1459–1467.
- Alamillo CM, Krantz D, Evans M, Fiddler M, Pergament E. Nearly a third of abnormalities found after first-trimester screening are different than expected: 10-year experience from a single center. Prenat Diagn. 2013;33(3):251–256.
- Wellesley D, Dolk H, Boyd PA, et al. Rare chromosome abnormalities, prevalence and prenatal diagnosis rates from population-based congenital anomaly registers in Europe. Eur J Hum Genet. 2012;20(5):521–526.
- Norton ME, Jelliffe-Pawlowski LL, Currier RJ. Chromosome abnormalities detected by current prenatal screening and noninvasive prenatal testing. Obstet Gynecol. 2014;124(5):979–986.
- Ashoor G, Syngelaki A, Poon LC, Rezende JC, Nicolaides KH. Fetal fraction in maternal plasma cell-free DNA at 11-13 weeks’ gestation: relation to maternal and fetal characteristics. Ultrasound Obstet Gynecol. 2013;41(1):26–32.
- Kaimal AJ, Norton ME, Kuppermann M. Prenatal testing in the genomic age: clinical outcomes, quality of life, and costs. Obstet Gynecol. 2015;126(4):737–746.
- Wapner RJ, Martin CL, Levy B, et al. Chromosomal microarray versus karyotyping for prenatal diagnosis. N Engl J Med. 2012;367(23):2175–2184.
- Kuppermann M, Pena S, Bishop JT, et al. Effect of enhanced information, values clarification, and removal of financial barriers on use of prenatal genetic testing: a randomized clinical trial. JAMA. 2014;312(12):1210–1217.
- Cuckle H, Benn P, Pergament E. Maternal cfDNA screening for Down syndrome—a cost sensitivity analysis. Prenat Diagn. 2013;33(7):636–642.
- Beulen L, Grutters JPC, Faas BH, Feenstra I, van Vugt JMG, Bekker MN. The consequences of implementing non-invasive prenatal testing in Dutch national health care: a cost-effectiveness analysis. Eur J Obstet Gynecol Reprod Biol. 2014;182:53–61.
- Okun N, Teitelbaum M, Huang T, Dewa CS, Hoch JS. The price of performance: a cost and performance analysis of the implementation of cell-free fetal DNA testing for Down syndrome in Ontario, Canada: Cost and performance analysis of cfDNA testing for Down syndrome in Ontario. Prenat Diagn. 2014;34(4):350–356.
- Bianchi DW, Chudova D, Sehnert AJ, et al. Noninvasive prenatal testing and incidental detection of occult maternal malignancies. JAMA. 2015;314(2):162–169.
- Wang Y, Chen Y, Tian F, et al. Maternal mosaicism is a significant contributor to discordant sex chromosomal aneuploidies associated with noninvasive prenatal testing. Clin Chem. 2014;60(1):251–259.
- Norton ME, Jelliffe-Pawlowski LL, Currier RJ. Chromosome abnormalities detected by current prenatal screening and noninvasive prenatal testing. Obstet Gynecol. 2014;124(5):979–986Society for Maternal-Fetal Medicine (SMFM) Publications Committee. Prenatal aneuploidy screening using cell-free DNA. Am J Obstet Gynecol. 2015;212(6):711–716.
In this Article
- Pros and cons of cfDNA in low-risk patients
- Optimal and less optimal candidates for cfDNA screening
- Checklist for pretest counseling for cfDNA
6 Supreme Court decisions that affected ObGyns in 2015
You might ask, why do I need to know what the Supreme Court does, it will not affect me! Well, we all know that is not exactly true. We chose these 6 cases because of their importance to ObGyns. In a number of them, the American Medical Association (AMA) or specific specialty board filed amicus curiae briefs, which suggested that the profession felt these were especially critical cases. (An amicus brief is a “friend of the Court” brief filed not by one of the affected parties, but by an organization or person with an interest or special expertise in the case.) You can find additional analysis of the 2015 term of the Supreme Court at the website of the National Register (http://www.nationalregister.org/pub/the-national-registerreport-pub/the-register-report-fall-2015/the-aca-survives-and-same-sex-marriage-thrives-the-2014-2015-supreme-court/).
1. Affordable Care Act upheld
King v Burwell was likely the Court’s most important case for physicians and their patients during the 2015 term.
At stake. The question was whether or not people who use the federal Affordable Care Act (ACA) Exchange could receive the same subsidy as those who use the state established Exchanges.1
Final ruling. The Court said “yes,” they could receive the same subsidy, ruling in favor of King.
Key points of the case
The ACA provides for state Exchanges (an electronic marketplace in which people can compare and purchase health insurance policies), but most states did not establish Exchanges. As a result, in many states the federal Exchange became the default. Because the ACA subsidies (which help many people afford mandated insurance coverage) are processed through exchanges, the question of whether those who used the federal Exchange received the subsidy was enormously important. Subsidies for millions of individuals depended on it.
The language of the ACA provides that the insurance subsidy is available only if the person(s) enroll in “an Exchange established by the State” (emphasis added).1 This case was about what “Exchange established by the State” means. A 6-justice majority held that the best interpretation of the statute was that it permitted subsidies through the federal Exchange. This was a difficult decision because, as the majority noted, the ACA is sloppily written. Nonetheless, the Court had to do its best to read the language in the context of the whole statute. Six justices held that the statute meant that the subsidies would cover people who signed up through federal as well as state Exchanges.
The dissenting justices essentially took the position that the language of the statute is clear. Among other things, the dissent said, it means that the words “established by the state” have no meaning at all in the statute, and it is unclear why Congress did not say “Exchange” instead of “Exchange established by the state.”
The results of the case were that the subsidies granted through the federal Exchange will continue. It will not expand the subsidies. Had the decision gone the other way, there would have been a real challenge to the future of the ACA. For that reason a number of medical and health care organizations filed amicus briefs with the Court in this case.
2. State licensing boards and antitrust
At stake. Antitrust laws prohibit combinations and conspiracies in restraint of trade. Competitors cannot come together to seek to set prices, divide the market, or prevent new competitors from entering the market. Since the 1940s, however, the Supreme Court has recognized a “state action” exception to the antitrust laws. The question before the Court this term was whether or not a state licensing board is included in the state-action immunity.2
The AMA and others filed an amicus brief in this case, noting threat to the public health if the Court disrupted state medical boards’ regulation of professional licensing and unauthorized practice.
Final ruling. The Court rejected this argument. It held that, where a state board is “controlled by active market participants” (as most state professional boards are), antitrust immunity is not automatic. For the immunity to protect boards, 2 conditions must exist, the Court held:
1. The state must have articulated a clear policy to allow the regulation that is an anticompetitive conduct (eg, licensing)
2. The state must have provided active supervision of the anticompetitive conduct. This requires that the state appoint someone or some group to approve policies of the board.
The first of these requirements often would be met by the statute setting up the board. The Court focused some attention on the second requirement. It concluded that “the adequacy of supervision otherwise will depend on all the circumstances of a case.”2
Key points of the case
In most states, this decision will require some kind of restructuring so that the professional boards are not the final decision makers but, in effect, only make recommendations to a “supervisor.” The Court gave short shrift to the AMA’s concerns that the decision might make it more difficult to attract really good professionals to the boards. The possibility of personal liability probably can be dealt with, but it deserves attention. The problems with litigation and antitrust claims, and reviews of decisions of a board (potentially by nonprofessionals) hardly can be a plus in attracting the right professionals to the boards.
This case will give rise to considerable litigation for many years. Medical boards should endeavor to get ahead of the issue by immediately studying ways in which the concerns of the Federal Trade Commissioncan be accommodated without significantly reducing the public protection that is part of well-administered professional licensing.
3. State reimbursement for Medicaid services
Medicaid is a federal-state program, and federal law requires, in part, that states must “assure that payments are … sufficient to enlist enough providers so that care and services are available under the plan at least to the extent that such care and services are available to the general population in the geographic area.”3 Providers claimed that the state had failed to establish such a payment system. A number of medical groups, including the AMA, filed amicus briefs in support of the providers.
At stake. State funding for various Medicaid services has been a problem for many health care professionals for some time. But the Medicaid law does not clearly give providers the right to file lawsuits claiming inadequate reimbursement,4 so the question in this case was whether or not there was an implied right to do so.
Final ruling. The Court, in a 5-4 decision, held that Medicaid providers do not have the authority to sue states in federal courts torequire that the states provide higher Medicaid rates for services.4 As a practical matter, this decision leaves with the states broad authority to set Medicaid reimbursement rates. It is possible, of course, that in the future Congress would change the law to grant such rights or more clearly set reimbursement rates.
4. False Claims Act cases
Unfortunately, False Claims Act cases occur in health care. False claims transpire when someone (or an organization) presents to the government a claim for payment that is not legitimate or is for inadequate or low quality services. False claims include everything from fraudulent billing for services never performed to a pharmaceutical company’s promotion of a drug for off-label use.
The federal False Claims Act incentivizes private whistleblowers (often disgruntled employees) to initiate false claims lawsuits. (The government may then choose to take over the false claims or allow the private whistleblower to pursue them.)
At stake. Because Medicare and Medicaid are federally financed programs, it is common for providers who participate in those programs to be subject to false claims.5 This term the Court heard an important False Claims Act case involving the statute of limitations and multiple claims based on the same activity. The AMA joined an amicus brief urging the Court to prohibit both kinds of expansion.
Final ruling. The Court agreed that the statute of limitations for these claims should not be extended, but it did determine that the “first-to-file” limitation in the statute “keeps new claims out of court only while related claims are still alive, not in perpetuity.”5 The result of this second holding is that the “firstto-file” rule does not preclude another false claims suit that is duplicative to be filed as soon as the prior suit is no longer pending.
It is not clear that the practical effect of the decision will be great, but it may in some cases open up clinicians to multiple, serial lawsuits over the same claims.
5. Pregnancy and employment discrimination
The federal Pregnancy Discrimination Act (PDA) prohibits discrimination “because of or on the basis of pregnancy, childbirth, or related medical conditions.” It also requires that employers treat “women affected by pregnancy . . . the same for all employment-related purposes . . . as other persons not so affected but similar in their ability or inability to work.”
At stake. United Parcel Service (UPS) declined to give a pregnant employee a “light duty” accommodation during pregnancy so that she could avoid having to lift heavy packages. But it had given other employees just that kind of accommodation when they were injured or lost certification to drive a delivery truck. The suit claimed violation of the PDA.6
Final ruling. The Court held that UPS violated the PDA by giving some employees this accommodation but refusing it to pregnant workers who requested it.6 Once an organization voluntarily grants a particular accommodation to, for example, a temporarily injured worker, it may be required to provide similar accommodation to pregnant workers. The case probably will increase employment protection for pregnant women.
6. Children “testifying” in abuse cases
All states require physicians and teachers, among others, to report suspected child abuse. An ongoing question has been whether those reporters may be called to testify about what the child said at the time of abuse discovery/suspicion. This case involved a teacher, but it could as easily have been a physician.7
Key points of the case. Teachers found suspicious injuries on 3-year-old L.P. The child gave conflicting statements about what happened, but claimed that Clark had hurt him. At Clark’s criminal trial, L.P. did not testify, but the state wanted to introduce L.P.’s statements to the teachers as evidence of Clark’s guilt.
At stake. The question was whether or not this introduction would violate the right of Clark to “confront his accuser” as guaranteed by the Constitution.
Final ruling. All 9 justices said it was proper to allow L.P.’s statements to be introduced at trial.7 Essentially this was permitted because the primary purpose of L.P.’s statements was not to gather testimony to be presented at trial.
The final opinion creates incentives for some prosecutors to make abuse victims unavailable in order to allow their testimony by hearsay. Aside from the legal technicalities, the likelihood of wrongful convictions under such a system must be considered for the long run.
Other major 2015 Supreme Court decisions
- The Constitution requires states to recognize same-sex marriages and also accept such marriages performed in other states.1 (The American Medical Association joined an amicus brief in this case.)
- The Court turned down the appeal of several inmates who had received lethal injection death sentences. They challenged the mix of drugs that Oklahoma planned to use to execute them.2
- In 2 cases justices went out of the way to raise questions about the constitutionality of the death penalty. This may suggest that the Court will take up this issue in the near future.2,3
- Federal housing discrimination laws were expanded to cases in which there is “disparate impact” discrimination.4
- The Court narrowed prosecution for “threatening” statements in social network/Internet communications by holding that negligence in the communication is not sufficient for conviction under federal law.5
- The Court held that the Environmental Protection Agency violated the Clean Air Act with its power plant emission regulations because it failed to do a proper cost-benefit analysis.6
References
1. Obergefell et al v Hodges, Director, Ohio Department of Health et al, No. 14–556 (2015). http://www.supremecourt.gov/opinions/14pdf/14-556_3204.pdf. Accessed December 14, 2015.
2. Glossip et al v Gross et al, No. 14–7955 (2015). http://www.supremecourt.gov/opinions/14pdf/14-7955_aplc.pdf. Accessed December 14, 2015.
3. Davis, Acting Worden v Ayala, No. 13–1428 (2015). http://www.supremecourt.gov/opinions/14pdf/13-1428_1a7d.pdf. Accessed December 14, 2015.
4. Texas Department of Housing and Community Affairs et al v Inclusive Communities Project, Inc et al, No. 13–1371 (2015). http://www.supremecourt.gov/opinions/14pdf/13-1371_8m58.pdf. Accessed December 14, 2015.
5. Elonis v United States, No. 13–983 (2015). http://www.supremecourt.gov/opinions/14pdf/13-983_7148.pdf. Accessed December 14, 2015.
6. Michigan et al v Environmental Protection Agency et al, No. 14–46 (2015). http://www.supremecourt.gov/opinions/14pdf/14-46_bqmc.pdf. Accessed December 14, 2015.
What’s coming in 2016
This term of the Supreme Court is a reminder of how important the decisions of the Court are to the work of physicians and ObGyns in particular. This trend is continuing—the Court already has, for the next term, accepted cases regarding abortion, contraception, and health care delivery. It will, therefore, be worthwhile to follow the developments at the nation’s highest court.
Share your thoughts on this article! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.
1. King et al v Burwell, Secretary of Health and Human Services et al, No. 14–114 (2015). http://www.supremecourt.gov/opinions/14pdf/14-114_qol1.pdf. Accessed December 14, 2015.
2. North Carolina State Board of Dental Examiners v Federal Trade Commission, No. 13–534 (2015). http://www.supremecourt.gov/opinions/14pd/13-534_19m2.pdf. Accessed December 14, 2015.
3. Federal Policy Guidance. Medicaid.gov website. http://medicaid.gov/federal-policy-guidance/federal-policyguidance.html. Accessed December 14, 2015.
4. Armstrong et al v Exceptional Child Center, Inc et al, No. 14–15 (2015). http://www.supremecourt.gov/opinions/14pdf/14-15_d1oe.pdf. Accessed December 14, 2015.
5. Kellogg Brown & Root Services, Inc et al v United States ex rel. Carter, No 12–1497 (2015). http://www.supremecourt.gov/opinions/14pdf/12-1497_2d8f.pdf. Accessed December 14, 2015.
6. Young v United Parcel Service, Inc., No. 12–1226 (2015). http://www.supremecourt.gov/opinions/14pdf/12-1226_k5fl.pdf. Accessed December 14, 2015.
7. Ohio v Clark, No. 13–1352 (2015). http://www.supremecourt.gov/opinion/14pdf/13-1352_ed9l.pdf. Accessed December 14, 2015.
You might ask, why do I need to know what the Supreme Court does, it will not affect me! Well, we all know that is not exactly true. We chose these 6 cases because of their importance to ObGyns. In a number of them, the American Medical Association (AMA) or specific specialty board filed amicus curiae briefs, which suggested that the profession felt these were especially critical cases. (An amicus brief is a “friend of the Court” brief filed not by one of the affected parties, but by an organization or person with an interest or special expertise in the case.) You can find additional analysis of the 2015 term of the Supreme Court at the website of the National Register (http://www.nationalregister.org/pub/the-national-registerreport-pub/the-register-report-fall-2015/the-aca-survives-and-same-sex-marriage-thrives-the-2014-2015-supreme-court/).
1. Affordable Care Act upheld
King v Burwell was likely the Court’s most important case for physicians and their patients during the 2015 term.
At stake. The question was whether or not people who use the federal Affordable Care Act (ACA) Exchange could receive the same subsidy as those who use the state established Exchanges.1
Final ruling. The Court said “yes,” they could receive the same subsidy, ruling in favor of King.
Key points of the case
The ACA provides for state Exchanges (an electronic marketplace in which people can compare and purchase health insurance policies), but most states did not establish Exchanges. As a result, in many states the federal Exchange became the default. Because the ACA subsidies (which help many people afford mandated insurance coverage) are processed through exchanges, the question of whether those who used the federal Exchange received the subsidy was enormously important. Subsidies for millions of individuals depended on it.
The language of the ACA provides that the insurance subsidy is available only if the person(s) enroll in “an Exchange established by the State” (emphasis added).1 This case was about what “Exchange established by the State” means. A 6-justice majority held that the best interpretation of the statute was that it permitted subsidies through the federal Exchange. This was a difficult decision because, as the majority noted, the ACA is sloppily written. Nonetheless, the Court had to do its best to read the language in the context of the whole statute. Six justices held that the statute meant that the subsidies would cover people who signed up through federal as well as state Exchanges.
The dissenting justices essentially took the position that the language of the statute is clear. Among other things, the dissent said, it means that the words “established by the state” have no meaning at all in the statute, and it is unclear why Congress did not say “Exchange” instead of “Exchange established by the state.”
The results of the case were that the subsidies granted through the federal Exchange will continue. It will not expand the subsidies. Had the decision gone the other way, there would have been a real challenge to the future of the ACA. For that reason a number of medical and health care organizations filed amicus briefs with the Court in this case.
2. State licensing boards and antitrust
At stake. Antitrust laws prohibit combinations and conspiracies in restraint of trade. Competitors cannot come together to seek to set prices, divide the market, or prevent new competitors from entering the market. Since the 1940s, however, the Supreme Court has recognized a “state action” exception to the antitrust laws. The question before the Court this term was whether or not a state licensing board is included in the state-action immunity.2
The AMA and others filed an amicus brief in this case, noting threat to the public health if the Court disrupted state medical boards’ regulation of professional licensing and unauthorized practice.
Final ruling. The Court rejected this argument. It held that, where a state board is “controlled by active market participants” (as most state professional boards are), antitrust immunity is not automatic. For the immunity to protect boards, 2 conditions must exist, the Court held:
1. The state must have articulated a clear policy to allow the regulation that is an anticompetitive conduct (eg, licensing)
2. The state must have provided active supervision of the anticompetitive conduct. This requires that the state appoint someone or some group to approve policies of the board.
The first of these requirements often would be met by the statute setting up the board. The Court focused some attention on the second requirement. It concluded that “the adequacy of supervision otherwise will depend on all the circumstances of a case.”2
Key points of the case
In most states, this decision will require some kind of restructuring so that the professional boards are not the final decision makers but, in effect, only make recommendations to a “supervisor.” The Court gave short shrift to the AMA’s concerns that the decision might make it more difficult to attract really good professionals to the boards. The possibility of personal liability probably can be dealt with, but it deserves attention. The problems with litigation and antitrust claims, and reviews of decisions of a board (potentially by nonprofessionals) hardly can be a plus in attracting the right professionals to the boards.
This case will give rise to considerable litigation for many years. Medical boards should endeavor to get ahead of the issue by immediately studying ways in which the concerns of the Federal Trade Commissioncan be accommodated without significantly reducing the public protection that is part of well-administered professional licensing.
3. State reimbursement for Medicaid services
Medicaid is a federal-state program, and federal law requires, in part, that states must “assure that payments are … sufficient to enlist enough providers so that care and services are available under the plan at least to the extent that such care and services are available to the general population in the geographic area.”3 Providers claimed that the state had failed to establish such a payment system. A number of medical groups, including the AMA, filed amicus briefs in support of the providers.
At stake. State funding for various Medicaid services has been a problem for many health care professionals for some time. But the Medicaid law does not clearly give providers the right to file lawsuits claiming inadequate reimbursement,4 so the question in this case was whether or not there was an implied right to do so.
Final ruling. The Court, in a 5-4 decision, held that Medicaid providers do not have the authority to sue states in federal courts torequire that the states provide higher Medicaid rates for services.4 As a practical matter, this decision leaves with the states broad authority to set Medicaid reimbursement rates. It is possible, of course, that in the future Congress would change the law to grant such rights or more clearly set reimbursement rates.
4. False Claims Act cases
Unfortunately, False Claims Act cases occur in health care. False claims transpire when someone (or an organization) presents to the government a claim for payment that is not legitimate or is for inadequate or low quality services. False claims include everything from fraudulent billing for services never performed to a pharmaceutical company’s promotion of a drug for off-label use.
The federal False Claims Act incentivizes private whistleblowers (often disgruntled employees) to initiate false claims lawsuits. (The government may then choose to take over the false claims or allow the private whistleblower to pursue them.)
At stake. Because Medicare and Medicaid are federally financed programs, it is common for providers who participate in those programs to be subject to false claims.5 This term the Court heard an important False Claims Act case involving the statute of limitations and multiple claims based on the same activity. The AMA joined an amicus brief urging the Court to prohibit both kinds of expansion.
Final ruling. The Court agreed that the statute of limitations for these claims should not be extended, but it did determine that the “first-to-file” limitation in the statute “keeps new claims out of court only while related claims are still alive, not in perpetuity.”5 The result of this second holding is that the “firstto-file” rule does not preclude another false claims suit that is duplicative to be filed as soon as the prior suit is no longer pending.
It is not clear that the practical effect of the decision will be great, but it may in some cases open up clinicians to multiple, serial lawsuits over the same claims.
5. Pregnancy and employment discrimination
The federal Pregnancy Discrimination Act (PDA) prohibits discrimination “because of or on the basis of pregnancy, childbirth, or related medical conditions.” It also requires that employers treat “women affected by pregnancy . . . the same for all employment-related purposes . . . as other persons not so affected but similar in their ability or inability to work.”
At stake. United Parcel Service (UPS) declined to give a pregnant employee a “light duty” accommodation during pregnancy so that she could avoid having to lift heavy packages. But it had given other employees just that kind of accommodation when they were injured or lost certification to drive a delivery truck. The suit claimed violation of the PDA.6
Final ruling. The Court held that UPS violated the PDA by giving some employees this accommodation but refusing it to pregnant workers who requested it.6 Once an organization voluntarily grants a particular accommodation to, for example, a temporarily injured worker, it may be required to provide similar accommodation to pregnant workers. The case probably will increase employment protection for pregnant women.
6. Children “testifying” in abuse cases
All states require physicians and teachers, among others, to report suspected child abuse. An ongoing question has been whether those reporters may be called to testify about what the child said at the time of abuse discovery/suspicion. This case involved a teacher, but it could as easily have been a physician.7
Key points of the case. Teachers found suspicious injuries on 3-year-old L.P. The child gave conflicting statements about what happened, but claimed that Clark had hurt him. At Clark’s criminal trial, L.P. did not testify, but the state wanted to introduce L.P.’s statements to the teachers as evidence of Clark’s guilt.
At stake. The question was whether or not this introduction would violate the right of Clark to “confront his accuser” as guaranteed by the Constitution.
Final ruling. All 9 justices said it was proper to allow L.P.’s statements to be introduced at trial.7 Essentially this was permitted because the primary purpose of L.P.’s statements was not to gather testimony to be presented at trial.
The final opinion creates incentives for some prosecutors to make abuse victims unavailable in order to allow their testimony by hearsay. Aside from the legal technicalities, the likelihood of wrongful convictions under such a system must be considered for the long run.
Other major 2015 Supreme Court decisions
- The Constitution requires states to recognize same-sex marriages and also accept such marriages performed in other states.1 (The American Medical Association joined an amicus brief in this case.)
- The Court turned down the appeal of several inmates who had received lethal injection death sentences. They challenged the mix of drugs that Oklahoma planned to use to execute them.2
- In 2 cases justices went out of the way to raise questions about the constitutionality of the death penalty. This may suggest that the Court will take up this issue in the near future.2,3
- Federal housing discrimination laws were expanded to cases in which there is “disparate impact” discrimination.4
- The Court narrowed prosecution for “threatening” statements in social network/Internet communications by holding that negligence in the communication is not sufficient for conviction under federal law.5
- The Court held that the Environmental Protection Agency violated the Clean Air Act with its power plant emission regulations because it failed to do a proper cost-benefit analysis.6
References
1. Obergefell et al v Hodges, Director, Ohio Department of Health et al, No. 14–556 (2015). http://www.supremecourt.gov/opinions/14pdf/14-556_3204.pdf. Accessed December 14, 2015.
2. Glossip et al v Gross et al, No. 14–7955 (2015). http://www.supremecourt.gov/opinions/14pdf/14-7955_aplc.pdf. Accessed December 14, 2015.
3. Davis, Acting Worden v Ayala, No. 13–1428 (2015). http://www.supremecourt.gov/opinions/14pdf/13-1428_1a7d.pdf. Accessed December 14, 2015.
4. Texas Department of Housing and Community Affairs et al v Inclusive Communities Project, Inc et al, No. 13–1371 (2015). http://www.supremecourt.gov/opinions/14pdf/13-1371_8m58.pdf. Accessed December 14, 2015.
5. Elonis v United States, No. 13–983 (2015). http://www.supremecourt.gov/opinions/14pdf/13-983_7148.pdf. Accessed December 14, 2015.
6. Michigan et al v Environmental Protection Agency et al, No. 14–46 (2015). http://www.supremecourt.gov/opinions/14pdf/14-46_bqmc.pdf. Accessed December 14, 2015.
What’s coming in 2016
This term of the Supreme Court is a reminder of how important the decisions of the Court are to the work of physicians and ObGyns in particular. This trend is continuing—the Court already has, for the next term, accepted cases regarding abortion, contraception, and health care delivery. It will, therefore, be worthwhile to follow the developments at the nation’s highest court.
Share your thoughts on this article! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.
You might ask, why do I need to know what the Supreme Court does, it will not affect me! Well, we all know that is not exactly true. We chose these 6 cases because of their importance to ObGyns. In a number of them, the American Medical Association (AMA) or specific specialty board filed amicus curiae briefs, which suggested that the profession felt these were especially critical cases. (An amicus brief is a “friend of the Court” brief filed not by one of the affected parties, but by an organization or person with an interest or special expertise in the case.) You can find additional analysis of the 2015 term of the Supreme Court at the website of the National Register (http://www.nationalregister.org/pub/the-national-registerreport-pub/the-register-report-fall-2015/the-aca-survives-and-same-sex-marriage-thrives-the-2014-2015-supreme-court/).
1. Affordable Care Act upheld
King v Burwell was likely the Court’s most important case for physicians and their patients during the 2015 term.
At stake. The question was whether or not people who use the federal Affordable Care Act (ACA) Exchange could receive the same subsidy as those who use the state established Exchanges.1
Final ruling. The Court said “yes,” they could receive the same subsidy, ruling in favor of King.
Key points of the case
The ACA provides for state Exchanges (an electronic marketplace in which people can compare and purchase health insurance policies), but most states did not establish Exchanges. As a result, in many states the federal Exchange became the default. Because the ACA subsidies (which help many people afford mandated insurance coverage) are processed through exchanges, the question of whether those who used the federal Exchange received the subsidy was enormously important. Subsidies for millions of individuals depended on it.
The language of the ACA provides that the insurance subsidy is available only if the person(s) enroll in “an Exchange established by the State” (emphasis added).1 This case was about what “Exchange established by the State” means. A 6-justice majority held that the best interpretation of the statute was that it permitted subsidies through the federal Exchange. This was a difficult decision because, as the majority noted, the ACA is sloppily written. Nonetheless, the Court had to do its best to read the language in the context of the whole statute. Six justices held that the statute meant that the subsidies would cover people who signed up through federal as well as state Exchanges.
The dissenting justices essentially took the position that the language of the statute is clear. Among other things, the dissent said, it means that the words “established by the state” have no meaning at all in the statute, and it is unclear why Congress did not say “Exchange” instead of “Exchange established by the state.”
The results of the case were that the subsidies granted through the federal Exchange will continue. It will not expand the subsidies. Had the decision gone the other way, there would have been a real challenge to the future of the ACA. For that reason a number of medical and health care organizations filed amicus briefs with the Court in this case.
2. State licensing boards and antitrust
At stake. Antitrust laws prohibit combinations and conspiracies in restraint of trade. Competitors cannot come together to seek to set prices, divide the market, or prevent new competitors from entering the market. Since the 1940s, however, the Supreme Court has recognized a “state action” exception to the antitrust laws. The question before the Court this term was whether or not a state licensing board is included in the state-action immunity.2
The AMA and others filed an amicus brief in this case, noting threat to the public health if the Court disrupted state medical boards’ regulation of professional licensing and unauthorized practice.
Final ruling. The Court rejected this argument. It held that, where a state board is “controlled by active market participants” (as most state professional boards are), antitrust immunity is not automatic. For the immunity to protect boards, 2 conditions must exist, the Court held:
1. The state must have articulated a clear policy to allow the regulation that is an anticompetitive conduct (eg, licensing)
2. The state must have provided active supervision of the anticompetitive conduct. This requires that the state appoint someone or some group to approve policies of the board.
The first of these requirements often would be met by the statute setting up the board. The Court focused some attention on the second requirement. It concluded that “the adequacy of supervision otherwise will depend on all the circumstances of a case.”2
Key points of the case
In most states, this decision will require some kind of restructuring so that the professional boards are not the final decision makers but, in effect, only make recommendations to a “supervisor.” The Court gave short shrift to the AMA’s concerns that the decision might make it more difficult to attract really good professionals to the boards. The possibility of personal liability probably can be dealt with, but it deserves attention. The problems with litigation and antitrust claims, and reviews of decisions of a board (potentially by nonprofessionals) hardly can be a plus in attracting the right professionals to the boards.
This case will give rise to considerable litigation for many years. Medical boards should endeavor to get ahead of the issue by immediately studying ways in which the concerns of the Federal Trade Commissioncan be accommodated without significantly reducing the public protection that is part of well-administered professional licensing.
3. State reimbursement for Medicaid services
Medicaid is a federal-state program, and federal law requires, in part, that states must “assure that payments are … sufficient to enlist enough providers so that care and services are available under the plan at least to the extent that such care and services are available to the general population in the geographic area.”3 Providers claimed that the state had failed to establish such a payment system. A number of medical groups, including the AMA, filed amicus briefs in support of the providers.
At stake. State funding for various Medicaid services has been a problem for many health care professionals for some time. But the Medicaid law does not clearly give providers the right to file lawsuits claiming inadequate reimbursement,4 so the question in this case was whether or not there was an implied right to do so.
Final ruling. The Court, in a 5-4 decision, held that Medicaid providers do not have the authority to sue states in federal courts torequire that the states provide higher Medicaid rates for services.4 As a practical matter, this decision leaves with the states broad authority to set Medicaid reimbursement rates. It is possible, of course, that in the future Congress would change the law to grant such rights or more clearly set reimbursement rates.
4. False Claims Act cases
Unfortunately, False Claims Act cases occur in health care. False claims transpire when someone (or an organization) presents to the government a claim for payment that is not legitimate or is for inadequate or low quality services. False claims include everything from fraudulent billing for services never performed to a pharmaceutical company’s promotion of a drug for off-label use.
The federal False Claims Act incentivizes private whistleblowers (often disgruntled employees) to initiate false claims lawsuits. (The government may then choose to take over the false claims or allow the private whistleblower to pursue them.)
At stake. Because Medicare and Medicaid are federally financed programs, it is common for providers who participate in those programs to be subject to false claims.5 This term the Court heard an important False Claims Act case involving the statute of limitations and multiple claims based on the same activity. The AMA joined an amicus brief urging the Court to prohibit both kinds of expansion.
Final ruling. The Court agreed that the statute of limitations for these claims should not be extended, but it did determine that the “first-to-file” limitation in the statute “keeps new claims out of court only while related claims are still alive, not in perpetuity.”5 The result of this second holding is that the “firstto-file” rule does not preclude another false claims suit that is duplicative to be filed as soon as the prior suit is no longer pending.
It is not clear that the practical effect of the decision will be great, but it may in some cases open up clinicians to multiple, serial lawsuits over the same claims.
5. Pregnancy and employment discrimination
The federal Pregnancy Discrimination Act (PDA) prohibits discrimination “because of or on the basis of pregnancy, childbirth, or related medical conditions.” It also requires that employers treat “women affected by pregnancy . . . the same for all employment-related purposes . . . as other persons not so affected but similar in their ability or inability to work.”
At stake. United Parcel Service (UPS) declined to give a pregnant employee a “light duty” accommodation during pregnancy so that she could avoid having to lift heavy packages. But it had given other employees just that kind of accommodation when they were injured or lost certification to drive a delivery truck. The suit claimed violation of the PDA.6
Final ruling. The Court held that UPS violated the PDA by giving some employees this accommodation but refusing it to pregnant workers who requested it.6 Once an organization voluntarily grants a particular accommodation to, for example, a temporarily injured worker, it may be required to provide similar accommodation to pregnant workers. The case probably will increase employment protection for pregnant women.
6. Children “testifying” in abuse cases
All states require physicians and teachers, among others, to report suspected child abuse. An ongoing question has been whether those reporters may be called to testify about what the child said at the time of abuse discovery/suspicion. This case involved a teacher, but it could as easily have been a physician.7
Key points of the case. Teachers found suspicious injuries on 3-year-old L.P. The child gave conflicting statements about what happened, but claimed that Clark had hurt him. At Clark’s criminal trial, L.P. did not testify, but the state wanted to introduce L.P.’s statements to the teachers as evidence of Clark’s guilt.
At stake. The question was whether or not this introduction would violate the right of Clark to “confront his accuser” as guaranteed by the Constitution.
Final ruling. All 9 justices said it was proper to allow L.P.’s statements to be introduced at trial.7 Essentially this was permitted because the primary purpose of L.P.’s statements was not to gather testimony to be presented at trial.
The final opinion creates incentives for some prosecutors to make abuse victims unavailable in order to allow their testimony by hearsay. Aside from the legal technicalities, the likelihood of wrongful convictions under such a system must be considered for the long run.
Other major 2015 Supreme Court decisions
- The Constitution requires states to recognize same-sex marriages and also accept such marriages performed in other states.1 (The American Medical Association joined an amicus brief in this case.)
- The Court turned down the appeal of several inmates who had received lethal injection death sentences. They challenged the mix of drugs that Oklahoma planned to use to execute them.2
- In 2 cases justices went out of the way to raise questions about the constitutionality of the death penalty. This may suggest that the Court will take up this issue in the near future.2,3
- Federal housing discrimination laws were expanded to cases in which there is “disparate impact” discrimination.4
- The Court narrowed prosecution for “threatening” statements in social network/Internet communications by holding that negligence in the communication is not sufficient for conviction under federal law.5
- The Court held that the Environmental Protection Agency violated the Clean Air Act with its power plant emission regulations because it failed to do a proper cost-benefit analysis.6
References
1. Obergefell et al v Hodges, Director, Ohio Department of Health et al, No. 14–556 (2015). http://www.supremecourt.gov/opinions/14pdf/14-556_3204.pdf. Accessed December 14, 2015.
2. Glossip et al v Gross et al, No. 14–7955 (2015). http://www.supremecourt.gov/opinions/14pdf/14-7955_aplc.pdf. Accessed December 14, 2015.
3. Davis, Acting Worden v Ayala, No. 13–1428 (2015). http://www.supremecourt.gov/opinions/14pdf/13-1428_1a7d.pdf. Accessed December 14, 2015.
4. Texas Department of Housing and Community Affairs et al v Inclusive Communities Project, Inc et al, No. 13–1371 (2015). http://www.supremecourt.gov/opinions/14pdf/13-1371_8m58.pdf. Accessed December 14, 2015.
5. Elonis v United States, No. 13–983 (2015). http://www.supremecourt.gov/opinions/14pdf/13-983_7148.pdf. Accessed December 14, 2015.
6. Michigan et al v Environmental Protection Agency et al, No. 14–46 (2015). http://www.supremecourt.gov/opinions/14pdf/14-46_bqmc.pdf. Accessed December 14, 2015.
What’s coming in 2016
This term of the Supreme Court is a reminder of how important the decisions of the Court are to the work of physicians and ObGyns in particular. This trend is continuing—the Court already has, for the next term, accepted cases regarding abortion, contraception, and health care delivery. It will, therefore, be worthwhile to follow the developments at the nation’s highest court.
Share your thoughts on this article! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.
1. King et al v Burwell, Secretary of Health and Human Services et al, No. 14–114 (2015). http://www.supremecourt.gov/opinions/14pdf/14-114_qol1.pdf. Accessed December 14, 2015.
2. North Carolina State Board of Dental Examiners v Federal Trade Commission, No. 13–534 (2015). http://www.supremecourt.gov/opinions/14pd/13-534_19m2.pdf. Accessed December 14, 2015.
3. Federal Policy Guidance. Medicaid.gov website. http://medicaid.gov/federal-policy-guidance/federal-policyguidance.html. Accessed December 14, 2015.
4. Armstrong et al v Exceptional Child Center, Inc et al, No. 14–15 (2015). http://www.supremecourt.gov/opinions/14pdf/14-15_d1oe.pdf. Accessed December 14, 2015.
5. Kellogg Brown & Root Services, Inc et al v United States ex rel. Carter, No 12–1497 (2015). http://www.supremecourt.gov/opinions/14pdf/12-1497_2d8f.pdf. Accessed December 14, 2015.
6. Young v United Parcel Service, Inc., No. 12–1226 (2015). http://www.supremecourt.gov/opinions/14pdf/12-1226_k5fl.pdf. Accessed December 14, 2015.
7. Ohio v Clark, No. 13–1352 (2015). http://www.supremecourt.gov/opinion/14pdf/13-1352_ed9l.pdf. Accessed December 14, 2015.
1. King et al v Burwell, Secretary of Health and Human Services et al, No. 14–114 (2015). http://www.supremecourt.gov/opinions/14pdf/14-114_qol1.pdf. Accessed December 14, 2015.
2. North Carolina State Board of Dental Examiners v Federal Trade Commission, No. 13–534 (2015). http://www.supremecourt.gov/opinions/14pd/13-534_19m2.pdf. Accessed December 14, 2015.
3. Federal Policy Guidance. Medicaid.gov website. http://medicaid.gov/federal-policy-guidance/federal-policyguidance.html. Accessed December 14, 2015.
4. Armstrong et al v Exceptional Child Center, Inc et al, No. 14–15 (2015). http://www.supremecourt.gov/opinions/14pdf/14-15_d1oe.pdf. Accessed December 14, 2015.
5. Kellogg Brown & Root Services, Inc et al v United States ex rel. Carter, No 12–1497 (2015). http://www.supremecourt.gov/opinions/14pdf/12-1497_2d8f.pdf. Accessed December 14, 2015.
6. Young v United Parcel Service, Inc., No. 12–1226 (2015). http://www.supremecourt.gov/opinions/14pdf/12-1226_k5fl.pdf. Accessed December 14, 2015.
7. Ohio v Clark, No. 13–1352 (2015). http://www.supremecourt.gov/opinion/14pdf/13-1352_ed9l.pdf. Accessed December 14, 2015.
Should you adopt the practice of vaginal cleansing with povidone-iodine prior to cesarean delivery?
There are approximately 4,000,000 births annually in the United States, and about 32% of them occur by cesarean delivery. Compared with vaginal birth, cesarean delivery is associated with an increased risk of endometritis (defined as fever plus uterine or abdominal tenderness). Although surgical complications cannot be eliminated entirely, surgeons are deeply dedicated to the continuous improvement of surgical practice in order to reduce the risk of complications.
With cesarean delivery, many surgical practices have been adopted universally to reduce postoperative complications, including administration of intravenous (IV) antibiotics before skin incision to minimize postoperative infection and the use of postoperative mechanical or pharmacologic interventions to help prevent venous thromboembolism and pulmonary embolism. Preoperative vaginal cleansing with povidone-iodine may reduce the risk of postoperative endometritis, but the practice is not currently common in the United States.
Should you adopt a policy of preoperative vaginal cleansing prior to cesarean delivery? The data suggest perhaps you should.
Data-driven support for povidone-iodine precesareanThree large randomized trials published within the past 10 years concluded that preoperative vaginal cleansing with povidone-iodine reduced the risk of postcesarean endometritis in women who also received prophylactic IV antibiotics (TABLE).1−3 Vaginal cleansing did not reduce the rate of postpartum fever or wound infection in these studies.
Clinical factors that increased the risk of postpartum endometritis independent of vaginal cleansing included:
- extended duration of cesarean surgery
- being in labor prior to cesarean delivery
- ruptured membranes
- advanced cervical examination
- maternal anemia
- use of intrapartum internal monitors
- prior history of genitourinary infection.
Authors of two recent, large nonrandomized studies also have reported that vaginal cleansing reduced the risk of postcesarean endometritis.4,5 By contrast, investigators from one large trial from 2001 did not observe a decrease in endometritis with vaginal cleansing.6
To test the impact of metronidazole vaginal gel on post‑cesarean endometritis, 224 women undergoing cesarean delivery for various indications were randomly assigned to placebo vaginal gel or metronidazole vaginal gel 5 g prior to surgery initiation.1 Most women also received intravenous antibiotics. The rates of endometritis were 17% and 7% in the placebo and metronidazole groups, respectively (relative risk, 0.42; 95% confidence interval, 0.19−0.92).
Vaginal antibiotic administration shows promise as an alternative to povidone-iodine cleansing in the prevention of postcesarean endometritis. Additional randomized clinical trials are necessary to fully evaluate the benefits and risks of this practice.
Reference
1. Pitt C, Sanchez-Ramos L, Kaunitz AM. Adjunctive intravaginal metronidazole for the prevention of postcesarean endometritis: a randomized controlled trial. Obstet Gynecol. 2001;98(5 pt 1):745−750.
Cochrane review of precesarean vaginal cleansingAuthors of a Cochrane review, in which they synthesized 7 studies involving 2,635 women, reported that vaginal cleansing with povidone-iodine immediately before cesarean delivery was associated with a reduced risk of postcesarean endometritis: 8.3% vs 4.3% in the control and vaginal cleansing groups, respectively, (risk ratio [RR], 0.45; 95% confidence interval [CI], 0.25−0.81).7
The positive effect of vaginal cleansing was particularly noteworthy in the subgroup of women with ruptured membranes (3 trials involving 272 women). The rates of endometritis in the control versus vaginal cleansing groups were 17.9% and 4.3%, respectively (RR, 0.24; 95% CI, 0.10−0.55).
Women who went into labor prior to cesarean delivery (523 women from 3 trials) also benefitted from vaginal cleansing, with endometritis rates of 13.0% and 7.4% in the control and vaginal cleansing groups, respectively (RR, 0.56; 95% CI, 0.34−0.95).
In this review, again, vaginal cleansing did not significantly reduce the rate of postoperative fever or wound infection.
The American College of Obstetricians and Gynecologists has noted that chlorohexidine gluconate solutions with high concentrations of alcohol are contraindicated for vaginal cleansing.1 However, although not approved for vaginal cleansing, solutions of chlorohexidine gluconate with low alcohol content (4% alcohol concentration) are safe and may be effective for off-label use as vaginal cleansings.
Reference
1. American College of Obstetricians and Gynecologists Women’s Health Care Physicians; Committee on Gynecologic Practice. Committee Opinion No. 571: solutions for surgical cleansing of the vagina. Obstet Gynecol. 2013;122(3):718−720.
Is vaginal cleansing prior to cesarean delivery best practice?In the United States, precesarean vaginal cleansing is not a common practice. To close the gap between current practice and what is potentially a best practice, two approaches to using vaginal cleansing could be instituted in delivery units.
Approach #1: A liberal clinical protocol. In this scenario, all women (who are not allergic to iodine or povidone-iodine) undergoing cesarean delivery should undergo vaginal cleansing. The World Health Organization conditionally recommends vaginal cleansing for all women undergoing a cesarean delivery.8
Approach #2: A focused clinical protocol. For this protocol, only women (again, who are not allergic to iodine or povidone-iodine) who have ruptured membranes or are in labor upon advanced cervical examination should receive vaginal cleansing.
The advantage of a liberal protocol is that vaginal preparation becomes embedded within the standard practice of cesarean delivery and, hence, is seldom overlooked. The upside of the focused protocol is that only those women most likely to benefit receive the intervention.
Tell me what you thinkWill you consider using vaginal cleansing in your practice? Please let me know your views on vaginal cleansing for cesarean delivery, as well as your clinical pearls on cesarean delivery surgery, at obgmanagement.com. In addition, weigh in on the Quick Poll posted to OBG Management’s homepage. Send your letter to the editor to rbarbieri@frontlinemedcom.com.
- Starr RV, Zurawski J, Ismail M. Preoperative vaginal preparation with povidone-iodine and the risk of postcesarean endometritis. Obstet Gynecol. 2015;105(5 pt 1):1024–1029.
- Haas DM, Pazouki F, Smith RR, et al. Vaginal cleansing before cesarean delivery to reduce postoperative infectious morbidity: a randomized, controlled trial. Am J Obstet Gynecol. 2010;202(3):310.e1–e6.
- Yildrim G, Gungorduk K, Asicioglu O, et al. Does vaginal preparation with povidone-iodine prior to cesarean delivery reduce the risk of endometritis?A randomized controlled trial. J Matern Fetal Neonatal Med. 2012;25(11):2316–2321.
- Asghania M, Mirblouk F, Shakiba M, Faraji R. Preoperative vaginal preparation with povidone-iodine on post-cesarean infectious morbidity. J Obstet Gynaecol. 2011;31(5):400–403.
- Memon S, Qazi RA, Bibi S, Parveen N. Effect of preoperative vaginal cleansing with an antiseptic solution to reduce post caesarean infectious morbidity. J Pak Med Assoc. 2011;61(12):1179–1183.
- Reid VC, Hartmann KE, McMahon M, Fry EP. Vaginal preparation with povidone-iodine and postcesarean infectious morbidity: a randomized controlled trial. Obstet Gynecol. 2001;97(1):147–152.
- Haas DM, Morgan S, Contreras K. Vaginal preparation with antiseptic solution before cesarean section for preventing postoperative infections. Cochrane Database Syst Rev. 2014;12:CD007892.
- Yildrim G, Gungorduk K, Asicioglu O, et al. Does vaginal preparation with povidone-iodine prior to
There are approximately 4,000,000 births annually in the United States, and about 32% of them occur by cesarean delivery. Compared with vaginal birth, cesarean delivery is associated with an increased risk of endometritis (defined as fever plus uterine or abdominal tenderness). Although surgical complications cannot be eliminated entirely, surgeons are deeply dedicated to the continuous improvement of surgical practice in order to reduce the risk of complications.
With cesarean delivery, many surgical practices have been adopted universally to reduce postoperative complications, including administration of intravenous (IV) antibiotics before skin incision to minimize postoperative infection and the use of postoperative mechanical or pharmacologic interventions to help prevent venous thromboembolism and pulmonary embolism. Preoperative vaginal cleansing with povidone-iodine may reduce the risk of postoperative endometritis, but the practice is not currently common in the United States.
Should you adopt a policy of preoperative vaginal cleansing prior to cesarean delivery? The data suggest perhaps you should.
Data-driven support for povidone-iodine precesareanThree large randomized trials published within the past 10 years concluded that preoperative vaginal cleansing with povidone-iodine reduced the risk of postcesarean endometritis in women who also received prophylactic IV antibiotics (TABLE).1−3 Vaginal cleansing did not reduce the rate of postpartum fever or wound infection in these studies.
Clinical factors that increased the risk of postpartum endometritis independent of vaginal cleansing included:
- extended duration of cesarean surgery
- being in labor prior to cesarean delivery
- ruptured membranes
- advanced cervical examination
- maternal anemia
- use of intrapartum internal monitors
- prior history of genitourinary infection.
Authors of two recent, large nonrandomized studies also have reported that vaginal cleansing reduced the risk of postcesarean endometritis.4,5 By contrast, investigators from one large trial from 2001 did not observe a decrease in endometritis with vaginal cleansing.6
To test the impact of metronidazole vaginal gel on post‑cesarean endometritis, 224 women undergoing cesarean delivery for various indications were randomly assigned to placebo vaginal gel or metronidazole vaginal gel 5 g prior to surgery initiation.1 Most women also received intravenous antibiotics. The rates of endometritis were 17% and 7% in the placebo and metronidazole groups, respectively (relative risk, 0.42; 95% confidence interval, 0.19−0.92).
Vaginal antibiotic administration shows promise as an alternative to povidone-iodine cleansing in the prevention of postcesarean endometritis. Additional randomized clinical trials are necessary to fully evaluate the benefits and risks of this practice.
Reference
1. Pitt C, Sanchez-Ramos L, Kaunitz AM. Adjunctive intravaginal metronidazole for the prevention of postcesarean endometritis: a randomized controlled trial. Obstet Gynecol. 2001;98(5 pt 1):745−750.
Cochrane review of precesarean vaginal cleansingAuthors of a Cochrane review, in which they synthesized 7 studies involving 2,635 women, reported that vaginal cleansing with povidone-iodine immediately before cesarean delivery was associated with a reduced risk of postcesarean endometritis: 8.3% vs 4.3% in the control and vaginal cleansing groups, respectively, (risk ratio [RR], 0.45; 95% confidence interval [CI], 0.25−0.81).7
The positive effect of vaginal cleansing was particularly noteworthy in the subgroup of women with ruptured membranes (3 trials involving 272 women). The rates of endometritis in the control versus vaginal cleansing groups were 17.9% and 4.3%, respectively (RR, 0.24; 95% CI, 0.10−0.55).
Women who went into labor prior to cesarean delivery (523 women from 3 trials) also benefitted from vaginal cleansing, with endometritis rates of 13.0% and 7.4% in the control and vaginal cleansing groups, respectively (RR, 0.56; 95% CI, 0.34−0.95).
In this review, again, vaginal cleansing did not significantly reduce the rate of postoperative fever or wound infection.
The American College of Obstetricians and Gynecologists has noted that chlorohexidine gluconate solutions with high concentrations of alcohol are contraindicated for vaginal cleansing.1 However, although not approved for vaginal cleansing, solutions of chlorohexidine gluconate with low alcohol content (4% alcohol concentration) are safe and may be effective for off-label use as vaginal cleansings.
Reference
1. American College of Obstetricians and Gynecologists Women’s Health Care Physicians; Committee on Gynecologic Practice. Committee Opinion No. 571: solutions for surgical cleansing of the vagina. Obstet Gynecol. 2013;122(3):718−720.
Is vaginal cleansing prior to cesarean delivery best practice?In the United States, precesarean vaginal cleansing is not a common practice. To close the gap between current practice and what is potentially a best practice, two approaches to using vaginal cleansing could be instituted in delivery units.
Approach #1: A liberal clinical protocol. In this scenario, all women (who are not allergic to iodine or povidone-iodine) undergoing cesarean delivery should undergo vaginal cleansing. The World Health Organization conditionally recommends vaginal cleansing for all women undergoing a cesarean delivery.8
Approach #2: A focused clinical protocol. For this protocol, only women (again, who are not allergic to iodine or povidone-iodine) who have ruptured membranes or are in labor upon advanced cervical examination should receive vaginal cleansing.
The advantage of a liberal protocol is that vaginal preparation becomes embedded within the standard practice of cesarean delivery and, hence, is seldom overlooked. The upside of the focused protocol is that only those women most likely to benefit receive the intervention.
Tell me what you thinkWill you consider using vaginal cleansing in your practice? Please let me know your views on vaginal cleansing for cesarean delivery, as well as your clinical pearls on cesarean delivery surgery, at obgmanagement.com. In addition, weigh in on the Quick Poll posted to OBG Management’s homepage. Send your letter to the editor to rbarbieri@frontlinemedcom.com.
There are approximately 4,000,000 births annually in the United States, and about 32% of them occur by cesarean delivery. Compared with vaginal birth, cesarean delivery is associated with an increased risk of endometritis (defined as fever plus uterine or abdominal tenderness). Although surgical complications cannot be eliminated entirely, surgeons are deeply dedicated to the continuous improvement of surgical practice in order to reduce the risk of complications.
With cesarean delivery, many surgical practices have been adopted universally to reduce postoperative complications, including administration of intravenous (IV) antibiotics before skin incision to minimize postoperative infection and the use of postoperative mechanical or pharmacologic interventions to help prevent venous thromboembolism and pulmonary embolism. Preoperative vaginal cleansing with povidone-iodine may reduce the risk of postoperative endometritis, but the practice is not currently common in the United States.
Should you adopt a policy of preoperative vaginal cleansing prior to cesarean delivery? The data suggest perhaps you should.
Data-driven support for povidone-iodine precesareanThree large randomized trials published within the past 10 years concluded that preoperative vaginal cleansing with povidone-iodine reduced the risk of postcesarean endometritis in women who also received prophylactic IV antibiotics (TABLE).1−3 Vaginal cleansing did not reduce the rate of postpartum fever or wound infection in these studies.
Clinical factors that increased the risk of postpartum endometritis independent of vaginal cleansing included:
- extended duration of cesarean surgery
- being in labor prior to cesarean delivery
- ruptured membranes
- advanced cervical examination
- maternal anemia
- use of intrapartum internal monitors
- prior history of genitourinary infection.
Authors of two recent, large nonrandomized studies also have reported that vaginal cleansing reduced the risk of postcesarean endometritis.4,5 By contrast, investigators from one large trial from 2001 did not observe a decrease in endometritis with vaginal cleansing.6
To test the impact of metronidazole vaginal gel on post‑cesarean endometritis, 224 women undergoing cesarean delivery for various indications were randomly assigned to placebo vaginal gel or metronidazole vaginal gel 5 g prior to surgery initiation.1 Most women also received intravenous antibiotics. The rates of endometritis were 17% and 7% in the placebo and metronidazole groups, respectively (relative risk, 0.42; 95% confidence interval, 0.19−0.92).
Vaginal antibiotic administration shows promise as an alternative to povidone-iodine cleansing in the prevention of postcesarean endometritis. Additional randomized clinical trials are necessary to fully evaluate the benefits and risks of this practice.
Reference
1. Pitt C, Sanchez-Ramos L, Kaunitz AM. Adjunctive intravaginal metronidazole for the prevention of postcesarean endometritis: a randomized controlled trial. Obstet Gynecol. 2001;98(5 pt 1):745−750.
Cochrane review of precesarean vaginal cleansingAuthors of a Cochrane review, in which they synthesized 7 studies involving 2,635 women, reported that vaginal cleansing with povidone-iodine immediately before cesarean delivery was associated with a reduced risk of postcesarean endometritis: 8.3% vs 4.3% in the control and vaginal cleansing groups, respectively, (risk ratio [RR], 0.45; 95% confidence interval [CI], 0.25−0.81).7
The positive effect of vaginal cleansing was particularly noteworthy in the subgroup of women with ruptured membranes (3 trials involving 272 women). The rates of endometritis in the control versus vaginal cleansing groups were 17.9% and 4.3%, respectively (RR, 0.24; 95% CI, 0.10−0.55).
Women who went into labor prior to cesarean delivery (523 women from 3 trials) also benefitted from vaginal cleansing, with endometritis rates of 13.0% and 7.4% in the control and vaginal cleansing groups, respectively (RR, 0.56; 95% CI, 0.34−0.95).
In this review, again, vaginal cleansing did not significantly reduce the rate of postoperative fever or wound infection.
The American College of Obstetricians and Gynecologists has noted that chlorohexidine gluconate solutions with high concentrations of alcohol are contraindicated for vaginal cleansing.1 However, although not approved for vaginal cleansing, solutions of chlorohexidine gluconate with low alcohol content (4% alcohol concentration) are safe and may be effective for off-label use as vaginal cleansings.
Reference
1. American College of Obstetricians and Gynecologists Women’s Health Care Physicians; Committee on Gynecologic Practice. Committee Opinion No. 571: solutions for surgical cleansing of the vagina. Obstet Gynecol. 2013;122(3):718−720.
Is vaginal cleansing prior to cesarean delivery best practice?In the United States, precesarean vaginal cleansing is not a common practice. To close the gap between current practice and what is potentially a best practice, two approaches to using vaginal cleansing could be instituted in delivery units.
Approach #1: A liberal clinical protocol. In this scenario, all women (who are not allergic to iodine or povidone-iodine) undergoing cesarean delivery should undergo vaginal cleansing. The World Health Organization conditionally recommends vaginal cleansing for all women undergoing a cesarean delivery.8
Approach #2: A focused clinical protocol. For this protocol, only women (again, who are not allergic to iodine or povidone-iodine) who have ruptured membranes or are in labor upon advanced cervical examination should receive vaginal cleansing.
The advantage of a liberal protocol is that vaginal preparation becomes embedded within the standard practice of cesarean delivery and, hence, is seldom overlooked. The upside of the focused protocol is that only those women most likely to benefit receive the intervention.
Tell me what you thinkWill you consider using vaginal cleansing in your practice? Please let me know your views on vaginal cleansing for cesarean delivery, as well as your clinical pearls on cesarean delivery surgery, at obgmanagement.com. In addition, weigh in on the Quick Poll posted to OBG Management’s homepage. Send your letter to the editor to rbarbieri@frontlinemedcom.com.
- Starr RV, Zurawski J, Ismail M. Preoperative vaginal preparation with povidone-iodine and the risk of postcesarean endometritis. Obstet Gynecol. 2015;105(5 pt 1):1024–1029.
- Haas DM, Pazouki F, Smith RR, et al. Vaginal cleansing before cesarean delivery to reduce postoperative infectious morbidity: a randomized, controlled trial. Am J Obstet Gynecol. 2010;202(3):310.e1–e6.
- Yildrim G, Gungorduk K, Asicioglu O, et al. Does vaginal preparation with povidone-iodine prior to cesarean delivery reduce the risk of endometritis?A randomized controlled trial. J Matern Fetal Neonatal Med. 2012;25(11):2316–2321.
- Asghania M, Mirblouk F, Shakiba M, Faraji R. Preoperative vaginal preparation with povidone-iodine on post-cesarean infectious morbidity. J Obstet Gynaecol. 2011;31(5):400–403.
- Memon S, Qazi RA, Bibi S, Parveen N. Effect of preoperative vaginal cleansing with an antiseptic solution to reduce post caesarean infectious morbidity. J Pak Med Assoc. 2011;61(12):1179–1183.
- Reid VC, Hartmann KE, McMahon M, Fry EP. Vaginal preparation with povidone-iodine and postcesarean infectious morbidity: a randomized controlled trial. Obstet Gynecol. 2001;97(1):147–152.
- Haas DM, Morgan S, Contreras K. Vaginal preparation with antiseptic solution before cesarean section for preventing postoperative infections. Cochrane Database Syst Rev. 2014;12:CD007892.
- Yildrim G, Gungorduk K, Asicioglu O, et al. Does vaginal preparation with povidone-iodine prior to
- Starr RV, Zurawski J, Ismail M. Preoperative vaginal preparation with povidone-iodine and the risk of postcesarean endometritis. Obstet Gynecol. 2015;105(5 pt 1):1024–1029.
- Haas DM, Pazouki F, Smith RR, et al. Vaginal cleansing before cesarean delivery to reduce postoperative infectious morbidity: a randomized, controlled trial. Am J Obstet Gynecol. 2010;202(3):310.e1–e6.
- Yildrim G, Gungorduk K, Asicioglu O, et al. Does vaginal preparation with povidone-iodine prior to cesarean delivery reduce the risk of endometritis?A randomized controlled trial. J Matern Fetal Neonatal Med. 2012;25(11):2316–2321.
- Asghania M, Mirblouk F, Shakiba M, Faraji R. Preoperative vaginal preparation with povidone-iodine on post-cesarean infectious morbidity. J Obstet Gynaecol. 2011;31(5):400–403.
- Memon S, Qazi RA, Bibi S, Parveen N. Effect of preoperative vaginal cleansing with an antiseptic solution to reduce post caesarean infectious morbidity. J Pak Med Assoc. 2011;61(12):1179–1183.
- Reid VC, Hartmann KE, McMahon M, Fry EP. Vaginal preparation with povidone-iodine and postcesarean infectious morbidity: a randomized controlled trial. Obstet Gynecol. 2001;97(1):147–152.
- Haas DM, Morgan S, Contreras K. Vaginal preparation with antiseptic solution before cesarean section for preventing postoperative infections. Cochrane Database Syst Rev. 2014;12:CD007892.
- Yildrim G, Gungorduk K, Asicioglu O, et al. Does vaginal preparation with povidone-iodine prior to
Can transabdominal ultrasound exclude short cervix?
Preterm birth (PTB) remains a major cause of perinatal morbidity and mortality, and so its prediction and prevention are 2 of the most important issues in obstetrics. Cervical length (CL) measured by ultrasound has been shown to be the best predictor; several interventions (vaginal progesterone and cerclage) have been shown to be effective at reducing PTB if a short CL is identified. In fact, both the American College of Obstetricians and Gynecologists (ACOG) and the Society for Maternal-Fetal Medicine (SMFM) recommend CL being measured every 2 weeks from 16 to 23 weeks in singletons with prior spontaneous PTB (sPTB), with cerclage placed for CL less than 25 mm. Moreover, both ACOG and SMFM recommend that “universal CL screening” (CL measured in singletons without a prior sPTB) be considered as a single measurement at about 18 to 23 weeks.
Details of the study
Rhoades and colleagues present data on CL screening done by transabdominal ultrasound (TAU), as an alternative to transvaginal ultrasound (TVU). This study confirms early data:
- TAU cannot visualize CL in several women (20.6%).
- To make sure a high sensitivity (92.9% in this study) is achieved to detect a TVU CL less than 30 mm, a high cutoff (in this case 35 mm) needs to be used with TAU. Nonetheless, 7% of women with a short TVU CL would not be detected, raising clinical and legal issues.
- A high percentage (in this case 32.4%; 103/318) of women screened by TAU would screen positive (TAU CL less than 35 mm) and therefore need to have a TVU anyway.
- Overall, more than 50% (in this study 53%–20.6% because TAU could not visualize CL, and 32.4% because TAU was less than 35 mm) of women having TAU CL screening would need to have TVU anyway! In the largest study comparing TAU to TVU CL screening (TABLE1–6), 66% of women screened by TAU would have to be screened also by TVU.5
There are several other reasons why TVU is considered the gold standard for CL screening, and instead TAU CL should be avoided as possible. All randomized controlled trials that showed benefit from interventions (vaginal progesterone, cerclage, pessary) aimed at decreasing PTB in women with short CL used TVU CL screening and never TAU CL screening. In addition, TAU CL is less accurate than TVU CL screening. On TAU, fetal parts can obscure the cervix, obesity makes it hard to visualize CL, the distance between probe and cervix is longer, manual pressure can mask CL shortening, and bladder filling can elongate CL.7 Cost-effectiveness studies show that TVU CL screening is more effective, and less costly, compared with TAU CL screening, even in singletons without a prior sPTB.8
Societies such as ACOG and SMFM all have recommended TVU CL for prediction and prevention of PTB, over TAU CL.9,10 Importantly, a TVU CL should be done by sonographers educated and trained formally, through such programs as those made available by SMFM.11
What this evidence means for practice
If CL assessment is done, TVU should be preferred, as it is the gold standard, and not TAU.
>>Vincenzo Berghella, MD
Share your thoughts on this article! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.
- Saul LL, Kurtzman JT, Hagemann C, Ghamsary M, Wing DA. Is transabdominal sonography of the cervix after voiding a reliable method of cervical length assessment? J Ultrasound Med. 2008;27(9):1305−1311.
- Stone PR, Chan EH, McCowan LM, Taylor RS, Mitchell JM; SCOPE Consortium. Aust N Z J Obstet Gynaecol. 2010;50(6):523−527.
- To MS, Skentou C, Cicero S, Nicolaides KH. Cervical assessment at the routine 23-weeks’ scan: problems with transabdominal sonography. Ultrasound Obstet Gynecol 2000;15(4):292−296.
- Hernandez-Andrade E, Romero R, Ahn H, et al. Transabdominal evaluation of uterine cervical length during pregnancy fails to identify a substantial number of women with a short cervix. 2012;25(9):1682−1689.
- Friedman AM, Srinivas SK, Parry S, et al. Can transabdominal ultrasound be used as a screening test for short cervical length? Am J Obstet Gynecol. 2013;208(3):190.e1−e7.
- Rhoades JS, Park JM, Stout MJ, Macones GA, Cahill AG, Tuuli MG. Can transabdominal cervical length measurement exclude short cervix? 2015 Nov 2. [Epub ahead of print]
- Berghella V, Bega G, Tolosa JE, Berghella M. Ultrasound assessment of the cervix. Clin Obstet Gynecol. 2003; 46(4):947–623.
- Miller ES, Grobman WA. Cost-effectiveness of transabdominal ultrasound for cervical length screening for preterm birth prevention. Am J Obstet Gynecol. 2013;209(6): 546.e1–e6.
- American College of Obstetricians and Gynecologists. Practice bulletin No. 130: prediction and prevention of preterm birth. Obstet Gynecol. 2012;120(4):964–973.
- Society for Maternal-Fetal Medicine Publications Committee; Berghella V. Progesterone and preterm birth prevention: translating clinical trial data into clinical practice. Am J Obstet Gynecol. 2012;206(5):376–386.
- Cervical Length Education and Review (CLEAR) guidelines. https://clear.perinatalquality.org. Published 2015. Accessed December 15, 2015.
Preterm birth (PTB) remains a major cause of perinatal morbidity and mortality, and so its prediction and prevention are 2 of the most important issues in obstetrics. Cervical length (CL) measured by ultrasound has been shown to be the best predictor; several interventions (vaginal progesterone and cerclage) have been shown to be effective at reducing PTB if a short CL is identified. In fact, both the American College of Obstetricians and Gynecologists (ACOG) and the Society for Maternal-Fetal Medicine (SMFM) recommend CL being measured every 2 weeks from 16 to 23 weeks in singletons with prior spontaneous PTB (sPTB), with cerclage placed for CL less than 25 mm. Moreover, both ACOG and SMFM recommend that “universal CL screening” (CL measured in singletons without a prior sPTB) be considered as a single measurement at about 18 to 23 weeks.
Details of the study
Rhoades and colleagues present data on CL screening done by transabdominal ultrasound (TAU), as an alternative to transvaginal ultrasound (TVU). This study confirms early data:
- TAU cannot visualize CL in several women (20.6%).
- To make sure a high sensitivity (92.9% in this study) is achieved to detect a TVU CL less than 30 mm, a high cutoff (in this case 35 mm) needs to be used with TAU. Nonetheless, 7% of women with a short TVU CL would not be detected, raising clinical and legal issues.
- A high percentage (in this case 32.4%; 103/318) of women screened by TAU would screen positive (TAU CL less than 35 mm) and therefore need to have a TVU anyway.
- Overall, more than 50% (in this study 53%–20.6% because TAU could not visualize CL, and 32.4% because TAU was less than 35 mm) of women having TAU CL screening would need to have TVU anyway! In the largest study comparing TAU to TVU CL screening (TABLE1–6), 66% of women screened by TAU would have to be screened also by TVU.5
There are several other reasons why TVU is considered the gold standard for CL screening, and instead TAU CL should be avoided as possible. All randomized controlled trials that showed benefit from interventions (vaginal progesterone, cerclage, pessary) aimed at decreasing PTB in women with short CL used TVU CL screening and never TAU CL screening. In addition, TAU CL is less accurate than TVU CL screening. On TAU, fetal parts can obscure the cervix, obesity makes it hard to visualize CL, the distance between probe and cervix is longer, manual pressure can mask CL shortening, and bladder filling can elongate CL.7 Cost-effectiveness studies show that TVU CL screening is more effective, and less costly, compared with TAU CL screening, even in singletons without a prior sPTB.8
Societies such as ACOG and SMFM all have recommended TVU CL for prediction and prevention of PTB, over TAU CL.9,10 Importantly, a TVU CL should be done by sonographers educated and trained formally, through such programs as those made available by SMFM.11
What this evidence means for practice
If CL assessment is done, TVU should be preferred, as it is the gold standard, and not TAU.
>>Vincenzo Berghella, MD
Share your thoughts on this article! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.
Preterm birth (PTB) remains a major cause of perinatal morbidity and mortality, and so its prediction and prevention are 2 of the most important issues in obstetrics. Cervical length (CL) measured by ultrasound has been shown to be the best predictor; several interventions (vaginal progesterone and cerclage) have been shown to be effective at reducing PTB if a short CL is identified. In fact, both the American College of Obstetricians and Gynecologists (ACOG) and the Society for Maternal-Fetal Medicine (SMFM) recommend CL being measured every 2 weeks from 16 to 23 weeks in singletons with prior spontaneous PTB (sPTB), with cerclage placed for CL less than 25 mm. Moreover, both ACOG and SMFM recommend that “universal CL screening” (CL measured in singletons without a prior sPTB) be considered as a single measurement at about 18 to 23 weeks.
Details of the study
Rhoades and colleagues present data on CL screening done by transabdominal ultrasound (TAU), as an alternative to transvaginal ultrasound (TVU). This study confirms early data:
- TAU cannot visualize CL in several women (20.6%).
- To make sure a high sensitivity (92.9% in this study) is achieved to detect a TVU CL less than 30 mm, a high cutoff (in this case 35 mm) needs to be used with TAU. Nonetheless, 7% of women with a short TVU CL would not be detected, raising clinical and legal issues.
- A high percentage (in this case 32.4%; 103/318) of women screened by TAU would screen positive (TAU CL less than 35 mm) and therefore need to have a TVU anyway.
- Overall, more than 50% (in this study 53%–20.6% because TAU could not visualize CL, and 32.4% because TAU was less than 35 mm) of women having TAU CL screening would need to have TVU anyway! In the largest study comparing TAU to TVU CL screening (TABLE1–6), 66% of women screened by TAU would have to be screened also by TVU.5
There are several other reasons why TVU is considered the gold standard for CL screening, and instead TAU CL should be avoided as possible. All randomized controlled trials that showed benefit from interventions (vaginal progesterone, cerclage, pessary) aimed at decreasing PTB in women with short CL used TVU CL screening and never TAU CL screening. In addition, TAU CL is less accurate than TVU CL screening. On TAU, fetal parts can obscure the cervix, obesity makes it hard to visualize CL, the distance between probe and cervix is longer, manual pressure can mask CL shortening, and bladder filling can elongate CL.7 Cost-effectiveness studies show that TVU CL screening is more effective, and less costly, compared with TAU CL screening, even in singletons without a prior sPTB.8
Societies such as ACOG and SMFM all have recommended TVU CL for prediction and prevention of PTB, over TAU CL.9,10 Importantly, a TVU CL should be done by sonographers educated and trained formally, through such programs as those made available by SMFM.11
What this evidence means for practice
If CL assessment is done, TVU should be preferred, as it is the gold standard, and not TAU.
>>Vincenzo Berghella, MD
Share your thoughts on this article! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.
- Saul LL, Kurtzman JT, Hagemann C, Ghamsary M, Wing DA. Is transabdominal sonography of the cervix after voiding a reliable method of cervical length assessment? J Ultrasound Med. 2008;27(9):1305−1311.
- Stone PR, Chan EH, McCowan LM, Taylor RS, Mitchell JM; SCOPE Consortium. Aust N Z J Obstet Gynaecol. 2010;50(6):523−527.
- To MS, Skentou C, Cicero S, Nicolaides KH. Cervical assessment at the routine 23-weeks’ scan: problems with transabdominal sonography. Ultrasound Obstet Gynecol 2000;15(4):292−296.
- Hernandez-Andrade E, Romero R, Ahn H, et al. Transabdominal evaluation of uterine cervical length during pregnancy fails to identify a substantial number of women with a short cervix. 2012;25(9):1682−1689.
- Friedman AM, Srinivas SK, Parry S, et al. Can transabdominal ultrasound be used as a screening test for short cervical length? Am J Obstet Gynecol. 2013;208(3):190.e1−e7.
- Rhoades JS, Park JM, Stout MJ, Macones GA, Cahill AG, Tuuli MG. Can transabdominal cervical length measurement exclude short cervix? 2015 Nov 2. [Epub ahead of print]
- Berghella V, Bega G, Tolosa JE, Berghella M. Ultrasound assessment of the cervix. Clin Obstet Gynecol. 2003; 46(4):947–623.
- Miller ES, Grobman WA. Cost-effectiveness of transabdominal ultrasound for cervical length screening for preterm birth prevention. Am J Obstet Gynecol. 2013;209(6): 546.e1–e6.
- American College of Obstetricians and Gynecologists. Practice bulletin No. 130: prediction and prevention of preterm birth. Obstet Gynecol. 2012;120(4):964–973.
- Society for Maternal-Fetal Medicine Publications Committee; Berghella V. Progesterone and preterm birth prevention: translating clinical trial data into clinical practice. Am J Obstet Gynecol. 2012;206(5):376–386.
- Cervical Length Education and Review (CLEAR) guidelines. https://clear.perinatalquality.org. Published 2015. Accessed December 15, 2015.
- Saul LL, Kurtzman JT, Hagemann C, Ghamsary M, Wing DA. Is transabdominal sonography of the cervix after voiding a reliable method of cervical length assessment? J Ultrasound Med. 2008;27(9):1305−1311.
- Stone PR, Chan EH, McCowan LM, Taylor RS, Mitchell JM; SCOPE Consortium. Aust N Z J Obstet Gynaecol. 2010;50(6):523−527.
- To MS, Skentou C, Cicero S, Nicolaides KH. Cervical assessment at the routine 23-weeks’ scan: problems with transabdominal sonography. Ultrasound Obstet Gynecol 2000;15(4):292−296.
- Hernandez-Andrade E, Romero R, Ahn H, et al. Transabdominal evaluation of uterine cervical length during pregnancy fails to identify a substantial number of women with a short cervix. 2012;25(9):1682−1689.
- Friedman AM, Srinivas SK, Parry S, et al. Can transabdominal ultrasound be used as a screening test for short cervical length? Am J Obstet Gynecol. 2013;208(3):190.e1−e7.
- Rhoades JS, Park JM, Stout MJ, Macones GA, Cahill AG, Tuuli MG. Can transabdominal cervical length measurement exclude short cervix? 2015 Nov 2. [Epub ahead of print]
- Berghella V, Bega G, Tolosa JE, Berghella M. Ultrasound assessment of the cervix. Clin Obstet Gynecol. 2003; 46(4):947–623.
- Miller ES, Grobman WA. Cost-effectiveness of transabdominal ultrasound for cervical length screening for preterm birth prevention. Am J Obstet Gynecol. 2013;209(6): 546.e1–e6.
- American College of Obstetricians and Gynecologists. Practice bulletin No. 130: prediction and prevention of preterm birth. Obstet Gynecol. 2012;120(4):964–973.
- Society for Maternal-Fetal Medicine Publications Committee; Berghella V. Progesterone and preterm birth prevention: translating clinical trial data into clinical practice. Am J Obstet Gynecol. 2012;206(5):376–386.
- Cervical Length Education and Review (CLEAR) guidelines. https://clear.perinatalquality.org. Published 2015. Accessed December 15, 2015.