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Proclivity ID
18811001
Unpublish
Citation Name
OBG Manag
Specialty Focus
Obstetrics
Gynecology
Surgery
Negative Keywords
gaming
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
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aholeed
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aholees
aholeing
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alcohol
alcoholed
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alcoholes
alcoholing
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allmaned
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alted
altes
alting
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analer
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anilingused
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anus
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areola
areolaed
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aryaned
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aryaning
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asiaed
asiaer
asiaes
asiaing
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asias
ass
ass hole
ass lick
ass licked
ass licker
ass lickes
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assbangedes
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asshated
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azz
azzed
azzer
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azzing
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beardedclamed
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beardedclames
beardedclaming
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beastialityed
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beastialityes
beastialitying
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beatched
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beatered
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biatched
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biatching
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biatchs
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big titsed
big titser
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bisexualed
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bitched
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bitching
bitchly
bitchs
bitchy
bitchyed
bitchyer
bitchyes
bitchying
bitchyly
bitchys
bleached
bleacher
bleaches
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bleachly
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blow job
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blow jobes
blow jobing
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boink
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boinkes
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bollock
bollocked
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bollocks
bollocksed
bollockser
bollockses
bollocksing
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bollockss
bollok
bolloked
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boner
bonered
bonerer
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bonering
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bonerser
bonerses
bonersing
bonersly
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bong
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bonges
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boob
boobed
boober
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boobies
boobiesed
boobieser
boobieses
boobiesing
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boobiess
boobing
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boobser
boobses
boobsing
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boobyes
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boogered
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boogering
boogerly
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bookie
bookieed
bookieer
bookiees
bookieing
bookiely
bookies
bootee
booteeed
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booteees
booteeing
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bootieed
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bootieing
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bootyed
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bootyes
bootying
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boozeed
boozeer
boozees
boozeing
boozely
boozer
boozered
boozerer
boozeres
boozering
boozerly
boozers
boozes
boozy
boozyed
boozyer
boozyes
boozying
boozyly
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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
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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
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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
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cummines
cumming
cumminged
cumminger
cumminges
cumminging
cummingly
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cumminly
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cums
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cumshoted
cumshoter
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cumshoting
cumshotly
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cumshotsed
cumshotser
cumshotses
cumshotsing
cumshotsly
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cumsluted
cumsluter
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cumsluting
cumslutly
cumsluts
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cumstained
cumstainer
cumstaines
cumstaining
cumstainly
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cunilingus
cunilingused
cunilinguser
cunilinguses
cunilingusing
cunilingusly
cunilinguss
cunnilingus
cunnilingused
cunnilinguser
cunnilinguses
cunnilingusing
cunnilingusly
cunnilinguss
cunny
cunnyed
cunnyer
cunnyes
cunnying
cunnyly
cunnys
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cunted
cunter
cuntes
cuntface
cuntfaceed
cuntfaceer
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cuntfaceing
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cuntfaces
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cunthuntered
cunthunterer
cunthunteres
cunthuntering
cunthunterly
cunthunters
cunting
cuntlick
cuntlicked
cuntlicker
cuntlickered
cuntlickerer
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cuntlickerly
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cuntlickes
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cuntly
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cuntser
cuntses
cuntsing
cuntsly
cuntss
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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
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damnly
damns
dick
dickbag
dickbaged
dickbager
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dickbaging
dickbagly
dickbags
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dickdippered
dickdipperer
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dickdippering
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dicker
dickes
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dickfaceed
dickfaceer
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dickfaceing
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dickheaded
dickheader
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dickheading
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dickheadsing
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dickishly
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dickly
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dicksipper
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dickweed
dickweeded
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dickweedly
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dickwhipperer
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dickzipper
dickzippered
dickzipperer
dickzipperes
dickzippering
dickzipperly
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diddle
diddleed
diddleer
diddlees
diddleing
diddlely
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dikeing
dikely
dikes
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dildoed
dildoer
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dildoing
dildoly
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dildosing
dildosly
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diligafed
diligafer
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diligafing
diligafly
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dillweed
dillweeded
dillweeder
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dillweeding
dillweedly
dillweeds
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dimwited
dimwiter
dimwites
dimwiting
dimwitly
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dingle
dingleed
dingleer
dinglees
dingleing
dinglely
dingles
dipship
dipshiped
dipshiper
dipshipes
dipshiping
dipshiply
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dizzyed
dizzyer
dizzyes
dizzying
dizzyly
dizzys
doggiestyleed
doggiestyleer
doggiestylees
doggiestyleing
doggiestylely
doggiestyles
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doggystyleer
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doggystyleing
doggystylely
doggystyles
dong
donged
donger
donges
donging
dongly
dongs
doofus
doofused
doofuser
doofuses
doofusing
doofusly
doofuss
doosh
dooshed
doosher
dooshes
dooshing
dooshly
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dopeyed
dopeyer
dopeyes
dopeying
dopeyly
dopeys
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douchebaged
douchebager
douchebages
douchebaging
douchebagly
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douchebagsed
douchebagser
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douchebagsing
douchebagsly
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doucheer
douchees
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douchely
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doucheyes
doucheying
doucheyly
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drunked
drunker
drunkes
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drunkly
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dumassed
dumasser
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dumassly
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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
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dykeser
dykeses
dykesing
dykesly
dykess
erotic
eroticed
eroticer
erotices
eroticing
eroticly
erotics
extacy
extacyed
extacyer
extacyes
extacying
extacyly
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extasyed
extasyer
extasyes
extasying
extasyly
extasys
fack
facked
facker
fackes
facking
fackly
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fag
faged
fager
fages
fagg
fagged
faggeded
faggeder
faggedes
faggeding
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faggeds
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fagges
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faggited
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faggites
faggiting
faggitly
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faggly
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faggoter
faggotes
faggoting
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faggs
faging
fagly
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fagoted
fagoter
fagotes
fagoting
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fagser
fagses
fagsing
fagsly
fagss
faig
faiged
faiger
faiges
faiging
faigly
faigs
faigt
faigted
faigter
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faigting
faigtly
faigts
fannybandit
fannybandited
fannybanditer
fannybandites
fannybanditing
fannybanditly
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farter
fartes
farting
fartknocker
fartknockered
fartknockerer
fartknockeres
fartknockering
fartknockerly
fartknockers
fartly
farts
felch
felched
felcher
felchered
felcherer
felcheres
felchering
felcherly
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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
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Should newborns at 22 or 23 weeks’ gestational age be aggressively resuscitated?

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Tue, 08/28/2018 - 11:06
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Should newborns at 22 or 23 weeks’ gestational age be aggressively resuscitated?

For many decades the limit of viability was believed to be approximately 24 weeks of gestation. In many medical centers, newborns delivered at less than 25 weeks are evaluated in the delivery room and the decision to resuscitate is based on the infant’s clinical response. In the past, aggressive and extended resuscitation of newborns at 22 and 23 weeks was not common because the prognosis was bleak and clinicians did not want to inflict unnecessary pain when the chances for survival were limited. Recent advances in obstetric and pediatric care, however, have resulted in the survival of some infants born at 22 weeks’ gestation, calling into question long-held beliefs about the limits of viability.

In 2 recent reports, investigators used data from the National Institute of Child Health and Human Development (NICHD) Neonatal Research Network to acquire detailed information about newborn survival and morbidity at 22 through 28 weeks’ gestation (TABLES 1 and 2).1,2 These data show that the survival of newborns at 23 through 27 weeks’ gestation is increasing, albeit slowly. Survival, without major morbidity, is gradually improving for newborns at 25 through 28 weeks.1,2 But what is the prognosis for a fetus born at 22 or 23 weeks?

 

 

There are several aspects of this issue to consider, including accurate dating of the gestational age and current viability outcomes data.

Determining the limit of viability: Accurate dating is essentialThe limit of viability is the milestone in gestation when there is a high probability of extrauterine survival. A major challenge in studies of the limit of viability for newborns is that accurate gestational dating is not always available. For example, in recent reports from the NICHD Neonatal Research Network the gestational age was determined by the best obstetric estimate, or the Ballard or Dubowitz examination, of the newborn.1,2

It is well known that ultrasound dating early in gestation is a better estimate of gestational age than last menstrual period, uterine sizing, or pediatric examination of the newborn. Hence, the available data are limited by the absence of precise gestational dating with early ultrasound. Data on the limit of viability with large numbers of births between 22 and 24 weeks with early ultrasound dating would help to refine our understanding of the limit of viability.

At 23 weeks, each day of in utero development is criticalThe importance of each additional day spent in utero during the 23rd week of gestation was demonstrated in a small cohort in 2001.4 Overall, during the 23rd week of gestation the survival of newborns to discharge was 33%.4 This finding is similar to the survival rate reported by the NICHD Neonatal Research Network in 2012.1 However, survival was vastly different early, compared with later, in the 23rd week4:

  • from 23 weeks 0 days to 23 weeks 2 days: no newborn survived
  • at 23 weeks 3 days and 23 weeks 4 days: 40% of newborns survived
  • at 23 weeks 5 days and 23 weeks 6 days: 63% of newborns survived (a similar survival rate of 24-week gestations was reported by the NICHD Neonatal Research Network1).

The development of the fetus across the 23rd week of gestation appears to be critical to newborn survival. Hence, every day of in utero development during the 23rd week is critically important. A great challenge for obstetricians is how to approach the woman with threatened preterm birth at 22 weeks 0 days’ gestation. If the woman delivers within a few days, the likelihood of survival is minimal. However, if the pregnancy can be extended to 23 weeks and 5 days, survival rates increase significantly.

Aligning the actions of birth team, mother, and familyFactors that influence the limit of viability include:

  • gestational age
  • gender of the fetus (Females are more likely than males to survive.)
  • treatment of the mother with glucocorticoids prior to birth
  • newborn weight.

To increase the likelihood of newborn survival, obstetricians need to treat women at risk for preterm birth with antenatal glucocorticoids and antibiotics for rupture of membranes and to limit fetal stress during the birth process. Guidelines have evolved to encourage clinicians to treat women at preterm birth risk with glucocorticoids either at:

  • 23 weeks’ gestation or
  • 22 weeks’ gestation, if birth is anticipated to occur at 23 weeks or later.5

At birth, pediatricians are then faced with the very difficult decision of whether or not to aggressively resuscitate the severely preterm infant. Complex medical, social, and ethical issues ultimately guide pediatricians’ actions in this challenging situation. It is important for their actions to be in consensus with the obstetrician, the mother, and the mother’s family and for a consensus to be reached. Dissonant plans may increase adverse outcomes for the newborn. In one study when pediatricians and obstetricians were not aligned in their actions, the risk of death of an extremely preterm newborn significantly increased.6

 

 

Prior to birth, team meetings that include the obstetricians, pediatricians, mother, and family will help to set expectations about the course of care and, in turn, improve perceived outcomes.5 If feasible, obstetricians and pediatricians should develop joint institutional guidelines about the general approach to pregnant women when birth may occur at 22 or 23 weeks’ gestation.5

 

A neonatal outcomes predictor

The National Institute of Child Health and Human Development provides a Web-based tool for estimating newborn outcomes based on gestational age (22 to 25 weeks), birth weight, gender, singleton or multiple gestation, and exposure to antenatal glucocorticoid treatment. The outcomes tool provides estimates for survival and survival with severe morbidity. It uses data collected by the Neonatal Research Network to predict outcomes. To access the outcomes data assessment, visit https://www.nichd.nih.gov/about/org/der/branches/ppb/programs/epbo/Pages/epbo_case.aspx.

Is aggressive management of preterm birth and neonatal resuscitation a self-fulfilling prophecy?The beliefs and training of clinicians may influence the outcome of extremely preterm newborns. For example, if obstetricians and pediatricians focus on the fact that birth at 23 weeks is not likely to result in survival without severe morbidity, they may withhold key interventions such as antenatal glucocorticoids, antibiotics for rupture of the membranes, and aggressive newborn resuscitation.7 Consequently the likelihood of survival may be reduced.

If clinicians believe in maximal interventions for all newborns at 22 and 23 weeks’ gestation, their actions may result in a small increase in newborn survival—but at the cost of painful and unnecessary interventions in many newborns who are destined to die. Finding the right balance along the broad spectrum from expectant management to aggressive and extended resuscitation is challenging. Clearly there is no “right answer” with these extremely difficult decisions.

Future trends in the limit of viabilityIn 1963, Jacqueline Bouvier Kennedy, at 34 weeks’ gestation, went into preterm labor and delivered her son Patrick at a community hospital. Patrick developed respiratory distress syndrome and was transferred to the Boston Children’s Hospital. He died shortly thereafter.8 Would Patrick have survived if he had been delivered at an institution capable of providing high-risk obstetric and newborn services? Would such modern interventions as antenatal glucocorticoids, antibiotics for ruptured membranes, liberal use of cesarean delivery, and aggressive neonatal resuscitation have improved his chances for survival?

From our current perspective, it is surprising that a 34-week newborn died shortly after birth. With modern obstetric and pediatric care that scenario is unusual. It is possible that future advances in medical care will push the limit of viability to 22 weeks’ gestation. Future generations of clinicians may be surprised that the medicine we practice today is so limited.

However, given our current resources, it is unlikely that newborns at 22 weeks’ gestation will survive, or survive without severe morbidity. Consequently, routine aggressive resuscitation of newborns at 22 weeks should be approached with caution. At 23 weeks and later, many newborns will survive and a few will survive without severe morbidity. Given the complexity of the issues, the approach to resuscitation of infants at 22 and 23 weeks must account for the perspectives of the birth mother and her family, obstetricians, and pediatricians. Managing threatened preterm birth at 22 and 23 weeks is one of our greatest challenges as obstetricians, and we need to meet this challenge with grace and skill.

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.

References
  1. Stoll BJ, Hansen NI, Bell EF, et al; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Trends in care practices, morbidity and mortality of extremely preterm neonates, 1993-2012. JAMA. 2015;314(10):1039–1051.
  2. Patel RM, Kandefer S, Walsh MC, et al; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Causes and timing of death in extremely premature infants from 2000 through 2011. N Engl J Med. 2015;372(4):331–340.
  3. Donovan EF, Tyson JE, Ehrenkranz RA, et al. Inaccuracy of Ballard scores before 28 weeks’ gestation. National Institute of Child Health and Human Development Neonatal Research Network. J Pediatr. 1999;135(2 pt 1):147–152.
  4. McElrath TF, Robinson JN, Ecker JL, Ringer SA, Norwitz ER. Neonatal outcome of infants born at 23 weeks’ gestation. Obstet Gynecol. 2001;97(1):49–52.
  5. Raju TN, Mercer BM, Burchfield DJ, Joseph GF Jr. Periviable birth: executive summary of a joint workshop by the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Society for Maternal-Fetal Medicine, American Academy of Pediatrics, and American College of Obstetricians and Gynecologists. Obstet Gynecol. 2014;123(5):1083–1096.
  6. Guinsburg R, Branco de Almeida MF, dos Santos Rodrigues Sadeck L, et al; Brazilian Network on Neonatal Research. Proactive management of extreme prematurity: disagreement between obstetricians and neonatologists. J Perinatol. 2012;32(12):913-919.
  7. Tucker Emonds B, McKenzie F, Farrow V, Raglan G, Schulkin J. A national survey of obstetricians’ attitudes toward and practice of periviable interventions. J Perinatol. 2015;35(5):338–343.
  8. Altman LK. A Kennedy baby’s life and death. New York Times. http://www.nytimes.com/2013/07/30/health/a-kennedy-babys-life-and-death.html?_r=0. Published July 29, 2013. Accessed November 19, 2015.
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Dr. Barbieri is Editor in Chief, OBG Management; Chair, Obstetrics and Gynecology, Brigham and Women’s Hospital; and Kate Macy Ladd Professor of Obstetrics, Gynecology, and Reproductive Biology, Harvard Medical School, Boston, Massachusetts.

Dr. Barbieri reports no financial relationships relevant to this article.

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Dr. Barbieri reports no financial relationships relevant to this article.

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Dr. Barbieri is Editor in Chief, OBG Management; Chair, Obstetrics and Gynecology, Brigham and Women’s Hospital; and Kate Macy Ladd Professor of Obstetrics, Gynecology, and Reproductive Biology, Harvard Medical School, Boston, Massachusetts.

Dr. Barbieri reports no financial relationships relevant to this article.

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For many decades the limit of viability was believed to be approximately 24 weeks of gestation. In many medical centers, newborns delivered at less than 25 weeks are evaluated in the delivery room and the decision to resuscitate is based on the infant’s clinical response. In the past, aggressive and extended resuscitation of newborns at 22 and 23 weeks was not common because the prognosis was bleak and clinicians did not want to inflict unnecessary pain when the chances for survival were limited. Recent advances in obstetric and pediatric care, however, have resulted in the survival of some infants born at 22 weeks’ gestation, calling into question long-held beliefs about the limits of viability.

In 2 recent reports, investigators used data from the National Institute of Child Health and Human Development (NICHD) Neonatal Research Network to acquire detailed information about newborn survival and morbidity at 22 through 28 weeks’ gestation (TABLES 1 and 2).1,2 These data show that the survival of newborns at 23 through 27 weeks’ gestation is increasing, albeit slowly. Survival, without major morbidity, is gradually improving for newborns at 25 through 28 weeks.1,2 But what is the prognosis for a fetus born at 22 or 23 weeks?

 

 

There are several aspects of this issue to consider, including accurate dating of the gestational age and current viability outcomes data.

Determining the limit of viability: Accurate dating is essentialThe limit of viability is the milestone in gestation when there is a high probability of extrauterine survival. A major challenge in studies of the limit of viability for newborns is that accurate gestational dating is not always available. For example, in recent reports from the NICHD Neonatal Research Network the gestational age was determined by the best obstetric estimate, or the Ballard or Dubowitz examination, of the newborn.1,2

It is well known that ultrasound dating early in gestation is a better estimate of gestational age than last menstrual period, uterine sizing, or pediatric examination of the newborn. Hence, the available data are limited by the absence of precise gestational dating with early ultrasound. Data on the limit of viability with large numbers of births between 22 and 24 weeks with early ultrasound dating would help to refine our understanding of the limit of viability.

At 23 weeks, each day of in utero development is criticalThe importance of each additional day spent in utero during the 23rd week of gestation was demonstrated in a small cohort in 2001.4 Overall, during the 23rd week of gestation the survival of newborns to discharge was 33%.4 This finding is similar to the survival rate reported by the NICHD Neonatal Research Network in 2012.1 However, survival was vastly different early, compared with later, in the 23rd week4:

  • from 23 weeks 0 days to 23 weeks 2 days: no newborn survived
  • at 23 weeks 3 days and 23 weeks 4 days: 40% of newborns survived
  • at 23 weeks 5 days and 23 weeks 6 days: 63% of newborns survived (a similar survival rate of 24-week gestations was reported by the NICHD Neonatal Research Network1).

The development of the fetus across the 23rd week of gestation appears to be critical to newborn survival. Hence, every day of in utero development during the 23rd week is critically important. A great challenge for obstetricians is how to approach the woman with threatened preterm birth at 22 weeks 0 days’ gestation. If the woman delivers within a few days, the likelihood of survival is minimal. However, if the pregnancy can be extended to 23 weeks and 5 days, survival rates increase significantly.

Aligning the actions of birth team, mother, and familyFactors that influence the limit of viability include:

  • gestational age
  • gender of the fetus (Females are more likely than males to survive.)
  • treatment of the mother with glucocorticoids prior to birth
  • newborn weight.

To increase the likelihood of newborn survival, obstetricians need to treat women at risk for preterm birth with antenatal glucocorticoids and antibiotics for rupture of membranes and to limit fetal stress during the birth process. Guidelines have evolved to encourage clinicians to treat women at preterm birth risk with glucocorticoids either at:

  • 23 weeks’ gestation or
  • 22 weeks’ gestation, if birth is anticipated to occur at 23 weeks or later.5

At birth, pediatricians are then faced with the very difficult decision of whether or not to aggressively resuscitate the severely preterm infant. Complex medical, social, and ethical issues ultimately guide pediatricians’ actions in this challenging situation. It is important for their actions to be in consensus with the obstetrician, the mother, and the mother’s family and for a consensus to be reached. Dissonant plans may increase adverse outcomes for the newborn. In one study when pediatricians and obstetricians were not aligned in their actions, the risk of death of an extremely preterm newborn significantly increased.6

 

 

Prior to birth, team meetings that include the obstetricians, pediatricians, mother, and family will help to set expectations about the course of care and, in turn, improve perceived outcomes.5 If feasible, obstetricians and pediatricians should develop joint institutional guidelines about the general approach to pregnant women when birth may occur at 22 or 23 weeks’ gestation.5

 

A neonatal outcomes predictor

The National Institute of Child Health and Human Development provides a Web-based tool for estimating newborn outcomes based on gestational age (22 to 25 weeks), birth weight, gender, singleton or multiple gestation, and exposure to antenatal glucocorticoid treatment. The outcomes tool provides estimates for survival and survival with severe morbidity. It uses data collected by the Neonatal Research Network to predict outcomes. To access the outcomes data assessment, visit https://www.nichd.nih.gov/about/org/der/branches/ppb/programs/epbo/Pages/epbo_case.aspx.

Is aggressive management of preterm birth and neonatal resuscitation a self-fulfilling prophecy?The beliefs and training of clinicians may influence the outcome of extremely preterm newborns. For example, if obstetricians and pediatricians focus on the fact that birth at 23 weeks is not likely to result in survival without severe morbidity, they may withhold key interventions such as antenatal glucocorticoids, antibiotics for rupture of the membranes, and aggressive newborn resuscitation.7 Consequently the likelihood of survival may be reduced.

If clinicians believe in maximal interventions for all newborns at 22 and 23 weeks’ gestation, their actions may result in a small increase in newborn survival—but at the cost of painful and unnecessary interventions in many newborns who are destined to die. Finding the right balance along the broad spectrum from expectant management to aggressive and extended resuscitation is challenging. Clearly there is no “right answer” with these extremely difficult decisions.

Future trends in the limit of viabilityIn 1963, Jacqueline Bouvier Kennedy, at 34 weeks’ gestation, went into preterm labor and delivered her son Patrick at a community hospital. Patrick developed respiratory distress syndrome and was transferred to the Boston Children’s Hospital. He died shortly thereafter.8 Would Patrick have survived if he had been delivered at an institution capable of providing high-risk obstetric and newborn services? Would such modern interventions as antenatal glucocorticoids, antibiotics for ruptured membranes, liberal use of cesarean delivery, and aggressive neonatal resuscitation have improved his chances for survival?

From our current perspective, it is surprising that a 34-week newborn died shortly after birth. With modern obstetric and pediatric care that scenario is unusual. It is possible that future advances in medical care will push the limit of viability to 22 weeks’ gestation. Future generations of clinicians may be surprised that the medicine we practice today is so limited.

However, given our current resources, it is unlikely that newborns at 22 weeks’ gestation will survive, or survive without severe morbidity. Consequently, routine aggressive resuscitation of newborns at 22 weeks should be approached with caution. At 23 weeks and later, many newborns will survive and a few will survive without severe morbidity. Given the complexity of the issues, the approach to resuscitation of infants at 22 and 23 weeks must account for the perspectives of the birth mother and her family, obstetricians, and pediatricians. Managing threatened preterm birth at 22 and 23 weeks is one of our greatest challenges as obstetricians, and we need to meet this challenge with grace and skill.

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.

For many decades the limit of viability was believed to be approximately 24 weeks of gestation. In many medical centers, newborns delivered at less than 25 weeks are evaluated in the delivery room and the decision to resuscitate is based on the infant’s clinical response. In the past, aggressive and extended resuscitation of newborns at 22 and 23 weeks was not common because the prognosis was bleak and clinicians did not want to inflict unnecessary pain when the chances for survival were limited. Recent advances in obstetric and pediatric care, however, have resulted in the survival of some infants born at 22 weeks’ gestation, calling into question long-held beliefs about the limits of viability.

In 2 recent reports, investigators used data from the National Institute of Child Health and Human Development (NICHD) Neonatal Research Network to acquire detailed information about newborn survival and morbidity at 22 through 28 weeks’ gestation (TABLES 1 and 2).1,2 These data show that the survival of newborns at 23 through 27 weeks’ gestation is increasing, albeit slowly. Survival, without major morbidity, is gradually improving for newborns at 25 through 28 weeks.1,2 But what is the prognosis for a fetus born at 22 or 23 weeks?

 

 

There are several aspects of this issue to consider, including accurate dating of the gestational age and current viability outcomes data.

Determining the limit of viability: Accurate dating is essentialThe limit of viability is the milestone in gestation when there is a high probability of extrauterine survival. A major challenge in studies of the limit of viability for newborns is that accurate gestational dating is not always available. For example, in recent reports from the NICHD Neonatal Research Network the gestational age was determined by the best obstetric estimate, or the Ballard or Dubowitz examination, of the newborn.1,2

It is well known that ultrasound dating early in gestation is a better estimate of gestational age than last menstrual period, uterine sizing, or pediatric examination of the newborn. Hence, the available data are limited by the absence of precise gestational dating with early ultrasound. Data on the limit of viability with large numbers of births between 22 and 24 weeks with early ultrasound dating would help to refine our understanding of the limit of viability.

At 23 weeks, each day of in utero development is criticalThe importance of each additional day spent in utero during the 23rd week of gestation was demonstrated in a small cohort in 2001.4 Overall, during the 23rd week of gestation the survival of newborns to discharge was 33%.4 This finding is similar to the survival rate reported by the NICHD Neonatal Research Network in 2012.1 However, survival was vastly different early, compared with later, in the 23rd week4:

  • from 23 weeks 0 days to 23 weeks 2 days: no newborn survived
  • at 23 weeks 3 days and 23 weeks 4 days: 40% of newborns survived
  • at 23 weeks 5 days and 23 weeks 6 days: 63% of newborns survived (a similar survival rate of 24-week gestations was reported by the NICHD Neonatal Research Network1).

The development of the fetus across the 23rd week of gestation appears to be critical to newborn survival. Hence, every day of in utero development during the 23rd week is critically important. A great challenge for obstetricians is how to approach the woman with threatened preterm birth at 22 weeks 0 days’ gestation. If the woman delivers within a few days, the likelihood of survival is minimal. However, if the pregnancy can be extended to 23 weeks and 5 days, survival rates increase significantly.

Aligning the actions of birth team, mother, and familyFactors that influence the limit of viability include:

  • gestational age
  • gender of the fetus (Females are more likely than males to survive.)
  • treatment of the mother with glucocorticoids prior to birth
  • newborn weight.

To increase the likelihood of newborn survival, obstetricians need to treat women at risk for preterm birth with antenatal glucocorticoids and antibiotics for rupture of membranes and to limit fetal stress during the birth process. Guidelines have evolved to encourage clinicians to treat women at preterm birth risk with glucocorticoids either at:

  • 23 weeks’ gestation or
  • 22 weeks’ gestation, if birth is anticipated to occur at 23 weeks or later.5

At birth, pediatricians are then faced with the very difficult decision of whether or not to aggressively resuscitate the severely preterm infant. Complex medical, social, and ethical issues ultimately guide pediatricians’ actions in this challenging situation. It is important for their actions to be in consensus with the obstetrician, the mother, and the mother’s family and for a consensus to be reached. Dissonant plans may increase adverse outcomes for the newborn. In one study when pediatricians and obstetricians were not aligned in their actions, the risk of death of an extremely preterm newborn significantly increased.6

 

 

Prior to birth, team meetings that include the obstetricians, pediatricians, mother, and family will help to set expectations about the course of care and, in turn, improve perceived outcomes.5 If feasible, obstetricians and pediatricians should develop joint institutional guidelines about the general approach to pregnant women when birth may occur at 22 or 23 weeks’ gestation.5

 

A neonatal outcomes predictor

The National Institute of Child Health and Human Development provides a Web-based tool for estimating newborn outcomes based on gestational age (22 to 25 weeks), birth weight, gender, singleton or multiple gestation, and exposure to antenatal glucocorticoid treatment. The outcomes tool provides estimates for survival and survival with severe morbidity. It uses data collected by the Neonatal Research Network to predict outcomes. To access the outcomes data assessment, visit https://www.nichd.nih.gov/about/org/der/branches/ppb/programs/epbo/Pages/epbo_case.aspx.

Is aggressive management of preterm birth and neonatal resuscitation a self-fulfilling prophecy?The beliefs and training of clinicians may influence the outcome of extremely preterm newborns. For example, if obstetricians and pediatricians focus on the fact that birth at 23 weeks is not likely to result in survival without severe morbidity, they may withhold key interventions such as antenatal glucocorticoids, antibiotics for rupture of the membranes, and aggressive newborn resuscitation.7 Consequently the likelihood of survival may be reduced.

If clinicians believe in maximal interventions for all newborns at 22 and 23 weeks’ gestation, their actions may result in a small increase in newborn survival—but at the cost of painful and unnecessary interventions in many newborns who are destined to die. Finding the right balance along the broad spectrum from expectant management to aggressive and extended resuscitation is challenging. Clearly there is no “right answer” with these extremely difficult decisions.

Future trends in the limit of viabilityIn 1963, Jacqueline Bouvier Kennedy, at 34 weeks’ gestation, went into preterm labor and delivered her son Patrick at a community hospital. Patrick developed respiratory distress syndrome and was transferred to the Boston Children’s Hospital. He died shortly thereafter.8 Would Patrick have survived if he had been delivered at an institution capable of providing high-risk obstetric and newborn services? Would such modern interventions as antenatal glucocorticoids, antibiotics for ruptured membranes, liberal use of cesarean delivery, and aggressive neonatal resuscitation have improved his chances for survival?

From our current perspective, it is surprising that a 34-week newborn died shortly after birth. With modern obstetric and pediatric care that scenario is unusual. It is possible that future advances in medical care will push the limit of viability to 22 weeks’ gestation. Future generations of clinicians may be surprised that the medicine we practice today is so limited.

However, given our current resources, it is unlikely that newborns at 22 weeks’ gestation will survive, or survive without severe morbidity. Consequently, routine aggressive resuscitation of newborns at 22 weeks should be approached with caution. At 23 weeks and later, many newborns will survive and a few will survive without severe morbidity. Given the complexity of the issues, the approach to resuscitation of infants at 22 and 23 weeks must account for the perspectives of the birth mother and her family, obstetricians, and pediatricians. Managing threatened preterm birth at 22 and 23 weeks is one of our greatest challenges as obstetricians, and we need to meet this challenge with grace and skill.

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.

References
  1. Stoll BJ, Hansen NI, Bell EF, et al; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Trends in care practices, morbidity and mortality of extremely preterm neonates, 1993-2012. JAMA. 2015;314(10):1039–1051.
  2. Patel RM, Kandefer S, Walsh MC, et al; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Causes and timing of death in extremely premature infants from 2000 through 2011. N Engl J Med. 2015;372(4):331–340.
  3. Donovan EF, Tyson JE, Ehrenkranz RA, et al. Inaccuracy of Ballard scores before 28 weeks’ gestation. National Institute of Child Health and Human Development Neonatal Research Network. J Pediatr. 1999;135(2 pt 1):147–152.
  4. McElrath TF, Robinson JN, Ecker JL, Ringer SA, Norwitz ER. Neonatal outcome of infants born at 23 weeks’ gestation. Obstet Gynecol. 2001;97(1):49–52.
  5. Raju TN, Mercer BM, Burchfield DJ, Joseph GF Jr. Periviable birth: executive summary of a joint workshop by the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Society for Maternal-Fetal Medicine, American Academy of Pediatrics, and American College of Obstetricians and Gynecologists. Obstet Gynecol. 2014;123(5):1083–1096.
  6. Guinsburg R, Branco de Almeida MF, dos Santos Rodrigues Sadeck L, et al; Brazilian Network on Neonatal Research. Proactive management of extreme prematurity: disagreement between obstetricians and neonatologists. J Perinatol. 2012;32(12):913-919.
  7. Tucker Emonds B, McKenzie F, Farrow V, Raglan G, Schulkin J. A national survey of obstetricians’ attitudes toward and practice of periviable interventions. J Perinatol. 2015;35(5):338–343.
  8. Altman LK. A Kennedy baby’s life and death. New York Times. http://www.nytimes.com/2013/07/30/health/a-kennedy-babys-life-and-death.html?_r=0. Published July 29, 2013. Accessed November 19, 2015.
References
  1. Stoll BJ, Hansen NI, Bell EF, et al; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Trends in care practices, morbidity and mortality of extremely preterm neonates, 1993-2012. JAMA. 2015;314(10):1039–1051.
  2. Patel RM, Kandefer S, Walsh MC, et al; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Causes and timing of death in extremely premature infants from 2000 through 2011. N Engl J Med. 2015;372(4):331–340.
  3. Donovan EF, Tyson JE, Ehrenkranz RA, et al. Inaccuracy of Ballard scores before 28 weeks’ gestation. National Institute of Child Health and Human Development Neonatal Research Network. J Pediatr. 1999;135(2 pt 1):147–152.
  4. McElrath TF, Robinson JN, Ecker JL, Ringer SA, Norwitz ER. Neonatal outcome of infants born at 23 weeks’ gestation. Obstet Gynecol. 2001;97(1):49–52.
  5. Raju TN, Mercer BM, Burchfield DJ, Joseph GF Jr. Periviable birth: executive summary of a joint workshop by the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Society for Maternal-Fetal Medicine, American Academy of Pediatrics, and American College of Obstetricians and Gynecologists. Obstet Gynecol. 2014;123(5):1083–1096.
  6. Guinsburg R, Branco de Almeida MF, dos Santos Rodrigues Sadeck L, et al; Brazilian Network on Neonatal Research. Proactive management of extreme prematurity: disagreement between obstetricians and neonatologists. J Perinatol. 2012;32(12):913-919.
  7. Tucker Emonds B, McKenzie F, Farrow V, Raglan G, Schulkin J. A national survey of obstetricians’ attitudes toward and practice of periviable interventions. J Perinatol. 2015;35(5):338–343.
  8. Altman LK. A Kennedy baby’s life and death. New York Times. http://www.nytimes.com/2013/07/30/health/a-kennedy-babys-life-and-death.html?_r=0. Published July 29, 2013. Accessed November 19, 2015.
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Should newborns at 22 or 23 weeks’ gestational age be aggressively resuscitated?
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Does the discontinuation of menopausal hormone therapy affect a woman’s cardiovascular risk?

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Does the discontinuation of menopausal hormone therapy affect a woman’s cardiovascular risk?

This recently published study from Finland generated headlines when its authors concluded that stopping HT elevates the risk of mortality from cardiovascular disease (CVD), including cardiac and cerebrovascular events. Using nationwide data, investigators compared the CVD mortality rate among women who discontinued HT during the years 1994 through 2009 (n = 332,202) with expected (not actual) CVD mortality rates in the background population.
Within the first year after HT discontinuation, elevations in death rates from cardiac events and stroke were noted (standardized mortality ratio, 1.26 and 1.63, respectively), while in the subsequent year, reductions in such mortality were observed (P<.05 for all comparisons).
The absolute increased risk of death from cardiac events reported within the first year after discontinuation of HT was 4 deaths per 10,000 woman-years of exposure. The absolute risk of death from stroke was 5 additional events per 10,000 woman-years. This level of risk is considered to be rare.

How these data compare to those of other studiesIn contrast with these Finnish data, findings from the Women’s Health Initiative—the largest randomized trial of menopausal HT—do not indicate an increase in mortality or an increase in coronary heart or stroke events among women stopping HT.1,2
It seems likely that limitations associated with the Finnish observational data account for this discordance. For example, Mikkola and colleagues did not know why women discontinued HT, raising the possibility that women with symptoms suggestive of CVD or development of new risk factors preferentially stopped HT, potentially introducing important bias into the Finnish analysis.

What this evidence means for practiceWomen and their clinicians should make decisions regarding whether to continue, reduce the dose, or discontinue HT through shared decision making, focusing on individual patient quality of life parameters as well as changing risk concerns related to such entities as cancer, CVD, and osteoporosis.3 Dramatic as they are, findings from this Finnish report should not impact how we counsel women regarding use or discontinuation of HT.
—Andrew M. Kaunitz, MD; JoAnn E. Manson, MD, DrPH; and Cynthia A. Stuenkel, MD

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.

References
  1. Heiss G, Wallace R, Anderson GL, et al; WHI investigators. Health risks and benefits 3 years after stopping randomized treatment with estrogen and progestin. JAMA. 2008;299(9):1036–1045.
  2. LaCroix AZ, Chlebowski RT, Manson JE, et al; WHI investigators. Health outcomes after stopping conjugated equine estrogens among postmenopausal women with prior hysterectomy. JAMA. 2011;305(13):1305–1314.
  3. Kaunitz AM. Extended duration use of menopausal hormone therapy. Menopause. 2014;21(6):679–68.
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Andrew M. Kaunitz, MD
University of Florida Research Foundation Professor and Associate Chairman, Department of Obstetrics and Gynecology, University of Florida College of Medicine–Jacksonville. Dr. Kaunitz directs Menopause and Gynecologic Ultrasound Services, UF Women’s Health Specialists–Emerson. He serves on the OBG Management Board of Editors.

JoAnn E. Manson, MD, DrPH
Chief of the Division of Preventive Medicine at Brigham and Women’s Hospital in Boston and Professor of Medicine at Harvard Medical School. Dr. Manson is a Past President of the North American Menopause
Society (NAMS) and one of the principal investigators of the Women’s Health Initiative.

Cynthia A. Stuenkel, MD
Clinical Professor of Medicine, University of California, San Diego, School of Medicine, and Past President of NAMS.

Dr. Kaunitz reports that he is a consultant (contraception) to Actavis, Bayer, and Pfizer. The University of Florida receives clinical trial support from Bayer and TherapeuticsMD. Drs. Manson and Stuenkel report no financial relationships relevant to this article.

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Andrew M. Kaunitz, MD
University of Florida Research Foundation Professor and Associate Chairman, Department of Obstetrics and Gynecology, University of Florida College of Medicine–Jacksonville. Dr. Kaunitz directs Menopause and Gynecologic Ultrasound Services, UF Women’s Health Specialists–Emerson. He serves on the OBG Management Board of Editors.

JoAnn E. Manson, MD, DrPH
Chief of the Division of Preventive Medicine at Brigham and Women’s Hospital in Boston and Professor of Medicine at Harvard Medical School. Dr. Manson is a Past President of the North American Menopause
Society (NAMS) and one of the principal investigators of the Women’s Health Initiative.

Cynthia A. Stuenkel, MD
Clinical Professor of Medicine, University of California, San Diego, School of Medicine, and Past President of NAMS.

Dr. Kaunitz reports that he is a consultant (contraception) to Actavis, Bayer, and Pfizer. The University of Florida receives clinical trial support from Bayer and TherapeuticsMD. Drs. Manson and Stuenkel report no financial relationships relevant to this article.

Author and Disclosure Information

Andrew M. Kaunitz, MD
University of Florida Research Foundation Professor and Associate Chairman, Department of Obstetrics and Gynecology, University of Florida College of Medicine–Jacksonville. Dr. Kaunitz directs Menopause and Gynecologic Ultrasound Services, UF Women’s Health Specialists–Emerson. He serves on the OBG Management Board of Editors.

JoAnn E. Manson, MD, DrPH
Chief of the Division of Preventive Medicine at Brigham and Women’s Hospital in Boston and Professor of Medicine at Harvard Medical School. Dr. Manson is a Past President of the North American Menopause
Society (NAMS) and one of the principal investigators of the Women’s Health Initiative.

Cynthia A. Stuenkel, MD
Clinical Professor of Medicine, University of California, San Diego, School of Medicine, and Past President of NAMS.

Dr. Kaunitz reports that he is a consultant (contraception) to Actavis, Bayer, and Pfizer. The University of Florida receives clinical trial support from Bayer and TherapeuticsMD. Drs. Manson and Stuenkel report no financial relationships relevant to this article.

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This recently published study from Finland generated headlines when its authors concluded that stopping HT elevates the risk of mortality from cardiovascular disease (CVD), including cardiac and cerebrovascular events. Using nationwide data, investigators compared the CVD mortality rate among women who discontinued HT during the years 1994 through 2009 (n = 332,202) with expected (not actual) CVD mortality rates in the background population.
Within the first year after HT discontinuation, elevations in death rates from cardiac events and stroke were noted (standardized mortality ratio, 1.26 and 1.63, respectively), while in the subsequent year, reductions in such mortality were observed (P<.05 for all comparisons).
The absolute increased risk of death from cardiac events reported within the first year after discontinuation of HT was 4 deaths per 10,000 woman-years of exposure. The absolute risk of death from stroke was 5 additional events per 10,000 woman-years. This level of risk is considered to be rare.

How these data compare to those of other studiesIn contrast with these Finnish data, findings from the Women’s Health Initiative—the largest randomized trial of menopausal HT—do not indicate an increase in mortality or an increase in coronary heart or stroke events among women stopping HT.1,2
It seems likely that limitations associated with the Finnish observational data account for this discordance. For example, Mikkola and colleagues did not know why women discontinued HT, raising the possibility that women with symptoms suggestive of CVD or development of new risk factors preferentially stopped HT, potentially introducing important bias into the Finnish analysis.

What this evidence means for practiceWomen and their clinicians should make decisions regarding whether to continue, reduce the dose, or discontinue HT through shared decision making, focusing on individual patient quality of life parameters as well as changing risk concerns related to such entities as cancer, CVD, and osteoporosis.3 Dramatic as they are, findings from this Finnish report should not impact how we counsel women regarding use or discontinuation of HT.
—Andrew M. Kaunitz, MD; JoAnn E. Manson, MD, DrPH; and Cynthia A. Stuenkel, MD

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.

This recently published study from Finland generated headlines when its authors concluded that stopping HT elevates the risk of mortality from cardiovascular disease (CVD), including cardiac and cerebrovascular events. Using nationwide data, investigators compared the CVD mortality rate among women who discontinued HT during the years 1994 through 2009 (n = 332,202) with expected (not actual) CVD mortality rates in the background population.
Within the first year after HT discontinuation, elevations in death rates from cardiac events and stroke were noted (standardized mortality ratio, 1.26 and 1.63, respectively), while in the subsequent year, reductions in such mortality were observed (P<.05 for all comparisons).
The absolute increased risk of death from cardiac events reported within the first year after discontinuation of HT was 4 deaths per 10,000 woman-years of exposure. The absolute risk of death from stroke was 5 additional events per 10,000 woman-years. This level of risk is considered to be rare.

How these data compare to those of other studiesIn contrast with these Finnish data, findings from the Women’s Health Initiative—the largest randomized trial of menopausal HT—do not indicate an increase in mortality or an increase in coronary heart or stroke events among women stopping HT.1,2
It seems likely that limitations associated with the Finnish observational data account for this discordance. For example, Mikkola and colleagues did not know why women discontinued HT, raising the possibility that women with symptoms suggestive of CVD or development of new risk factors preferentially stopped HT, potentially introducing important bias into the Finnish analysis.

What this evidence means for practiceWomen and their clinicians should make decisions regarding whether to continue, reduce the dose, or discontinue HT through shared decision making, focusing on individual patient quality of life parameters as well as changing risk concerns related to such entities as cancer, CVD, and osteoporosis.3 Dramatic as they are, findings from this Finnish report should not impact how we counsel women regarding use or discontinuation of HT.
—Andrew M. Kaunitz, MD; JoAnn E. Manson, MD, DrPH; and Cynthia A. Stuenkel, MD

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.

References
  1. Heiss G, Wallace R, Anderson GL, et al; WHI investigators. Health risks and benefits 3 years after stopping randomized treatment with estrogen and progestin. JAMA. 2008;299(9):1036–1045.
  2. LaCroix AZ, Chlebowski RT, Manson JE, et al; WHI investigators. Health outcomes after stopping conjugated equine estrogens among postmenopausal women with prior hysterectomy. JAMA. 2011;305(13):1305–1314.
  3. Kaunitz AM. Extended duration use of menopausal hormone therapy. Menopause. 2014;21(6):679–68.
References
  1. Heiss G, Wallace R, Anderson GL, et al; WHI investigators. Health risks and benefits 3 years after stopping randomized treatment with estrogen and progestin. JAMA. 2008;299(9):1036–1045.
  2. LaCroix AZ, Chlebowski RT, Manson JE, et al; WHI investigators. Health outcomes after stopping conjugated equine estrogens among postmenopausal women with prior hysterectomy. JAMA. 2011;305(13):1305–1314.
  3. Kaunitz AM. Extended duration use of menopausal hormone therapy. Menopause. 2014;21(6):679–68.
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Does the discontinuation of menopausal hormone therapy affect a woman’s cardiovascular risk?
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Andrew M. Kaunitz MD,JoAnn E. Manson MD,Cynthia A. Stuenkel MD,discontinuation of menopausal hormone therapy,cardiovascular risk,hormone therapy,HT,cardiovascular disease,CVD,stroke,Women’s Health Initiative,WHI,osteoporosis,quality of life
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Patient denies consent to endometriosis treatment

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Patient denies consent to endometriosis treatment

 

Patient denies consent to endometriosis treatment
A woman underwent laparoscopic surgery to remove an ovarian cyst. During surgery, the gynecologist found endometriosis and used electrosurgery to destroy the implants. Following extensive electrosurgery, a hemorrhage occurred. The gynecologist placed 5 large clips to control bleeding. The patient was discharged. When she returned to the hospital in pain, she was sent home again. She visited another emergency department (ED), where a clip was found to have blocked a ureter. She underwent ureteroneocystostomy to repair the damage. The patient now reports incontinence, a ligated ureter, and extensive scar tissue, which may keep her from being able to become pregnant.

Patient’s claim She only consented to ovarian cyst removal, not to any other procedures. The gynecologist was negligent in performing electrosurgery and placing the clips. A urologist should have checked for injury.

Physician’s defense When a patient agrees to laparoscopic surgery, she also agrees to exploratory abdominal surgery. The gynecologist performs electrosurgery to treat endometriosis in 30% to 60% of her surgical cases. Electrosurgery was essential to stop the patient’s pain. The clips were carefully placed when treating the hemorrhage.

Verdict A $206,886 California verdict was returned against the gynecologist.

 

Eclampsia, death: $6.9M settlement
A mother delivered a healthy baby on May 21. Twice in the week following delivery, she returned to the ED reporting shortness of breath, swollen legs, and elevated blood pressure. Pulmonary embolism was excluded both times. After the second visit, she was discharged with a diagnosis of shortness of breath of unknown etiology. The patient’s ObGyn was not contacted nor was urinalysis performed. On June 1, she suffered seizures and brain injury; she died on June 10.

Estate’s claim The ED physicians failed to diagnose and treat eclampsia.

Defendant’s defense The case was settled early in the trial.

Verdict A $6.9 million Illinois settlement was reached with the hospital.

 

Child has CP: $8M settlement
At 40 1/7 weeks’ gestation, labor was induced in an obese woman who had a heart condition. Over the next 36 hours, dinoprostone and oxytocin were administered, but her cervix only dilated to 2 cm. Two days later, the fetal heart rate reached 160 bpm. The ObGyn ordered terbutaline in anticipation of cesarean delivery, but he did not come to the hospital. The fetal heart rate continued to rise and then bradycardia occurred. When notified, the ObGyn came to the hospital for an emergency cesarean delivery. The child was severely depressed at birth with Apgar scores of 0, 1, and 2 at 1, 5, and 10 minutes, respectively. Magnetic resonance imaging at 23 days showed distinct hypoxic ischemic injury in the infant. Cerebral palsy was later diagnosed. The child is nonambulatory with significant cognitive impairment.

Parents’ claim Failure to perform cesarean delivery in a timely manner caused injury to the child.

Defendant’s defense The case was settled during the trial.

Verdict An $8 million Wisconsin settlement was reached with the medical center and physician group.

 

Infant has a stroke: $3M settlement
A 26-year-old diabetic woman was referred to a maternal-fetal medicine (MFM) specialist. She had been hospitalized for nausea and dehydration several times during her pregnancy, but it appeared that fetal development was normal.

As labor progressed, fetal distress was diagnosed in the setting of low blood pressure. When notified, the MFM immediately ordered an emergency cesarean delivery. A few days after birth, it was determined that the child had a stroke in utero.

Parents’ claim Emergency cesarean delivery should have been performed earlier. Hospital staff did not communicate fetal distress to the MFM in a timely manner.

Defendant’s defense The case was settled at trial.

Verdict A $3 million Connecticut settlement was reached with the hospital.

 

These cases were selected by the editors of 
OBG Management from Medical Malpractice Verdicts, Settlements, & Experts, with permission of the editor, Lewis Laska (www.verdictslaska.com). The information available to the editors about the cases presented here is sometimes incomplete. Moreover, the cases may or may not have merit. Nevertheless, these cases represent the types of clinical situations that typically result in litigation and are meant to illustrate nationwide variation in jury verdicts 
and awards.

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.

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Patient denies consent to endometriosis treatment
A woman underwent laparoscopic surgery to remove an ovarian cyst. During surgery, the gynecologist found endometriosis and used electrosurgery to destroy the implants. Following extensive electrosurgery, a hemorrhage occurred. The gynecologist placed 5 large clips to control bleeding. The patient was discharged. When she returned to the hospital in pain, she was sent home again. She visited another emergency department (ED), where a clip was found to have blocked a ureter. She underwent ureteroneocystostomy to repair the damage. The patient now reports incontinence, a ligated ureter, and extensive scar tissue, which may keep her from being able to become pregnant.

Patient’s claim She only consented to ovarian cyst removal, not to any other procedures. The gynecologist was negligent in performing electrosurgery and placing the clips. A urologist should have checked for injury.

Physician’s defense When a patient agrees to laparoscopic surgery, she also agrees to exploratory abdominal surgery. The gynecologist performs electrosurgery to treat endometriosis in 30% to 60% of her surgical cases. Electrosurgery was essential to stop the patient’s pain. The clips were carefully placed when treating the hemorrhage.

Verdict A $206,886 California verdict was returned against the gynecologist.

 

Eclampsia, death: $6.9M settlement
A mother delivered a healthy baby on May 21. Twice in the week following delivery, she returned to the ED reporting shortness of breath, swollen legs, and elevated blood pressure. Pulmonary embolism was excluded both times. After the second visit, she was discharged with a diagnosis of shortness of breath of unknown etiology. The patient’s ObGyn was not contacted nor was urinalysis performed. On June 1, she suffered seizures and brain injury; she died on June 10.

Estate’s claim The ED physicians failed to diagnose and treat eclampsia.

Defendant’s defense The case was settled early in the trial.

Verdict A $6.9 million Illinois settlement was reached with the hospital.

 

Child has CP: $8M settlement
At 40 1/7 weeks’ gestation, labor was induced in an obese woman who had a heart condition. Over the next 36 hours, dinoprostone and oxytocin were administered, but her cervix only dilated to 2 cm. Two days later, the fetal heart rate reached 160 bpm. The ObGyn ordered terbutaline in anticipation of cesarean delivery, but he did not come to the hospital. The fetal heart rate continued to rise and then bradycardia occurred. When notified, the ObGyn came to the hospital for an emergency cesarean delivery. The child was severely depressed at birth with Apgar scores of 0, 1, and 2 at 1, 5, and 10 minutes, respectively. Magnetic resonance imaging at 23 days showed distinct hypoxic ischemic injury in the infant. Cerebral palsy was later diagnosed. The child is nonambulatory with significant cognitive impairment.

Parents’ claim Failure to perform cesarean delivery in a timely manner caused injury to the child.

Defendant’s defense The case was settled during the trial.

Verdict An $8 million Wisconsin settlement was reached with the medical center and physician group.

 

Infant has a stroke: $3M settlement
A 26-year-old diabetic woman was referred to a maternal-fetal medicine (MFM) specialist. She had been hospitalized for nausea and dehydration several times during her pregnancy, but it appeared that fetal development was normal.

As labor progressed, fetal distress was diagnosed in the setting of low blood pressure. When notified, the MFM immediately ordered an emergency cesarean delivery. A few days after birth, it was determined that the child had a stroke in utero.

Parents’ claim Emergency cesarean delivery should have been performed earlier. Hospital staff did not communicate fetal distress to the MFM in a timely manner.

Defendant’s defense The case was settled at trial.

Verdict A $3 million Connecticut settlement was reached with the hospital.

 

These cases were selected by the editors of 
OBG Management from Medical Malpractice Verdicts, Settlements, & Experts, with permission of the editor, Lewis Laska (www.verdictslaska.com). The information available to the editors about the cases presented here is sometimes incomplete. Moreover, the cases may or may not have merit. Nevertheless, these cases represent the types of clinical situations that typically result in litigation and are meant to illustrate nationwide variation in jury verdicts 
and awards.

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.

 

Patient denies consent to endometriosis treatment
A woman underwent laparoscopic surgery to remove an ovarian cyst. During surgery, the gynecologist found endometriosis and used electrosurgery to destroy the implants. Following extensive electrosurgery, a hemorrhage occurred. The gynecologist placed 5 large clips to control bleeding. The patient was discharged. When she returned to the hospital in pain, she was sent home again. She visited another emergency department (ED), where a clip was found to have blocked a ureter. She underwent ureteroneocystostomy to repair the damage. The patient now reports incontinence, a ligated ureter, and extensive scar tissue, which may keep her from being able to become pregnant.

Patient’s claim She only consented to ovarian cyst removal, not to any other procedures. The gynecologist was negligent in performing electrosurgery and placing the clips. A urologist should have checked for injury.

Physician’s defense When a patient agrees to laparoscopic surgery, she also agrees to exploratory abdominal surgery. The gynecologist performs electrosurgery to treat endometriosis in 30% to 60% of her surgical cases. Electrosurgery was essential to stop the patient’s pain. The clips were carefully placed when treating the hemorrhage.

Verdict A $206,886 California verdict was returned against the gynecologist.

 

Eclampsia, death: $6.9M settlement
A mother delivered a healthy baby on May 21. Twice in the week following delivery, she returned to the ED reporting shortness of breath, swollen legs, and elevated blood pressure. Pulmonary embolism was excluded both times. After the second visit, she was discharged with a diagnosis of shortness of breath of unknown etiology. The patient’s ObGyn was not contacted nor was urinalysis performed. On June 1, she suffered seizures and brain injury; she died on June 10.

Estate’s claim The ED physicians failed to diagnose and treat eclampsia.

Defendant’s defense The case was settled early in the trial.

Verdict A $6.9 million Illinois settlement was reached with the hospital.

 

Child has CP: $8M settlement
At 40 1/7 weeks’ gestation, labor was induced in an obese woman who had a heart condition. Over the next 36 hours, dinoprostone and oxytocin were administered, but her cervix only dilated to 2 cm. Two days later, the fetal heart rate reached 160 bpm. The ObGyn ordered terbutaline in anticipation of cesarean delivery, but he did not come to the hospital. The fetal heart rate continued to rise and then bradycardia occurred. When notified, the ObGyn came to the hospital for an emergency cesarean delivery. The child was severely depressed at birth with Apgar scores of 0, 1, and 2 at 1, 5, and 10 minutes, respectively. Magnetic resonance imaging at 23 days showed distinct hypoxic ischemic injury in the infant. Cerebral palsy was later diagnosed. The child is nonambulatory with significant cognitive impairment.

Parents’ claim Failure to perform cesarean delivery in a timely manner caused injury to the child.

Defendant’s defense The case was settled during the trial.

Verdict An $8 million Wisconsin settlement was reached with the medical center and physician group.

 

Infant has a stroke: $3M settlement
A 26-year-old diabetic woman was referred to a maternal-fetal medicine (MFM) specialist. She had been hospitalized for nausea and dehydration several times during her pregnancy, but it appeared that fetal development was normal.

As labor progressed, fetal distress was diagnosed in the setting of low blood pressure. When notified, the MFM immediately ordered an emergency cesarean delivery. A few days after birth, it was determined that the child had a stroke in utero.

Parents’ claim Emergency cesarean delivery should have been performed earlier. Hospital staff did not communicate fetal distress to the MFM in a timely manner.

Defendant’s defense The case was settled at trial.

Verdict A $3 million Connecticut settlement was reached with the hospital.

 

These cases were selected by the editors of 
OBG Management from Medical Malpractice Verdicts, Settlements, & Experts, with permission of the editor, Lewis Laska (www.verdictslaska.com). The information available to the editors about the cases presented here is sometimes incomplete. Moreover, the cases may or may not have merit. Nevertheless, these cases represent the types of clinical situations that typically result in litigation and are meant to illustrate nationwide variation in jury verdicts 
and awards.

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.

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Legacy Keywords
Medical malpractice, medical verdicts, Lewis Laska, Medical Malpractice Verdicts Settlements & Experts, endometriosis, ureteroneocystostomy, preeclampsia, cesarean, fetal heart rate, stroke, cerebral palsy, maternal-fetal medicine, MFM, hypoxic ischemic injury, CP
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  • Eclampsia, death: $6.9M settlement
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“Where is it safe to practice obstetrics?” is a broader question

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“Where is it safe to practice obstetrics?” is a broader question

“SHOULD THE 30-MINUTE RULE FOR EMERGENT CESAREAN DELIVERY BE APPLIED UNIVERSALLY?”

“Where is it safe to practice obstetrics?” is a broader question Drs. Chauhan and Mendez-Figueroa presented a thoughtful series of case studies. Unfortunately, the cases were intended for the considerate ObGyn—the one who can appreciate that every case has a differing set of variables—and did not account for the context and legal environment in which we practice. In the theater that is our malpractice reality, these cases would carry little weight with a jury that is empathizing with a child with cerebral palsy, often years after the event.

“Where is it safe to practice obstetrics?” is a broader, and perhaps more interesting, question. And a more relevant case would involve a smaller hospital, perhaps in a rural area, that does not have in-house anesthesia available for 30-minute starts.

Daniel R. Szekely, MD, PhD
Tacoma, Washington

We are hoisted on a petard of our own makingThere is absolutely no justification for ObGyns being held to this so-called “standard of care.” The evidence is scant or lacking that delivery in a 30-minute timeframe has any significant bearing on the neonatal outcome. Despite this, the lay public and medical-legal community see this as an absolute rule to be followed. If there is a less-than-perfect outcome, we are hoisted on this petard of our own making.

We as a group (that is, the American College of Obstetricians and  
Gynecologists) need to work to right this unfortunate wrong!

William H. Deschner, MD
Seattle, Washington

Practicing is downright scary
The “30-minute rule” is no help to ObGyns in the field. At a community hospital, where surgical teams are called in from home (we cannot afford to do otherwise), it is often impossible to meet this standard. University-level care even cannot meet the measure at times. We never should have been painted into this corner. Now, any attempts to loosen the rule will be seen as trying to practice defensive medicine.

People who do not do what we do for a living have no concept of the anxiety and sleep loss we incur while seeking the best outcomes for our patients. I long for the soon-to-come day when I retire. Due to the litigious environment, I am saddened that I cannot heartily recommend the field to young doctors.

James Nunn, MD
Chicago, Illinois

“UPDATE ON VAGINAL HYSTERECTOMY”
BARBARA S. LEVY, MD (SEPTEMBER 2015)

Why has TAH remained the dominant hysterectomy route for generations?I read with great interest Dr. Levy’s recent comments on the benefits of new technology to improve the vaginal hysterectomy (VH) rate. Thank you and Dr. Levy for all the work you have done to advance the care of our patients. I have some other fundamental concerns about the future of hysterectomy.

Why has total abdominal hysterectomy (TAH) remained the dominant route of hysterectomy for generations? Why have past efforts to minimize TAH met with limited results?

Dr. Levy maintains in her article that, “the biggest barrier to widespread use [of VH] may simply be the lack of industry support.” What industry has supported TAH in a manner not also applicable to VH?

What do the techniques in Dr. Levy’s article and the efforts by ACOG and other authorities1 offer that will materially increase the adoption of VH?  What evidence is there that the use of such devices as VITOM system will overcome the low rate of VH? How much training is required before a surgeon can realize patient-centered benefit from using the VITOM or other new devices during VH?

The lack of evidence-based training and implementation of robotic surgery has resulted in well-deserved criticism of robotics, centered, in part, around complications. Will the complication rate rise as those who do not perform VH transition to its adoption using VITOM and other devices?

I hope that the generations-long failure of all efforts to raise the VH rate is overcome with evidence-based educational protocols.

Antonio R. Pizarro, MD
Shreveport, Louisiana

Reference
1. Bosworth T. ACOG taking steps to increase vaginal hysterectomy rates. Ob.Gyn. News. http://www.obgynnews.com/?id=11146&tx_ttnews[tt_news]=392609&cHash=d78b8bea4aa3483c10dc5d843207d211. Posted April 6, 2015. Accessed October 2, 2015.

The problem: lack of trainingSadly, lack of training is the problem in this best approach to removing the benign uterus. These tools are helpful and should be in the surgeon’s armamentarium. We need experienced vaginal surgeons to teach this procedure. In some ways, just as much skill and dexterity are needed as with laparoscopic or robotic methods.

William H. Deschner, MD
Seattle, Washington

Dr. Levy respondsI appreciate the insightful comments of Drs. Pizarro and Deschner. Clearly,  as the volume of hysterectomies has decreased and the number of techniques we must teach our residents has expanded, we are challenged to provide robust training in all hysterectomy routes. TAH, as the status quo, has not required the development of new equipment and technology, whereas assisting gynecologic surgeons to convert open procedures to minimally invasive approaches has been advanced and driven by our industry partners.

 

 

I totally agree with the concern that we cannot rely on historic data to determine the safest and most cost-effective route for hysterectomy. I encourage all of us to track and publically report our outcomes and monitor the complication rates of gynecologic surgical procedures. Our ongoing commitment to delivering the best care for our patients requires nothing less.

“REDUCING MATERNAL MORTALITY IN THE UNITED STATES—LET’S GET ORGANIZED!”
ROBERT L. BARBIERI, MD (EDITORIAL; SEPTEMBER 2015)

Structured business methods will improve outcomesDr. Barbieri’s call for getting organized and breaking down health care silos while establishing multidisciplinary teams is of great importance. Most providers have not witnessed a maternal mortality in their careers and many are not aware of the near misses. Incorporating foundations of established business methods has been advocated to reduce waste, improve collaboration, decrease variance, and improve patient safety.

If we view the adverse outcomes through this lens, then the increase in maternal mortality and morbidity are lagging indicators in the structured analysis methods (such as Six Sigma and Lean Six Sigma). These methods lead us to focus and measure the leading indicators of input and process (prenatal care and pregnancy management). Our reliance on lagging indicators often comes too late to make any change effective.

Around 1973, several important processes were introduced into obstetric practice: fetal heart-rate monitoring; ultrasonography; and a reduction of the use of forceps with an increase in the use of vacuum extraction. Safety rates improved, but we witnessed the 8% cesarean delivery rate in 1973 rise to 32% in 2013.1,2 The maternal mortality rate reported in 2013 is now the same as it was in 1973. A corresponding increase in the cesarean delivery rate over this time frame could be inferred.

By focusing on analysis and management of variables in pregnancy and implementing standardization of care based on good evidence from all disciplines involved in patient safety, we can improve maternal mortality. Simulations and debriefings are critical instruments to enhance management of all aspects of prenatal management, particularly emergent care.

As leaders in improving maternal quality, ObGyns must implement structured business methods (input and process analysis) to improve outcomes. A culture also can be positively altered if the mission and vision are clearly elucidated. Transparent, dynamic, granular, accurate, and reliable data will facilitate “buy-in” of the caregivers and provide more successful solutions. Decreased variance is critical. Expect resistance due to provider autonomy. The alteration in culture of the multidisciplinary team takes time, but a reduction in cesarean delivery rates should be number one on the list to reduce maternal mortality. The unintended consequences of all interventions and monitoring methods also should be pursued.

Robert A. Knuppel, MD, MPH, MBA
Naples, Florida
Judith Withers, RN, MN, MBA
San Diego, California

References
1. Blanchette E. The rising cesarean delivery rate in America. Obstet Gynecol. 2011;118(3):687–690.
2. Knuppel RA. Personal review of Centers for Disease Control and Prevention, National Vital Statistics Reports, 1973–2015.

Dr. Barbieri respondsI wholeheartedly agree with Dr. Knuppel and Ms. Withers: increasing the use of high reliability clinical processes is critically important in our quest to reduce maternal mortality. In addition to decreasing the cesarean delivery rate, I would prioritize ensuring the use of highly effective contraceptives by women with serious medical comorbidities that increase their risk of maternal mortality.

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.

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Suneet P. Chauhan,Hector Mendez-Figueroa,Daniel R. Szekely,William H. Deschner,James Nunn,Barbara S. Levy,Antonio R. Pizarro,Robert L. Barbieri,Robert A. Knuppel,Judith Withers,30-minute rule,emergent cesarean delivery,community hospital,vaginal hysterectomy,total abdominal hysterectomy,VH, TAH,VITOM system,lack of training,structured business methods,maternal mortality,prenatal care,pregnancy management
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“SHOULD THE 30-MINUTE RULE FOR EMERGENT CESAREAN DELIVERY BE APPLIED UNIVERSALLY?”

“Where is it safe to practice obstetrics?” is a broader question Drs. Chauhan and Mendez-Figueroa presented a thoughtful series of case studies. Unfortunately, the cases were intended for the considerate ObGyn—the one who can appreciate that every case has a differing set of variables—and did not account for the context and legal environment in which we practice. In the theater that is our malpractice reality, these cases would carry little weight with a jury that is empathizing with a child with cerebral palsy, often years after the event.

“Where is it safe to practice obstetrics?” is a broader, and perhaps more interesting, question. And a more relevant case would involve a smaller hospital, perhaps in a rural area, that does not have in-house anesthesia available for 30-minute starts.

Daniel R. Szekely, MD, PhD
Tacoma, Washington

We are hoisted on a petard of our own makingThere is absolutely no justification for ObGyns being held to this so-called “standard of care.” The evidence is scant or lacking that delivery in a 30-minute timeframe has any significant bearing on the neonatal outcome. Despite this, the lay public and medical-legal community see this as an absolute rule to be followed. If there is a less-than-perfect outcome, we are hoisted on this petard of our own making.

We as a group (that is, the American College of Obstetricians and  
Gynecologists) need to work to right this unfortunate wrong!

William H. Deschner, MD
Seattle, Washington

Practicing is downright scary
The “30-minute rule” is no help to ObGyns in the field. At a community hospital, where surgical teams are called in from home (we cannot afford to do otherwise), it is often impossible to meet this standard. University-level care even cannot meet the measure at times. We never should have been painted into this corner. Now, any attempts to loosen the rule will be seen as trying to practice defensive medicine.

People who do not do what we do for a living have no concept of the anxiety and sleep loss we incur while seeking the best outcomes for our patients. I long for the soon-to-come day when I retire. Due to the litigious environment, I am saddened that I cannot heartily recommend the field to young doctors.

James Nunn, MD
Chicago, Illinois

“UPDATE ON VAGINAL HYSTERECTOMY”
BARBARA S. LEVY, MD (SEPTEMBER 2015)

Why has TAH remained the dominant hysterectomy route for generations?I read with great interest Dr. Levy’s recent comments on the benefits of new technology to improve the vaginal hysterectomy (VH) rate. Thank you and Dr. Levy for all the work you have done to advance the care of our patients. I have some other fundamental concerns about the future of hysterectomy.

Why has total abdominal hysterectomy (TAH) remained the dominant route of hysterectomy for generations? Why have past efforts to minimize TAH met with limited results?

Dr. Levy maintains in her article that, “the biggest barrier to widespread use [of VH] may simply be the lack of industry support.” What industry has supported TAH in a manner not also applicable to VH?

What do the techniques in Dr. Levy’s article and the efforts by ACOG and other authorities1 offer that will materially increase the adoption of VH?  What evidence is there that the use of such devices as VITOM system will overcome the low rate of VH? How much training is required before a surgeon can realize patient-centered benefit from using the VITOM or other new devices during VH?

The lack of evidence-based training and implementation of robotic surgery has resulted in well-deserved criticism of robotics, centered, in part, around complications. Will the complication rate rise as those who do not perform VH transition to its adoption using VITOM and other devices?

I hope that the generations-long failure of all efforts to raise the VH rate is overcome with evidence-based educational protocols.

Antonio R. Pizarro, MD
Shreveport, Louisiana

Reference
1. Bosworth T. ACOG taking steps to increase vaginal hysterectomy rates. Ob.Gyn. News. http://www.obgynnews.com/?id=11146&tx_ttnews[tt_news]=392609&cHash=d78b8bea4aa3483c10dc5d843207d211. Posted April 6, 2015. Accessed October 2, 2015.

The problem: lack of trainingSadly, lack of training is the problem in this best approach to removing the benign uterus. These tools are helpful and should be in the surgeon’s armamentarium. We need experienced vaginal surgeons to teach this procedure. In some ways, just as much skill and dexterity are needed as with laparoscopic or robotic methods.

William H. Deschner, MD
Seattle, Washington

Dr. Levy respondsI appreciate the insightful comments of Drs. Pizarro and Deschner. Clearly,  as the volume of hysterectomies has decreased and the number of techniques we must teach our residents has expanded, we are challenged to provide robust training in all hysterectomy routes. TAH, as the status quo, has not required the development of new equipment and technology, whereas assisting gynecologic surgeons to convert open procedures to minimally invasive approaches has been advanced and driven by our industry partners.

 

 

I totally agree with the concern that we cannot rely on historic data to determine the safest and most cost-effective route for hysterectomy. I encourage all of us to track and publically report our outcomes and monitor the complication rates of gynecologic surgical procedures. Our ongoing commitment to delivering the best care for our patients requires nothing less.

“REDUCING MATERNAL MORTALITY IN THE UNITED STATES—LET’S GET ORGANIZED!”
ROBERT L. BARBIERI, MD (EDITORIAL; SEPTEMBER 2015)

Structured business methods will improve outcomesDr. Barbieri’s call for getting organized and breaking down health care silos while establishing multidisciplinary teams is of great importance. Most providers have not witnessed a maternal mortality in their careers and many are not aware of the near misses. Incorporating foundations of established business methods has been advocated to reduce waste, improve collaboration, decrease variance, and improve patient safety.

If we view the adverse outcomes through this lens, then the increase in maternal mortality and morbidity are lagging indicators in the structured analysis methods (such as Six Sigma and Lean Six Sigma). These methods lead us to focus and measure the leading indicators of input and process (prenatal care and pregnancy management). Our reliance on lagging indicators often comes too late to make any change effective.

Around 1973, several important processes were introduced into obstetric practice: fetal heart-rate monitoring; ultrasonography; and a reduction of the use of forceps with an increase in the use of vacuum extraction. Safety rates improved, but we witnessed the 8% cesarean delivery rate in 1973 rise to 32% in 2013.1,2 The maternal mortality rate reported in 2013 is now the same as it was in 1973. A corresponding increase in the cesarean delivery rate over this time frame could be inferred.

By focusing on analysis and management of variables in pregnancy and implementing standardization of care based on good evidence from all disciplines involved in patient safety, we can improve maternal mortality. Simulations and debriefings are critical instruments to enhance management of all aspects of prenatal management, particularly emergent care.

As leaders in improving maternal quality, ObGyns must implement structured business methods (input and process analysis) to improve outcomes. A culture also can be positively altered if the mission and vision are clearly elucidated. Transparent, dynamic, granular, accurate, and reliable data will facilitate “buy-in” of the caregivers and provide more successful solutions. Decreased variance is critical. Expect resistance due to provider autonomy. The alteration in culture of the multidisciplinary team takes time, but a reduction in cesarean delivery rates should be number one on the list to reduce maternal mortality. The unintended consequences of all interventions and monitoring methods also should be pursued.

Robert A. Knuppel, MD, MPH, MBA
Naples, Florida
Judith Withers, RN, MN, MBA
San Diego, California

References
1. Blanchette E. The rising cesarean delivery rate in America. Obstet Gynecol. 2011;118(3):687–690.
2. Knuppel RA. Personal review of Centers for Disease Control and Prevention, National Vital Statistics Reports, 1973–2015.

Dr. Barbieri respondsI wholeheartedly agree with Dr. Knuppel and Ms. Withers: increasing the use of high reliability clinical processes is critically important in our quest to reduce maternal mortality. In addition to decreasing the cesarean delivery rate, I would prioritize ensuring the use of highly effective contraceptives by women with serious medical comorbidities that increase their risk of maternal mortality.

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.

“SHOULD THE 30-MINUTE RULE FOR EMERGENT CESAREAN DELIVERY BE APPLIED UNIVERSALLY?”

“Where is it safe to practice obstetrics?” is a broader question Drs. Chauhan and Mendez-Figueroa presented a thoughtful series of case studies. Unfortunately, the cases were intended for the considerate ObGyn—the one who can appreciate that every case has a differing set of variables—and did not account for the context and legal environment in which we practice. In the theater that is our malpractice reality, these cases would carry little weight with a jury that is empathizing with a child with cerebral palsy, often years after the event.

“Where is it safe to practice obstetrics?” is a broader, and perhaps more interesting, question. And a more relevant case would involve a smaller hospital, perhaps in a rural area, that does not have in-house anesthesia available for 30-minute starts.

Daniel R. Szekely, MD, PhD
Tacoma, Washington

We are hoisted on a petard of our own makingThere is absolutely no justification for ObGyns being held to this so-called “standard of care.” The evidence is scant or lacking that delivery in a 30-minute timeframe has any significant bearing on the neonatal outcome. Despite this, the lay public and medical-legal community see this as an absolute rule to be followed. If there is a less-than-perfect outcome, we are hoisted on this petard of our own making.

We as a group (that is, the American College of Obstetricians and  
Gynecologists) need to work to right this unfortunate wrong!

William H. Deschner, MD
Seattle, Washington

Practicing is downright scary
The “30-minute rule” is no help to ObGyns in the field. At a community hospital, where surgical teams are called in from home (we cannot afford to do otherwise), it is often impossible to meet this standard. University-level care even cannot meet the measure at times. We never should have been painted into this corner. Now, any attempts to loosen the rule will be seen as trying to practice defensive medicine.

People who do not do what we do for a living have no concept of the anxiety and sleep loss we incur while seeking the best outcomes for our patients. I long for the soon-to-come day when I retire. Due to the litigious environment, I am saddened that I cannot heartily recommend the field to young doctors.

James Nunn, MD
Chicago, Illinois

“UPDATE ON VAGINAL HYSTERECTOMY”
BARBARA S. LEVY, MD (SEPTEMBER 2015)

Why has TAH remained the dominant hysterectomy route for generations?I read with great interest Dr. Levy’s recent comments on the benefits of new technology to improve the vaginal hysterectomy (VH) rate. Thank you and Dr. Levy for all the work you have done to advance the care of our patients. I have some other fundamental concerns about the future of hysterectomy.

Why has total abdominal hysterectomy (TAH) remained the dominant route of hysterectomy for generations? Why have past efforts to minimize TAH met with limited results?

Dr. Levy maintains in her article that, “the biggest barrier to widespread use [of VH] may simply be the lack of industry support.” What industry has supported TAH in a manner not also applicable to VH?

What do the techniques in Dr. Levy’s article and the efforts by ACOG and other authorities1 offer that will materially increase the adoption of VH?  What evidence is there that the use of such devices as VITOM system will overcome the low rate of VH? How much training is required before a surgeon can realize patient-centered benefit from using the VITOM or other new devices during VH?

The lack of evidence-based training and implementation of robotic surgery has resulted in well-deserved criticism of robotics, centered, in part, around complications. Will the complication rate rise as those who do not perform VH transition to its adoption using VITOM and other devices?

I hope that the generations-long failure of all efforts to raise the VH rate is overcome with evidence-based educational protocols.

Antonio R. Pizarro, MD
Shreveport, Louisiana

Reference
1. Bosworth T. ACOG taking steps to increase vaginal hysterectomy rates. Ob.Gyn. News. http://www.obgynnews.com/?id=11146&tx_ttnews[tt_news]=392609&cHash=d78b8bea4aa3483c10dc5d843207d211. Posted April 6, 2015. Accessed October 2, 2015.

The problem: lack of trainingSadly, lack of training is the problem in this best approach to removing the benign uterus. These tools are helpful and should be in the surgeon’s armamentarium. We need experienced vaginal surgeons to teach this procedure. In some ways, just as much skill and dexterity are needed as with laparoscopic or robotic methods.

William H. Deschner, MD
Seattle, Washington

Dr. Levy respondsI appreciate the insightful comments of Drs. Pizarro and Deschner. Clearly,  as the volume of hysterectomies has decreased and the number of techniques we must teach our residents has expanded, we are challenged to provide robust training in all hysterectomy routes. TAH, as the status quo, has not required the development of new equipment and technology, whereas assisting gynecologic surgeons to convert open procedures to minimally invasive approaches has been advanced and driven by our industry partners.

 

 

I totally agree with the concern that we cannot rely on historic data to determine the safest and most cost-effective route for hysterectomy. I encourage all of us to track and publically report our outcomes and monitor the complication rates of gynecologic surgical procedures. Our ongoing commitment to delivering the best care for our patients requires nothing less.

“REDUCING MATERNAL MORTALITY IN THE UNITED STATES—LET’S GET ORGANIZED!”
ROBERT L. BARBIERI, MD (EDITORIAL; SEPTEMBER 2015)

Structured business methods will improve outcomesDr. Barbieri’s call for getting organized and breaking down health care silos while establishing multidisciplinary teams is of great importance. Most providers have not witnessed a maternal mortality in their careers and many are not aware of the near misses. Incorporating foundations of established business methods has been advocated to reduce waste, improve collaboration, decrease variance, and improve patient safety.

If we view the adverse outcomes through this lens, then the increase in maternal mortality and morbidity are lagging indicators in the structured analysis methods (such as Six Sigma and Lean Six Sigma). These methods lead us to focus and measure the leading indicators of input and process (prenatal care and pregnancy management). Our reliance on lagging indicators often comes too late to make any change effective.

Around 1973, several important processes were introduced into obstetric practice: fetal heart-rate monitoring; ultrasonography; and a reduction of the use of forceps with an increase in the use of vacuum extraction. Safety rates improved, but we witnessed the 8% cesarean delivery rate in 1973 rise to 32% in 2013.1,2 The maternal mortality rate reported in 2013 is now the same as it was in 1973. A corresponding increase in the cesarean delivery rate over this time frame could be inferred.

By focusing on analysis and management of variables in pregnancy and implementing standardization of care based on good evidence from all disciplines involved in patient safety, we can improve maternal mortality. Simulations and debriefings are critical instruments to enhance management of all aspects of prenatal management, particularly emergent care.

As leaders in improving maternal quality, ObGyns must implement structured business methods (input and process analysis) to improve outcomes. A culture also can be positively altered if the mission and vision are clearly elucidated. Transparent, dynamic, granular, accurate, and reliable data will facilitate “buy-in” of the caregivers and provide more successful solutions. Decreased variance is critical. Expect resistance due to provider autonomy. The alteration in culture of the multidisciplinary team takes time, but a reduction in cesarean delivery rates should be number one on the list to reduce maternal mortality. The unintended consequences of all interventions and monitoring methods also should be pursued.

Robert A. Knuppel, MD, MPH, MBA
Naples, Florida
Judith Withers, RN, MN, MBA
San Diego, California

References
1. Blanchette E. The rising cesarean delivery rate in America. Obstet Gynecol. 2011;118(3):687–690.
2. Knuppel RA. Personal review of Centers for Disease Control and Prevention, National Vital Statistics Reports, 1973–2015.

Dr. Barbieri respondsI wholeheartedly agree with Dr. Knuppel and Ms. Withers: increasing the use of high reliability clinical processes is critically important in our quest to reduce maternal mortality. In addition to decreasing the cesarean delivery rate, I would prioritize ensuring the use of highly effective contraceptives by women with serious medical comorbidities that increase their risk of maternal mortality.

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.

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Randomized trial: When a vaginal approach is feasible, the robot offers no advantages for benign hysterectomy

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When investigators compared the cost of vaginal hysterectomy with robot-assisted laparoscopic hysterectomy head to head, they found hospital costs of $4,579 and $7,059, respectively, with no other significant differences between the approaches. Accordingly, they concluded that vaginal hysterectomy should be the “first-choice” approach when it is feasible.

The randomized controlled trial by Lönnerfors and colleagues also compared “traditional” minimally invasive hysterectomy (vaginal or laparoscopic approach) with robot-assisted hysterectomy in 122 women undergoing hysterectomy for benign conditions. Women with a uterine size of 16 gestational weeks or smaller were randomly allocated to:

  • traditional minimally invasive hysterectomy (n = 61) or
  • robotic assisted hysterectomy (n = 61).

In the traditional group, vaginal hysterectomy was the first-choice approach when it was feasible; otherwise, laparoscopic hysterectomy was performed. Vaginal hysterectomy was possible in 41% of cases in this group.

When costs for vaginal and laparoscopic approaches were consolidated and compared with the cost of the robot-assisted approach, the differential was $993 for the robotic approach when the robot was considered a preexisting investment. The hospital cost increased by $1,607 for the robotic approach when investment costs and maintenance expenses were included.

When laparoscopic hysterectomy was compared directly with robot-assisted hysterectomy, costs were similar ($7,016 vs $7,059, respectively) when the robot was considered a preexisting investment, and the robotic approach was associated with less blood loss and fewer postoperative complications.

Investigators noted that: “per-protocol analysis indicates that laparoscopic and robotic-assisted hysterectomy can be performed at similar hospital cost because of higher robot capacity that entails excluding the cost of investment and maintenance, i.e., the basic cost of the robot. This cost differs among institutions, depending on the number of procedures performed; however, the difference becomes less pronounced when 300 to 400 procedures or more are performed annually and the cost for instruments and disposables accounts for most of the cost of the procedure.”

This randomized controlled trial was awarded the Robert B. Hunt Award at the 2015 AAGL Global Congress in Las Vegas as the best paper published over the past year in the Journal of Minimally Invasive Gynecology.

References

Reference

Lönnerfors C, Reynisson P, Persson J. A randomized trial comparing vaginal and laparoscopic hysterectomy vs robot-assisted hysterectomy. J Minim Invasive Gynecol. 2015;22(1):78–86.

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When investigators compared the cost of vaginal hysterectomy with robot-assisted laparoscopic hysterectomy head to head, they found hospital costs of $4,579 and $7,059, respectively, with no other significant differences between the approaches. Accordingly, they concluded that vaginal hysterectomy should be the “first-choice” approach when it is feasible.

The randomized controlled trial by Lönnerfors and colleagues also compared “traditional” minimally invasive hysterectomy (vaginal or laparoscopic approach) with robot-assisted hysterectomy in 122 women undergoing hysterectomy for benign conditions. Women with a uterine size of 16 gestational weeks or smaller were randomly allocated to:

  • traditional minimally invasive hysterectomy (n = 61) or
  • robotic assisted hysterectomy (n = 61).

In the traditional group, vaginal hysterectomy was the first-choice approach when it was feasible; otherwise, laparoscopic hysterectomy was performed. Vaginal hysterectomy was possible in 41% of cases in this group.

When costs for vaginal and laparoscopic approaches were consolidated and compared with the cost of the robot-assisted approach, the differential was $993 for the robotic approach when the robot was considered a preexisting investment. The hospital cost increased by $1,607 for the robotic approach when investment costs and maintenance expenses were included.

When laparoscopic hysterectomy was compared directly with robot-assisted hysterectomy, costs were similar ($7,016 vs $7,059, respectively) when the robot was considered a preexisting investment, and the robotic approach was associated with less blood loss and fewer postoperative complications.

Investigators noted that: “per-protocol analysis indicates that laparoscopic and robotic-assisted hysterectomy can be performed at similar hospital cost because of higher robot capacity that entails excluding the cost of investment and maintenance, i.e., the basic cost of the robot. This cost differs among institutions, depending on the number of procedures performed; however, the difference becomes less pronounced when 300 to 400 procedures or more are performed annually and the cost for instruments and disposables accounts for most of the cost of the procedure.”

This randomized controlled trial was awarded the Robert B. Hunt Award at the 2015 AAGL Global Congress in Las Vegas as the best paper published over the past year in the Journal of Minimally Invasive Gynecology.

When investigators compared the cost of vaginal hysterectomy with robot-assisted laparoscopic hysterectomy head to head, they found hospital costs of $4,579 and $7,059, respectively, with no other significant differences between the approaches. Accordingly, they concluded that vaginal hysterectomy should be the “first-choice” approach when it is feasible.

The randomized controlled trial by Lönnerfors and colleagues also compared “traditional” minimally invasive hysterectomy (vaginal or laparoscopic approach) with robot-assisted hysterectomy in 122 women undergoing hysterectomy for benign conditions. Women with a uterine size of 16 gestational weeks or smaller were randomly allocated to:

  • traditional minimally invasive hysterectomy (n = 61) or
  • robotic assisted hysterectomy (n = 61).

In the traditional group, vaginal hysterectomy was the first-choice approach when it was feasible; otherwise, laparoscopic hysterectomy was performed. Vaginal hysterectomy was possible in 41% of cases in this group.

When costs for vaginal and laparoscopic approaches were consolidated and compared with the cost of the robot-assisted approach, the differential was $993 for the robotic approach when the robot was considered a preexisting investment. The hospital cost increased by $1,607 for the robotic approach when investment costs and maintenance expenses were included.

When laparoscopic hysterectomy was compared directly with robot-assisted hysterectomy, costs were similar ($7,016 vs $7,059, respectively) when the robot was considered a preexisting investment, and the robotic approach was associated with less blood loss and fewer postoperative complications.

Investigators noted that: “per-protocol analysis indicates that laparoscopic and robotic-assisted hysterectomy can be performed at similar hospital cost because of higher robot capacity that entails excluding the cost of investment and maintenance, i.e., the basic cost of the robot. This cost differs among institutions, depending on the number of procedures performed; however, the difference becomes less pronounced when 300 to 400 procedures or more are performed annually and the cost for instruments and disposables accounts for most of the cost of the procedure.”

This randomized controlled trial was awarded the Robert B. Hunt Award at the 2015 AAGL Global Congress in Las Vegas as the best paper published over the past year in the Journal of Minimally Invasive Gynecology.

References

Reference

Lönnerfors C, Reynisson P, Persson J. A randomized trial comparing vaginal and laparoscopic hysterectomy vs robot-assisted hysterectomy. J Minim Invasive Gynecol. 2015;22(1):78–86.

References

Reference

Lönnerfors C, Reynisson P, Persson J. A randomized trial comparing vaginal and laparoscopic hysterectomy vs robot-assisted hysterectomy. J Minim Invasive Gynecol. 2015;22(1):78–86.

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When the surgeon is experienced, operative times are comparable for robot-assisted and standard laparoscopic hysterectomy

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When investigators from the Penn State Milton S. Hershey Medical Center randomly allocated 144 women to robot-assisted or standard laparoscopic hysterectomy (n = 72 in each arm) and recorded complications for 12 weeks, they found no significant differences between groups in estimated blood loss.1 In addition, mean operative times (surgeon incision to surgeon stop, including docking in the robot-assisted group) were similar (73.9 min for robot-assisted surgery vs 74.9 min for standard laparoscopy), as were complication rates. In this trial, operative time was the primary outcome.

Pain was assessed at 2 postoperative hours and was found to be similar between groups.

Two intraoperative complications occurred in the robot-assisted group, compared with none for standard laparoscopy (P = .50). Six postoperative complications occurred in the robot-assisted group, compared with 9 in the standard laparoscopy group (P = 0.58).

Complications included: a need for reoperation/readmission (2 patients in each group; P = 1.00), infection (1 patient in each group; P = 1.00), hemorrhage/transfusion (4 in the standard laparoscopy group; P = 0.12), and vaginal cuff dehiscence (2 in the robot-assisted group vs 1 for standard laparoscopy; P = 1.00).

Investigators concluded that robot-assisted hysterectomy is “noninferior” to standard laparoscopy with regard to operative time when it is performed by experienced minimally invasive surgeons.

Gerald J. Harkins, MD, an author and primary surgeon of the trial, notes that it is the first randomized comparison involving surgeons with expertise in both robot-assisted and standard laparoscopic hysterectomy. As such, its findings represent Level I evidence. Dr. Harkins had completed more than 600 robot-assisted cases prior to initiation of the trial.

Cost was not analyzed in this study, the abstract of which won the Jay M. Cooper Award as the best paper on minimally invasive gynecology by a fellow and was presented on November 17 at the AAGL annual meeting in Las Vegas.

References

Reference

1.     1. Deimling TA, Eldridge JL, Riley KA, Kunselman AR, Harkins GJ. Standard versus robot-assisted laparoscopic hysterectomy: a prospective randomized trial [abstract]. Presented at the 2015 AAGL Global Congress in Las Vegas, Nevada, November 2015.

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When investigators from the Penn State Milton S. Hershey Medical Center randomly allocated 144 women to robot-assisted or standard laparoscopic hysterectomy (n = 72 in each arm) and recorded complications for 12 weeks, they found no significant differences between groups in estimated blood loss.1 In addition, mean operative times (surgeon incision to surgeon stop, including docking in the robot-assisted group) were similar (73.9 min for robot-assisted surgery vs 74.9 min for standard laparoscopy), as were complication rates. In this trial, operative time was the primary outcome.

Pain was assessed at 2 postoperative hours and was found to be similar between groups.

Two intraoperative complications occurred in the robot-assisted group, compared with none for standard laparoscopy (P = .50). Six postoperative complications occurred in the robot-assisted group, compared with 9 in the standard laparoscopy group (P = 0.58).

Complications included: a need for reoperation/readmission (2 patients in each group; P = 1.00), infection (1 patient in each group; P = 1.00), hemorrhage/transfusion (4 in the standard laparoscopy group; P = 0.12), and vaginal cuff dehiscence (2 in the robot-assisted group vs 1 for standard laparoscopy; P = 1.00).

Investigators concluded that robot-assisted hysterectomy is “noninferior” to standard laparoscopy with regard to operative time when it is performed by experienced minimally invasive surgeons.

Gerald J. Harkins, MD, an author and primary surgeon of the trial, notes that it is the first randomized comparison involving surgeons with expertise in both robot-assisted and standard laparoscopic hysterectomy. As such, its findings represent Level I evidence. Dr. Harkins had completed more than 600 robot-assisted cases prior to initiation of the trial.

Cost was not analyzed in this study, the abstract of which won the Jay M. Cooper Award as the best paper on minimally invasive gynecology by a fellow and was presented on November 17 at the AAGL annual meeting in Las Vegas.

When investigators from the Penn State Milton S. Hershey Medical Center randomly allocated 144 women to robot-assisted or standard laparoscopic hysterectomy (n = 72 in each arm) and recorded complications for 12 weeks, they found no significant differences between groups in estimated blood loss.1 In addition, mean operative times (surgeon incision to surgeon stop, including docking in the robot-assisted group) were similar (73.9 min for robot-assisted surgery vs 74.9 min for standard laparoscopy), as were complication rates. In this trial, operative time was the primary outcome.

Pain was assessed at 2 postoperative hours and was found to be similar between groups.

Two intraoperative complications occurred in the robot-assisted group, compared with none for standard laparoscopy (P = .50). Six postoperative complications occurred in the robot-assisted group, compared with 9 in the standard laparoscopy group (P = 0.58).

Complications included: a need for reoperation/readmission (2 patients in each group; P = 1.00), infection (1 patient in each group; P = 1.00), hemorrhage/transfusion (4 in the standard laparoscopy group; P = 0.12), and vaginal cuff dehiscence (2 in the robot-assisted group vs 1 for standard laparoscopy; P = 1.00).

Investigators concluded that robot-assisted hysterectomy is “noninferior” to standard laparoscopy with regard to operative time when it is performed by experienced minimally invasive surgeons.

Gerald J. Harkins, MD, an author and primary surgeon of the trial, notes that it is the first randomized comparison involving surgeons with expertise in both robot-assisted and standard laparoscopic hysterectomy. As such, its findings represent Level I evidence. Dr. Harkins had completed more than 600 robot-assisted cases prior to initiation of the trial.

Cost was not analyzed in this study, the abstract of which won the Jay M. Cooper Award as the best paper on minimally invasive gynecology by a fellow and was presented on November 17 at the AAGL annual meeting in Las Vegas.

References

Reference

1.     1. Deimling TA, Eldridge JL, Riley KA, Kunselman AR, Harkins GJ. Standard versus robot-assisted laparoscopic hysterectomy: a prospective randomized trial [abstract]. Presented at the 2015 AAGL Global Congress in Las Vegas, Nevada, November 2015.

References

Reference

1.     1. Deimling TA, Eldridge JL, Riley KA, Kunselman AR, Harkins GJ. Standard versus robot-assisted laparoscopic hysterectomy: a prospective randomized trial [abstract]. Presented at the 2015 AAGL Global Congress in Las Vegas, Nevada, November 2015.

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My response to ACOG’s emphasis on vaginal hysterectomy first

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Recorded November 17, 2015, at the AAGL Global Congress in Las Vegas, Nevada.    

 

 

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Dr. Advincula is President of AAGL. He is the Levine Family Professor of Women’s Health and Vice-Chair, Department of Obstetrics & Gynecology and Chief of Gynecology, Sloane Hospital for Women at Columbia University Medical Center. He also serves on the OBG Management Board of Editors.

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Dr. Advincula is President of AAGL. He is the Levine Family Professor of Women’s Health and Vice-Chair, Department of Obstetrics & Gynecology and Chief of Gynecology, Sloane Hospital for Women at Columbia University Medical Center. He also serves on the OBG Management Board of Editors.

Recorded November 17, 2015, at the AAGL Global Congress in Las Vegas, Nevada.    

 

 

Recorded November 17, 2015, at the AAGL Global Congress in Las Vegas, Nevada.    

 

 

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A surge in congenital syphilis reveals gaps in obstetric practice

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The rate of congenital syphilis increased to 11.6 cases per 100,000 live births in 2014 in the United States—the highest rate documented since 2001, according to a new report from the Centers for Disease Control and Prevention (CDC).1 The increase in the rate of congenital syphilis reflects a rise in the rate of primary and secondary syphilis among US women, from 0.9 to 1.1 cases per 100,000 women, during the same period.1

The rate of congenital syphilis had declined between 2008 and 2012, from 10.5 cases to 8.4 cases per 100,000 live births.

Congenital syphilis occurs when an infected mother transmits the disease to her fetus during pregnancy. Among the adverse effects of congenital syphilis are deformities, stillbirth, and early infant death. “However, among mothers identified with syphilis who deliver past 20 weeks’ gestation, treatment with penicillin at least 30 days before delivery is 98% effective at preventing [congenital syphilis],” the CDC report notes.1

For the purposes of the CDC report, congenital syphilis includes “both infants and stillbirths with clinical evidence” of the disease, “as well as those infants and stillbirths born to mothers with untreated or inadequately treated syphilis, regardless of the infant’s manifestation of clinical disease.”1

CDC recommendations
The CDC notes that most of the increases in the rates of maternal and congenital syphilis likely stem from inadequate prenatal care.

“A large percentage of [congenital syphilis] cases continue to be attributable to a lack of prenatal care; even among those receiving some prenatal care, the detection and treatment of maternal syphilis is often not early enough….At particular risk are those who are uninsured or underinsured and those with substance use issues.”1

Among the recommendations of the CDC:

  • Screen all pregnant women for syphilis at their first prenatal visit.
  • Screen women at elevated risk for syphilis, as well as those who live in “high-morbidity geographic areas” at the beginning of the third trimester and again at delivery.
  • In cases where prenatal care has been lacking, screen the woman for syphilis using a rapid plasma reagin (RPR) card and treat the patient who tests positive at the time the pregnancy is confirmed.
  • Do not discharge an infant from the hospital unless the syphilis serologic status of the mother has been tested at least once during pregnancy and, preferably, again at delivery (in high-risk cases).
  • Test any woman who delivers a stillborn infant for syphilis.
References

Reference

1. Bowen V, Su J, Torrone E, Kidd S, Weinstock H. Increase in incidence of congenital syphilis—United States, 2008–2014. MMWR. 2015;64(44):1241–1245.

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The rate of congenital syphilis increased to 11.6 cases per 100,000 live births in 2014 in the United States—the highest rate documented since 2001, according to a new report from the Centers for Disease Control and Prevention (CDC).1 The increase in the rate of congenital syphilis reflects a rise in the rate of primary and secondary syphilis among US women, from 0.9 to 1.1 cases per 100,000 women, during the same period.1

The rate of congenital syphilis had declined between 2008 and 2012, from 10.5 cases to 8.4 cases per 100,000 live births.

Congenital syphilis occurs when an infected mother transmits the disease to her fetus during pregnancy. Among the adverse effects of congenital syphilis are deformities, stillbirth, and early infant death. “However, among mothers identified with syphilis who deliver past 20 weeks’ gestation, treatment with penicillin at least 30 days before delivery is 98% effective at preventing [congenital syphilis],” the CDC report notes.1

For the purposes of the CDC report, congenital syphilis includes “both infants and stillbirths with clinical evidence” of the disease, “as well as those infants and stillbirths born to mothers with untreated or inadequately treated syphilis, regardless of the infant’s manifestation of clinical disease.”1

CDC recommendations
The CDC notes that most of the increases in the rates of maternal and congenital syphilis likely stem from inadequate prenatal care.

“A large percentage of [congenital syphilis] cases continue to be attributable to a lack of prenatal care; even among those receiving some prenatal care, the detection and treatment of maternal syphilis is often not early enough….At particular risk are those who are uninsured or underinsured and those with substance use issues.”1

Among the recommendations of the CDC:

  • Screen all pregnant women for syphilis at their first prenatal visit.
  • Screen women at elevated risk for syphilis, as well as those who live in “high-morbidity geographic areas” at the beginning of the third trimester and again at delivery.
  • In cases where prenatal care has been lacking, screen the woman for syphilis using a rapid plasma reagin (RPR) card and treat the patient who tests positive at the time the pregnancy is confirmed.
  • Do not discharge an infant from the hospital unless the syphilis serologic status of the mother has been tested at least once during pregnancy and, preferably, again at delivery (in high-risk cases).
  • Test any woman who delivers a stillborn infant for syphilis.

The rate of congenital syphilis increased to 11.6 cases per 100,000 live births in 2014 in the United States—the highest rate documented since 2001, according to a new report from the Centers for Disease Control and Prevention (CDC).1 The increase in the rate of congenital syphilis reflects a rise in the rate of primary and secondary syphilis among US women, from 0.9 to 1.1 cases per 100,000 women, during the same period.1

The rate of congenital syphilis had declined between 2008 and 2012, from 10.5 cases to 8.4 cases per 100,000 live births.

Congenital syphilis occurs when an infected mother transmits the disease to her fetus during pregnancy. Among the adverse effects of congenital syphilis are deformities, stillbirth, and early infant death. “However, among mothers identified with syphilis who deliver past 20 weeks’ gestation, treatment with penicillin at least 30 days before delivery is 98% effective at preventing [congenital syphilis],” the CDC report notes.1

For the purposes of the CDC report, congenital syphilis includes “both infants and stillbirths with clinical evidence” of the disease, “as well as those infants and stillbirths born to mothers with untreated or inadequately treated syphilis, regardless of the infant’s manifestation of clinical disease.”1

CDC recommendations
The CDC notes that most of the increases in the rates of maternal and congenital syphilis likely stem from inadequate prenatal care.

“A large percentage of [congenital syphilis] cases continue to be attributable to a lack of prenatal care; even among those receiving some prenatal care, the detection and treatment of maternal syphilis is often not early enough….At particular risk are those who are uninsured or underinsured and those with substance use issues.”1

Among the recommendations of the CDC:

  • Screen all pregnant women for syphilis at their first prenatal visit.
  • Screen women at elevated risk for syphilis, as well as those who live in “high-morbidity geographic areas” at the beginning of the third trimester and again at delivery.
  • In cases where prenatal care has been lacking, screen the woman for syphilis using a rapid plasma reagin (RPR) card and treat the patient who tests positive at the time the pregnancy is confirmed.
  • Do not discharge an infant from the hospital unless the syphilis serologic status of the mother has been tested at least once during pregnancy and, preferably, again at delivery (in high-risk cases).
  • Test any woman who delivers a stillborn infant for syphilis.
References

Reference

1. Bowen V, Su J, Torrone E, Kidd S, Weinstock H. Increase in incidence of congenital syphilis—United States, 2008–2014. MMWR. 2015;64(44):1241–1245.

References

Reference

1. Bowen V, Su J, Torrone E, Kidd S, Weinstock H. Increase in incidence of congenital syphilis—United States, 2008–2014. MMWR. 2015;64(44):1241–1245.

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Is a minimally invasive approach to hysterectomy for Gyn cancer utilized equally in all racial and income groups?

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Is a minimally invasive approach to hysterectomy for Gyn cancer utilized equally in all racial and income groups?

The minimally invasive approach to hysterectomy (laparoscopic, robot-assisted, or vaginal) is associated with less blood loss, a shorter length of stay, and quicker recovery than the abdominal approach (laparotomy). In this study, Esselen and colleagues drew from the 2012 National Inpatient Sample, the largest national all-payer database of hospital discharges, which samples some 20% of hospital discharges. Of an estimated 28,160 hysterectomies performed in 2012 for endometrial cancer, 50% were abdominal and 50% involved MIS (38% robot-assisted, 11% laparoscopic, and 1% vaginal).

MIS was used less often for black women (adjusted odds ratio [OR], 0.50) and Native American women (0.56), compared with white women. Similarly, Medicaid patients were less likely to undergo MIS (adjusted OR, 0.58) than those who were covered by commercial medical insurance.

MIS was used 3.68 times more often in women cared for in urban teaching hospitals, compared with women undergoing hysterectomy for endometrial cancer in rural hospitals (P<.04 for all comparisons).

Length of stay was substantially longer and total costs were higher for women undergoing abdominal hysterectomy.

Study did not control for stage of cancer at presentation
These striking findings parallel higher cancer-specific mortality and other disparities faced by minority patients. Esselen and colleagues point out that higher stage at presentation sometimes mandates use of an abdominal approach for hysterectomy and that minority and low-income women often present with higher-stage disease; accordingly, their inability to control for stage represents an important limitation.

WHAT THIS EVIDENCE MEANS FOR PRACTICE
This report indicates that, for US women of different ethnic and socioeconomic status, important differences are present with respect to access to MIS for gynecologic malignancy.
— Andrew M. Kaunitz, MD

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.

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The author reports no financial relationships relevant to this article.

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The minimally invasive approach to hysterectomy (laparoscopic, robot-assisted, or vaginal) is associated with less blood loss, a shorter length of stay, and quicker recovery than the abdominal approach (laparotomy). In this study, Esselen and colleagues drew from the 2012 National Inpatient Sample, the largest national all-payer database of hospital discharges, which samples some 20% of hospital discharges. Of an estimated 28,160 hysterectomies performed in 2012 for endometrial cancer, 50% were abdominal and 50% involved MIS (38% robot-assisted, 11% laparoscopic, and 1% vaginal).

MIS was used less often for black women (adjusted odds ratio [OR], 0.50) and Native American women (0.56), compared with white women. Similarly, Medicaid patients were less likely to undergo MIS (adjusted OR, 0.58) than those who were covered by commercial medical insurance.

MIS was used 3.68 times more often in women cared for in urban teaching hospitals, compared with women undergoing hysterectomy for endometrial cancer in rural hospitals (P<.04 for all comparisons).

Length of stay was substantially longer and total costs were higher for women undergoing abdominal hysterectomy.

Study did not control for stage of cancer at presentation
These striking findings parallel higher cancer-specific mortality and other disparities faced by minority patients. Esselen and colleagues point out that higher stage at presentation sometimes mandates use of an abdominal approach for hysterectomy and that minority and low-income women often present with higher-stage disease; accordingly, their inability to control for stage represents an important limitation.

WHAT THIS EVIDENCE MEANS FOR PRACTICE
This report indicates that, for US women of different ethnic and socioeconomic status, important differences are present with respect to access to MIS for gynecologic malignancy.
— Andrew M. Kaunitz, MD

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.

The minimally invasive approach to hysterectomy (laparoscopic, robot-assisted, or vaginal) is associated with less blood loss, a shorter length of stay, and quicker recovery than the abdominal approach (laparotomy). In this study, Esselen and colleagues drew from the 2012 National Inpatient Sample, the largest national all-payer database of hospital discharges, which samples some 20% of hospital discharges. Of an estimated 28,160 hysterectomies performed in 2012 for endometrial cancer, 50% were abdominal and 50% involved MIS (38% robot-assisted, 11% laparoscopic, and 1% vaginal).

MIS was used less often for black women (adjusted odds ratio [OR], 0.50) and Native American women (0.56), compared with white women. Similarly, Medicaid patients were less likely to undergo MIS (adjusted OR, 0.58) than those who were covered by commercial medical insurance.

MIS was used 3.68 times more often in women cared for in urban teaching hospitals, compared with women undergoing hysterectomy for endometrial cancer in rural hospitals (P<.04 for all comparisons).

Length of stay was substantially longer and total costs were higher for women undergoing abdominal hysterectomy.

Study did not control for stage of cancer at presentation
These striking findings parallel higher cancer-specific mortality and other disparities faced by minority patients. Esselen and colleagues point out that higher stage at presentation sometimes mandates use of an abdominal approach for hysterectomy and that minority and low-income women often present with higher-stage disease; accordingly, their inability to control for stage represents an important limitation.

WHAT THIS EVIDENCE MEANS FOR PRACTICE
This report indicates that, for US women of different ethnic and socioeconomic status, important differences are present with respect to access to MIS for gynecologic malignancy.
— Andrew M. Kaunitz, MD

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.

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Is a minimally invasive approach to hysterectomy for Gyn cancer utilized equally in all racial and income groups?
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Is a minimally invasive approach to hysterectomy for Gyn cancer utilized equally in all racial and income groups?
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Andrew M. Kaunitz MD,minimally invasive surgery, hysterectomy, gynecologic cancer, racial and income groups,ethnic and socioeconomic status, uterine cancer, cervical cancer, ovarian cancer, black women, Native American women, white women, Medicaid,2012 National Inpatient Sample, urban teaching hospitals, rural hospitals, length of stay, Examining the Evidence
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Andrew M. Kaunitz MD,minimally invasive surgery, hysterectomy, gynecologic cancer, racial and income groups,ethnic and socioeconomic status, uterine cancer, cervical cancer, ovarian cancer, black women, Native American women, white women, Medicaid,2012 National Inpatient Sample, urban teaching hospitals, rural hospitals, length of stay, Examining the Evidence
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