Women's Health

More pregnant Americans indulged – and overindulged – in alcohol from 2018 to 2020 than in previous years, but researchers found no sharp increase associated with the first wave of COVID-19 lockdowns, according to a new report from the Centers for Disease Control and Prevention.

The pandemic notwithstanding, health officials worry about a rising tide of pregnant women using alcohol and binge drinking since the CDC survey began in 2011. In the period ending in 2013, 1 in 10 women reported having had a drink in the previous 30 days; by 2017, that figure was 1 in 9; and in the latest survey, the number had risen to 1 in 7.

That mark is “the highest to date,” said Lucas Gosdin, PhD, MPH, an epidemic intelligence officer at the CDC’s National Center on Birth Defects and Developmental Disabilities, Atlanta, and first author of the report, which was published in Morbidity and Mortality Weekly Report.

“We’re concerned that this number has been slowly increasing,” Amanda Cohn, MD, director of the CDC’s Division of Birth Defects and Infant Disorders, told this news organization. “We need to be doing more outreach, both to pregnant persons as well as health care providers who are caring for them.”

Exposure to alcohol in the womb has been linked to a wide range of neurologic and physical problems in children, ranging from fetal alcohol syndrome to stunted learning abilities. Even if these problems are unlikely, experts insist there’s no known “safe” amount of alcohol a pregnant woman can have.

Dr. Cohn likened alcohol use to that of tobacco. “Lots of people smoke who don’t get lung cancer. Still, everyone is at an increased risk,” she said. “The safest way to not get lung cancer is to not smoke at all. It’s a behavior that can prevent additional harm.”

The report summarizes the results of a phone survey of 6,327 pregnant Americans between the ages of 18 and 49. The survey asked whether women had consumed an alcoholic beverage or had at least four drinks on one occasion – a common definition of binge drinking – in the past 30 days.

According to the report, 13.5% of women reported using alcohol, and 5.2% said they had binged on alcohol. Women who experienced frequent mental distress – describing their mental health as “not good” for 14 or more days in the past month – were twice as likely to drink and three times likelier to binge drink, the researchers found.

The increase within the 3-year period was roughly the same as in previous surveys.

“There was no evidence of increased alcohol consumption by pregnant adults in 2020 relative to 2019, despite possible increased alcohol sales and consumption among the general population during the first months of the COVID-19 pandemic,” the report states.

“That is one finding that was unexpected but that we were pleased to see,” Dr. Gosdin said.

Experts stressed that the survey covered only the first 9 months of the COVID-19 pandemic. “We’re still in the depths of it,” Samuel T. Bauer, MD, associate professor of obstetrics and gynecology at Duke University Medical Center, Durham, N.C., told this news organization. “People with alcohol use disorders certainly have been challenged during COVID. I think this is a preliminary answer.”

Dr. Gosdin said the effects of the pandemic on drinking habits bear watching. “We are concerned about the impacts of COVID-19,” he said. “We know it’s affected how people access regular care.”

Although virtual care has “exploded during COVID,” Dr. Bauer said, insurers have “turned off reimbursing” for doctor-patient visits via telephone, but not for visits by Internet-based video platforms like Zoom.

That split creates equity issues in many parts of the country, including his home state of North Carolina, where broadband is scarce, and patients may live 100 miles or more away from caregivers.

The “full-blown birth defect” of fetal alcohol syndrome is just the most visible hazard of drinking. Other medical and developmental issues include speech delays, slower learning and reading skills, attention-deficit and hyperactivity disorders, and problems with the heart and kidneys.

So, when Dr. Bauer encounters patients who believe that a few drinks will not harm their baby, he says he tells them: “’Why is this going to be where you put your flag?’ That leads to a different form of conversation.”

A version of this article first appeared on Medscape.com.

More pregnant Americans indulged – and overindulged – in alcohol from 2018 to 2020 than in previous years, but researchers found no sharp increase associated with the first wave of COVID-19 lockdowns, according to a new report from the Centers for Disease Control and Prevention.

The pandemic notwithstanding, health officials worry about a rising tide of pregnant women using alcohol and binge drinking since the CDC survey began in 2011. In the period ending in 2013, 1 in 10 women reported having had a drink in the previous 30 days; by 2017, that figure was 1 in 9; and in the latest survey, the number had risen to 1 in 7.

That mark is “the highest to date,” said Lucas Gosdin, PhD, MPH, an epidemic intelligence officer at the CDC’s National Center on Birth Defects and Developmental Disabilities, Atlanta, and first author of the report, which was published in Morbidity and Mortality Weekly Report.

“We’re concerned that this number has been slowly increasing,” Amanda Cohn, MD, director of the CDC’s Division of Birth Defects and Infant Disorders, told this news organization. “We need to be doing more outreach, both to pregnant persons as well as health care providers who are caring for them.”

Exposure to alcohol in the womb has been linked to a wide range of neurologic and physical problems in children, ranging from fetal alcohol syndrome to stunted learning abilities. Even if these problems are unlikely, experts insist there’s no known “safe” amount of alcohol a pregnant woman can have.

Dr. Cohn likened alcohol use to that of tobacco. “Lots of people smoke who don’t get lung cancer. Still, everyone is at an increased risk,” she said. “The safest way to not get lung cancer is to not smoke at all. It’s a behavior that can prevent additional harm.”

The report summarizes the results of a phone survey of 6,327 pregnant Americans between the ages of 18 and 49. The survey asked whether women had consumed an alcoholic beverage or had at least four drinks on one occasion – a common definition of binge drinking – in the past 30 days.

According to the report, 13.5% of women reported using alcohol, and 5.2% said they had binged on alcohol. Women who experienced frequent mental distress – describing their mental health as “not good” for 14 or more days in the past month – were twice as likely to drink and three times likelier to binge drink, the researchers found.

The increase within the 3-year period was roughly the same as in previous surveys.

“There was no evidence of increased alcohol consumption by pregnant adults in 2020 relative to 2019, despite possible increased alcohol sales and consumption among the general population during the first months of the COVID-19 pandemic,” the report states.

“That is one finding that was unexpected but that we were pleased to see,” Dr. Gosdin said.

Experts stressed that the survey covered only the first 9 months of the COVID-19 pandemic. “We’re still in the depths of it,” Samuel T. Bauer, MD, associate professor of obstetrics and gynecology at Duke University Medical Center, Durham, N.C., told this news organization. “People with alcohol use disorders certainly have been challenged during COVID. I think this is a preliminary answer.”

Dr. Gosdin said the effects of the pandemic on drinking habits bear watching. “We are concerned about the impacts of COVID-19,” he said. “We know it’s affected how people access regular care.”

Although virtual care has “exploded during COVID,” Dr. Bauer said, insurers have “turned off reimbursing” for doctor-patient visits via telephone, but not for visits by Internet-based video platforms like Zoom.

That split creates equity issues in many parts of the country, including his home state of North Carolina, where broadband is scarce, and patients may live 100 miles or more away from caregivers.

The “full-blown birth defect” of fetal alcohol syndrome is just the most visible hazard of drinking. Other medical and developmental issues include speech delays, slower learning and reading skills, attention-deficit and hyperactivity disorders, and problems with the heart and kidneys.

So, when Dr. Bauer encounters patients who believe that a few drinks will not harm their baby, he says he tells them: “’Why is this going to be where you put your flag?’ That leads to a different form of conversation.”

A version of this article first appeared on Medscape.com.

More pregnant Americans indulged – and overindulged – in alcohol from 2018 to 2020 than in previous years, but researchers found no sharp increase associated with the first wave of COVID-19 lockdowns, according to a new report from the Centers for Disease Control and Prevention.

The pandemic notwithstanding, health officials worry about a rising tide of pregnant women using alcohol and binge drinking since the CDC survey began in 2011. In the period ending in 2013, 1 in 10 women reported having had a drink in the previous 30 days; by 2017, that figure was 1 in 9; and in the latest survey, the number had risen to 1 in 7.

That mark is “the highest to date,” said Lucas Gosdin, PhD, MPH, an epidemic intelligence officer at the CDC’s National Center on Birth Defects and Developmental Disabilities, Atlanta, and first author of the report, which was published in Morbidity and Mortality Weekly Report.

“We’re concerned that this number has been slowly increasing,” Amanda Cohn, MD, director of the CDC’s Division of Birth Defects and Infant Disorders, told this news organization. “We need to be doing more outreach, both to pregnant persons as well as health care providers who are caring for them.”

Exposure to alcohol in the womb has been linked to a wide range of neurologic and physical problems in children, ranging from fetal alcohol syndrome to stunted learning abilities. Even if these problems are unlikely, experts insist there’s no known “safe” amount of alcohol a pregnant woman can have.

Dr. Cohn likened alcohol use to that of tobacco. “Lots of people smoke who don’t get lung cancer. Still, everyone is at an increased risk,” she said. “The safest way to not get lung cancer is to not smoke at all. It’s a behavior that can prevent additional harm.”

The report summarizes the results of a phone survey of 6,327 pregnant Americans between the ages of 18 and 49. The survey asked whether women had consumed an alcoholic beverage or had at least four drinks on one occasion – a common definition of binge drinking – in the past 30 days.

According to the report, 13.5% of women reported using alcohol, and 5.2% said they had binged on alcohol. Women who experienced frequent mental distress – describing their mental health as “not good” for 14 or more days in the past month – were twice as likely to drink and three times likelier to binge drink, the researchers found.

The increase within the 3-year period was roughly the same as in previous surveys.

“There was no evidence of increased alcohol consumption by pregnant adults in 2020 relative to 2019, despite possible increased alcohol sales and consumption among the general population during the first months of the COVID-19 pandemic,” the report states.

“That is one finding that was unexpected but that we were pleased to see,” Dr. Gosdin said.

Experts stressed that the survey covered only the first 9 months of the COVID-19 pandemic. “We’re still in the depths of it,” Samuel T. Bauer, MD, associate professor of obstetrics and gynecology at Duke University Medical Center, Durham, N.C., told this news organization. “People with alcohol use disorders certainly have been challenged during COVID. I think this is a preliminary answer.”

Dr. Gosdin said the effects of the pandemic on drinking habits bear watching. “We are concerned about the impacts of COVID-19,” he said. “We know it’s affected how people access regular care.”

Although virtual care has “exploded during COVID,” Dr. Bauer said, insurers have “turned off reimbursing” for doctor-patient visits via telephone, but not for visits by Internet-based video platforms like Zoom.

That split creates equity issues in many parts of the country, including his home state of North Carolina, where broadband is scarce, and patients may live 100 miles or more away from caregivers.

The “full-blown birth defect” of fetal alcohol syndrome is just the most visible hazard of drinking. Other medical and developmental issues include speech delays, slower learning and reading skills, attention-deficit and hyperactivity disorders, and problems with the heart and kidneys.

So, when Dr. Bauer encounters patients who believe that a few drinks will not harm their baby, he says he tells them: “’Why is this going to be where you put your flag?’ That leads to a different form of conversation.”

A version of this article first appeared on Medscape.com.

Evidence summary

Early evidence suggested benefit from IM progesterone

A 2003 RCT compared weekly IM progesterone (n = 310) and placebo (n = 153) injections in women with a history of spontaneous preterm delivery. Participants were at 15w0d to 20w3d of a singleton pregnancy with no fetal abnormality. The 17-OHP group, compared to the placebo group, had significantly fewer deliveries at < 37 weeks (36.3% vs 54.9%; relative risk [RR] = 0.66; 95% CI, 0.54 to 0.81; number needed to treat [NNT] = 6), at < 35 weeks (20.6% vs 30.7%; RR = 0.67; 95% CI, 0.48 to 0.93; NNT = 10), and at < 32 weeks (11.4% vs 19.6%; RR = 0.58; 95% CI, 0.37 to 0.91; NNT = 13).¹ There were significantly lower rates of necrotizing enterocolitis, intraventricular hemorrhage, and need for supplemental oxygen in infants of women in the treatment group.¹ The study was underpowered to detect neonatal morbidity.

A 2013 Cochrane Review (5 studies including the 2003 RCT; 602 women) found that 17-OHP led to a decreased risk of birth at < 34 weeks (RR = 0.31; 95% CI, 0.14-0.69). It also led to a significant reduction in perinatal and neonatal mortality, birth at < 37 weeks, birthweight < 2500 g, use of assisted ventilation, incidence of necrotizing enterocolitis, and admission to the neonatal ICU.²

In a large follow-up study, progesterone did not demonstrate benefit

The PROLONG study was a double-blind, placebo-controlled international RCT of women with a previous singleton spontaneous preterm birth. The study involved 93 clinical centers in 9 countries: 41 in the United States and 52 outside the United States. The ­PROLONG study was much larger than the 2003 study: 1139 active treatment (vs 310) and 578 placebo (vs 153) participants. Women were randomized 2:1 to receive either 250 mg 17-OHP or inert oil placebo weekly from 16w0d-20w6d until 36 weeks. The outcome measures were: (1) delivery at < 35 weeks and (2) a neonatal morbidity composite index. This composite index included any of the following: neonatal death, grade 3 or 4 intraventricular hemorrhage, respiratory distress syndrome, bronchopulmonary dysplasia, necrotizing enterocolitis, and proven sepsis.³

Our best evidence does not support routine IM progesterone use to prevent preterm delivery.

Progesterone did not improve any of the studied outcomes: there were no significant differences in the frequency of birth at < 35 weeks (17-OHP 11% vs placebo 11.5%; RR = 0.95; 95% CI, 0.71-1.26), in neonatal morbidity index (17-OHP 5.6% vs placebo 5%; RR = 1.12; 95% CI, 0.68-1.61), and in frequency of fetal/early infant death (17-OHP 1.7% vs placebo 1.9%; RR = 0.87; 95% CI, 0.4-1.81).³ In the United States subgroup (n = 391; 23% of all patients), there was no significant difference in rate of birth at < 35 weeks (17-OHP 15.6% vs placebo 17.6%; RR = 0.88; 95% CI, 0.55-1.40).³

However, PROLONG had some limitations. Importantly, the 2003 RCT included 183 (59%) non-Hispanic Black women in the experimental group and 90 (58.5%) in the control group, whereas the 2020 PROLONG study had only 6.6% non-Hispanic Black participants. The neonatal outcome data for the PROLONG study only included 6 Black women in the experimental arm and 3 in the control arm.^3,4 Black women have prematurity rates that are 2 to 3 times higher than those in White women.⁵

Additionally, the PROLONG study had fewer smokers and more women who were married/living with a partner. Compared with prior studies, the PROLONG study had a lower proportion of women with > 1 spontaneous preterm birth and fewer with a shortened cervix (< 2%).³ As a result of having lower risk participants, PROLONG may have been underpowered to detect improvements in outcome.³

A subsequent meta-analysis suggests some benefit for high-risk women

The 2021 Evaluating Progestogens for Preventing Preterm birth International Collaborative (EPPPIC) meta-analysis of individual data from 31 RCTs—involving 11,644 women and 16,185 babies—found that, compared with placebo, 17-OHP for women with a history of preterm delivery or short cervix did not significantly decrease the number of babies born before 34 weeks (5 trials [including the 2003 RCT and PROLONG studies]; 3053 women; RR = 0.83; 95% CI, 0.68–1.01).⁶ However, it found that vaginal progesterone significantly decreased birth prior to 34 weeks (9 trials; 3769 women; RR = 0.78, 95% CI, 0.68-0.90).⁶ The authors concluded that both IM and vaginal progesterone decreased preterm delivery in high-risk women. The effect was stronger for women with a short cervix than for women with a history of preterm delivery.⁶

Continue to: Recommendations from others

In 2008, a joint ACOG/SMFM statement said, “Progesterone supplementation for the prevention of recurrent preterm birth should be offered to women with a singleton pregnancy and prior spontaneous preterm birth.”⁷ A 2012 ACOG Practice Bulletin stated that, “A woman with a singleton gestation and a prior spontaneous preterm singleton birth should be offered progesterone supplementation starting at 16 to 24 weeks of gestation, regardless of transvaginal ultrasound cervical length, to reduce the risk of recurrent spontaneous preterm birth.”⁸

In 2011, Makena (hydroxyprogesterone caproate injection) received accelerated approval from the FDA. In October 2020, the FDA Advisory Committee recommended that Makena be withdrawn from the market (9 to 7 vote).⁹ On October 5, 2020, the FDA’s Center for Drug Evaluation and Research (CDER) proposed that Makena be withdrawn from the market “because the required postmarket study failed to verify clinical benefit and we have concluded that the available evidence does not show Makena is effective for its approved use.”¹⁰ A subgroup analysis by CDER did not find benefit for any subgroup, including high-risk women.¹⁰ However, Makena will remain on the market unless its manufacturer withdraws it or the FDA Commissioner mandates its removal.

In response to the FDA’s proposal, both ACOG and SMFM recommended that “obstetric health care professionals discuss Makena’s benefits, risks, and uncertainties with their patients”¹¹ as part of “a shared ­decision-making approach, taking into account the lack of short-term safety concerns but uncertainty regarding benefit.”¹² Both organizations reiterated their position on shared decision-making after the EPPPIC meta-analysis was published.¹³

Studies comparing the 2 routes of administration (vaginal and IM) are underway.¹³

Editor’s takeaway

Our best evidence does not support routine IM progesterone use to prevent preterm delivery. However, therapeutic inertia, uncertainty, and defensive medicine may slow down adoption of this newer evidence. Shared decision-making can assist treatment decisions, but it is not a substitute for following the best evidence.

Evidence summary

Early evidence suggested benefit from IM progesterone

A 2003 RCT compared weekly IM progesterone (n = 310) and placebo (n = 153) injections in women with a history of spontaneous preterm delivery. Participants were at 15w0d to 20w3d of a singleton pregnancy with no fetal abnormality. The 17-OHP group, compared to the placebo group, had significantly fewer deliveries at < 37 weeks (36.3% vs 54.9%; relative risk [RR] = 0.66; 95% CI, 0.54 to 0.81; number needed to treat [NNT] = 6), at < 35 weeks (20.6% vs 30.7%; RR = 0.67; 95% CI, 0.48 to 0.93; NNT = 10), and at < 32 weeks (11.4% vs 19.6%; RR = 0.58; 95% CI, 0.37 to 0.91; NNT = 13).¹ There were significantly lower rates of necrotizing enterocolitis, intraventricular hemorrhage, and need for supplemental oxygen in infants of women in the treatment group.¹ The study was underpowered to detect neonatal morbidity.

A 2013 Cochrane Review (5 studies including the 2003 RCT; 602 women) found that 17-OHP led to a decreased risk of birth at < 34 weeks (RR = 0.31; 95% CI, 0.14-0.69). It also led to a significant reduction in perinatal and neonatal mortality, birth at < 37 weeks, birthweight < 2500 g, use of assisted ventilation, incidence of necrotizing enterocolitis, and admission to the neonatal ICU.²

In a large follow-up study, progesterone did not demonstrate benefit

The PROLONG study was a double-blind, placebo-controlled international RCT of women with a previous singleton spontaneous preterm birth. The study involved 93 clinical centers in 9 countries: 41 in the United States and 52 outside the United States. The ­PROLONG study was much larger than the 2003 study: 1139 active treatment (vs 310) and 578 placebo (vs 153) participants. Women were randomized 2:1 to receive either 250 mg 17-OHP or inert oil placebo weekly from 16w0d-20w6d until 36 weeks. The outcome measures were: (1) delivery at < 35 weeks and (2) a neonatal morbidity composite index. This composite index included any of the following: neonatal death, grade 3 or 4 intraventricular hemorrhage, respiratory distress syndrome, bronchopulmonary dysplasia, necrotizing enterocolitis, and proven sepsis.³

Our best evidence does not support routine IM progesterone use to prevent preterm delivery.

Progesterone did not improve any of the studied outcomes: there were no significant differences in the frequency of birth at < 35 weeks (17-OHP 11% vs placebo 11.5%; RR = 0.95; 95% CI, 0.71-1.26), in neonatal morbidity index (17-OHP 5.6% vs placebo 5%; RR = 1.12; 95% CI, 0.68-1.61), and in frequency of fetal/early infant death (17-OHP 1.7% vs placebo 1.9%; RR = 0.87; 95% CI, 0.4-1.81).³ In the United States subgroup (n = 391; 23% of all patients), there was no significant difference in rate of birth at < 35 weeks (17-OHP 15.6% vs placebo 17.6%; RR = 0.88; 95% CI, 0.55-1.40).³

However, PROLONG had some limitations. Importantly, the 2003 RCT included 183 (59%) non-Hispanic Black women in the experimental group and 90 (58.5%) in the control group, whereas the 2020 PROLONG study had only 6.6% non-Hispanic Black participants. The neonatal outcome data for the PROLONG study only included 6 Black women in the experimental arm and 3 in the control arm.^3,4 Black women have prematurity rates that are 2 to 3 times higher than those in White women.⁵

Additionally, the PROLONG study had fewer smokers and more women who were married/living with a partner. Compared with prior studies, the PROLONG study had a lower proportion of women with > 1 spontaneous preterm birth and fewer with a shortened cervix (< 2%).³ As a result of having lower risk participants, PROLONG may have been underpowered to detect improvements in outcome.³

A subsequent meta-analysis suggests some benefit for high-risk women

The 2021 Evaluating Progestogens for Preventing Preterm birth International Collaborative (EPPPIC) meta-analysis of individual data from 31 RCTs—involving 11,644 women and 16,185 babies—found that, compared with placebo, 17-OHP for women with a history of preterm delivery or short cervix did not significantly decrease the number of babies born before 34 weeks (5 trials [including the 2003 RCT and PROLONG studies]; 3053 women; RR = 0.83; 95% CI, 0.68–1.01).⁶ However, it found that vaginal progesterone significantly decreased birth prior to 34 weeks (9 trials; 3769 women; RR = 0.78, 95% CI, 0.68-0.90).⁶ The authors concluded that both IM and vaginal progesterone decreased preterm delivery in high-risk women. The effect was stronger for women with a short cervix than for women with a history of preterm delivery.⁶

Continue to: Recommendations from others

In 2008, a joint ACOG/SMFM statement said, “Progesterone supplementation for the prevention of recurrent preterm birth should be offered to women with a singleton pregnancy and prior spontaneous preterm birth.”⁷ A 2012 ACOG Practice Bulletin stated that, “A woman with a singleton gestation and a prior spontaneous preterm singleton birth should be offered progesterone supplementation starting at 16 to 24 weeks of gestation, regardless of transvaginal ultrasound cervical length, to reduce the risk of recurrent spontaneous preterm birth.”⁸

In 2011, Makena (hydroxyprogesterone caproate injection) received accelerated approval from the FDA. In October 2020, the FDA Advisory Committee recommended that Makena be withdrawn from the market (9 to 7 vote).⁹ On October 5, 2020, the FDA’s Center for Drug Evaluation and Research (CDER) proposed that Makena be withdrawn from the market “because the required postmarket study failed to verify clinical benefit and we have concluded that the available evidence does not show Makena is effective for its approved use.”¹⁰ A subgroup analysis by CDER did not find benefit for any subgroup, including high-risk women.¹⁰ However, Makena will remain on the market unless its manufacturer withdraws it or the FDA Commissioner mandates its removal.

In response to the FDA’s proposal, both ACOG and SMFM recommended that “obstetric health care professionals discuss Makena’s benefits, risks, and uncertainties with their patients”¹¹ as part of “a shared ­decision-making approach, taking into account the lack of short-term safety concerns but uncertainty regarding benefit.”¹² Both organizations reiterated their position on shared decision-making after the EPPPIC meta-analysis was published.¹³

Studies comparing the 2 routes of administration (vaginal and IM) are underway.¹³

Editor’s takeaway

Our best evidence does not support routine IM progesterone use to prevent preterm delivery. However, therapeutic inertia, uncertainty, and defensive medicine may slow down adoption of this newer evidence. Shared decision-making can assist treatment decisions, but it is not a substitute for following the best evidence.

Evidence summary

Early evidence suggested benefit from IM progesterone

A 2003 RCT compared weekly IM progesterone (n = 310) and placebo (n = 153) injections in women with a history of spontaneous preterm delivery. Participants were at 15w0d to 20w3d of a singleton pregnancy with no fetal abnormality. The 17-OHP group, compared to the placebo group, had significantly fewer deliveries at < 37 weeks (36.3% vs 54.9%; relative risk [RR] = 0.66; 95% CI, 0.54 to 0.81; number needed to treat [NNT] = 6), at < 35 weeks (20.6% vs 30.7%; RR = 0.67; 95% CI, 0.48 to 0.93; NNT = 10), and at < 32 weeks (11.4% vs 19.6%; RR = 0.58; 95% CI, 0.37 to 0.91; NNT = 13).¹ There were significantly lower rates of necrotizing enterocolitis, intraventricular hemorrhage, and need for supplemental oxygen in infants of women in the treatment group.¹ The study was underpowered to detect neonatal morbidity.

A 2013 Cochrane Review (5 studies including the 2003 RCT; 602 women) found that 17-OHP led to a decreased risk of birth at < 34 weeks (RR = 0.31; 95% CI, 0.14-0.69). It also led to a significant reduction in perinatal and neonatal mortality, birth at < 37 weeks, birthweight < 2500 g, use of assisted ventilation, incidence of necrotizing enterocolitis, and admission to the neonatal ICU.²

In a large follow-up study, progesterone did not demonstrate benefit

The PROLONG study was a double-blind, placebo-controlled international RCT of women with a previous singleton spontaneous preterm birth. The study involved 93 clinical centers in 9 countries: 41 in the United States and 52 outside the United States. The ­PROLONG study was much larger than the 2003 study: 1139 active treatment (vs 310) and 578 placebo (vs 153) participants. Women were randomized 2:1 to receive either 250 mg 17-OHP or inert oil placebo weekly from 16w0d-20w6d until 36 weeks. The outcome measures were: (1) delivery at < 35 weeks and (2) a neonatal morbidity composite index. This composite index included any of the following: neonatal death, grade 3 or 4 intraventricular hemorrhage, respiratory distress syndrome, bronchopulmonary dysplasia, necrotizing enterocolitis, and proven sepsis.³

Our best evidence does not support routine IM progesterone use to prevent preterm delivery.

Progesterone did not improve any of the studied outcomes: there were no significant differences in the frequency of birth at < 35 weeks (17-OHP 11% vs placebo 11.5%; RR = 0.95; 95% CI, 0.71-1.26), in neonatal morbidity index (17-OHP 5.6% vs placebo 5%; RR = 1.12; 95% CI, 0.68-1.61), and in frequency of fetal/early infant death (17-OHP 1.7% vs placebo 1.9%; RR = 0.87; 95% CI, 0.4-1.81).³ In the United States subgroup (n = 391; 23% of all patients), there was no significant difference in rate of birth at < 35 weeks (17-OHP 15.6% vs placebo 17.6%; RR = 0.88; 95% CI, 0.55-1.40).³

However, PROLONG had some limitations. Importantly, the 2003 RCT included 183 (59%) non-Hispanic Black women in the experimental group and 90 (58.5%) in the control group, whereas the 2020 PROLONG study had only 6.6% non-Hispanic Black participants. The neonatal outcome data for the PROLONG study only included 6 Black women in the experimental arm and 3 in the control arm.^3,4 Black women have prematurity rates that are 2 to 3 times higher than those in White women.⁵

Additionally, the PROLONG study had fewer smokers and more women who were married/living with a partner. Compared with prior studies, the PROLONG study had a lower proportion of women with > 1 spontaneous preterm birth and fewer with a shortened cervix (< 2%).³ As a result of having lower risk participants, PROLONG may have been underpowered to detect improvements in outcome.³

A subsequent meta-analysis suggests some benefit for high-risk women

The 2021 Evaluating Progestogens for Preventing Preterm birth International Collaborative (EPPPIC) meta-analysis of individual data from 31 RCTs—involving 11,644 women and 16,185 babies—found that, compared with placebo, 17-OHP for women with a history of preterm delivery or short cervix did not significantly decrease the number of babies born before 34 weeks (5 trials [including the 2003 RCT and PROLONG studies]; 3053 women; RR = 0.83; 95% CI, 0.68–1.01).⁶ However, it found that vaginal progesterone significantly decreased birth prior to 34 weeks (9 trials; 3769 women; RR = 0.78, 95% CI, 0.68-0.90).⁶ The authors concluded that both IM and vaginal progesterone decreased preterm delivery in high-risk women. The effect was stronger for women with a short cervix than for women with a history of preterm delivery.⁶

Continue to: Recommendations from others

In 2008, a joint ACOG/SMFM statement said, “Progesterone supplementation for the prevention of recurrent preterm birth should be offered to women with a singleton pregnancy and prior spontaneous preterm birth.”⁷ A 2012 ACOG Practice Bulletin stated that, “A woman with a singleton gestation and a prior spontaneous preterm singleton birth should be offered progesterone supplementation starting at 16 to 24 weeks of gestation, regardless of transvaginal ultrasound cervical length, to reduce the risk of recurrent spontaneous preterm birth.”⁸

In 2011, Makena (hydroxyprogesterone caproate injection) received accelerated approval from the FDA. In October 2020, the FDA Advisory Committee recommended that Makena be withdrawn from the market (9 to 7 vote).⁹ On October 5, 2020, the FDA’s Center for Drug Evaluation and Research (CDER) proposed that Makena be withdrawn from the market “because the required postmarket study failed to verify clinical benefit and we have concluded that the available evidence does not show Makena is effective for its approved use.”¹⁰ A subgroup analysis by CDER did not find benefit for any subgroup, including high-risk women.¹⁰ However, Makena will remain on the market unless its manufacturer withdraws it or the FDA Commissioner mandates its removal.

In response to the FDA’s proposal, both ACOG and SMFM recommended that “obstetric health care professionals discuss Makena’s benefits, risks, and uncertainties with their patients”¹¹ as part of “a shared ­decision-making approach, taking into account the lack of short-term safety concerns but uncertainty regarding benefit.”¹² Both organizations reiterated their position on shared decision-making after the EPPPIC meta-analysis was published.¹³

Studies comparing the 2 routes of administration (vaginal and IM) are underway.¹³

Editor’s takeaway

Our best evidence does not support routine IM progesterone use to prevent preterm delivery. However, therapeutic inertia, uncertainty, and defensive medicine may slow down adoption of this newer evidence. Shared decision-making can assist treatment decisions, but it is not a substitute for following the best evidence.

Two new studies show how COVID-19 threatens the health of pregnant people and their newborn infants.

A study conducted in Scotland showed that unvaccinated pregnant people who got COVID were much more likely to have a stillborn infant or one that dies in the first 28 days. The study also found that pregnant women infected with COVID died or needed hospitalization at a much higher rate than vaccinated women who got pregnant.

The University of Edinburgh and Public Health Scotland studied national data in 88,000 pregnancies between Dec. 2020 and Oct. 2021, according to the study published in Nature Medicine.

Overall, 77.4% of infections, 90.9% of COVID-related hospitalizations, and 98% of critical care cases occurred in the unvaccinated people, as did all newborn deaths.

The study said 2,364 babies were born to women infected with COVID, with 2,353 live births. Eleven babies were stillborn and eight live-born babies died within 28 days. Of the live births, 241 were premature.

The problems were more likely if the infection occurred 28 days or less before the delivery date, the researchers said.

The authors said the low vaccination rate among pregnant people was a problem. Only 32% of people giving birth in Oct. 2021 were fully vaccinated, while 77% of the Scottish female population aged 18-44 was fully vaccinated.

“Vaccine hesitancy in pregnancy thus requires addressing, especially in light of new recommendations for booster vaccination administration 3 months after the initial vaccination course to help protect against new variants such as Omicron,” the authors wrote. “Addressing low vaccine uptake rates in pregnant women is imperative to protect the health of women and babies in the ongoing pandemic.”

Vaccinated women who were pregnant had complication rates that were about the same for all pregnant women, the study shows.

The second study, published in The Lancet, found that women who got COVID while pregnant in five Western U.S. states were more likely to have premature births, low birth weights, and stillbirths, even when the COVID cases are mild.

The Institute for Systems Biology researchers in Seattle studied data for women who gave birth in Alaska, California, Montana, Oregon, or Washington from March 5, 2020, to July 4, 2021. About 18,000 of them were tested for COVID, with 882 testing positive. Of the positive tests, 85 came in the first trimester, 226 in the second trimester, and 571 in the third semester. None of the pregnant women had been vaccinated at the time they were infected.

Most of the birth problems occurred with first and second trimester infections, the study noted, and problems occurred even if the pregnant person didn’t have respiratory complications, a major COVID symptom.

“Pregnant people are at an increased risk of adverse outcomes following SARS-CoV-2 infection, even when maternal COVID-19 is less severe, and they may benefit from increased monitoring following infection,” Jennifer Hadlock, MD, an author of the paper, said in a news release.

The study also pointed out continuing inequities in health care, with most of the positive cases occurring among young, non-White people with Medicaid and high body mass index.

A version of this article first appeared on WebMD.com.

Two new studies show how COVID-19 threatens the health of pregnant people and their newborn infants.

A study conducted in Scotland showed that unvaccinated pregnant people who got COVID were much more likely to have a stillborn infant or one that dies in the first 28 days. The study also found that pregnant women infected with COVID died or needed hospitalization at a much higher rate than vaccinated women who got pregnant.

The University of Edinburgh and Public Health Scotland studied national data in 88,000 pregnancies between Dec. 2020 and Oct. 2021, according to the study published in Nature Medicine.

Overall, 77.4% of infections, 90.9% of COVID-related hospitalizations, and 98% of critical care cases occurred in the unvaccinated people, as did all newborn deaths.

The study said 2,364 babies were born to women infected with COVID, with 2,353 live births. Eleven babies were stillborn and eight live-born babies died within 28 days. Of the live births, 241 were premature.

The problems were more likely if the infection occurred 28 days or less before the delivery date, the researchers said.

The authors said the low vaccination rate among pregnant people was a problem. Only 32% of people giving birth in Oct. 2021 were fully vaccinated, while 77% of the Scottish female population aged 18-44 was fully vaccinated.

“Vaccine hesitancy in pregnancy thus requires addressing, especially in light of new recommendations for booster vaccination administration 3 months after the initial vaccination course to help protect against new variants such as Omicron,” the authors wrote. “Addressing low vaccine uptake rates in pregnant women is imperative to protect the health of women and babies in the ongoing pandemic.”

Vaccinated women who were pregnant had complication rates that were about the same for all pregnant women, the study shows.

The second study, published in The Lancet, found that women who got COVID while pregnant in five Western U.S. states were more likely to have premature births, low birth weights, and stillbirths, even when the COVID cases are mild.

The Institute for Systems Biology researchers in Seattle studied data for women who gave birth in Alaska, California, Montana, Oregon, or Washington from March 5, 2020, to July 4, 2021. About 18,000 of them were tested for COVID, with 882 testing positive. Of the positive tests, 85 came in the first trimester, 226 in the second trimester, and 571 in the third semester. None of the pregnant women had been vaccinated at the time they were infected.

Most of the birth problems occurred with first and second trimester infections, the study noted, and problems occurred even if the pregnant person didn’t have respiratory complications, a major COVID symptom.

“Pregnant people are at an increased risk of adverse outcomes following SARS-CoV-2 infection, even when maternal COVID-19 is less severe, and they may benefit from increased monitoring following infection,” Jennifer Hadlock, MD, an author of the paper, said in a news release.

The study also pointed out continuing inequities in health care, with most of the positive cases occurring among young, non-White people with Medicaid and high body mass index.

A version of this article first appeared on WebMD.com.

Two new studies show how COVID-19 threatens the health of pregnant people and their newborn infants.

A study conducted in Scotland showed that unvaccinated pregnant people who got COVID were much more likely to have a stillborn infant or one that dies in the first 28 days. The study also found that pregnant women infected with COVID died or needed hospitalization at a much higher rate than vaccinated women who got pregnant.

The University of Edinburgh and Public Health Scotland studied national data in 88,000 pregnancies between Dec. 2020 and Oct. 2021, according to the study published in Nature Medicine.

Overall, 77.4% of infections, 90.9% of COVID-related hospitalizations, and 98% of critical care cases occurred in the unvaccinated people, as did all newborn deaths.

The study said 2,364 babies were born to women infected with COVID, with 2,353 live births. Eleven babies were stillborn and eight live-born babies died within 28 days. Of the live births, 241 were premature.

The problems were more likely if the infection occurred 28 days or less before the delivery date, the researchers said.

The authors said the low vaccination rate among pregnant people was a problem. Only 32% of people giving birth in Oct. 2021 were fully vaccinated, while 77% of the Scottish female population aged 18-44 was fully vaccinated.

“Vaccine hesitancy in pregnancy thus requires addressing, especially in light of new recommendations for booster vaccination administration 3 months after the initial vaccination course to help protect against new variants such as Omicron,” the authors wrote. “Addressing low vaccine uptake rates in pregnant women is imperative to protect the health of women and babies in the ongoing pandemic.”

Vaccinated women who were pregnant had complication rates that were about the same for all pregnant women, the study shows.

The second study, published in The Lancet, found that women who got COVID while pregnant in five Western U.S. states were more likely to have premature births, low birth weights, and stillbirths, even when the COVID cases are mild.

The Institute for Systems Biology researchers in Seattle studied data for women who gave birth in Alaska, California, Montana, Oregon, or Washington from March 5, 2020, to July 4, 2021. About 18,000 of them were tested for COVID, with 882 testing positive. Of the positive tests, 85 came in the first trimester, 226 in the second trimester, and 571 in the third semester. None of the pregnant women had been vaccinated at the time they were infected.

Most of the birth problems occurred with first and second trimester infections, the study noted, and problems occurred even if the pregnant person didn’t have respiratory complications, a major COVID symptom.

“Pregnant people are at an increased risk of adverse outcomes following SARS-CoV-2 infection, even when maternal COVID-19 is less severe, and they may benefit from increased monitoring following infection,” Jennifer Hadlock, MD, an author of the paper, said in a news release.

The study also pointed out continuing inequities in health care, with most of the positive cases occurring among young, non-White people with Medicaid and high body mass index.

A version of this article first appeared on WebMD.com.

In a meta-analysis of more than 1 million mothers, those who breastfed their children had an 11% to 17% lower risk of developing cardiovascular disease (CVD), coronary heart disease (CHD), or stroke, and of dying from CVD, in later life than mothers who did not.

On average, the women had two children and had breastfed for 15.9 months in total. Longer breastfeeding was associated with greater CV health benefit.

This meta-analysis of eight studies from different countries was published online Jan. 11 in an issue of the Journal of the American Heart Association devoted to the impact of pregnancy on CV health in the mother and child.

Breastfeeding is known to be associated with a lower risk for death from infectious disease and with fewer respiratory infections in babies, the researchers write, but what is less well known is that it is also associated with a reduced risk for breast and ovarian cancer and type 2 diabetes in mothers.

The current study showed a clear association between breastfeeding and reduced risk for CVD in later life, lead author Lena Tschiderer, Dipl.-Ing., PhD, and senior author Peter Willeit, MD, MPhil, PhD, summarized in a joint email to this news organization.

Specifically, mothers who had breastfed their children at any time had an 11% lower risk for CVD, a 14% lower risk for CHD, a 12% lower risk for stroke, and a 17% lower risk of dying from CVD in later life, compared with other mothers.

On the basis of existing evidence, the researchers write, the World Health Organization recommends exclusive breastfeeding until a baby is 6 months old, followed by breastfeeding plus complementary feeding until the baby is 2 years or older.

“We believe that [breastfeeding] benefits for the mother are communicated poorly,” said Dr. Tschiderer and Dr. Willeit, from the University of Innsbruck, Austria.

“Positive effects of breastfeeding on mothers need to be communicated effectively, awareness for breastfeeding recommendations needs to be raised, and interventions to promote and facilitate breastfeeding need to be implemented and reinforced,” the researchers conclude.
 

‘Should not be ignored’

Two cardiologists invited to comment, who were not involved with the research, noted that this study provides insight into an important topic.

“This is yet another body of evidence [and the largest population to date] to show that breastfeeding is protective for women and may show important beneficial effects in terms of CV risk,” Roxana Mehran, MD, said in an email.

“The risk reductions were 11% for CVD events and 14% for CHD events; these are impressive numbers,” said Dr. Mehran, from Icahn School of Medicine at Mount Sinai, New York.

“The caveat,” she said, “is that these are data from several trials, but nonetheless, this is a very important observation that should not be ignored.”

The study did not address the definitive amount of time of breastfeeding and its correlation to the improvement of CVD risk, but it did show that for the lifetime duration, the longer the better.

“The beneficial effects,” she noted, “can be linked to hormones during breastfeeding, as well as weight loss associated with breastfeeding, and resetting the maternal metabolism, as the authors suggest.”

Clinicians and employers “must provide ways to educate women about breastfeeding and make it easy for women who are in the workplace to pump, and to provide them with resources” where possible, Dr. Mehran said.

Michelle O’Donoghue, MD, MPH, noted that over the past several years, there has been intense interest in the possible health benefits of breastfeeding for both mother and child.

There is biologic plausibility for some of the possible maternal benefits because the favorable CV effects of both prolactin and oxytocin are only now being better understood, said Dr. O’Donoghue, from Brigham and Women’s Hospital and Harvard Medical School, Boston.

“The current meta-analysis provides a large dataset that helps support the concept that breastfeeding may offer some cardiovascular benefit for the mother,” she agreed.

“However, ultimately more research will be necessary since this method of combining data across trials relies upon the robustness of the statistical method in each study,” Dr. O’Donoghue said. “I applaud the authors for shining a spotlight on this important topic.”

Although the benefits of breastfeeding appear to continue over time, “it is incredibly difficult for women to continue breastfeeding once they return to work,” she added. “Women in some countries outside the U.S. have an advantage due to longer durations of maternity leave.

“If we want to encourage breastfeeding,” Dr. O’Donoghue stressed, “we need to make sure that we put the right supports in place. Women need protected places to breastfeed in the workplace and places to store their milk. Most importantly, women need to be allowed dedicated time to make it happen.”
 

First large study of CVD in mothers

Emerging individual studies suggest that mothers who breastfeed may have a lower risk for CVD in later life, but studies have been inconsistent, and it is not clear if longer breastfeeding would strengthen this benefit, the authors note.

To examine this, they pooled data from the following eight studies (with study acronym, country, and baseline enrolment dates in brackets): 45&Up (Australia, 2006-2009), China Kadoorie Biobank (CKB, China, 2004-2008), European Prospective Investigation into Cancer and Nutrition (EPIC, multinational, 1992-2000), Gallagher et al. (China, 1989-1991), Nord-Trøndelag Health Survey 2 (HUNT2, Norway, 1995-1997), Japan Public Health Center-based Prospective Study (JPHC, Japan, 1990-1994), Nurses’ Health Study (NHS, U.S., 1986), and the Woman’s Health Initiative (WHI, U.S., 1993-1998).

On average, the women were 51.3 years old (range, 40-65 years) when they enrolled in the study, and they were followed for a median of 10.3 years (range, 7.9-20.9 years, in the individual studies).

On average, they had their first child at age 25 and had two to three children (mean, 2.3); 82% had breastfed at some point (ranging from 58% of women in the two U.S. studies to 97% in CKB and HUNT2).

The women had breastfed for a mean of 7.4 to 18.9 months during their lifetimes (except women in the CKB study, who had breastfed for a median of 24 months).

Among the 1,192,700 women, there were 54,226 incident CVD events, 26,913 incident CHD events, 30,843 incident strokes, and 10,766 deaths from CVD during follow-up.

The researchers acknowledge that study limitations include the fact that there could have been publication bias, since fewer than 10 studies were available for pooling. There was significant between-study heterogeneity for CVD, CHD, and stroke outcomes.

Participant-level data were also lacking, and breastfeeding was self-reported. There may have been unaccounted residual confounding, and the benefits of lifetime breastfeeding that is longer than 2 years are not clear, because few women in this population breastfed that long.

The research was funded by the Austrian Science Fund. The researchers and Dr. Mehran and Dr. O’Donoghue have no relevant financial disclosures.

A version of this article first appeared on Medscape.com.

In a meta-analysis of more than 1 million mothers, those who breastfed their children had an 11% to 17% lower risk of developing cardiovascular disease (CVD), coronary heart disease (CHD), or stroke, and of dying from CVD, in later life than mothers who did not.

On average, the women had two children and had breastfed for 15.9 months in total. Longer breastfeeding was associated with greater CV health benefit.

This meta-analysis of eight studies from different countries was published online Jan. 11 in an issue of the Journal of the American Heart Association devoted to the impact of pregnancy on CV health in the mother and child.

Breastfeeding is known to be associated with a lower risk for death from infectious disease and with fewer respiratory infections in babies, the researchers write, but what is less well known is that it is also associated with a reduced risk for breast and ovarian cancer and type 2 diabetes in mothers.

The current study showed a clear association between breastfeeding and reduced risk for CVD in later life, lead author Lena Tschiderer, Dipl.-Ing., PhD, and senior author Peter Willeit, MD, MPhil, PhD, summarized in a joint email to this news organization.

Specifically, mothers who had breastfed their children at any time had an 11% lower risk for CVD, a 14% lower risk for CHD, a 12% lower risk for stroke, and a 17% lower risk of dying from CVD in later life, compared with other mothers.

On the basis of existing evidence, the researchers write, the World Health Organization recommends exclusive breastfeeding until a baby is 6 months old, followed by breastfeeding plus complementary feeding until the baby is 2 years or older.

“We believe that [breastfeeding] benefits for the mother are communicated poorly,” said Dr. Tschiderer and Dr. Willeit, from the University of Innsbruck, Austria.

“Positive effects of breastfeeding on mothers need to be communicated effectively, awareness for breastfeeding recommendations needs to be raised, and interventions to promote and facilitate breastfeeding need to be implemented and reinforced,” the researchers conclude.
 

‘Should not be ignored’

Two cardiologists invited to comment, who were not involved with the research, noted that this study provides insight into an important topic.

“This is yet another body of evidence [and the largest population to date] to show that breastfeeding is protective for women and may show important beneficial effects in terms of CV risk,” Roxana Mehran, MD, said in an email.

“The risk reductions were 11% for CVD events and 14% for CHD events; these are impressive numbers,” said Dr. Mehran, from Icahn School of Medicine at Mount Sinai, New York.

“The caveat,” she said, “is that these are data from several trials, but nonetheless, this is a very important observation that should not be ignored.”

The study did not address the definitive amount of time of breastfeeding and its correlation to the improvement of CVD risk, but it did show that for the lifetime duration, the longer the better.

“The beneficial effects,” she noted, “can be linked to hormones during breastfeeding, as well as weight loss associated with breastfeeding, and resetting the maternal metabolism, as the authors suggest.”

Clinicians and employers “must provide ways to educate women about breastfeeding and make it easy for women who are in the workplace to pump, and to provide them with resources” where possible, Dr. Mehran said.

Michelle O’Donoghue, MD, MPH, noted that over the past several years, there has been intense interest in the possible health benefits of breastfeeding for both mother and child.

There is biologic plausibility for some of the possible maternal benefits because the favorable CV effects of both prolactin and oxytocin are only now being better understood, said Dr. O’Donoghue, from Brigham and Women’s Hospital and Harvard Medical School, Boston.

“The current meta-analysis provides a large dataset that helps support the concept that breastfeeding may offer some cardiovascular benefit for the mother,” she agreed.

“However, ultimately more research will be necessary since this method of combining data across trials relies upon the robustness of the statistical method in each study,” Dr. O’Donoghue said. “I applaud the authors for shining a spotlight on this important topic.”

Although the benefits of breastfeeding appear to continue over time, “it is incredibly difficult for women to continue breastfeeding once they return to work,” she added. “Women in some countries outside the U.S. have an advantage due to longer durations of maternity leave.

“If we want to encourage breastfeeding,” Dr. O’Donoghue stressed, “we need to make sure that we put the right supports in place. Women need protected places to breastfeed in the workplace and places to store their milk. Most importantly, women need to be allowed dedicated time to make it happen.”
 

First large study of CVD in mothers

Emerging individual studies suggest that mothers who breastfeed may have a lower risk for CVD in later life, but studies have been inconsistent, and it is not clear if longer breastfeeding would strengthen this benefit, the authors note.

To examine this, they pooled data from the following eight studies (with study acronym, country, and baseline enrolment dates in brackets): 45&Up (Australia, 2006-2009), China Kadoorie Biobank (CKB, China, 2004-2008), European Prospective Investigation into Cancer and Nutrition (EPIC, multinational, 1992-2000), Gallagher et al. (China, 1989-1991), Nord-Trøndelag Health Survey 2 (HUNT2, Norway, 1995-1997), Japan Public Health Center-based Prospective Study (JPHC, Japan, 1990-1994), Nurses’ Health Study (NHS, U.S., 1986), and the Woman’s Health Initiative (WHI, U.S., 1993-1998).

On average, the women were 51.3 years old (range, 40-65 years) when they enrolled in the study, and they were followed for a median of 10.3 years (range, 7.9-20.9 years, in the individual studies).

On average, they had their first child at age 25 and had two to three children (mean, 2.3); 82% had breastfed at some point (ranging from 58% of women in the two U.S. studies to 97% in CKB and HUNT2).

The women had breastfed for a mean of 7.4 to 18.9 months during their lifetimes (except women in the CKB study, who had breastfed for a median of 24 months).

Among the 1,192,700 women, there were 54,226 incident CVD events, 26,913 incident CHD events, 30,843 incident strokes, and 10,766 deaths from CVD during follow-up.

The researchers acknowledge that study limitations include the fact that there could have been publication bias, since fewer than 10 studies were available for pooling. There was significant between-study heterogeneity for CVD, CHD, and stroke outcomes.

Participant-level data were also lacking, and breastfeeding was self-reported. There may have been unaccounted residual confounding, and the benefits of lifetime breastfeeding that is longer than 2 years are not clear, because few women in this population breastfed that long.

The research was funded by the Austrian Science Fund. The researchers and Dr. Mehran and Dr. O’Donoghue have no relevant financial disclosures.

A version of this article first appeared on Medscape.com.

In a meta-analysis of more than 1 million mothers, those who breastfed their children had an 11% to 17% lower risk of developing cardiovascular disease (CVD), coronary heart disease (CHD), or stroke, and of dying from CVD, in later life than mothers who did not.

On average, the women had two children and had breastfed for 15.9 months in total. Longer breastfeeding was associated with greater CV health benefit.

This meta-analysis of eight studies from different countries was published online Jan. 11 in an issue of the Journal of the American Heart Association devoted to the impact of pregnancy on CV health in the mother and child.

Breastfeeding is known to be associated with a lower risk for death from infectious disease and with fewer respiratory infections in babies, the researchers write, but what is less well known is that it is also associated with a reduced risk for breast and ovarian cancer and type 2 diabetes in mothers.

The current study showed a clear association between breastfeeding and reduced risk for CVD in later life, lead author Lena Tschiderer, Dipl.-Ing., PhD, and senior author Peter Willeit, MD, MPhil, PhD, summarized in a joint email to this news organization.

Specifically, mothers who had breastfed their children at any time had an 11% lower risk for CVD, a 14% lower risk for CHD, a 12% lower risk for stroke, and a 17% lower risk of dying from CVD in later life, compared with other mothers.

On the basis of existing evidence, the researchers write, the World Health Organization recommends exclusive breastfeeding until a baby is 6 months old, followed by breastfeeding plus complementary feeding until the baby is 2 years or older.

“We believe that [breastfeeding] benefits for the mother are communicated poorly,” said Dr. Tschiderer and Dr. Willeit, from the University of Innsbruck, Austria.

“Positive effects of breastfeeding on mothers need to be communicated effectively, awareness for breastfeeding recommendations needs to be raised, and interventions to promote and facilitate breastfeeding need to be implemented and reinforced,” the researchers conclude.
 

‘Should not be ignored’

Two cardiologists invited to comment, who were not involved with the research, noted that this study provides insight into an important topic.

“This is yet another body of evidence [and the largest population to date] to show that breastfeeding is protective for women and may show important beneficial effects in terms of CV risk,” Roxana Mehran, MD, said in an email.

“The risk reductions were 11% for CVD events and 14% for CHD events; these are impressive numbers,” said Dr. Mehran, from Icahn School of Medicine at Mount Sinai, New York.

“The caveat,” she said, “is that these are data from several trials, but nonetheless, this is a very important observation that should not be ignored.”

The study did not address the definitive amount of time of breastfeeding and its correlation to the improvement of CVD risk, but it did show that for the lifetime duration, the longer the better.

“The beneficial effects,” she noted, “can be linked to hormones during breastfeeding, as well as weight loss associated with breastfeeding, and resetting the maternal metabolism, as the authors suggest.”

Clinicians and employers “must provide ways to educate women about breastfeeding and make it easy for women who are in the workplace to pump, and to provide them with resources” where possible, Dr. Mehran said.

Michelle O’Donoghue, MD, MPH, noted that over the past several years, there has been intense interest in the possible health benefits of breastfeeding for both mother and child.

There is biologic plausibility for some of the possible maternal benefits because the favorable CV effects of both prolactin and oxytocin are only now being better understood, said Dr. O’Donoghue, from Brigham and Women’s Hospital and Harvard Medical School, Boston.

“The current meta-analysis provides a large dataset that helps support the concept that breastfeeding may offer some cardiovascular benefit for the mother,” she agreed.

“However, ultimately more research will be necessary since this method of combining data across trials relies upon the robustness of the statistical method in each study,” Dr. O’Donoghue said. “I applaud the authors for shining a spotlight on this important topic.”

Although the benefits of breastfeeding appear to continue over time, “it is incredibly difficult for women to continue breastfeeding once they return to work,” she added. “Women in some countries outside the U.S. have an advantage due to longer durations of maternity leave.

“If we want to encourage breastfeeding,” Dr. O’Donoghue stressed, “we need to make sure that we put the right supports in place. Women need protected places to breastfeed in the workplace and places to store their milk. Most importantly, women need to be allowed dedicated time to make it happen.”
 

First large study of CVD in mothers

Emerging individual studies suggest that mothers who breastfeed may have a lower risk for CVD in later life, but studies have been inconsistent, and it is not clear if longer breastfeeding would strengthen this benefit, the authors note.

To examine this, they pooled data from the following eight studies (with study acronym, country, and baseline enrolment dates in brackets): 45&Up (Australia, 2006-2009), China Kadoorie Biobank (CKB, China, 2004-2008), European Prospective Investigation into Cancer and Nutrition (EPIC, multinational, 1992-2000), Gallagher et al. (China, 1989-1991), Nord-Trøndelag Health Survey 2 (HUNT2, Norway, 1995-1997), Japan Public Health Center-based Prospective Study (JPHC, Japan, 1990-1994), Nurses’ Health Study (NHS, U.S., 1986), and the Woman’s Health Initiative (WHI, U.S., 1993-1998).

On average, the women were 51.3 years old (range, 40-65 years) when they enrolled in the study, and they were followed for a median of 10.3 years (range, 7.9-20.9 years, in the individual studies).

On average, they had their first child at age 25 and had two to three children (mean, 2.3); 82% had breastfed at some point (ranging from 58% of women in the two U.S. studies to 97% in CKB and HUNT2).

The women had breastfed for a mean of 7.4 to 18.9 months during their lifetimes (except women in the CKB study, who had breastfed for a median of 24 months).

Among the 1,192,700 women, there were 54,226 incident CVD events, 26,913 incident CHD events, 30,843 incident strokes, and 10,766 deaths from CVD during follow-up.

The researchers acknowledge that study limitations include the fact that there could have been publication bias, since fewer than 10 studies were available for pooling. There was significant between-study heterogeneity for CVD, CHD, and stroke outcomes.

Participant-level data were also lacking, and breastfeeding was self-reported. There may have been unaccounted residual confounding, and the benefits of lifetime breastfeeding that is longer than 2 years are not clear, because few women in this population breastfed that long.

The research was funded by the Austrian Science Fund. The researchers and Dr. Mehran and Dr. O’Donoghue have no relevant financial disclosures.

A version of this article first appeared on Medscape.com.

A new investigation has found that rates of physical trauma following operative vaginal delivery (OVD) in Canada are higher than previously reported.

The cohort study of more than 1.3 million deliveries in the country found trauma rates were highest with forceps delivery, with more than 1 in 4 pregnancies resulting in maternal trauma and 1 in 105 infants experiencing neonatal trauma. Maternal and neonatal trauma following vacuum deliveries was less common, occurring in 1 in 8 pregnancies and 1 in 104 infants, according to the researchers, who reported their findings in the Canadian Medical Association Journal .

“The rates of trauma following OVD in Canada are higher than previously reported, irrespective of region, level of obstetric care, and volume of instrument use among hospitals,” lead author Giulia Muraca, PhD, MPH, assistant professor of obstetrics and gynecology at McMaster University, Hamilton, Ont., said in an interview. “While OVDs may be associated with low rates of morbidity in carefully selected circumstances, the uniformly high rates of trauma among forceps and vacuum deliveries documented across regions, levels of obstetric care, and hospitals show that such conditions do not apply to routine obstetric practice in Canada.”

The American College of Obstetricians and Gynecologists considers OVD a way to reduce the rate of cesarean deliveries. However, the group has also pointed to a decline in familiarity with the procedures among clinicians new to the field.

Current reports also show that while OVD accounts for up to 15% of deliveries in Canada, Australia, and the United Kingdom, the risks associated with the approach are heavily dependent on the expertise of the provider. Declining use of OVD in favor of cesarean delivery has reduced opportunities for clinicians to acquire proficiency in performing these deliveries, according to the researchers.

Given these various factors, the investigators said the consensus on the safety of OVD is under scrutiny.

“An examination of maternal and neonatal trauma among OVD in contemporary practice is necessary to ensure that health care providers, policy makers, and pregnant individuals are informed regarding the risks of OVD typically experienced in routine obstetric practice, rather than those encountered under ideal conditions,” Dr. Muraca said.
 

Over 1 million deliveries studied

Dr. Muraca and colleagues looked at 1,326,191 deliveries occurring across Canada (except Quebec) between April 2013 and March 2019. The researchers included all singleton, term (≥37 weeks), in-hospital deliveries to women who had not undergone a previous cesarean delivery.

The study’s primary outcome measures were composite maternal trauma and composite neonatal trauma. Maternal trauma included obstetric anal sphincter injury (OASI); cervical or high vaginal laceration; pelvic hematoma; obstetric injury to the pelvic organs, pelvic joints, or ligaments; injury to the bladder or urethra; and other pelvic trauma. Neonatal trauma comprised intracranial hemorrhage and laceration, skull fracture, severe injury to the central or peripheral nervous system, fracture of the long bones, injury to the liver or spleen, seizures, and neonatal death.

The analysis found that 38,500 (2.9%) of the cases involved attempted forceps deliveries while 110,987 (8.4%) were attempted vacuum deliveries. Of the attempted forceps deliveries, 1,606 (4.2%) failed, while 8,791 (7.9%) of attempted vacuum deliveries failed.

Maternal trauma was observed in 25.3% of all forceps deliveries (n = 9,728) and 13.2% of all vacuum deliveries (n = 14,614), the researchers reported. The most common form of maternal trauma was OASI, which was observed in 21.52% of women undergoing forceps delivery and 11.67% of those undergoing vacuum delivery. The rates of all other forms of maternal trauma were higher among patients undergoing attempted forceps delivery than among their counterparts undergoing attempted vacuum delivery.

After adjusting for possible confounders, rates of maternal trauma remained higher with forceps than with vacuum deliveries (adjusted rate ratio, 1.70).

The rate of neonatal trauma was comparable for forceps (9.56/1,000 live births) and vacuum deliveries (9.58/1,000 live births). In these cases, damage to the peripheral nervous system was the most common form of neonatal trauma, occurring in 4.85/1,000 live births with forceps delivery and 3.41/1,000 live births for vacuum delivery, the researchers found.
 

Consider morbidity following OVD against potential alternatives, authors say

According to Dr. Muraca, the rates of maternal trauma in her study – along with accumulating evidence of the severe long-term consequences of these injuries – demonstrates the importance of reporting timely, empirically derived risk measures that accurately reflect those that pregnant individuals may encounter in typical obstetric practice.

“Although there is merit in understanding the estimates of risk that can be achieved when conditions are optimal, the interpretation of these estimates can be misleading, especially given secular shifts in patterns of practice,” she said. “The failure to do so compromises women’s autonomy in making evidence-informed decisions regarding childbirth interventions, such as evaluating the short- and long-term risks of OVD and cesarean delivery.

Her group recommended that morbidity following OVD be weighed against potential alternatives to such procedures, which carry their own risks. “This includes an extended second stage of labor and a spontaneous vaginal delivery, or a second-stage cesarean delivery, both of which are associated with significant morbidity,” Dr. Muraca said. “However, a comprehensive consideration of high population rates of OVD morbidity also prompts questions about choice of instrument, obstetrician training in OVD use, and for recognizing cases that would benefit from a cesarean delivery earlier in labor.”

Alan Peaceman, MD, professor of obstetrics and gynecology at Northwestern University, Chicago, said he was not surprised by the rates of sphincter injury, but that the rate of severe neonatal injury rate was higher than he expected. However, he added, “I don’t think clinicians should change their approach based on a single study. They should continue with the approach that they are most skilled at and is appropriate for the clinical circumstances.”

The study was funded by a grant from the Canadian Institutes of Health Research. Dr. Muraca and Dr. Peaceman have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

A new investigation has found that rates of physical trauma following operative vaginal delivery (OVD) in Canada are higher than previously reported.

The cohort study of more than 1.3 million deliveries in the country found trauma rates were highest with forceps delivery, with more than 1 in 4 pregnancies resulting in maternal trauma and 1 in 105 infants experiencing neonatal trauma. Maternal and neonatal trauma following vacuum deliveries was less common, occurring in 1 in 8 pregnancies and 1 in 104 infants, according to the researchers, who reported their findings in the Canadian Medical Association Journal .

“The rates of trauma following OVD in Canada are higher than previously reported, irrespective of region, level of obstetric care, and volume of instrument use among hospitals,” lead author Giulia Muraca, PhD, MPH, assistant professor of obstetrics and gynecology at McMaster University, Hamilton, Ont., said in an interview. “While OVDs may be associated with low rates of morbidity in carefully selected circumstances, the uniformly high rates of trauma among forceps and vacuum deliveries documented across regions, levels of obstetric care, and hospitals show that such conditions do not apply to routine obstetric practice in Canada.”

The American College of Obstetricians and Gynecologists considers OVD a way to reduce the rate of cesarean deliveries. However, the group has also pointed to a decline in familiarity with the procedures among clinicians new to the field.

Current reports also show that while OVD accounts for up to 15% of deliveries in Canada, Australia, and the United Kingdom, the risks associated with the approach are heavily dependent on the expertise of the provider. Declining use of OVD in favor of cesarean delivery has reduced opportunities for clinicians to acquire proficiency in performing these deliveries, according to the researchers.

Given these various factors, the investigators said the consensus on the safety of OVD is under scrutiny.

“An examination of maternal and neonatal trauma among OVD in contemporary practice is necessary to ensure that health care providers, policy makers, and pregnant individuals are informed regarding the risks of OVD typically experienced in routine obstetric practice, rather than those encountered under ideal conditions,” Dr. Muraca said.
 

Over 1 million deliveries studied

Dr. Muraca and colleagues looked at 1,326,191 deliveries occurring across Canada (except Quebec) between April 2013 and March 2019. The researchers included all singleton, term (≥37 weeks), in-hospital deliveries to women who had not undergone a previous cesarean delivery.

The study’s primary outcome measures were composite maternal trauma and composite neonatal trauma. Maternal trauma included obstetric anal sphincter injury (OASI); cervical or high vaginal laceration; pelvic hematoma; obstetric injury to the pelvic organs, pelvic joints, or ligaments; injury to the bladder or urethra; and other pelvic trauma. Neonatal trauma comprised intracranial hemorrhage and laceration, skull fracture, severe injury to the central or peripheral nervous system, fracture of the long bones, injury to the liver or spleen, seizures, and neonatal death.

The analysis found that 38,500 (2.9%) of the cases involved attempted forceps deliveries while 110,987 (8.4%) were attempted vacuum deliveries. Of the attempted forceps deliveries, 1,606 (4.2%) failed, while 8,791 (7.9%) of attempted vacuum deliveries failed.

Maternal trauma was observed in 25.3% of all forceps deliveries (n = 9,728) and 13.2% of all vacuum deliveries (n = 14,614), the researchers reported. The most common form of maternal trauma was OASI, which was observed in 21.52% of women undergoing forceps delivery and 11.67% of those undergoing vacuum delivery. The rates of all other forms of maternal trauma were higher among patients undergoing attempted forceps delivery than among their counterparts undergoing attempted vacuum delivery.

After adjusting for possible confounders, rates of maternal trauma remained higher with forceps than with vacuum deliveries (adjusted rate ratio, 1.70).

The rate of neonatal trauma was comparable for forceps (9.56/1,000 live births) and vacuum deliveries (9.58/1,000 live births). In these cases, damage to the peripheral nervous system was the most common form of neonatal trauma, occurring in 4.85/1,000 live births with forceps delivery and 3.41/1,000 live births for vacuum delivery, the researchers found.
 

Consider morbidity following OVD against potential alternatives, authors say

According to Dr. Muraca, the rates of maternal trauma in her study – along with accumulating evidence of the severe long-term consequences of these injuries – demonstrates the importance of reporting timely, empirically derived risk measures that accurately reflect those that pregnant individuals may encounter in typical obstetric practice.

“Although there is merit in understanding the estimates of risk that can be achieved when conditions are optimal, the interpretation of these estimates can be misleading, especially given secular shifts in patterns of practice,” she said. “The failure to do so compromises women’s autonomy in making evidence-informed decisions regarding childbirth interventions, such as evaluating the short- and long-term risks of OVD and cesarean delivery.

Her group recommended that morbidity following OVD be weighed against potential alternatives to such procedures, which carry their own risks. “This includes an extended second stage of labor and a spontaneous vaginal delivery, or a second-stage cesarean delivery, both of which are associated with significant morbidity,” Dr. Muraca said. “However, a comprehensive consideration of high population rates of OVD morbidity also prompts questions about choice of instrument, obstetrician training in OVD use, and for recognizing cases that would benefit from a cesarean delivery earlier in labor.”

Alan Peaceman, MD, professor of obstetrics and gynecology at Northwestern University, Chicago, said he was not surprised by the rates of sphincter injury, but that the rate of severe neonatal injury rate was higher than he expected. However, he added, “I don’t think clinicians should change their approach based on a single study. They should continue with the approach that they are most skilled at and is appropriate for the clinical circumstances.”

The study was funded by a grant from the Canadian Institutes of Health Research. Dr. Muraca and Dr. Peaceman have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

A new investigation has found that rates of physical trauma following operative vaginal delivery (OVD) in Canada are higher than previously reported.

The cohort study of more than 1.3 million deliveries in the country found trauma rates were highest with forceps delivery, with more than 1 in 4 pregnancies resulting in maternal trauma and 1 in 105 infants experiencing neonatal trauma. Maternal and neonatal trauma following vacuum deliveries was less common, occurring in 1 in 8 pregnancies and 1 in 104 infants, according to the researchers, who reported their findings in the Canadian Medical Association Journal .

“The rates of trauma following OVD in Canada are higher than previously reported, irrespective of region, level of obstetric care, and volume of instrument use among hospitals,” lead author Giulia Muraca, PhD, MPH, assistant professor of obstetrics and gynecology at McMaster University, Hamilton, Ont., said in an interview. “While OVDs may be associated with low rates of morbidity in carefully selected circumstances, the uniformly high rates of trauma among forceps and vacuum deliveries documented across regions, levels of obstetric care, and hospitals show that such conditions do not apply to routine obstetric practice in Canada.”

The American College of Obstetricians and Gynecologists considers OVD a way to reduce the rate of cesarean deliveries. However, the group has also pointed to a decline in familiarity with the procedures among clinicians new to the field.

Current reports also show that while OVD accounts for up to 15% of deliveries in Canada, Australia, and the United Kingdom, the risks associated with the approach are heavily dependent on the expertise of the provider. Declining use of OVD in favor of cesarean delivery has reduced opportunities for clinicians to acquire proficiency in performing these deliveries, according to the researchers.

Given these various factors, the investigators said the consensus on the safety of OVD is under scrutiny.

“An examination of maternal and neonatal trauma among OVD in contemporary practice is necessary to ensure that health care providers, policy makers, and pregnant individuals are informed regarding the risks of OVD typically experienced in routine obstetric practice, rather than those encountered under ideal conditions,” Dr. Muraca said.
 

Over 1 million deliveries studied

Dr. Muraca and colleagues looked at 1,326,191 deliveries occurring across Canada (except Quebec) between April 2013 and March 2019. The researchers included all singleton, term (≥37 weeks), in-hospital deliveries to women who had not undergone a previous cesarean delivery.

The study’s primary outcome measures were composite maternal trauma and composite neonatal trauma. Maternal trauma included obstetric anal sphincter injury (OASI); cervical or high vaginal laceration; pelvic hematoma; obstetric injury to the pelvic organs, pelvic joints, or ligaments; injury to the bladder or urethra; and other pelvic trauma. Neonatal trauma comprised intracranial hemorrhage and laceration, skull fracture, severe injury to the central or peripheral nervous system, fracture of the long bones, injury to the liver or spleen, seizures, and neonatal death.

The analysis found that 38,500 (2.9%) of the cases involved attempted forceps deliveries while 110,987 (8.4%) were attempted vacuum deliveries. Of the attempted forceps deliveries, 1,606 (4.2%) failed, while 8,791 (7.9%) of attempted vacuum deliveries failed.

Maternal trauma was observed in 25.3% of all forceps deliveries (n = 9,728) and 13.2% of all vacuum deliveries (n = 14,614), the researchers reported. The most common form of maternal trauma was OASI, which was observed in 21.52% of women undergoing forceps delivery and 11.67% of those undergoing vacuum delivery. The rates of all other forms of maternal trauma were higher among patients undergoing attempted forceps delivery than among their counterparts undergoing attempted vacuum delivery.

After adjusting for possible confounders, rates of maternal trauma remained higher with forceps than with vacuum deliveries (adjusted rate ratio, 1.70).

The rate of neonatal trauma was comparable for forceps (9.56/1,000 live births) and vacuum deliveries (9.58/1,000 live births). In these cases, damage to the peripheral nervous system was the most common form of neonatal trauma, occurring in 4.85/1,000 live births with forceps delivery and 3.41/1,000 live births for vacuum delivery, the researchers found.
 

Consider morbidity following OVD against potential alternatives, authors say

According to Dr. Muraca, the rates of maternal trauma in her study – along with accumulating evidence of the severe long-term consequences of these injuries – demonstrates the importance of reporting timely, empirically derived risk measures that accurately reflect those that pregnant individuals may encounter in typical obstetric practice.

“Although there is merit in understanding the estimates of risk that can be achieved when conditions are optimal, the interpretation of these estimates can be misleading, especially given secular shifts in patterns of practice,” she said. “The failure to do so compromises women’s autonomy in making evidence-informed decisions regarding childbirth interventions, such as evaluating the short- and long-term risks of OVD and cesarean delivery.

Her group recommended that morbidity following OVD be weighed against potential alternatives to such procedures, which carry their own risks. “This includes an extended second stage of labor and a spontaneous vaginal delivery, or a second-stage cesarean delivery, both of which are associated with significant morbidity,” Dr. Muraca said. “However, a comprehensive consideration of high population rates of OVD morbidity also prompts questions about choice of instrument, obstetrician training in OVD use, and for recognizing cases that would benefit from a cesarean delivery earlier in labor.”

Alan Peaceman, MD, professor of obstetrics and gynecology at Northwestern University, Chicago, said he was not surprised by the rates of sphincter injury, but that the rate of severe neonatal injury rate was higher than he expected. However, he added, “I don’t think clinicians should change their approach based on a single study. They should continue with the approach that they are most skilled at and is appropriate for the clinical circumstances.”

The study was funded by a grant from the Canadian Institutes of Health Research. Dr. Muraca and Dr. Peaceman have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Pregnant women’s thyroid hormone trajectories (levels in the first, second, and third trimester) may predict whether their male offspring are aggressive or withdrawn at age 4.

Certain maternal thyroid hormone trajectories were associated with problem behaviors in preschool boys in a study of close to 2,000 mother-child pairs in China.

The researchers identified low, moderate, and high thyroid-stimulating hormone (TSH) and free thyroxine (FT4) trajectories. 

shironosov/Getty Images

‘Study supports monitoring thyroid function in pregnancy’

“Our findings highlight the significance of close monitoring and management of maternal thyroid function during pregnancy,” senior author Kun Huang, PhD, said in a press release from the Endocrine Society.

“This research presents a new perspective in early intervention of children’s emotional and behavioral problems,” added Dr. Huang, from Anhui Medical University, Hefei, China.

The results add to a growing body of literature about a controversial link between maternal thyroid hormones in pregnancy, when the fetal brain is developing, and subsequent behavior in preschool children, Caroline T. Nguyen, MD, who was not involved with this research, commented in an email.

“Some studies show an association between thyroid levels and behavioral outcomes, others not,” added Dr. Nguyen, assistant professor of clinical medicine, Keck School of Medicine, University of Southern California, Los Angeles. And “some studies have found sex-specific associations with maternal thyroid levels and neurocognitive/behavioral outcomes, others have not.”

Women considering pregnancy should be evaluated for possible thyroid disease, she continued. Currently, no universal screening mandates exist for thyroid disease in pregnancy, but the 2017 American Thyroid Association guidelines do recommend screening women at risk for thyroid dysfunction.

“I think screening for thyroid peroxidase antibody (TPOAb) positivity is helpful in women desiring pregnancy,” Dr. Nguyen continued, “because we know that patients with TPOAb positivity are at increased risk for miscarriage and have a blunted response to the increased demands of pregnancy for thyroid hormone production.”

TPOAb positivity is also associated with the increased risk of postpartum and long-term thyroid dysfunction.

This current study, Dr. Nguyen summarized, “adds to a growing body of research of the relationship of thyroid hormone levels and neurocognitive outcomes [in offspring] and supports the monitoring of thyroid disease in pregnancy.”  

“However, we do not have sufficient data to demonstrate the benefits of intervention with levothyroxine treatment,” she noted. 

Nevertheless, the lack of positive data does not suggest there is no theoretical benefit of intervention, she said, as such studies are very challenging to do. 

“Physicians can help reduce stress and anxiety in patients desiring pregnancy by [recommending] preconception counseling, screening patients at risk for thyroid disease, and optimizing thyroid hormone levels before and during pregnancy,” according to Dr. Nguyen.
 

Maternal TSH and FT4 trajectories and preschoolers’ behaviors

Previous studies have reported that during pregnancy, maternal subclinical hypothyroidism (elevated TSH with normal FT4) as well as isolated hypothyroxinemia (decreased FT4 with normal TSH) are associated with adverse maternal and child outcomes, including preterm delivery and low birth weight.

However, most studies have not determined maternal thyroid hormone levels in different trimesters.

Researchers recruited pregnant women going for their first antenatal checkup at the Ma’anshan Maternal and Child Health Hospital in China from May 2013 to September 2014 and identified 1,860 mother-child pairs.

They determined maternal thyroid hormone levels from blood samples taken during the first, second, and third trimester: on average, gestational week 10, 25, and 34, respectively.

The researchers found that TSH levels increased somewhat from trimester 1 to trimester 2 and then decreased slightly in trimester 3. Most women (68%) had a low TSH trajectory, 28% had a moderate TSH trajectory, and 4% had a high TSH trajectory.

FT4 levels dropped sharply from trimester 1 to trimester 2 and then increased somewhat in trimester 3. About half of the women (52%) had a moderate FT4 trajectory, 33% had a low FT4 trajectory, and 15% had a high FT4 trajectory.

Most women (96.5%) had a low and stable TPOAb level, and the rest (3.5%) had high and decreasing TPOAb levels.  

When the children in the study were 4 years old, their main caregiver (parent or grandparent) completed the 100-question Achenbach Child Behavior checklist to identify whether the child often, sometimes, or never displayed three internalizing problem behaviors (emotionally reactive, anxious/depressed, or withdrawn) and/or two externalizing problem behaviors (attention problems or aggressive behavior).
 

Study limitations, more research needed

It is not clear why the associations between maternal hormones and offspring behavior were only seen in boys. Perhaps male fetuses are more sensitive than female fetuses to changing maternal thyroid hormone levels in pregnancy, the researchers speculate.

They acknowledge that study limitations include there were few children with aggressive behavior, so the confidence interval for the association of the moderate TSH trajectory with aggressive behavior was very wide.

In addition, evaluation of children’s behavior by caregivers was subjective. Also, the researchers did not have information about iodine levels, and low iodine levels can impair child brain development.

And there may have been residual confounders that researchers did not account for, such as differences in family upbringing, parental marital status, and the mother’s exposure to endocrine disruptors.

Therefore, further research is needed.

The study was supported by grants from the National Natural Science Foundation of China, the University Synergy Innovation Program of Anhui Province, the Sci-Tech Basic Resources Research Program of China, the National Key Research and Development Program, the Chinese Academy of Medical Sciences, and the Research Fund of Anhui Institute of Translational Medicine. The researchers and Dr. Nguyen have reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Pregnant women’s thyroid hormone trajectories (levels in the first, second, and third trimester) may predict whether their male offspring are aggressive or withdrawn at age 4.

Certain maternal thyroid hormone trajectories were associated with problem behaviors in preschool boys in a study of close to 2,000 mother-child pairs in China.

The researchers identified low, moderate, and high thyroid-stimulating hormone (TSH) and free thyroxine (FT4) trajectories. 

shironosov/Getty Images

‘Study supports monitoring thyroid function in pregnancy’

“Our findings highlight the significance of close monitoring and management of maternal thyroid function during pregnancy,” senior author Kun Huang, PhD, said in a press release from the Endocrine Society.

“This research presents a new perspective in early intervention of children’s emotional and behavioral problems,” added Dr. Huang, from Anhui Medical University, Hefei, China.

The results add to a growing body of literature about a controversial link between maternal thyroid hormones in pregnancy, when the fetal brain is developing, and subsequent behavior in preschool children, Caroline T. Nguyen, MD, who was not involved with this research, commented in an email.

“Some studies show an association between thyroid levels and behavioral outcomes, others not,” added Dr. Nguyen, assistant professor of clinical medicine, Keck School of Medicine, University of Southern California, Los Angeles. And “some studies have found sex-specific associations with maternal thyroid levels and neurocognitive/behavioral outcomes, others have not.”

Women considering pregnancy should be evaluated for possible thyroid disease, she continued. Currently, no universal screening mandates exist for thyroid disease in pregnancy, but the 2017 American Thyroid Association guidelines do recommend screening women at risk for thyroid dysfunction.

“I think screening for thyroid peroxidase antibody (TPOAb) positivity is helpful in women desiring pregnancy,” Dr. Nguyen continued, “because we know that patients with TPOAb positivity are at increased risk for miscarriage and have a blunted response to the increased demands of pregnancy for thyroid hormone production.”

TPOAb positivity is also associated with the increased risk of postpartum and long-term thyroid dysfunction.

This current study, Dr. Nguyen summarized, “adds to a growing body of research of the relationship of thyroid hormone levels and neurocognitive outcomes [in offspring] and supports the monitoring of thyroid disease in pregnancy.”  

“However, we do not have sufficient data to demonstrate the benefits of intervention with levothyroxine treatment,” she noted. 

Nevertheless, the lack of positive data does not suggest there is no theoretical benefit of intervention, she said, as such studies are very challenging to do. 

“Physicians can help reduce stress and anxiety in patients desiring pregnancy by [recommending] preconception counseling, screening patients at risk for thyroid disease, and optimizing thyroid hormone levels before and during pregnancy,” according to Dr. Nguyen.
 

Maternal TSH and FT4 trajectories and preschoolers’ behaviors

Previous studies have reported that during pregnancy, maternal subclinical hypothyroidism (elevated TSH with normal FT4) as well as isolated hypothyroxinemia (decreased FT4 with normal TSH) are associated with adverse maternal and child outcomes, including preterm delivery and low birth weight.

However, most studies have not determined maternal thyroid hormone levels in different trimesters.

Researchers recruited pregnant women going for their first antenatal checkup at the Ma’anshan Maternal and Child Health Hospital in China from May 2013 to September 2014 and identified 1,860 mother-child pairs.

They determined maternal thyroid hormone levels from blood samples taken during the first, second, and third trimester: on average, gestational week 10, 25, and 34, respectively.

The researchers found that TSH levels increased somewhat from trimester 1 to trimester 2 and then decreased slightly in trimester 3. Most women (68%) had a low TSH trajectory, 28% had a moderate TSH trajectory, and 4% had a high TSH trajectory.

FT4 levels dropped sharply from trimester 1 to trimester 2 and then increased somewhat in trimester 3. About half of the women (52%) had a moderate FT4 trajectory, 33% had a low FT4 trajectory, and 15% had a high FT4 trajectory.

Most women (96.5%) had a low and stable TPOAb level, and the rest (3.5%) had high and decreasing TPOAb levels.  

When the children in the study were 4 years old, their main caregiver (parent or grandparent) completed the 100-question Achenbach Child Behavior checklist to identify whether the child often, sometimes, or never displayed three internalizing problem behaviors (emotionally reactive, anxious/depressed, or withdrawn) and/or two externalizing problem behaviors (attention problems or aggressive behavior).
 

Study limitations, more research needed

It is not clear why the associations between maternal hormones and offspring behavior were only seen in boys. Perhaps male fetuses are more sensitive than female fetuses to changing maternal thyroid hormone levels in pregnancy, the researchers speculate.

They acknowledge that study limitations include there were few children with aggressive behavior, so the confidence interval for the association of the moderate TSH trajectory with aggressive behavior was very wide.

In addition, evaluation of children’s behavior by caregivers was subjective. Also, the researchers did not have information about iodine levels, and low iodine levels can impair child brain development.

And there may have been residual confounders that researchers did not account for, such as differences in family upbringing, parental marital status, and the mother’s exposure to endocrine disruptors.

Therefore, further research is needed.

The study was supported by grants from the National Natural Science Foundation of China, the University Synergy Innovation Program of Anhui Province, the Sci-Tech Basic Resources Research Program of China, the National Key Research and Development Program, the Chinese Academy of Medical Sciences, and the Research Fund of Anhui Institute of Translational Medicine. The researchers and Dr. Nguyen have reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Pregnant women’s thyroid hormone trajectories (levels in the first, second, and third trimester) may predict whether their male offspring are aggressive or withdrawn at age 4.

Certain maternal thyroid hormone trajectories were associated with problem behaviors in preschool boys in a study of close to 2,000 mother-child pairs in China.

The researchers identified low, moderate, and high thyroid-stimulating hormone (TSH) and free thyroxine (FT4) trajectories. 

shironosov/Getty Images

‘Study supports monitoring thyroid function in pregnancy’

“Our findings highlight the significance of close monitoring and management of maternal thyroid function during pregnancy,” senior author Kun Huang, PhD, said in a press release from the Endocrine Society.

“This research presents a new perspective in early intervention of children’s emotional and behavioral problems,” added Dr. Huang, from Anhui Medical University, Hefei, China.

The results add to a growing body of literature about a controversial link between maternal thyroid hormones in pregnancy, when the fetal brain is developing, and subsequent behavior in preschool children, Caroline T. Nguyen, MD, who was not involved with this research, commented in an email.

“Some studies show an association between thyroid levels and behavioral outcomes, others not,” added Dr. Nguyen, assistant professor of clinical medicine, Keck School of Medicine, University of Southern California, Los Angeles. And “some studies have found sex-specific associations with maternal thyroid levels and neurocognitive/behavioral outcomes, others have not.”

Women considering pregnancy should be evaluated for possible thyroid disease, she continued. Currently, no universal screening mandates exist for thyroid disease in pregnancy, but the 2017 American Thyroid Association guidelines do recommend screening women at risk for thyroid dysfunction.

“I think screening for thyroid peroxidase antibody (TPOAb) positivity is helpful in women desiring pregnancy,” Dr. Nguyen continued, “because we know that patients with TPOAb positivity are at increased risk for miscarriage and have a blunted response to the increased demands of pregnancy for thyroid hormone production.”

TPOAb positivity is also associated with the increased risk of postpartum and long-term thyroid dysfunction.

This current study, Dr. Nguyen summarized, “adds to a growing body of research of the relationship of thyroid hormone levels and neurocognitive outcomes [in offspring] and supports the monitoring of thyroid disease in pregnancy.”  

“However, we do not have sufficient data to demonstrate the benefits of intervention with levothyroxine treatment,” she noted. 

Nevertheless, the lack of positive data does not suggest there is no theoretical benefit of intervention, she said, as such studies are very challenging to do. 

“Physicians can help reduce stress and anxiety in patients desiring pregnancy by [recommending] preconception counseling, screening patients at risk for thyroid disease, and optimizing thyroid hormone levels before and during pregnancy,” according to Dr. Nguyen.
 

Maternal TSH and FT4 trajectories and preschoolers’ behaviors

Previous studies have reported that during pregnancy, maternal subclinical hypothyroidism (elevated TSH with normal FT4) as well as isolated hypothyroxinemia (decreased FT4 with normal TSH) are associated with adverse maternal and child outcomes, including preterm delivery and low birth weight.

However, most studies have not determined maternal thyroid hormone levels in different trimesters.

Researchers recruited pregnant women going for their first antenatal checkup at the Ma’anshan Maternal and Child Health Hospital in China from May 2013 to September 2014 and identified 1,860 mother-child pairs.

They determined maternal thyroid hormone levels from blood samples taken during the first, second, and third trimester: on average, gestational week 10, 25, and 34, respectively.

The researchers found that TSH levels increased somewhat from trimester 1 to trimester 2 and then decreased slightly in trimester 3. Most women (68%) had a low TSH trajectory, 28% had a moderate TSH trajectory, and 4% had a high TSH trajectory.

FT4 levels dropped sharply from trimester 1 to trimester 2 and then increased somewhat in trimester 3. About half of the women (52%) had a moderate FT4 trajectory, 33% had a low FT4 trajectory, and 15% had a high FT4 trajectory.

Most women (96.5%) had a low and stable TPOAb level, and the rest (3.5%) had high and decreasing TPOAb levels.  

When the children in the study were 4 years old, their main caregiver (parent or grandparent) completed the 100-question Achenbach Child Behavior checklist to identify whether the child often, sometimes, or never displayed three internalizing problem behaviors (emotionally reactive, anxious/depressed, or withdrawn) and/or two externalizing problem behaviors (attention problems or aggressive behavior).
 

Study limitations, more research needed

It is not clear why the associations between maternal hormones and offspring behavior were only seen in boys. Perhaps male fetuses are more sensitive than female fetuses to changing maternal thyroid hormone levels in pregnancy, the researchers speculate.

They acknowledge that study limitations include there were few children with aggressive behavior, so the confidence interval for the association of the moderate TSH trajectory with aggressive behavior was very wide.

In addition, evaluation of children’s behavior by caregivers was subjective. Also, the researchers did not have information about iodine levels, and low iodine levels can impair child brain development.

And there may have been residual confounders that researchers did not account for, such as differences in family upbringing, parental marital status, and the mother’s exposure to endocrine disruptors.

Therefore, further research is needed.

The study was supported by grants from the National Natural Science Foundation of China, the University Synergy Innovation Program of Anhui Province, the Sci-Tech Basic Resources Research Program of China, the National Key Research and Development Program, the Chinese Academy of Medical Sciences, and the Research Fund of Anhui Institute of Translational Medicine. The researchers and Dr. Nguyen have reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Researchers found a small but greater risk of a hip fracture after 2 years of taking a “drug holiday” – stopping therapy – after long-term (≥3-year) use of one bisphosphonate, risedronate, versus another, alendronate.   

The risk of a hip fracture after stopping either of these oral bisphosphonate osteoporosis drugs was similar until 2 years, suggesting that patients who take a drug holiday from risedronate should be revaluated before 2 years.

These top-line findings from a propensity-matched cohort study of older patients in Ontario, Canada, were reported at the annual American Society of Bone and Mineral Research (ASBMR) last fall.

The full study, led by Kaleen N. Hayes, PharmD, PhD, Brown University School of Public Health, Providence, R.I., was published online in the Annals of Internal Medicine.

“We emphasize that our results do not indicate that alendronate therapy should be preferred over risedronate therapy,” the researchers stress, as several real-world studies found a similar risk of fractures while patients were receiving either drug.

“The decision to initiate alendronate or risedronate therapy [the two most commonly prescribed bisphosphonates] is driven by the prescriber,” they note, adding that some patients may prefer risedronate because it is available as a monthly dose or a weekly delayed-release formula that does not require fasting. 

“We found little difference in the association between risedronate versus alendronate drug holidays and hip fractures until approximately 2 years of not receiving therapy,” Dr. Hayes and colleagues summarize.

Over 3 years, risedronate drug holidays were associated with an 18% relative and 0.6% absolute increased risk for hip fracture compared with alendronate drug holidays.

“To further inform clinical decision-making on drug holidays,” they conclude, “future research should examine when to start and restart osteoporosis therapy on the basis of initial length and type of treatment, patient characteristics, and relative risk for hip fractures versus [atypical femoral fracture].”
 

Hip fracture risk with risedronate vs. alendronate drug holiday

Long-term bisphosphonate use is associated with a rare risk of osteonecrosis of the jaw or atypical femoral fractures. At the same time, bisphosphonates continue to have a therapeutic effect after therapy is discontinued.

Guidelines recommend that patients at low risk of fracture should therefore have a “drug holiday” after 3 to 5 years of bisphosphonate use and be reassessed 2 to 3 years later, largely based on the Fracture Intervention Trial Long-Term Extension (FLEX) study of alendronate. But risedronate has a shorter half-life, so it may provide shorter residual fracture protection.

Using Ontario administrative data, Dr. Hayes and associates identified more than 60,000 patients who were over aged 65, had received at least 3 years of continuous alendronate or risedronate, and had a subsequent 3-year drug holiday between 2000 and 2020.

They excluded patients who had a fracture or entered a nursing home within 120 days of starting a drug holiday who may have stopped the bisphosphonate due to declining health rather than a drug holiday.

Roughly half (55%) had been taking risedronate and 45% had been taking alendronate.

Using propensity scores, the researchers matched 25,077 patients who had been taking risedronate with an equal number who had been taking alendronate.

Most of the patients were women (82%) and were White.

They started the drug holiday when they were on average 81 years old, after taking the bisphosphonate for 5.9 years on average.

During the 3-year drug holiday, 915 of the 50,154 patients had hip fractures.

This was equivalent to 12.4 hip fractures per 1,000 patients per year during a risedronate holiday and 10.6 hip fractures per 1,000 patients per year during an alendronate holiday (hazard ratio, 1.18).  

The risk of hip fracture was not significantly higher at 1 year (HR, 1.03) or at 2 years of a risedronate holiday versus an alendronate holiday (HR, 1.14).

However, the risk of a hip fracture was significantly higher at 2 to 3 years of a risedronate holiday than after an alendronate holiday (HR, 1.34). 

There was no significant difference in the risk of any osteoporotic fracture overall (including hip, vertebrae, pelvis, ribs, forearm), however, during a 3-year risedronate versus alendronate drug holiday (HR, 1.07).

The research was supported by the Canadian Institutes of Health Research and Institute for Clinical Evaluative Sciences. Dr. Hayes was supported by a CIHR doctoral research award. The authors have reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Researchers found a small but greater risk of a hip fracture after 2 years of taking a “drug holiday” – stopping therapy – after long-term (≥3-year) use of one bisphosphonate, risedronate, versus another, alendronate.   

The risk of a hip fracture after stopping either of these oral bisphosphonate osteoporosis drugs was similar until 2 years, suggesting that patients who take a drug holiday from risedronate should be revaluated before 2 years.

These top-line findings from a propensity-matched cohort study of older patients in Ontario, Canada, were reported at the annual American Society of Bone and Mineral Research (ASBMR) last fall.

The full study, led by Kaleen N. Hayes, PharmD, PhD, Brown University School of Public Health, Providence, R.I., was published online in the Annals of Internal Medicine.

“We emphasize that our results do not indicate that alendronate therapy should be preferred over risedronate therapy,” the researchers stress, as several real-world studies found a similar risk of fractures while patients were receiving either drug.

“The decision to initiate alendronate or risedronate therapy [the two most commonly prescribed bisphosphonates] is driven by the prescriber,” they note, adding that some patients may prefer risedronate because it is available as a monthly dose or a weekly delayed-release formula that does not require fasting. 

“We found little difference in the association between risedronate versus alendronate drug holidays and hip fractures until approximately 2 years of not receiving therapy,” Dr. Hayes and colleagues summarize.

Over 3 years, risedronate drug holidays were associated with an 18% relative and 0.6% absolute increased risk for hip fracture compared with alendronate drug holidays.

“To further inform clinical decision-making on drug holidays,” they conclude, “future research should examine when to start and restart osteoporosis therapy on the basis of initial length and type of treatment, patient characteristics, and relative risk for hip fractures versus [atypical femoral fracture].”
 

Hip fracture risk with risedronate vs. alendronate drug holiday

Long-term bisphosphonate use is associated with a rare risk of osteonecrosis of the jaw or atypical femoral fractures. At the same time, bisphosphonates continue to have a therapeutic effect after therapy is discontinued.

Guidelines recommend that patients at low risk of fracture should therefore have a “drug holiday” after 3 to 5 years of bisphosphonate use and be reassessed 2 to 3 years later, largely based on the Fracture Intervention Trial Long-Term Extension (FLEX) study of alendronate. But risedronate has a shorter half-life, so it may provide shorter residual fracture protection.

Using Ontario administrative data, Dr. Hayes and associates identified more than 60,000 patients who were over aged 65, had received at least 3 years of continuous alendronate or risedronate, and had a subsequent 3-year drug holiday between 2000 and 2020.

They excluded patients who had a fracture or entered a nursing home within 120 days of starting a drug holiday who may have stopped the bisphosphonate due to declining health rather than a drug holiday.

Roughly half (55%) had been taking risedronate and 45% had been taking alendronate.

Using propensity scores, the researchers matched 25,077 patients who had been taking risedronate with an equal number who had been taking alendronate.

Most of the patients were women (82%) and were White.

They started the drug holiday when they were on average 81 years old, after taking the bisphosphonate for 5.9 years on average.

During the 3-year drug holiday, 915 of the 50,154 patients had hip fractures.

This was equivalent to 12.4 hip fractures per 1,000 patients per year during a risedronate holiday and 10.6 hip fractures per 1,000 patients per year during an alendronate holiday (hazard ratio, 1.18).  

The risk of hip fracture was not significantly higher at 1 year (HR, 1.03) or at 2 years of a risedronate holiday versus an alendronate holiday (HR, 1.14).

However, the risk of a hip fracture was significantly higher at 2 to 3 years of a risedronate holiday than after an alendronate holiday (HR, 1.34). 

There was no significant difference in the risk of any osteoporotic fracture overall (including hip, vertebrae, pelvis, ribs, forearm), however, during a 3-year risedronate versus alendronate drug holiday (HR, 1.07).

The research was supported by the Canadian Institutes of Health Research and Institute for Clinical Evaluative Sciences. Dr. Hayes was supported by a CIHR doctoral research award. The authors have reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Researchers found a small but greater risk of a hip fracture after 2 years of taking a “drug holiday” – stopping therapy – after long-term (≥3-year) use of one bisphosphonate, risedronate, versus another, alendronate.   

The risk of a hip fracture after stopping either of these oral bisphosphonate osteoporosis drugs was similar until 2 years, suggesting that patients who take a drug holiday from risedronate should be revaluated before 2 years.

These top-line findings from a propensity-matched cohort study of older patients in Ontario, Canada, were reported at the annual American Society of Bone and Mineral Research (ASBMR) last fall.

The full study, led by Kaleen N. Hayes, PharmD, PhD, Brown University School of Public Health, Providence, R.I., was published online in the Annals of Internal Medicine.

“We emphasize that our results do not indicate that alendronate therapy should be preferred over risedronate therapy,” the researchers stress, as several real-world studies found a similar risk of fractures while patients were receiving either drug.

“The decision to initiate alendronate or risedronate therapy [the two most commonly prescribed bisphosphonates] is driven by the prescriber,” they note, adding that some patients may prefer risedronate because it is available as a monthly dose or a weekly delayed-release formula that does not require fasting. 

“We found little difference in the association between risedronate versus alendronate drug holidays and hip fractures until approximately 2 years of not receiving therapy,” Dr. Hayes and colleagues summarize.

Over 3 years, risedronate drug holidays were associated with an 18% relative and 0.6% absolute increased risk for hip fracture compared with alendronate drug holidays.

“To further inform clinical decision-making on drug holidays,” they conclude, “future research should examine when to start and restart osteoporosis therapy on the basis of initial length and type of treatment, patient characteristics, and relative risk for hip fractures versus [atypical femoral fracture].”
 

Hip fracture risk with risedronate vs. alendronate drug holiday

Long-term bisphosphonate use is associated with a rare risk of osteonecrosis of the jaw or atypical femoral fractures. At the same time, bisphosphonates continue to have a therapeutic effect after therapy is discontinued.

Guidelines recommend that patients at low risk of fracture should therefore have a “drug holiday” after 3 to 5 years of bisphosphonate use and be reassessed 2 to 3 years later, largely based on the Fracture Intervention Trial Long-Term Extension (FLEX) study of alendronate. But risedronate has a shorter half-life, so it may provide shorter residual fracture protection.

Using Ontario administrative data, Dr. Hayes and associates identified more than 60,000 patients who were over aged 65, had received at least 3 years of continuous alendronate or risedronate, and had a subsequent 3-year drug holiday between 2000 and 2020.

They excluded patients who had a fracture or entered a nursing home within 120 days of starting a drug holiday who may have stopped the bisphosphonate due to declining health rather than a drug holiday.

Roughly half (55%) had been taking risedronate and 45% had been taking alendronate.

Using propensity scores, the researchers matched 25,077 patients who had been taking risedronate with an equal number who had been taking alendronate.

Most of the patients were women (82%) and were White.

They started the drug holiday when they were on average 81 years old, after taking the bisphosphonate for 5.9 years on average.

During the 3-year drug holiday, 915 of the 50,154 patients had hip fractures.

This was equivalent to 12.4 hip fractures per 1,000 patients per year during a risedronate holiday and 10.6 hip fractures per 1,000 patients per year during an alendronate holiday (hazard ratio, 1.18).  

The risk of hip fracture was not significantly higher at 1 year (HR, 1.03) or at 2 years of a risedronate holiday versus an alendronate holiday (HR, 1.14).

However, the risk of a hip fracture was significantly higher at 2 to 3 years of a risedronate holiday than after an alendronate holiday (HR, 1.34). 

There was no significant difference in the risk of any osteoporotic fracture overall (including hip, vertebrae, pelvis, ribs, forearm), however, during a 3-year risedronate versus alendronate drug holiday (HR, 1.07).

The research was supported by the Canadian Institutes of Health Research and Institute for Clinical Evaluative Sciences. Dr. Hayes was supported by a CIHR doctoral research award. The authors have reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

The number of women screened for cervical cancer in the United States declined between 2005 and 2019 with lack of knowledge about the need for screening being cited as the most common reason for not receiving up-to-date screening. These are the results of a population-based, cross-sectional study conducted by the U.S. Preventive Services Task Force and were published online in JAMA Network Open.

“The fact that this reason increased over time across most sociodemographic groups suggests a need for interventions targeting screening awareness for all women,” lead author Ryan Suk, PhD, MS, from the University of Texas Health Science Center, Houston, and colleagues wrote.

Between 2005 and 2019, the researchers evaluated data from 20,557 women (weighted, 113.1 million women) included in the U.S. National Health Interview Survey. The cohort included women aged 21-65 years without previous hysterectomy and included data on sociodemographic factors such as race, ethnicity, sexual orientation, health insurance type, and rurality of residence.

Dr. Suk and colleagues found that the proportion of women without current screening increased from 2005 to 2019 (from 14.4% to 23.0%; P < .001) and that a higher proportion of those women were in the 21- to 29-year age group (weighted, 29.1%), compared with women in the 30- to 65-year age group (weighted, 21.1%; P < .001). Regardless of age, not knowing that screening was indicated was the most common reason cited for not having up-to-date screening.
 

Sociodemographic factors influence on rates and reasons for overdue screening

Based on weighted population estimates, 6.1% of women included were Asian, 17.2% were Hispanic, 13.1% were non-Hispanic Black, 61% were non-Hispanic White, and 2.7% were other races and/or ethnicities.

Dr. Suk and colleagues found that Asian women had the highest rates of overdue screening, compared with non-Hispanic White women, who had the lowest rates (weighted, 31.4% vs. 20.1%, respectively). The authors also found that reasons for overdue screening varied by sociodemographic factors. For example, while both Asian and Hispanic women cited lack of knowledge as a barrier to routine screening, Asian women were more likely to also report lack of recommendation from a health care professional as a barrier while Hispanic women were more likely to also report lack of access as a barrier to timely screening.

Over the 14-year study period, higher rates of overdue screening were also noted among those identifying as LGBTQ+ versus heterosexual (32.0% vs. 22.2%; P < .001), those with no insurance versus private insurance (41.7% vs. 18.1%; P < .001), and those living in rural versus urban areas (26.2% vs. 22.6%; P = .04).

For the study, guideline-concordant, up-to-date screening in 2005 was defined as screening every 3 years for women aged 21-65 years based on USPSTF guidelines and clinical recommendations. For 2019, up-to-date screening was defined as screening every 3 years with a Papanicolaou (Pap smear) test alone for women aged 21-29 years and screening every 3 years with a Pap smear alone or every 5 years with high-risk human papillomavirus testing or cotesting for women aged 30-65 years.

Dr. Suk and colleagues suggested that guideline updates over the study period could have led to uncertainty regarding appropriate timing and recommended screening intervals, which in turn, may have played a role in decreased cancer screening recommendations.

“Studies have suggested that changing guidelines may produce an increase in both overscreening and underscreening but those already at higher risk of cervical cancer may be most susceptible to underscreening,” wrote the authors.

In an interview, Ruchi Garg, MD, from Mid Atlantic Gynecologic Oncology and Pelvic Surgery Associates, Fairfax, Va., commented: “I think it has been hard to keep up with the guidelines changing so frequently. Furthermore it’s not clearly delineated (or at least there seems to be confusion or extrapolation) that the guidelines are just for Pap smear and that it doesn’t translate into a well woman checkup/pelvic exam; [however], if physicians continue to tell the patients to come in every year, then there won’t be so much underscreening since the physicians/providers will be able to keep track of when the Pap smears need to get done.”

Similar to the study authors, Dr. Garg also suggested that community lectures and public health announcements, particularly when guidelines are updated, will be helpful in enhancing patient education and reducing the rate of this preventable cancer.

The study authors and commentator disclosed no relevant financial relationships.

The number of women screened for cervical cancer in the United States declined between 2005 and 2019 with lack of knowledge about the need for screening being cited as the most common reason for not receiving up-to-date screening. These are the results of a population-based, cross-sectional study conducted by the U.S. Preventive Services Task Force and were published online in JAMA Network Open.

“The fact that this reason increased over time across most sociodemographic groups suggests a need for interventions targeting screening awareness for all women,” lead author Ryan Suk, PhD, MS, from the University of Texas Health Science Center, Houston, and colleagues wrote.

Between 2005 and 2019, the researchers evaluated data from 20,557 women (weighted, 113.1 million women) included in the U.S. National Health Interview Survey. The cohort included women aged 21-65 years without previous hysterectomy and included data on sociodemographic factors such as race, ethnicity, sexual orientation, health insurance type, and rurality of residence.

Dr. Suk and colleagues found that the proportion of women without current screening increased from 2005 to 2019 (from 14.4% to 23.0%; P < .001) and that a higher proportion of those women were in the 21- to 29-year age group (weighted, 29.1%), compared with women in the 30- to 65-year age group (weighted, 21.1%; P < .001). Regardless of age, not knowing that screening was indicated was the most common reason cited for not having up-to-date screening.
 

Sociodemographic factors influence on rates and reasons for overdue screening

Based on weighted population estimates, 6.1% of women included were Asian, 17.2% were Hispanic, 13.1% were non-Hispanic Black, 61% were non-Hispanic White, and 2.7% were other races and/or ethnicities.

Dr. Suk and colleagues found that Asian women had the highest rates of overdue screening, compared with non-Hispanic White women, who had the lowest rates (weighted, 31.4% vs. 20.1%, respectively). The authors also found that reasons for overdue screening varied by sociodemographic factors. For example, while both Asian and Hispanic women cited lack of knowledge as a barrier to routine screening, Asian women were more likely to also report lack of recommendation from a health care professional as a barrier while Hispanic women were more likely to also report lack of access as a barrier to timely screening.

Over the 14-year study period, higher rates of overdue screening were also noted among those identifying as LGBTQ+ versus heterosexual (32.0% vs. 22.2%; P < .001), those with no insurance versus private insurance (41.7% vs. 18.1%; P < .001), and those living in rural versus urban areas (26.2% vs. 22.6%; P = .04).

For the study, guideline-concordant, up-to-date screening in 2005 was defined as screening every 3 years for women aged 21-65 years based on USPSTF guidelines and clinical recommendations. For 2019, up-to-date screening was defined as screening every 3 years with a Papanicolaou (Pap smear) test alone for women aged 21-29 years and screening every 3 years with a Pap smear alone or every 5 years with high-risk human papillomavirus testing or cotesting for women aged 30-65 years.

Dr. Suk and colleagues suggested that guideline updates over the study period could have led to uncertainty regarding appropriate timing and recommended screening intervals, which in turn, may have played a role in decreased cancer screening recommendations.

“Studies have suggested that changing guidelines may produce an increase in both overscreening and underscreening but those already at higher risk of cervical cancer may be most susceptible to underscreening,” wrote the authors.

In an interview, Ruchi Garg, MD, from Mid Atlantic Gynecologic Oncology and Pelvic Surgery Associates, Fairfax, Va., commented: “I think it has been hard to keep up with the guidelines changing so frequently. Furthermore it’s not clearly delineated (or at least there seems to be confusion or extrapolation) that the guidelines are just for Pap smear and that it doesn’t translate into a well woman checkup/pelvic exam; [however], if physicians continue to tell the patients to come in every year, then there won’t be so much underscreening since the physicians/providers will be able to keep track of when the Pap smears need to get done.”

Similar to the study authors, Dr. Garg also suggested that community lectures and public health announcements, particularly when guidelines are updated, will be helpful in enhancing patient education and reducing the rate of this preventable cancer.

The study authors and commentator disclosed no relevant financial relationships.

The number of women screened for cervical cancer in the United States declined between 2005 and 2019 with lack of knowledge about the need for screening being cited as the most common reason for not receiving up-to-date screening. These are the results of a population-based, cross-sectional study conducted by the U.S. Preventive Services Task Force and were published online in JAMA Network Open.

“The fact that this reason increased over time across most sociodemographic groups suggests a need for interventions targeting screening awareness for all women,” lead author Ryan Suk, PhD, MS, from the University of Texas Health Science Center, Houston, and colleagues wrote.

Between 2005 and 2019, the researchers evaluated data from 20,557 women (weighted, 113.1 million women) included in the U.S. National Health Interview Survey. The cohort included women aged 21-65 years without previous hysterectomy and included data on sociodemographic factors such as race, ethnicity, sexual orientation, health insurance type, and rurality of residence.

Dr. Suk and colleagues found that the proportion of women without current screening increased from 2005 to 2019 (from 14.4% to 23.0%; P < .001) and that a higher proportion of those women were in the 21- to 29-year age group (weighted, 29.1%), compared with women in the 30- to 65-year age group (weighted, 21.1%; P < .001). Regardless of age, not knowing that screening was indicated was the most common reason cited for not having up-to-date screening.
 

Sociodemographic factors influence on rates and reasons for overdue screening

Based on weighted population estimates, 6.1% of women included were Asian, 17.2% were Hispanic, 13.1% were non-Hispanic Black, 61% were non-Hispanic White, and 2.7% were other races and/or ethnicities.

Dr. Suk and colleagues found that Asian women had the highest rates of overdue screening, compared with non-Hispanic White women, who had the lowest rates (weighted, 31.4% vs. 20.1%, respectively). The authors also found that reasons for overdue screening varied by sociodemographic factors. For example, while both Asian and Hispanic women cited lack of knowledge as a barrier to routine screening, Asian women were more likely to also report lack of recommendation from a health care professional as a barrier while Hispanic women were more likely to also report lack of access as a barrier to timely screening.

Over the 14-year study period, higher rates of overdue screening were also noted among those identifying as LGBTQ+ versus heterosexual (32.0% vs. 22.2%; P < .001), those with no insurance versus private insurance (41.7% vs. 18.1%; P < .001), and those living in rural versus urban areas (26.2% vs. 22.6%; P = .04).

For the study, guideline-concordant, up-to-date screening in 2005 was defined as screening every 3 years for women aged 21-65 years based on USPSTF guidelines and clinical recommendations. For 2019, up-to-date screening was defined as screening every 3 years with a Papanicolaou (Pap smear) test alone for women aged 21-29 years and screening every 3 years with a Pap smear alone or every 5 years with high-risk human papillomavirus testing or cotesting for women aged 30-65 years.

Dr. Suk and colleagues suggested that guideline updates over the study period could have led to uncertainty regarding appropriate timing and recommended screening intervals, which in turn, may have played a role in decreased cancer screening recommendations.

“Studies have suggested that changing guidelines may produce an increase in both overscreening and underscreening but those already at higher risk of cervical cancer may be most susceptible to underscreening,” wrote the authors.

In an interview, Ruchi Garg, MD, from Mid Atlantic Gynecologic Oncology and Pelvic Surgery Associates, Fairfax, Va., commented: “I think it has been hard to keep up with the guidelines changing so frequently. Furthermore it’s not clearly delineated (or at least there seems to be confusion or extrapolation) that the guidelines are just for Pap smear and that it doesn’t translate into a well woman checkup/pelvic exam; [however], if physicians continue to tell the patients to come in every year, then there won’t be so much underscreening since the physicians/providers will be able to keep track of when the Pap smears need to get done.”

Similar to the study authors, Dr. Garg also suggested that community lectures and public health announcements, particularly when guidelines are updated, will be helpful in enhancing patient education and reducing the rate of this preventable cancer.

The study authors and commentator disclosed no relevant financial relationships.

Expanding Medicaid coverage has proved beneficial to postpartum women and may even help reduce disparities, say two new papers.

In the first study, expansion of Medicaid coverage under the Affordable Care Act was associated with higher rates of postpartum coverage and outpatient visits, according to results published in JAMA Health Forum.

Racial and ethnic disparities were also reduced in postpartum coverage, although these disparities remained between Black and White women for outpatient visits.

In the second study, published in JAMA Network Open, researchers found that when postpartum care is covered as part of Emergency Medicaid, women who have been denied access because of their citizenship status are able to use these services, which includes contraception.

Federal law currently prohibits undocumented and documented immigrants who have been in the United States for less than 5 years from receiving full-benefit Medicaid. Coverage is limited to Emergency Medicaid, which offers benefits only for life-threatening conditions, including hospital admission for childbirth. Coverage is not available for prenatal or postpartum care, including contraception.

For the first article, lead author Maria W. Steenland, SD, of Brown University, Providence, R.I., and colleagues point out that compared with other high-income countries, maternal mortality is higher in the United States and largely driven by persistent racial disparities. Compared with non-Hispanic White women, the rates of maternal death are more than twice as high among American Indian and Alaska Native women, and more than threefold greater in non-Hispanic Black women.

“To be clear, visits increased by around the same amount for Black and White individuals after Medicaid expansion, it is just that visits started off lower among Black women, and remained lower by a similar degree,” said Dr. Steenland.

One explanation is that Black women experience racial discrimination during pregnancy-related health care including childbirth hospitalizations and this may make them more reticent to seek postpartum care, she explained. “In addition, the ability to seek health care is determined by insurance as well as other social factors such as paid leave from work, childcare, and transportation, and these other factors may have remained a larger barrier for Black women after expansion.”

In this cohort study, they looked at the association of Medicaid expansion in Arkansas with continuous postpartum coverage, postpartum health care use, and change in racial disparities in the study outcomes. Using the Arkansas All-Payer Claims Database for persons with a childbirth between 2013 and 2015, the authors identified 60,990 childbirths. Of this group, 67% were White, 22% Black, and 7% Hispanic, and 72.3% were covered by Medicaid. The remaining 27.7% were paid for by a commercial payer.

Before Medicaid expansion, 50.6% of women with Medicaid had continuous coverage during the 6 months postpartum, and the share of women with Medicaid childbirth coverage who were continuously covered for 6 months postpartum increased to 69.3% in 2014 and 90.0% in 2015. Medicaid expansion was associated with a 27.8% increase in continuous coverage for 6-12 months postpartum, and 0.9 increase in visits or a relative increase of 75.0% in outpatient care compared with the visit rate of 1.2 visits within the first 6 months postpartum during the pre-expansion period.

A subgroup analysis was conducted to see if Medicaid expansion had any effect on the disparities between White and Black patients. In the 2-year period after expansion, the percentage of both Black and White women with continuous 6-month postpartum coverage increased to 87.9% and 85.9%, respectively. White individuals averaged 2 visits in the first 6 months postpartum versus 1.6 for Black individuals before expansion, and even though there was no difference in postpartum insurance coverage after expansion, racial disparities in the number of visits during the first 6 months postpartum remained after Medicaid expansion (2.5 vs. 2).

Commenting on the paper, Catherine Cansino, MD, MPH, associate clinical professor in the department of obstetrics and gynecology at the University of California, Davis, noted that she has seen the benefits of Medicaid expansion among obstetric population in California. “I’m glad to see similar expansion in other states,” she said. “But to address persistent health care inequities, I think concierge services or patient care navigation serve a role and can hopefully put a little dent in narrowing gaps.”

Dr. Cansino noted that there are many postpartum patients who need help arranging both pediatric and postpartum care, often prioritizing the newborn appointments. “They also need childcare help so they can focus on their own care as well as transportation,” she said, adding that “it would also be interesting to review racial/ethnic differences with regard to knowledge about contraceptive need immediately postpartum and also about the stigma related to postpartum mental health disorders. If patients don’t see the value of a postpartum visit, they would tend not to attend this visit especially given the many other challenges in the postpartum period.”
 

Access for immigrants

In the second study, the authors note that the decision to expand Emergency Medicaid options is largely up to individual states. Led by Maria I. Rodriguez, MD, MPH, of the department of obstetrics and gynecology, Oregon Health & Science University, Portland, and colleagues, they decided to compare two states – Oregon, which expanded Emergency Medicaid to include postpartum services and South Carolina, which kept only the federal minimum services – to see how it affected postpartum care among immigrant women.

Compared with South Carolina, there was a 40.6 percentage-point increase (95% confidence interval [CI] in postpartum care visits, P < .001) and postpartum contraception within 60 days grew by 33.2 percentage points (95% CI, P < .001), in Oregon after expansion went into effect.

“When postpartum care was covered for women who would have qualified for Medicaid, except for their citizenship status, their rates of attendance at a postpartum visit and use of postpartum contraception increased to levels observed in the traditional Medicaid population,” the authors wrote.

The calculations, drawn from Medicaid claims and birth certificate data from 2010 to 2019, assumed parallel trends, meaning the researchers made the assumption that use patterns would have remained the same in Oregon if the Emergency Medicaid expansion hadn’t happened and use in South Carolina would have remained consistent as well. A differential trend analysis showed significant increases in use of the services in Oregon relative to South Carolina.

“We included Oregon and South Carolina because both states have experienced similar growth in their immigrant population and have comparable immigrant populations, in terms of size and country of origin, residing in each state,” the authors noted.

Commenting on the study, Laura Mercer MD, MBA, MPH, associate professor in obstetrics and gynecology and director of the obstetrics and gynecology clerkship at the University of Arizona in Phoenix, said she was “excited and encouraged by the results” but not surprised, as it’s logical to assume that there would be more uptake of the services when they are provided free of charge or at low cost.

“Oftentimes, the mother of the family deprioritizes her own health and well-being in favor of diverting those resources to her children and her family,” said Dr. Mercer, who specializes in prenatal and postpartum care.

She added that the significant increase in contraception is a particularly representative sign of improvement as it is easier to quantify, compared to improvements in mental health or counseling.

But comprehensive postpartum care extends to physical, psychological, and social well-being. “Its components include counseling on the importance of birth spacing and providing the contraceptive method of their choice,” the authors wrote. “An absence of postpartum care has been associated with unintended pregnancy, short interpregnancy intervals, exacerbation of chronic diseases, and preterm birth.”

Dr. Mercer noted that closely spaced pregnancies, particularly less than 6 months but at least less than 18 months carry increased risk for mother and child. And for those who would say that immigrant women should be excluded from the Emergency Medicaid postpartum services, Dr. Mercer said she would encourage them to look at the data around the improved outcomes of comprehensive maternal care.

Being able to track health markers and intervene before a woman requires emergency care will reduce costs in the long run, she pointed out. But, regardless of the cost, policymakers have to ask themselves, “What do we value as a society? If we value families and healthy families and we want to promote the best possible outcomes, then I think this question becomes very easy to answer.”

The first study was funded by the National Institute for Health Care Management. Dr. Steenland was also supported by the Agency for Healthcare Research and Quality and the National Institutes of Health. Dr. Steenland reported grants from the Agency for Healthcare Research and Quality and from the National Institute for Child Health and Human Development during the conduct of the study. The second study was supported by the National Institute on Minority Health and Health Disparities. Dr. Rodriguez reports grants from Arnold Ventures and personal fees from the American College of Obstetricians and Gynecologists, Bayer, and Merck outside the submitted work. A coauthor reports grants from Merck/Organon and the Office of Population Affairs outside the submitted work, as well as membership on the board of directors of the Society of Family Planning and the ACOG Gynecology Clinical Practice Guideline committee. Dr. Mercer reported no relevant financial relationships.

Expanding Medicaid coverage has proved beneficial to postpartum women and may even help reduce disparities, say two new papers.

In the first study, expansion of Medicaid coverage under the Affordable Care Act was associated with higher rates of postpartum coverage and outpatient visits, according to results published in JAMA Health Forum.

Racial and ethnic disparities were also reduced in postpartum coverage, although these disparities remained between Black and White women for outpatient visits.

In the second study, published in JAMA Network Open, researchers found that when postpartum care is covered as part of Emergency Medicaid, women who have been denied access because of their citizenship status are able to use these services, which includes contraception.

Federal law currently prohibits undocumented and documented immigrants who have been in the United States for less than 5 years from receiving full-benefit Medicaid. Coverage is limited to Emergency Medicaid, which offers benefits only for life-threatening conditions, including hospital admission for childbirth. Coverage is not available for prenatal or postpartum care, including contraception.

For the first article, lead author Maria W. Steenland, SD, of Brown University, Providence, R.I., and colleagues point out that compared with other high-income countries, maternal mortality is higher in the United States and largely driven by persistent racial disparities. Compared with non-Hispanic White women, the rates of maternal death are more than twice as high among American Indian and Alaska Native women, and more than threefold greater in non-Hispanic Black women.

“To be clear, visits increased by around the same amount for Black and White individuals after Medicaid expansion, it is just that visits started off lower among Black women, and remained lower by a similar degree,” said Dr. Steenland.

One explanation is that Black women experience racial discrimination during pregnancy-related health care including childbirth hospitalizations and this may make them more reticent to seek postpartum care, she explained. “In addition, the ability to seek health care is determined by insurance as well as other social factors such as paid leave from work, childcare, and transportation, and these other factors may have remained a larger barrier for Black women after expansion.”

In this cohort study, they looked at the association of Medicaid expansion in Arkansas with continuous postpartum coverage, postpartum health care use, and change in racial disparities in the study outcomes. Using the Arkansas All-Payer Claims Database for persons with a childbirth between 2013 and 2015, the authors identified 60,990 childbirths. Of this group, 67% were White, 22% Black, and 7% Hispanic, and 72.3% were covered by Medicaid. The remaining 27.7% were paid for by a commercial payer.

Before Medicaid expansion, 50.6% of women with Medicaid had continuous coverage during the 6 months postpartum, and the share of women with Medicaid childbirth coverage who were continuously covered for 6 months postpartum increased to 69.3% in 2014 and 90.0% in 2015. Medicaid expansion was associated with a 27.8% increase in continuous coverage for 6-12 months postpartum, and 0.9 increase in visits or a relative increase of 75.0% in outpatient care compared with the visit rate of 1.2 visits within the first 6 months postpartum during the pre-expansion period.

A subgroup analysis was conducted to see if Medicaid expansion had any effect on the disparities between White and Black patients. In the 2-year period after expansion, the percentage of both Black and White women with continuous 6-month postpartum coverage increased to 87.9% and 85.9%, respectively. White individuals averaged 2 visits in the first 6 months postpartum versus 1.6 for Black individuals before expansion, and even though there was no difference in postpartum insurance coverage after expansion, racial disparities in the number of visits during the first 6 months postpartum remained after Medicaid expansion (2.5 vs. 2).

Commenting on the paper, Catherine Cansino, MD, MPH, associate clinical professor in the department of obstetrics and gynecology at the University of California, Davis, noted that she has seen the benefits of Medicaid expansion among obstetric population in California. “I’m glad to see similar expansion in other states,” she said. “But to address persistent health care inequities, I think concierge services or patient care navigation serve a role and can hopefully put a little dent in narrowing gaps.”

Dr. Cansino noted that there are many postpartum patients who need help arranging both pediatric and postpartum care, often prioritizing the newborn appointments. “They also need childcare help so they can focus on their own care as well as transportation,” she said, adding that “it would also be interesting to review racial/ethnic differences with regard to knowledge about contraceptive need immediately postpartum and also about the stigma related to postpartum mental health disorders. If patients don’t see the value of a postpartum visit, they would tend not to attend this visit especially given the many other challenges in the postpartum period.”
 

Access for immigrants

In the second study, the authors note that the decision to expand Emergency Medicaid options is largely up to individual states. Led by Maria I. Rodriguez, MD, MPH, of the department of obstetrics and gynecology, Oregon Health & Science University, Portland, and colleagues, they decided to compare two states – Oregon, which expanded Emergency Medicaid to include postpartum services and South Carolina, which kept only the federal minimum services – to see how it affected postpartum care among immigrant women.

Compared with South Carolina, there was a 40.6 percentage-point increase (95% confidence interval [CI] in postpartum care visits, P < .001) and postpartum contraception within 60 days grew by 33.2 percentage points (95% CI, P < .001), in Oregon after expansion went into effect.

“When postpartum care was covered for women who would have qualified for Medicaid, except for their citizenship status, their rates of attendance at a postpartum visit and use of postpartum contraception increased to levels observed in the traditional Medicaid population,” the authors wrote.

The calculations, drawn from Medicaid claims and birth certificate data from 2010 to 2019, assumed parallel trends, meaning the researchers made the assumption that use patterns would have remained the same in Oregon if the Emergency Medicaid expansion hadn’t happened and use in South Carolina would have remained consistent as well. A differential trend analysis showed significant increases in use of the services in Oregon relative to South Carolina.

“We included Oregon and South Carolina because both states have experienced similar growth in their immigrant population and have comparable immigrant populations, in terms of size and country of origin, residing in each state,” the authors noted.

Commenting on the study, Laura Mercer MD, MBA, MPH, associate professor in obstetrics and gynecology and director of the obstetrics and gynecology clerkship at the University of Arizona in Phoenix, said she was “excited and encouraged by the results” but not surprised, as it’s logical to assume that there would be more uptake of the services when they are provided free of charge or at low cost.

“Oftentimes, the mother of the family deprioritizes her own health and well-being in favor of diverting those resources to her children and her family,” said Dr. Mercer, who specializes in prenatal and postpartum care.

She added that the significant increase in contraception is a particularly representative sign of improvement as it is easier to quantify, compared to improvements in mental health or counseling.

But comprehensive postpartum care extends to physical, psychological, and social well-being. “Its components include counseling on the importance of birth spacing and providing the contraceptive method of their choice,” the authors wrote. “An absence of postpartum care has been associated with unintended pregnancy, short interpregnancy intervals, exacerbation of chronic diseases, and preterm birth.”

Dr. Mercer noted that closely spaced pregnancies, particularly less than 6 months but at least less than 18 months carry increased risk for mother and child. And for those who would say that immigrant women should be excluded from the Emergency Medicaid postpartum services, Dr. Mercer said she would encourage them to look at the data around the improved outcomes of comprehensive maternal care.

Being able to track health markers and intervene before a woman requires emergency care will reduce costs in the long run, she pointed out. But, regardless of the cost, policymakers have to ask themselves, “What do we value as a society? If we value families and healthy families and we want to promote the best possible outcomes, then I think this question becomes very easy to answer.”

The first study was funded by the National Institute for Health Care Management. Dr. Steenland was also supported by the Agency for Healthcare Research and Quality and the National Institutes of Health. Dr. Steenland reported grants from the Agency for Healthcare Research and Quality and from the National Institute for Child Health and Human Development during the conduct of the study. The second study was supported by the National Institute on Minority Health and Health Disparities. Dr. Rodriguez reports grants from Arnold Ventures and personal fees from the American College of Obstetricians and Gynecologists, Bayer, and Merck outside the submitted work. A coauthor reports grants from Merck/Organon and the Office of Population Affairs outside the submitted work, as well as membership on the board of directors of the Society of Family Planning and the ACOG Gynecology Clinical Practice Guideline committee. Dr. Mercer reported no relevant financial relationships.

Expanding Medicaid coverage has proved beneficial to postpartum women and may even help reduce disparities, say two new papers.

In the first study, expansion of Medicaid coverage under the Affordable Care Act was associated with higher rates of postpartum coverage and outpatient visits, according to results published in JAMA Health Forum.

Racial and ethnic disparities were also reduced in postpartum coverage, although these disparities remained between Black and White women for outpatient visits.

In the second study, published in JAMA Network Open, researchers found that when postpartum care is covered as part of Emergency Medicaid, women who have been denied access because of their citizenship status are able to use these services, which includes contraception.

Federal law currently prohibits undocumented and documented immigrants who have been in the United States for less than 5 years from receiving full-benefit Medicaid. Coverage is limited to Emergency Medicaid, which offers benefits only for life-threatening conditions, including hospital admission for childbirth. Coverage is not available for prenatal or postpartum care, including contraception.

For the first article, lead author Maria W. Steenland, SD, of Brown University, Providence, R.I., and colleagues point out that compared with other high-income countries, maternal mortality is higher in the United States and largely driven by persistent racial disparities. Compared with non-Hispanic White women, the rates of maternal death are more than twice as high among American Indian and Alaska Native women, and more than threefold greater in non-Hispanic Black women.

“To be clear, visits increased by around the same amount for Black and White individuals after Medicaid expansion, it is just that visits started off lower among Black women, and remained lower by a similar degree,” said Dr. Steenland.

One explanation is that Black women experience racial discrimination during pregnancy-related health care including childbirth hospitalizations and this may make them more reticent to seek postpartum care, she explained. “In addition, the ability to seek health care is determined by insurance as well as other social factors such as paid leave from work, childcare, and transportation, and these other factors may have remained a larger barrier for Black women after expansion.”

In this cohort study, they looked at the association of Medicaid expansion in Arkansas with continuous postpartum coverage, postpartum health care use, and change in racial disparities in the study outcomes. Using the Arkansas All-Payer Claims Database for persons with a childbirth between 2013 and 2015, the authors identified 60,990 childbirths. Of this group, 67% were White, 22% Black, and 7% Hispanic, and 72.3% were covered by Medicaid. The remaining 27.7% were paid for by a commercial payer.

Before Medicaid expansion, 50.6% of women with Medicaid had continuous coverage during the 6 months postpartum, and the share of women with Medicaid childbirth coverage who were continuously covered for 6 months postpartum increased to 69.3% in 2014 and 90.0% in 2015. Medicaid expansion was associated with a 27.8% increase in continuous coverage for 6-12 months postpartum, and 0.9 increase in visits or a relative increase of 75.0% in outpatient care compared with the visit rate of 1.2 visits within the first 6 months postpartum during the pre-expansion period.

A subgroup analysis was conducted to see if Medicaid expansion had any effect on the disparities between White and Black patients. In the 2-year period after expansion, the percentage of both Black and White women with continuous 6-month postpartum coverage increased to 87.9% and 85.9%, respectively. White individuals averaged 2 visits in the first 6 months postpartum versus 1.6 for Black individuals before expansion, and even though there was no difference in postpartum insurance coverage after expansion, racial disparities in the number of visits during the first 6 months postpartum remained after Medicaid expansion (2.5 vs. 2).

Commenting on the paper, Catherine Cansino, MD, MPH, associate clinical professor in the department of obstetrics and gynecology at the University of California, Davis, noted that she has seen the benefits of Medicaid expansion among obstetric population in California. “I’m glad to see similar expansion in other states,” she said. “But to address persistent health care inequities, I think concierge services or patient care navigation serve a role and can hopefully put a little dent in narrowing gaps.”

Dr. Cansino noted that there are many postpartum patients who need help arranging both pediatric and postpartum care, often prioritizing the newborn appointments. “They also need childcare help so they can focus on their own care as well as transportation,” she said, adding that “it would also be interesting to review racial/ethnic differences with regard to knowledge about contraceptive need immediately postpartum and also about the stigma related to postpartum mental health disorders. If patients don’t see the value of a postpartum visit, they would tend not to attend this visit especially given the many other challenges in the postpartum period.”
 

Access for immigrants

In the second study, the authors note that the decision to expand Emergency Medicaid options is largely up to individual states. Led by Maria I. Rodriguez, MD, MPH, of the department of obstetrics and gynecology, Oregon Health & Science University, Portland, and colleagues, they decided to compare two states – Oregon, which expanded Emergency Medicaid to include postpartum services and South Carolina, which kept only the federal minimum services – to see how it affected postpartum care among immigrant women.

Compared with South Carolina, there was a 40.6 percentage-point increase (95% confidence interval [CI] in postpartum care visits, P < .001) and postpartum contraception within 60 days grew by 33.2 percentage points (95% CI, P < .001), in Oregon after expansion went into effect.

“When postpartum care was covered for women who would have qualified for Medicaid, except for their citizenship status, their rates of attendance at a postpartum visit and use of postpartum contraception increased to levels observed in the traditional Medicaid population,” the authors wrote.

The calculations, drawn from Medicaid claims and birth certificate data from 2010 to 2019, assumed parallel trends, meaning the researchers made the assumption that use patterns would have remained the same in Oregon if the Emergency Medicaid expansion hadn’t happened and use in South Carolina would have remained consistent as well. A differential trend analysis showed significant increases in use of the services in Oregon relative to South Carolina.

“We included Oregon and South Carolina because both states have experienced similar growth in their immigrant population and have comparable immigrant populations, in terms of size and country of origin, residing in each state,” the authors noted.

Commenting on the study, Laura Mercer MD, MBA, MPH, associate professor in obstetrics and gynecology and director of the obstetrics and gynecology clerkship at the University of Arizona in Phoenix, said she was “excited and encouraged by the results” but not surprised, as it’s logical to assume that there would be more uptake of the services when they are provided free of charge or at low cost.

“Oftentimes, the mother of the family deprioritizes her own health and well-being in favor of diverting those resources to her children and her family,” said Dr. Mercer, who specializes in prenatal and postpartum care.

She added that the significant increase in contraception is a particularly representative sign of improvement as it is easier to quantify, compared to improvements in mental health or counseling.

But comprehensive postpartum care extends to physical, psychological, and social well-being. “Its components include counseling on the importance of birth spacing and providing the contraceptive method of their choice,” the authors wrote. “An absence of postpartum care has been associated with unintended pregnancy, short interpregnancy intervals, exacerbation of chronic diseases, and preterm birth.”

Dr. Mercer noted that closely spaced pregnancies, particularly less than 6 months but at least less than 18 months carry increased risk for mother and child. And for those who would say that immigrant women should be excluded from the Emergency Medicaid postpartum services, Dr. Mercer said she would encourage them to look at the data around the improved outcomes of comprehensive maternal care.

Being able to track health markers and intervene before a woman requires emergency care will reduce costs in the long run, she pointed out. But, regardless of the cost, policymakers have to ask themselves, “What do we value as a society? If we value families and healthy families and we want to promote the best possible outcomes, then I think this question becomes very easy to answer.”

The first study was funded by the National Institute for Health Care Management. Dr. Steenland was also supported by the Agency for Healthcare Research and Quality and the National Institutes of Health. Dr. Steenland reported grants from the Agency for Healthcare Research and Quality and from the National Institute for Child Health and Human Development during the conduct of the study. The second study was supported by the National Institute on Minority Health and Health Disparities. Dr. Rodriguez reports grants from Arnold Ventures and personal fees from the American College of Obstetricians and Gynecologists, Bayer, and Merck outside the submitted work. A coauthor reports grants from Merck/Organon and the Office of Population Affairs outside the submitted work, as well as membership on the board of directors of the Society of Family Planning and the ACOG Gynecology Clinical Practice Guideline committee. Dr. Mercer reported no relevant financial relationships.

ANSWER

The correct answer is all of the above (choice “e”).

DISCUSSION

Most cases of dermatomyositis, which the patient’s presentation and lab results suggested, require nerve conduction studies, a check of serum aldolase levels, and skin and muscle biopsies to complete the work-up. However, the arrival at a diagnosis is only the first step.

Patients with dermatomyositis, particularly those older than 60, require evaluation for occult malignancy. There is evidence that the body’s immune response to the cancer is what drives the disease process. Hence the need for the studies listed, looking for breast, lung, and gastrointestinal cancers especially.

Dermatomyositis is thought to be an inflammatory myopathy, possibly driven by autoimmune factors. It is rare (about 1 to 22 per 100,000) and affects women more than men.

The “sunburn” rash is typical, especially on the face, chest, and dorsal hands, and usually clears completely when the cancer is found and cured. Other common findings include elevated creatine kinase, hand rashes (known as Gottron’s papules), and dystrophic calcification in skin and/or joints.

TREATMENT

Aside from addressing a possible malignancy, treatment of dermatomyositis usually starts with glucocorticoids, eventually tapered and replaced by steroid-sparing agents such as azathioprine or cyclosporine. These drugs have dramatically increased the chances of survival and eventual cure.

It’s common for the photosensitivity to persist long after the myositis has resolved, which is why sunscreen and other sun-protective measures are advised.

ANSWER

The correct answer is all of the above (choice “e”).

DISCUSSION

Most cases of dermatomyositis, which the patient’s presentation and lab results suggested, require nerve conduction studies, a check of serum aldolase levels, and skin and muscle biopsies to complete the work-up. However, the arrival at a diagnosis is only the first step.

Patients with dermatomyositis, particularly those older than 60, require evaluation for occult malignancy. There is evidence that the body’s immune response to the cancer is what drives the disease process. Hence the need for the studies listed, looking for breast, lung, and gastrointestinal cancers especially.

Dermatomyositis is thought to be an inflammatory myopathy, possibly driven by autoimmune factors. It is rare (about 1 to 22 per 100,000) and affects women more than men.

The “sunburn” rash is typical, especially on the face, chest, and dorsal hands, and usually clears completely when the cancer is found and cured. Other common findings include elevated creatine kinase, hand rashes (known as Gottron’s papules), and dystrophic calcification in skin and/or joints.

TREATMENT

Aside from addressing a possible malignancy, treatment of dermatomyositis usually starts with glucocorticoids, eventually tapered and replaced by steroid-sparing agents such as azathioprine or cyclosporine. These drugs have dramatically increased the chances of survival and eventual cure.

It’s common for the photosensitivity to persist long after the myositis has resolved, which is why sunscreen and other sun-protective measures are advised.

ANSWER

The correct answer is all of the above (choice “e”).

DISCUSSION

Most cases of dermatomyositis, which the patient’s presentation and lab results suggested, require nerve conduction studies, a check of serum aldolase levels, and skin and muscle biopsies to complete the work-up. However, the arrival at a diagnosis is only the first step.

Patients with dermatomyositis, particularly those older than 60, require evaluation for occult malignancy. There is evidence that the body’s immune response to the cancer is what drives the disease process. Hence the need for the studies listed, looking for breast, lung, and gastrointestinal cancers especially.

Dermatomyositis is thought to be an inflammatory myopathy, possibly driven by autoimmune factors. It is rare (about 1 to 22 per 100,000) and affects women more than men.

The “sunburn” rash is typical, especially on the face, chest, and dorsal hands, and usually clears completely when the cancer is found and cured. Other common findings include elevated creatine kinase, hand rashes (known as Gottron’s papules), and dystrophic calcification in skin and/or joints.

TREATMENT

Aside from addressing a possible malignancy, treatment of dermatomyositis usually starts with glucocorticoids, eventually tapered and replaced by steroid-sparing agents such as azathioprine or cyclosporine. These drugs have dramatically increased the chances of survival and eventual cure.

It’s common for the photosensitivity to persist long after the myositis has resolved, which is why sunscreen and other sun-protective measures are advised.