Obstetrics

Giving corticosteroids to pregnant women at risk for preterm birth before 34 weeks of gestational age has been the standard of care since the 1990s, but a few scenarios for their use remain up for debate. Two studies presented this week at the 2023 meeting sponsored by the Society for Maternal–Fetal Medicine provided some fresh insight into the practice that could help clinicians better manage pregnant patients.

Neurodevelopmental outcomes in late preterm

First, should antenatal corticosteroids (ACS) be given to mothers who present with late preterm labor, defined as 34-36 weeks’ gestational age?

A landmark randomized clinical trial published in 2016 demonstrated that use of ACS in mothers in late preterm labor reduced severe respiratory complications. That practice has largely been adopted by clinicians. The only downside, according to the researchers, was that infants whose mothers received steroid therapy were more likely to develop hypoglycemia. The condition is self-limiting, but studies have raised concern about the potential long-term risk of neurocognitive or psychological outcomes in infants with hypoglycemia.

Cynthia Gyamfi-Bannerman, MD, MSc, endowed chair and professor of obstetrics, gynecology, and reproductive sciences at the University of California, San Diego, led the 2016 study. Her team was unable to secure funding for their originally planned follow-up study of the infants 2 years later. But once the American College of Obstetricians and Gynecologists endorsed the practice and more women received ACS in the late preterm period, Dr. Gyamfi-Bannerman and her colleagues felt the need to “follow up the infants just to see what the outcomes are from a neurodevelopmental standpoint,” she said.

Dr. Gyamfi-Bannerman and colleagues recruited children older than age 6 from the original trial whose parents were willing to have them participate in a follow-up study. A total of 949 from the initial 2,831 cohort completed cognitive testing and received assessments for cerebral palsy, social impairment within the autism spectrum, and behavioral and emotional problems.

At the SMFM conference, Dr. Gyamfi-Bannerman reported no differences in the primary outcome of cognitive function between those whose mothers had received a single course of betamethasone and those who did not, or any differences in rates of the other outcomes.

Kathy Zhang-Rutledge, MD, a maternal-fetal medicine specialist who practices with Obstetrix Maternal Fetal Medicine Group of Houston, part of Pediatrix Medical Group, said she was glad to see a study that addressed the potential long-term adverse events associated with ACS in the late preterm period.

“Having this pretty large study – with really good neurological testing results – should help reassure clinicians that this is something they should consider adopting in their practice,” Dr. Zhang-Rutledge said.
 

Are boosters better?

The second unresolved question was if a repeat course of ACS should be administered when a woman at risk for preterm birth receives a course of steroids but does not deliver in the following 7 days.

Any benefits to the initial course of ACS wear off after a week. As a result, clinicians often give booster courses 7 days after the first dose if the infant is likely to be delivered in the following week. A 2009 study showed this approach may protect infants from respiratory problems, but data on long-term outcomes have been weak.

ACOG guidelines say to “consider” a booster dose in women who are less than 34 weeks’ gestation at risk for preterm delivery within 7 days.

The exception is when the mother already has experienced preterm prelabor rupture of membranes (PPROM), because ACS may increase the risk for infection for both mother and child. ACOG doesn’t take a stand on use of booster doses for PPROM, citing a lack of data to show that potential benefits outweigh the potential risks of this approach.

A recent multicenter, double-blinded, randomized clinical trial attempted to fill that void in knowledge. Between 2016 and 2022, 194 women with PPROM and gestational age less than 32 weeks who had received an initial ACS course at least 7 days prior to randomization received a booster course of ACS or saline placebo.

“Our primary outcome was designed to be like the prior rescue study (in 2009) that we did with patients with intact membranes,” said Andrew Combs, MD, PhD, a maternal-fetal medicine specialist at Pediatrix Medical Group in Sunrise, Fla., who participated in the earlier study. “It was a composite of neonatal morbidity that was any one of a variety of outcomes including respiratory distress syndrome, intraventricular hemorrhage, necrotizing enterocolitis, and neonatal death.”

The primary outcome occurred in 64% of women who received booster ACS and 66% with placebo (odds ratio, 0.82; 95% confidence interval, 0.43-1.57), according to Dr. Combs, who presented the findings at SMFM.

Although the study was not powered to detect significant differences in specific outcomes, the rate of neonatal sepsis was not higher in the ACS group, suggesting that ACS may be safe if membranes have ruptured, the researchers reported. But because the booster course of ACS did not prevent respiratory morbidity, clinicians may wonder what to do with the findings.

Niraj Chavan, MD, an associate professor in the department of obstetrics, gynecology, and women’s health at Saint Louis University, said he was unsure how the study would affect clinical practice.

The relatively small sample number of patients prevented analysis of specific outcomes and subgroup analyses of important variables such as race, ethnicity, gestational age, and other comorbid conditions in the mothers, he said. So clinicians still must weigh potential risks and benefits on a case-by-case basis.

“You have to think about it in buckets,” he said, “One is conditions that would increase the risk for neonatal morbidity. The other is the risk for infection, both for the mom and the baby.”

But for Dr. Combs, the interpretation of the findings was simpler: “We concluded that there’s no indication to give a booster course of steroids after a week has elapsed in patients with ruptured membranes.”

The study presented by Dr. Gyamfi-Bannerman was funded by the National Institute of Child Health and Human Development. The study presented by Dr. Combs was funded by MEDNAX Center for Research, Education, and Quality, which in 2022 was renamed Pediatrix Center for Research, Education,and Quality. Dr. Combs is an employee of Pediatrix Medical Group but has no conflicts of interest. Dr. Gyamfi-Bannerman, Dr. Zhang-Rutledge, and Dr. Chavan report no relevant financial relationships.

Ann Thomas is a pediatrician and epidemiologist in Portland, Ore.

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

Giving corticosteroids to pregnant women at risk for preterm birth before 34 weeks of gestational age has been the standard of care since the 1990s, but a few scenarios for their use remain up for debate. Two studies presented this week at the 2023 meeting sponsored by the Society for Maternal–Fetal Medicine provided some fresh insight into the practice that could help clinicians better manage pregnant patients.

Neurodevelopmental outcomes in late preterm

First, should antenatal corticosteroids (ACS) be given to mothers who present with late preterm labor, defined as 34-36 weeks’ gestational age?

A landmark randomized clinical trial published in 2016 demonstrated that use of ACS in mothers in late preterm labor reduced severe respiratory complications. That practice has largely been adopted by clinicians. The only downside, according to the researchers, was that infants whose mothers received steroid therapy were more likely to develop hypoglycemia. The condition is self-limiting, but studies have raised concern about the potential long-term risk of neurocognitive or psychological outcomes in infants with hypoglycemia.

Cynthia Gyamfi-Bannerman, MD, MSc, endowed chair and professor of obstetrics, gynecology, and reproductive sciences at the University of California, San Diego, led the 2016 study. Her team was unable to secure funding for their originally planned follow-up study of the infants 2 years later. But once the American College of Obstetricians and Gynecologists endorsed the practice and more women received ACS in the late preterm period, Dr. Gyamfi-Bannerman and her colleagues felt the need to “follow up the infants just to see what the outcomes are from a neurodevelopmental standpoint,” she said.

Dr. Gyamfi-Bannerman and colleagues recruited children older than age 6 from the original trial whose parents were willing to have them participate in a follow-up study. A total of 949 from the initial 2,831 cohort completed cognitive testing and received assessments for cerebral palsy, social impairment within the autism spectrum, and behavioral and emotional problems.

At the SMFM conference, Dr. Gyamfi-Bannerman reported no differences in the primary outcome of cognitive function between those whose mothers had received a single course of betamethasone and those who did not, or any differences in rates of the other outcomes.

Kathy Zhang-Rutledge, MD, a maternal-fetal medicine specialist who practices with Obstetrix Maternal Fetal Medicine Group of Houston, part of Pediatrix Medical Group, said she was glad to see a study that addressed the potential long-term adverse events associated with ACS in the late preterm period.

“Having this pretty large study – with really good neurological testing results – should help reassure clinicians that this is something they should consider adopting in their practice,” Dr. Zhang-Rutledge said.
 

Are boosters better?

The second unresolved question was if a repeat course of ACS should be administered when a woman at risk for preterm birth receives a course of steroids but does not deliver in the following 7 days.

Any benefits to the initial course of ACS wear off after a week. As a result, clinicians often give booster courses 7 days after the first dose if the infant is likely to be delivered in the following week. A 2009 study showed this approach may protect infants from respiratory problems, but data on long-term outcomes have been weak.

ACOG guidelines say to “consider” a booster dose in women who are less than 34 weeks’ gestation at risk for preterm delivery within 7 days.

The exception is when the mother already has experienced preterm prelabor rupture of membranes (PPROM), because ACS may increase the risk for infection for both mother and child. ACOG doesn’t take a stand on use of booster doses for PPROM, citing a lack of data to show that potential benefits outweigh the potential risks of this approach.

A recent multicenter, double-blinded, randomized clinical trial attempted to fill that void in knowledge. Between 2016 and 2022, 194 women with PPROM and gestational age less than 32 weeks who had received an initial ACS course at least 7 days prior to randomization received a booster course of ACS or saline placebo.

“Our primary outcome was designed to be like the prior rescue study (in 2009) that we did with patients with intact membranes,” said Andrew Combs, MD, PhD, a maternal-fetal medicine specialist at Pediatrix Medical Group in Sunrise, Fla., who participated in the earlier study. “It was a composite of neonatal morbidity that was any one of a variety of outcomes including respiratory distress syndrome, intraventricular hemorrhage, necrotizing enterocolitis, and neonatal death.”

The primary outcome occurred in 64% of women who received booster ACS and 66% with placebo (odds ratio, 0.82; 95% confidence interval, 0.43-1.57), according to Dr. Combs, who presented the findings at SMFM.

Although the study was not powered to detect significant differences in specific outcomes, the rate of neonatal sepsis was not higher in the ACS group, suggesting that ACS may be safe if membranes have ruptured, the researchers reported. But because the booster course of ACS did not prevent respiratory morbidity, clinicians may wonder what to do with the findings.

Niraj Chavan, MD, an associate professor in the department of obstetrics, gynecology, and women’s health at Saint Louis University, said he was unsure how the study would affect clinical practice.

The relatively small sample number of patients prevented analysis of specific outcomes and subgroup analyses of important variables such as race, ethnicity, gestational age, and other comorbid conditions in the mothers, he said. So clinicians still must weigh potential risks and benefits on a case-by-case basis.

“You have to think about it in buckets,” he said, “One is conditions that would increase the risk for neonatal morbidity. The other is the risk for infection, both for the mom and the baby.”

But for Dr. Combs, the interpretation of the findings was simpler: “We concluded that there’s no indication to give a booster course of steroids after a week has elapsed in patients with ruptured membranes.”

The study presented by Dr. Gyamfi-Bannerman was funded by the National Institute of Child Health and Human Development. The study presented by Dr. Combs was funded by MEDNAX Center for Research, Education, and Quality, which in 2022 was renamed Pediatrix Center for Research, Education,and Quality. Dr. Combs is an employee of Pediatrix Medical Group but has no conflicts of interest. Dr. Gyamfi-Bannerman, Dr. Zhang-Rutledge, and Dr. Chavan report no relevant financial relationships.

Ann Thomas is a pediatrician and epidemiologist in Portland, Ore.

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

Giving corticosteroids to pregnant women at risk for preterm birth before 34 weeks of gestational age has been the standard of care since the 1990s, but a few scenarios for their use remain up for debate. Two studies presented this week at the 2023 meeting sponsored by the Society for Maternal–Fetal Medicine provided some fresh insight into the practice that could help clinicians better manage pregnant patients.

Neurodevelopmental outcomes in late preterm

First, should antenatal corticosteroids (ACS) be given to mothers who present with late preterm labor, defined as 34-36 weeks’ gestational age?

A landmark randomized clinical trial published in 2016 demonstrated that use of ACS in mothers in late preterm labor reduced severe respiratory complications. That practice has largely been adopted by clinicians. The only downside, according to the researchers, was that infants whose mothers received steroid therapy were more likely to develop hypoglycemia. The condition is self-limiting, but studies have raised concern about the potential long-term risk of neurocognitive or psychological outcomes in infants with hypoglycemia.

Cynthia Gyamfi-Bannerman, MD, MSc, endowed chair and professor of obstetrics, gynecology, and reproductive sciences at the University of California, San Diego, led the 2016 study. Her team was unable to secure funding for their originally planned follow-up study of the infants 2 years later. But once the American College of Obstetricians and Gynecologists endorsed the practice and more women received ACS in the late preterm period, Dr. Gyamfi-Bannerman and her colleagues felt the need to “follow up the infants just to see what the outcomes are from a neurodevelopmental standpoint,” she said.

Dr. Gyamfi-Bannerman and colleagues recruited children older than age 6 from the original trial whose parents were willing to have them participate in a follow-up study. A total of 949 from the initial 2,831 cohort completed cognitive testing and received assessments for cerebral palsy, social impairment within the autism spectrum, and behavioral and emotional problems.

At the SMFM conference, Dr. Gyamfi-Bannerman reported no differences in the primary outcome of cognitive function between those whose mothers had received a single course of betamethasone and those who did not, or any differences in rates of the other outcomes.

Kathy Zhang-Rutledge, MD, a maternal-fetal medicine specialist who practices with Obstetrix Maternal Fetal Medicine Group of Houston, part of Pediatrix Medical Group, said she was glad to see a study that addressed the potential long-term adverse events associated with ACS in the late preterm period.

“Having this pretty large study – with really good neurological testing results – should help reassure clinicians that this is something they should consider adopting in their practice,” Dr. Zhang-Rutledge said.
 

Are boosters better?

The second unresolved question was if a repeat course of ACS should be administered when a woman at risk for preterm birth receives a course of steroids but does not deliver in the following 7 days.

Any benefits to the initial course of ACS wear off after a week. As a result, clinicians often give booster courses 7 days after the first dose if the infant is likely to be delivered in the following week. A 2009 study showed this approach may protect infants from respiratory problems, but data on long-term outcomes have been weak.

ACOG guidelines say to “consider” a booster dose in women who are less than 34 weeks’ gestation at risk for preterm delivery within 7 days.

The exception is when the mother already has experienced preterm prelabor rupture of membranes (PPROM), because ACS may increase the risk for infection for both mother and child. ACOG doesn’t take a stand on use of booster doses for PPROM, citing a lack of data to show that potential benefits outweigh the potential risks of this approach.

A recent multicenter, double-blinded, randomized clinical trial attempted to fill that void in knowledge. Between 2016 and 2022, 194 women with PPROM and gestational age less than 32 weeks who had received an initial ACS course at least 7 days prior to randomization received a booster course of ACS or saline placebo.

“Our primary outcome was designed to be like the prior rescue study (in 2009) that we did with patients with intact membranes,” said Andrew Combs, MD, PhD, a maternal-fetal medicine specialist at Pediatrix Medical Group in Sunrise, Fla., who participated in the earlier study. “It was a composite of neonatal morbidity that was any one of a variety of outcomes including respiratory distress syndrome, intraventricular hemorrhage, necrotizing enterocolitis, and neonatal death.”

The primary outcome occurred in 64% of women who received booster ACS and 66% with placebo (odds ratio, 0.82; 95% confidence interval, 0.43-1.57), according to Dr. Combs, who presented the findings at SMFM.

Although the study was not powered to detect significant differences in specific outcomes, the rate of neonatal sepsis was not higher in the ACS group, suggesting that ACS may be safe if membranes have ruptured, the researchers reported. But because the booster course of ACS did not prevent respiratory morbidity, clinicians may wonder what to do with the findings.

Niraj Chavan, MD, an associate professor in the department of obstetrics, gynecology, and women’s health at Saint Louis University, said he was unsure how the study would affect clinical practice.

The relatively small sample number of patients prevented analysis of specific outcomes and subgroup analyses of important variables such as race, ethnicity, gestational age, and other comorbid conditions in the mothers, he said. So clinicians still must weigh potential risks and benefits on a case-by-case basis.

“You have to think about it in buckets,” he said, “One is conditions that would increase the risk for neonatal morbidity. The other is the risk for infection, both for the mom and the baby.”

But for Dr. Combs, the interpretation of the findings was simpler: “We concluded that there’s no indication to give a booster course of steroids after a week has elapsed in patients with ruptured membranes.”

The study presented by Dr. Gyamfi-Bannerman was funded by the National Institute of Child Health and Human Development. The study presented by Dr. Combs was funded by MEDNAX Center for Research, Education, and Quality, which in 2022 was renamed Pediatrix Center for Research, Education,and Quality. Dr. Combs is an employee of Pediatrix Medical Group but has no conflicts of interest. Dr. Gyamfi-Bannerman, Dr. Zhang-Rutledge, and Dr. Chavan report no relevant financial relationships.

Ann Thomas is a pediatrician and epidemiologist in Portland, Ore.

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

Infants born to women infected with the hepatitis C virus (HCV) faced twice the risk of stays in the neonatal ICU (NICU) and 2.7 times the risk of low birth weight, a new analysis finds, even when researchers adjusted their data to control for injectable drug use and maternal medical comorbidity.

Clinicians should be “aware that the infants of pregnant people with HCV may have a high rate of need for higher-level pediatric care,” said Brenna L. Hughes, MD, MSc, chief of maternal fetal medicine at Duke University Medical Center, Durham, N.C. She spoke in an interview about the findings, which were presented at the meeting sponsored by the Society for Maternal-Fetal Medicine.

As Dr. Hughes noted, “HCV remains a serious problem in pregnancy because it often goes undiagnosed and/or untreated prior to pregnancy. It can be passed to infants, and this can cause significant health-related outcomes for children as they age.”

For the multicenter U.S. study, researchers identified 249 pregnant mothers with HCV from a 2012-2018 cohort and matched them by gestational age to controls (n = 486). The average age was 28; 71.1% of the cases were non-Hispanic White versus 41.6% of the controls; 8.4% of cases were non-Hispanic Black versus 32.1% of controls (P < .001 for race/ethnicity analysis); and 73% of cases were smokers versus 18% of controls (P < .001). More than 19% of cases reported injectable drug use during pregnancy versus 0.2% of controls (P < .001).

The researchers adjusted their findings for maternal age, body mass index, injectable drug use, and maternal comorbidity.

An earlier analysis of the study data found that 6% of pregnant women with HCV passed it on to their infants, especially those with high levels of virus in their systems. For the new study, researchers focused on various outcomes to test the assumption that “adverse pregnancy outcomes associated with HCV are related to prematurity or to ongoing use of injection drugs,” Dr. Hughes said.

There was no increase in rates of preterm birth or adverse maternal outcomes in the HCV cases. However, infants born to women with HCV were more likely than the controls to require a stay in the NICU (45% vs. 19%; adjusted relative risk, 1.99; 95% confidence interval, 1.54-2.58). They were also more likely to have lower birth weights (small for gestational age < 5th percentile) (10.6% vs. 3.1%; ARR, 2.72; 95% CI, 1.38-5.34).

No difference in outcomes was seen when HCV cases with viremia (33%) were excluded.

“The most surprising finding was that the need for higher-level pediatric care was so high even though there wasn’t an increased risk of prematurity,” Dr. Hughes said.

She added it’s not clear why NICU stays and low birth weights were more common in infants of women with HCV. “It is possible that the higher risk of need for higher-level pediatric care was related to a need for observation or treatment due to use of opioid replacement therapies with opioid agonists.” As for lower birth weight, “there may be other unmeasured risk factors.”

Tatyana Kushner, MD, MSCE, of the division of liver diseases at Icahn School of Medicine at Mount Sinai, New York, said in an interview that the study adds to limited data about HCV in pregnancy. “These findings have been demonstrated in prior studies, and it would be important to tease apart whether [low birth weight] is related to the virus itself or more related to other confounding associated factors such as maternal substance use as well as other associated social determinants of health among women with HCV.”

As for the study’s message, Dr. Kushner said it makes it clear that “hepatitis C adversely impacts outcomes of pregnancy and it is important to identify women of childbearing age for treatment early, ideally prior to pregnancy, in order to improve their pregnancy outcomes. In addition, treatment of hepatitis C during pregnancy should be explored further to determine if treatment during pregnancy can improve outcomes.”

At the moment, she said, “there are ongoing studies to delineate the safety and efficacy of hepatitis C treatment during pregnancy. Given that we are screening for hepatitis C during pregnancy, we need clear recommendations on the use of direct-acting antivirals in people who screen positive.”

The study was funded by the National Institute of Child Health and Human Development. The authors have no disclosures. Dr. Kushner disclosed research support (Gilead) and advisory board service (Gilead, AbbVie, Bausch, GlaxoSmithKline, and Eiger).

Infants born to women infected with the hepatitis C virus (HCV) faced twice the risk of stays in the neonatal ICU (NICU) and 2.7 times the risk of low birth weight, a new analysis finds, even when researchers adjusted their data to control for injectable drug use and maternal medical comorbidity.

Clinicians should be “aware that the infants of pregnant people with HCV may have a high rate of need for higher-level pediatric care,” said Brenna L. Hughes, MD, MSc, chief of maternal fetal medicine at Duke University Medical Center, Durham, N.C. She spoke in an interview about the findings, which were presented at the meeting sponsored by the Society for Maternal-Fetal Medicine.

As Dr. Hughes noted, “HCV remains a serious problem in pregnancy because it often goes undiagnosed and/or untreated prior to pregnancy. It can be passed to infants, and this can cause significant health-related outcomes for children as they age.”

For the multicenter U.S. study, researchers identified 249 pregnant mothers with HCV from a 2012-2018 cohort and matched them by gestational age to controls (n = 486). The average age was 28; 71.1% of the cases were non-Hispanic White versus 41.6% of the controls; 8.4% of cases were non-Hispanic Black versus 32.1% of controls (P < .001 for race/ethnicity analysis); and 73% of cases were smokers versus 18% of controls (P < .001). More than 19% of cases reported injectable drug use during pregnancy versus 0.2% of controls (P < .001).

The researchers adjusted their findings for maternal age, body mass index, injectable drug use, and maternal comorbidity.

An earlier analysis of the study data found that 6% of pregnant women with HCV passed it on to their infants, especially those with high levels of virus in their systems. For the new study, researchers focused on various outcomes to test the assumption that “adverse pregnancy outcomes associated with HCV are related to prematurity or to ongoing use of injection drugs,” Dr. Hughes said.

There was no increase in rates of preterm birth or adverse maternal outcomes in the HCV cases. However, infants born to women with HCV were more likely than the controls to require a stay in the NICU (45% vs. 19%; adjusted relative risk, 1.99; 95% confidence interval, 1.54-2.58). They were also more likely to have lower birth weights (small for gestational age < 5th percentile) (10.6% vs. 3.1%; ARR, 2.72; 95% CI, 1.38-5.34).

No difference in outcomes was seen when HCV cases with viremia (33%) were excluded.

“The most surprising finding was that the need for higher-level pediatric care was so high even though there wasn’t an increased risk of prematurity,” Dr. Hughes said.

She added it’s not clear why NICU stays and low birth weights were more common in infants of women with HCV. “It is possible that the higher risk of need for higher-level pediatric care was related to a need for observation or treatment due to use of opioid replacement therapies with opioid agonists.” As for lower birth weight, “there may be other unmeasured risk factors.”

Tatyana Kushner, MD, MSCE, of the division of liver diseases at Icahn School of Medicine at Mount Sinai, New York, said in an interview that the study adds to limited data about HCV in pregnancy. “These findings have been demonstrated in prior studies, and it would be important to tease apart whether [low birth weight] is related to the virus itself or more related to other confounding associated factors such as maternal substance use as well as other associated social determinants of health among women with HCV.”

As for the study’s message, Dr. Kushner said it makes it clear that “hepatitis C adversely impacts outcomes of pregnancy and it is important to identify women of childbearing age for treatment early, ideally prior to pregnancy, in order to improve their pregnancy outcomes. In addition, treatment of hepatitis C during pregnancy should be explored further to determine if treatment during pregnancy can improve outcomes.”

At the moment, she said, “there are ongoing studies to delineate the safety and efficacy of hepatitis C treatment during pregnancy. Given that we are screening for hepatitis C during pregnancy, we need clear recommendations on the use of direct-acting antivirals in people who screen positive.”

The study was funded by the National Institute of Child Health and Human Development. The authors have no disclosures. Dr. Kushner disclosed research support (Gilead) and advisory board service (Gilead, AbbVie, Bausch, GlaxoSmithKline, and Eiger).

Infants born to women infected with the hepatitis C virus (HCV) faced twice the risk of stays in the neonatal ICU (NICU) and 2.7 times the risk of low birth weight, a new analysis finds, even when researchers adjusted their data to control for injectable drug use and maternal medical comorbidity.

Clinicians should be “aware that the infants of pregnant people with HCV may have a high rate of need for higher-level pediatric care,” said Brenna L. Hughes, MD, MSc, chief of maternal fetal medicine at Duke University Medical Center, Durham, N.C. She spoke in an interview about the findings, which were presented at the meeting sponsored by the Society for Maternal-Fetal Medicine.

As Dr. Hughes noted, “HCV remains a serious problem in pregnancy because it often goes undiagnosed and/or untreated prior to pregnancy. It can be passed to infants, and this can cause significant health-related outcomes for children as they age.”

For the multicenter U.S. study, researchers identified 249 pregnant mothers with HCV from a 2012-2018 cohort and matched them by gestational age to controls (n = 486). The average age was 28; 71.1% of the cases were non-Hispanic White versus 41.6% of the controls; 8.4% of cases were non-Hispanic Black versus 32.1% of controls (P < .001 for race/ethnicity analysis); and 73% of cases were smokers versus 18% of controls (P < .001). More than 19% of cases reported injectable drug use during pregnancy versus 0.2% of controls (P < .001).

The researchers adjusted their findings for maternal age, body mass index, injectable drug use, and maternal comorbidity.

An earlier analysis of the study data found that 6% of pregnant women with HCV passed it on to their infants, especially those with high levels of virus in their systems. For the new study, researchers focused on various outcomes to test the assumption that “adverse pregnancy outcomes associated with HCV are related to prematurity or to ongoing use of injection drugs,” Dr. Hughes said.

There was no increase in rates of preterm birth or adverse maternal outcomes in the HCV cases. However, infants born to women with HCV were more likely than the controls to require a stay in the NICU (45% vs. 19%; adjusted relative risk, 1.99; 95% confidence interval, 1.54-2.58). They were also more likely to have lower birth weights (small for gestational age < 5th percentile) (10.6% vs. 3.1%; ARR, 2.72; 95% CI, 1.38-5.34).

No difference in outcomes was seen when HCV cases with viremia (33%) were excluded.

“The most surprising finding was that the need for higher-level pediatric care was so high even though there wasn’t an increased risk of prematurity,” Dr. Hughes said.

She added it’s not clear why NICU stays and low birth weights were more common in infants of women with HCV. “It is possible that the higher risk of need for higher-level pediatric care was related to a need for observation or treatment due to use of opioid replacement therapies with opioid agonists.” As for lower birth weight, “there may be other unmeasured risk factors.”

Tatyana Kushner, MD, MSCE, of the division of liver diseases at Icahn School of Medicine at Mount Sinai, New York, said in an interview that the study adds to limited data about HCV in pregnancy. “These findings have been demonstrated in prior studies, and it would be important to tease apart whether [low birth weight] is related to the virus itself or more related to other confounding associated factors such as maternal substance use as well as other associated social determinants of health among women with HCV.”

As for the study’s message, Dr. Kushner said it makes it clear that “hepatitis C adversely impacts outcomes of pregnancy and it is important to identify women of childbearing age for treatment early, ideally prior to pregnancy, in order to improve their pregnancy outcomes. In addition, treatment of hepatitis C during pregnancy should be explored further to determine if treatment during pregnancy can improve outcomes.”

At the moment, she said, “there are ongoing studies to delineate the safety and efficacy of hepatitis C treatment during pregnancy. Given that we are screening for hepatitis C during pregnancy, we need clear recommendations on the use of direct-acting antivirals in people who screen positive.”

The study was funded by the National Institute of Child Health and Human Development. The authors have no disclosures. Dr. Kushner disclosed research support (Gilead) and advisory board service (Gilead, AbbVie, Bausch, GlaxoSmithKline, and Eiger).

For years, women’s health advocates have argued that far more research is needed on women’s bodies and health. The world’s first-ever “vagina on a chip,” recently developed at Harvard’s Wyss Institute for Biologically Inspired Engineering in Boston, could go a long way to making that happen. 

“Women’s health has not received the attention it deserves,” says Don Ingber, MD, PhD, who led the team that created the vagina chip. The advance quickly drew media attention after it was reported in the journal Microbiome. But researchers hope for more than headlines. They see the chip as a way to facilitate vaginal health research and open the door to vital new treatments. 

By now, you may have heard of “organs on chips”: tiny devices about the size of a flash drive that are designed to mimic the biological activity of human organs. These glass chips contain living human cells within grooves that allow the passage of fluid, to either maintain or disrupt the cells’ function. So far, Dr. Ingber and his team at the Wyss Institute have developed more than 15 organ chip models, including chips that mimic the lung, intestine, kidney, and bone marrow. 

The idea to develop a vagina chip grew out of research, funded by the Gates Foundation, on a childhood disease called environmental enteric dysfunction, an intestinal disease most commonly found in low-resource nations that is the second leading cause of death in children under 5. That’s when Dr. Ingber discovered just how much the child’s microbiome influences this disease. 

Stemming from that work, the Gates Foundation turned its attention to newborn health – in particular, the impact of bacterial vaginosis, an imbalance in the vagina’s bacterial makeup. Bacterial vaginosis occurs in one out of four women worldwide and has been linked to premature birth as well as HIV, HPV persistence, and cervical cancer. 

Upon establishing the Vaginal Microbiome Research Consortium,  the foundation asked Dr. Ingber to engineer an organ chip that mimicked the vagina’s microbiome. The goal was to test “live biotherapeutic products,” or living microbes like probiotics, that might restore the vagina’s microbiome to health.  

No other preclinical model exists to perform tests like that, says Dr. Ingber. 

“The vagina chip is a way to help make some advances,” he says. 

The Gates Foundation recognized that women’s reproductive health is a major issue, not only in low-income nations, but everywhere around the world. As the project evolved, Dr. Ingber began to hear from female colleagues about how neglected women’s reproductive health is in medical science. 

“It is something I became sensitive to and realized this is just the starting point,” Dr. Ingber says.

Take bacterial vaginosis, for example. Since 1982, treatment has revolved around the same two antibiotics. That’s partly because there is no animal model to study. No other species has the same vaginal bacterial community as humans do.

That makes developing any new therapy “incredibly challenging,” explains Caroline Mitchell, MD, MPH, an ob.gyn. at Massachusetts General Hospital, Boston, and a member of the consortium. 

It turns out, replicating the vagina in a lab dish is, to use the technical term, very hard. 

“That’s where a vagina chip offers an opportunity,” Dr. Mitchell says. “It’s not super-high throughput, but it’s way more high throughput than a [human] clinical trial.” 

As such, the vagina chip could help scientists find new treatments much faster. 

Like Dr. Ingber, Dr. Mitchell also sees the chip as a way to bring more attention to the largely unmet needs in female reproductive medicine.

“Women’s reproductive health has been under-resourced, under-prioritized, and largely disregarded for decades,” she says. And the time may be ripe for change: Dr. Mitchell says she was encouraged by the National Institutes of Health’s Advancing NIH Research on the Health of Women conference, held in 2021 in response to a congressional request to address women’s health research efforts.  

Beyond bacterial vaginosis, Dr. Mitchell imagines the chip could help scientists find new treatments for vaginal yeast infection (candidiasis), chlamydia, and endometriosis. As with bacterial vaginosis, medicines for vaginal yeast infections have not advanced in decades, Dr. Mitchell says.  Efforts to develop a vaccine for chlamydia – which can cause permanent damage to a woman’s reproductive system – have dragged on for many years. And endometriosis, an often painful condition in which the tissue that makes up the uterine lining grows outside the uterus, remains under-researched despite affecting 10% of childbearing-age women.

While some mouse models are used in chlamydia research, it’s hard to say if they’ll translate to humans, given the vaginal and cervical bacterial differences. 

“Our understanding of the basic physiology of the environment of the vagina and cervix is another area where we’re woefully ignorant,” Dr. Mitchell says.

To that end, Dr. Ingber’s team is developing more complex chips mimicking the vagina and the cervix. One of his team members wants to use the chips to study infertility. The researchers have already used the chips to see how bacterial vaginosis and mucous changes impact the way sperm migrates up the reproductive tract. 

The lab is now linking vagina and cervix chips together to study viral infections of the cervix, like HPV, and all types of bacterial diseases of the vaginal tract. By applying cervical mucus to the vagina chip, they hope to learn more about how female reproductive tissues respond to infection and inflammation.

“I always say that organ chips are like synthetic biology at the cell tissue and organ level,” says Dr. Ingber. “You start simple and see if you [can] mimic a clinical situation.” 

As they make the chips more complex – perhaps by adding blood vessel cells and female hormones – Dr. Ingber foresees being able to study the response to hormonal changes during the menstrual cycle.

“We can begin to explore the effects of cycling over time as well as other types of hormonal effects,” he says.

Dr. Ingber also envisions linking the vagina chip to other organ chips – he’s already succeeded in linking eight different organ types together. But for now, the team hopes the vagina chip will enhance our understanding of basic female reproductive biology and speed up the process of developing new treatments for women’s health. 

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

For years, women’s health advocates have argued that far more research is needed on women’s bodies and health. The world’s first-ever “vagina on a chip,” recently developed at Harvard’s Wyss Institute for Biologically Inspired Engineering in Boston, could go a long way to making that happen. 

“Women’s health has not received the attention it deserves,” says Don Ingber, MD, PhD, who led the team that created the vagina chip. The advance quickly drew media attention after it was reported in the journal Microbiome. But researchers hope for more than headlines. They see the chip as a way to facilitate vaginal health research and open the door to vital new treatments. 

By now, you may have heard of “organs on chips”: tiny devices about the size of a flash drive that are designed to mimic the biological activity of human organs. These glass chips contain living human cells within grooves that allow the passage of fluid, to either maintain or disrupt the cells’ function. So far, Dr. Ingber and his team at the Wyss Institute have developed more than 15 organ chip models, including chips that mimic the lung, intestine, kidney, and bone marrow. 

The idea to develop a vagina chip grew out of research, funded by the Gates Foundation, on a childhood disease called environmental enteric dysfunction, an intestinal disease most commonly found in low-resource nations that is the second leading cause of death in children under 5. That’s when Dr. Ingber discovered just how much the child’s microbiome influences this disease. 

Stemming from that work, the Gates Foundation turned its attention to newborn health – in particular, the impact of bacterial vaginosis, an imbalance in the vagina’s bacterial makeup. Bacterial vaginosis occurs in one out of four women worldwide and has been linked to premature birth as well as HIV, HPV persistence, and cervical cancer. 

Upon establishing the Vaginal Microbiome Research Consortium,  the foundation asked Dr. Ingber to engineer an organ chip that mimicked the vagina’s microbiome. The goal was to test “live biotherapeutic products,” or living microbes like probiotics, that might restore the vagina’s microbiome to health.  

No other preclinical model exists to perform tests like that, says Dr. Ingber. 

“The vagina chip is a way to help make some advances,” he says. 

The Gates Foundation recognized that women’s reproductive health is a major issue, not only in low-income nations, but everywhere around the world. As the project evolved, Dr. Ingber began to hear from female colleagues about how neglected women’s reproductive health is in medical science. 

“It is something I became sensitive to and realized this is just the starting point,” Dr. Ingber says.

Take bacterial vaginosis, for example. Since 1982, treatment has revolved around the same two antibiotics. That’s partly because there is no animal model to study. No other species has the same vaginal bacterial community as humans do.

That makes developing any new therapy “incredibly challenging,” explains Caroline Mitchell, MD, MPH, an ob.gyn. at Massachusetts General Hospital, Boston, and a member of the consortium. 

It turns out, replicating the vagina in a lab dish is, to use the technical term, very hard. 

“That’s where a vagina chip offers an opportunity,” Dr. Mitchell says. “It’s not super-high throughput, but it’s way more high throughput than a [human] clinical trial.” 

As such, the vagina chip could help scientists find new treatments much faster. 

Like Dr. Ingber, Dr. Mitchell also sees the chip as a way to bring more attention to the largely unmet needs in female reproductive medicine.

“Women’s reproductive health has been under-resourced, under-prioritized, and largely disregarded for decades,” she says. And the time may be ripe for change: Dr. Mitchell says she was encouraged by the National Institutes of Health’s Advancing NIH Research on the Health of Women conference, held in 2021 in response to a congressional request to address women’s health research efforts.  

Beyond bacterial vaginosis, Dr. Mitchell imagines the chip could help scientists find new treatments for vaginal yeast infection (candidiasis), chlamydia, and endometriosis. As with bacterial vaginosis, medicines for vaginal yeast infections have not advanced in decades, Dr. Mitchell says.  Efforts to develop a vaccine for chlamydia – which can cause permanent damage to a woman’s reproductive system – have dragged on for many years. And endometriosis, an often painful condition in which the tissue that makes up the uterine lining grows outside the uterus, remains under-researched despite affecting 10% of childbearing-age women.

While some mouse models are used in chlamydia research, it’s hard to say if they’ll translate to humans, given the vaginal and cervical bacterial differences. 

“Our understanding of the basic physiology of the environment of the vagina and cervix is another area where we’re woefully ignorant,” Dr. Mitchell says.

To that end, Dr. Ingber’s team is developing more complex chips mimicking the vagina and the cervix. One of his team members wants to use the chips to study infertility. The researchers have already used the chips to see how bacterial vaginosis and mucous changes impact the way sperm migrates up the reproductive tract. 

The lab is now linking vagina and cervix chips together to study viral infections of the cervix, like HPV, and all types of bacterial diseases of the vaginal tract. By applying cervical mucus to the vagina chip, they hope to learn more about how female reproductive tissues respond to infection and inflammation.

“I always say that organ chips are like synthetic biology at the cell tissue and organ level,” says Dr. Ingber. “You start simple and see if you [can] mimic a clinical situation.” 

As they make the chips more complex – perhaps by adding blood vessel cells and female hormones – Dr. Ingber foresees being able to study the response to hormonal changes during the menstrual cycle.

“We can begin to explore the effects of cycling over time as well as other types of hormonal effects,” he says.

Dr. Ingber also envisions linking the vagina chip to other organ chips – he’s already succeeded in linking eight different organ types together. But for now, the team hopes the vagina chip will enhance our understanding of basic female reproductive biology and speed up the process of developing new treatments for women’s health. 

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

For years, women’s health advocates have argued that far more research is needed on women’s bodies and health. The world’s first-ever “vagina on a chip,” recently developed at Harvard’s Wyss Institute for Biologically Inspired Engineering in Boston, could go a long way to making that happen. 

“Women’s health has not received the attention it deserves,” says Don Ingber, MD, PhD, who led the team that created the vagina chip. The advance quickly drew media attention after it was reported in the journal Microbiome. But researchers hope for more than headlines. They see the chip as a way to facilitate vaginal health research and open the door to vital new treatments. 

By now, you may have heard of “organs on chips”: tiny devices about the size of a flash drive that are designed to mimic the biological activity of human organs. These glass chips contain living human cells within grooves that allow the passage of fluid, to either maintain or disrupt the cells’ function. So far, Dr. Ingber and his team at the Wyss Institute have developed more than 15 organ chip models, including chips that mimic the lung, intestine, kidney, and bone marrow. 

The idea to develop a vagina chip grew out of research, funded by the Gates Foundation, on a childhood disease called environmental enteric dysfunction, an intestinal disease most commonly found in low-resource nations that is the second leading cause of death in children under 5. That’s when Dr. Ingber discovered just how much the child’s microbiome influences this disease. 

Stemming from that work, the Gates Foundation turned its attention to newborn health – in particular, the impact of bacterial vaginosis, an imbalance in the vagina’s bacterial makeup. Bacterial vaginosis occurs in one out of four women worldwide and has been linked to premature birth as well as HIV, HPV persistence, and cervical cancer. 

Upon establishing the Vaginal Microbiome Research Consortium,  the foundation asked Dr. Ingber to engineer an organ chip that mimicked the vagina’s microbiome. The goal was to test “live biotherapeutic products,” or living microbes like probiotics, that might restore the vagina’s microbiome to health.  

No other preclinical model exists to perform tests like that, says Dr. Ingber. 

“The vagina chip is a way to help make some advances,” he says. 

The Gates Foundation recognized that women’s reproductive health is a major issue, not only in low-income nations, but everywhere around the world. As the project evolved, Dr. Ingber began to hear from female colleagues about how neglected women’s reproductive health is in medical science. 

“It is something I became sensitive to and realized this is just the starting point,” Dr. Ingber says.

Take bacterial vaginosis, for example. Since 1982, treatment has revolved around the same two antibiotics. That’s partly because there is no animal model to study. No other species has the same vaginal bacterial community as humans do.

That makes developing any new therapy “incredibly challenging,” explains Caroline Mitchell, MD, MPH, an ob.gyn. at Massachusetts General Hospital, Boston, and a member of the consortium. 

It turns out, replicating the vagina in a lab dish is, to use the technical term, very hard. 

“That’s where a vagina chip offers an opportunity,” Dr. Mitchell says. “It’s not super-high throughput, but it’s way more high throughput than a [human] clinical trial.” 

As such, the vagina chip could help scientists find new treatments much faster. 

Like Dr. Ingber, Dr. Mitchell also sees the chip as a way to bring more attention to the largely unmet needs in female reproductive medicine.

“Women’s reproductive health has been under-resourced, under-prioritized, and largely disregarded for decades,” she says. And the time may be ripe for change: Dr. Mitchell says she was encouraged by the National Institutes of Health’s Advancing NIH Research on the Health of Women conference, held in 2021 in response to a congressional request to address women’s health research efforts.  

Beyond bacterial vaginosis, Dr. Mitchell imagines the chip could help scientists find new treatments for vaginal yeast infection (candidiasis), chlamydia, and endometriosis. As with bacterial vaginosis, medicines for vaginal yeast infections have not advanced in decades, Dr. Mitchell says.  Efforts to develop a vaccine for chlamydia – which can cause permanent damage to a woman’s reproductive system – have dragged on for many years. And endometriosis, an often painful condition in which the tissue that makes up the uterine lining grows outside the uterus, remains under-researched despite affecting 10% of childbearing-age women.

While some mouse models are used in chlamydia research, it’s hard to say if they’ll translate to humans, given the vaginal and cervical bacterial differences. 

“Our understanding of the basic physiology of the environment of the vagina and cervix is another area where we’re woefully ignorant,” Dr. Mitchell says.

To that end, Dr. Ingber’s team is developing more complex chips mimicking the vagina and the cervix. One of his team members wants to use the chips to study infertility. The researchers have already used the chips to see how bacterial vaginosis and mucous changes impact the way sperm migrates up the reproductive tract. 

The lab is now linking vagina and cervix chips together to study viral infections of the cervix, like HPV, and all types of bacterial diseases of the vaginal tract. By applying cervical mucus to the vagina chip, they hope to learn more about how female reproductive tissues respond to infection and inflammation.

“I always say that organ chips are like synthetic biology at the cell tissue and organ level,” says Dr. Ingber. “You start simple and see if you [can] mimic a clinical situation.” 

As they make the chips more complex – perhaps by adding blood vessel cells and female hormones – Dr. Ingber foresees being able to study the response to hormonal changes during the menstrual cycle.

“We can begin to explore the effects of cycling over time as well as other types of hormonal effects,” he says.

Dr. Ingber also envisions linking the vagina chip to other organ chips – he’s already succeeded in linking eight different organ types together. But for now, the team hopes the vagina chip will enhance our understanding of basic female reproductive biology and speed up the process of developing new treatments for women’s health. 

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

Postpartum hemorrhage is the leading cause of maternal mortality worldwide, accounting for 25% of deaths from obstetric causes. Although balloon tamponade has been widely used to manage uncontrolled postpartum bleeding, a recent evaluation of an intrauterine vacuum-induced hemorrhage control device demonstrated impressive safety and effectiveness, researchers reported at the meeting sponsored by the Society for Maternal-Fetal Medicine.

“It’s exciting to see new technology and new potential treatment modalities. We just don’t have that many tools in our toolkit right now,” said Dena Goffman, MD, professor of women’s health and obstetrics and gynecology and vice chair of quality and patient safety at Columbia University’s Irving Medical Center, in New York, who presented the findings.

Dr. Goffman led an earlier multicenter prospective single-arm treatment study of the Jada System, a vacuum device marketed by Organon. The U.S. Food and Drug Administration approved use of the Jada System in October 2020.

Dr. Goffman said she and her colleagues felt “a next logical step would be to see what happens with real-world use.” In the new study, researchers at 16 U.S. medical centers reviewed medical charts of 800 women who underwent treatment with the Jada System between October 2020 and April 2022.

Treatment was successful in 92.5% of the vaginal births (n = 530) and 83.7% of the cesarean births (n = 270), similar to the results of the initial treatment trial that led to FDA approval, according to the researchers. For both types of delivery, bleeding was controlled in less than 5 minutes for most patients. Three serious adverse events were identified that could have been related to use of the device (two in vaginal births, one in cesarean birth), they reported.

Although the study was not designed to directly compare the Jada System with balloon tamponade, in a recent meta-analysis, it was estimated that tamponade controls postpartum hemorrhage in roughly 87% of cases, with complication rates in as many as 6.5% among women who undergo the procedure.

Dr. Goffman pointed out additional benefits. The vacuum device typically must stay in place for less time (3.1 hours for vaginal birth and 4.6 hours for cesarean birth) than balloon tamponade, allowing women to recover more quickly. In the initial trial, which Dr. Goffman helped conduct, 98% of clinicians reported that the device was easy to use, which increases its attractiveness in lower-income countries. Dr. Goffman felt that the device “has potential for huge impact” in those countries, given the high rates of maternal morbidity and mortality in these areas.

Amber Samuel, MD, medical director of OBSETRIX Maternal Fetal Medicine Specialists of Houston, said the device recently became available in the hospitals in which she works, and she has used the Jada System several times. Like Dr. Goffman, she was excited to have a new tool for treating a life-threatening condition.

Although the device has been on the market for more than 2 years, Dr. Samuel felt clinicians who were reluctant to adopt a new technology would be reassured by the findings.

“We should make sure that it’s effective, and we should know what the safety profile is,” said Dr. Samuel, adding that “the more data we have, the more we’re able to counsel patients and work this into our protocols for what is a really common obstetric problem.”

Both Dr. Goffman and Dr. Samuel agreed that more data, ideally from randomized clinical trials, are needed to convince professional groups such as the American College of Obstetricians and Gynecologists to state a clear preference for use of vacuum-induced hemorrhage control devices over balloon tamponade.

“We should be supporting further investigation,” Dr. Goffman said, “but for people who have this tool available to them now, I think they can feel confident in using it.”

The study was funded by Alydia Health, the manufacturer of the Jada System. Alydia Health was acquired by Organon in 2021. Study sites received research-related financial support, but none of the authors received direct payments from Alydia Health/Organon. Dr. Goffman serves on the scientific advisory board of Alydia Health/Organon. Dr. Samuel has disclosed no relevant financial relationships.

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

Postpartum hemorrhage is the leading cause of maternal mortality worldwide, accounting for 25% of deaths from obstetric causes. Although balloon tamponade has been widely used to manage uncontrolled postpartum bleeding, a recent evaluation of an intrauterine vacuum-induced hemorrhage control device demonstrated impressive safety and effectiveness, researchers reported at the meeting sponsored by the Society for Maternal-Fetal Medicine.

“It’s exciting to see new technology and new potential treatment modalities. We just don’t have that many tools in our toolkit right now,” said Dena Goffman, MD, professor of women’s health and obstetrics and gynecology and vice chair of quality and patient safety at Columbia University’s Irving Medical Center, in New York, who presented the findings.

Dr. Goffman led an earlier multicenter prospective single-arm treatment study of the Jada System, a vacuum device marketed by Organon. The U.S. Food and Drug Administration approved use of the Jada System in October 2020.

Dr. Goffman said she and her colleagues felt “a next logical step would be to see what happens with real-world use.” In the new study, researchers at 16 U.S. medical centers reviewed medical charts of 800 women who underwent treatment with the Jada System between October 2020 and April 2022.

Treatment was successful in 92.5% of the vaginal births (n = 530) and 83.7% of the cesarean births (n = 270), similar to the results of the initial treatment trial that led to FDA approval, according to the researchers. For both types of delivery, bleeding was controlled in less than 5 minutes for most patients. Three serious adverse events were identified that could have been related to use of the device (two in vaginal births, one in cesarean birth), they reported.

Although the study was not designed to directly compare the Jada System with balloon tamponade, in a recent meta-analysis, it was estimated that tamponade controls postpartum hemorrhage in roughly 87% of cases, with complication rates in as many as 6.5% among women who undergo the procedure.

Dr. Goffman pointed out additional benefits. The vacuum device typically must stay in place for less time (3.1 hours for vaginal birth and 4.6 hours for cesarean birth) than balloon tamponade, allowing women to recover more quickly. In the initial trial, which Dr. Goffman helped conduct, 98% of clinicians reported that the device was easy to use, which increases its attractiveness in lower-income countries. Dr. Goffman felt that the device “has potential for huge impact” in those countries, given the high rates of maternal morbidity and mortality in these areas.

Amber Samuel, MD, medical director of OBSETRIX Maternal Fetal Medicine Specialists of Houston, said the device recently became available in the hospitals in which she works, and she has used the Jada System several times. Like Dr. Goffman, she was excited to have a new tool for treating a life-threatening condition.

Although the device has been on the market for more than 2 years, Dr. Samuel felt clinicians who were reluctant to adopt a new technology would be reassured by the findings.

“We should make sure that it’s effective, and we should know what the safety profile is,” said Dr. Samuel, adding that “the more data we have, the more we’re able to counsel patients and work this into our protocols for what is a really common obstetric problem.”

Both Dr. Goffman and Dr. Samuel agreed that more data, ideally from randomized clinical trials, are needed to convince professional groups such as the American College of Obstetricians and Gynecologists to state a clear preference for use of vacuum-induced hemorrhage control devices over balloon tamponade.

“We should be supporting further investigation,” Dr. Goffman said, “but for people who have this tool available to them now, I think they can feel confident in using it.”

The study was funded by Alydia Health, the manufacturer of the Jada System. Alydia Health was acquired by Organon in 2021. Study sites received research-related financial support, but none of the authors received direct payments from Alydia Health/Organon. Dr. Goffman serves on the scientific advisory board of Alydia Health/Organon. Dr. Samuel has disclosed no relevant financial relationships.

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

Postpartum hemorrhage is the leading cause of maternal mortality worldwide, accounting for 25% of deaths from obstetric causes. Although balloon tamponade has been widely used to manage uncontrolled postpartum bleeding, a recent evaluation of an intrauterine vacuum-induced hemorrhage control device demonstrated impressive safety and effectiveness, researchers reported at the meeting sponsored by the Society for Maternal-Fetal Medicine.

“It’s exciting to see new technology and new potential treatment modalities. We just don’t have that many tools in our toolkit right now,” said Dena Goffman, MD, professor of women’s health and obstetrics and gynecology and vice chair of quality and patient safety at Columbia University’s Irving Medical Center, in New York, who presented the findings.

Dr. Goffman led an earlier multicenter prospective single-arm treatment study of the Jada System, a vacuum device marketed by Organon. The U.S. Food and Drug Administration approved use of the Jada System in October 2020.

Dr. Goffman said she and her colleagues felt “a next logical step would be to see what happens with real-world use.” In the new study, researchers at 16 U.S. medical centers reviewed medical charts of 800 women who underwent treatment with the Jada System between October 2020 and April 2022.

Treatment was successful in 92.5% of the vaginal births (n = 530) and 83.7% of the cesarean births (n = 270), similar to the results of the initial treatment trial that led to FDA approval, according to the researchers. For both types of delivery, bleeding was controlled in less than 5 minutes for most patients. Three serious adverse events were identified that could have been related to use of the device (two in vaginal births, one in cesarean birth), they reported.

Although the study was not designed to directly compare the Jada System with balloon tamponade, in a recent meta-analysis, it was estimated that tamponade controls postpartum hemorrhage in roughly 87% of cases, with complication rates in as many as 6.5% among women who undergo the procedure.

Dr. Goffman pointed out additional benefits. The vacuum device typically must stay in place for less time (3.1 hours for vaginal birth and 4.6 hours for cesarean birth) than balloon tamponade, allowing women to recover more quickly. In the initial trial, which Dr. Goffman helped conduct, 98% of clinicians reported that the device was easy to use, which increases its attractiveness in lower-income countries. Dr. Goffman felt that the device “has potential for huge impact” in those countries, given the high rates of maternal morbidity and mortality in these areas.

Amber Samuel, MD, medical director of OBSETRIX Maternal Fetal Medicine Specialists of Houston, said the device recently became available in the hospitals in which she works, and she has used the Jada System several times. Like Dr. Goffman, she was excited to have a new tool for treating a life-threatening condition.

Although the device has been on the market for more than 2 years, Dr. Samuel felt clinicians who were reluctant to adopt a new technology would be reassured by the findings.

“We should make sure that it’s effective, and we should know what the safety profile is,” said Dr. Samuel, adding that “the more data we have, the more we’re able to counsel patients and work this into our protocols for what is a really common obstetric problem.”

Both Dr. Goffman and Dr. Samuel agreed that more data, ideally from randomized clinical trials, are needed to convince professional groups such as the American College of Obstetricians and Gynecologists to state a clear preference for use of vacuum-induced hemorrhage control devices over balloon tamponade.

“We should be supporting further investigation,” Dr. Goffman said, “but for people who have this tool available to them now, I think they can feel confident in using it.”

The study was funded by Alydia Health, the manufacturer of the Jada System. Alydia Health was acquired by Organon in 2021. Study sites received research-related financial support, but none of the authors received direct payments from Alydia Health/Organon. Dr. Goffman serves on the scientific advisory board of Alydia Health/Organon. Dr. Samuel has disclosed no relevant financial relationships.

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

A new randomized, open-label French trial offers more evidence that the discontinuation of oxytocin treatment after the earliest stages of labor may be safe. Stopping oxytocin didn’t appear to affect neonatal outcomes, compared with continual use of the medication. However, the first stage of labor lasted slightly longer – not surprisingly – in those in the intervention group, and many of those who stopped oxytocin treatment resumed it later.

“Our trial did not show any impact of oxytocin discontinuation in the active [labor] stage on neonatal morbidity cesarean delivery, postpartum hemorrhage, birth experience, and postpartum depression,” said Aude Girault, MD, PhD, of Paris Cité University, in a presentation in San Francisco at the meeting sponsored by the Society for Maternal-Fetal Medicine.

The goal of the STOPOXY study is to build upon previous research that found oxytocin discontinuation didn’t boost the risk of cesarean delivery rates, uterine hyperstimulation, and abnormal fetal heart rate, Dr. Girault said. “These studies were underpowered to show any effects on neonatal morbidity,” so she and colleagues decided to dig deeper into the issue by launching the new trial.

From 2020 to 2022, researchers assigned 2,367 women who received oxytocin before 4 centimeters dilation to either continue with the drug (n = 1,192) or discontinue it before reaching 6 centimeters dilation (n = 1,175). Overall, the women were pregnant for the first time (around 55%) with a median age around 32 years and body mass index around 24.1 kg/m². All had live, singleton, full-term babies.

More than a third – 37% – of those who discontinued oxytocin resumed treatment with the medication, while 5% of those in the control group stopped taking it.

The neonatal morbidity rate – defined via a composite variable based on umbilical arterial pH, umbilical arterial lactates, Apgar score, and/or neonatal ICU admission – was 10.0% in the intervention group and 10.1% in the control group (P = .94), the researchers reported. Cesarean delivery rates were similar (18.8% vs. 16.5%, respectively; P = .22). Apart from the duration of the active first stage, which was significantly higher in the intervention group (100 min [ interquartile range, 50-208 min] vs. 90 min [IQR, 45-150 min]; P = .001), there were no significant differences between the groups.

Dr. Girault said this increase in labor duration was “moderate and clinically debatable.”

In an interview, oncologist-gynecologist George Saade, MD, of the University of Texas Medical Branch, Galveston, noted that “oxytocin is frequently used for either induction or augmentation of labor ... with the goal of improving maternal and neonatal outcomes.”

Oxytocin itself is not expensive, Dr. Saade said. “However, when it is given, the patient requires more monitoring, which may increase cost.”

There’s debate over the proper use of oxytocin, which is available in a synthetic version as Pitocin, and researchers have been trying to understand whether it can safely be discontinued early in labor.

Potential side effects of oxytocin include heart disorders such as arrhythmia, asphyxia, neonatal seizure, and jaundice, low Apgar score, and fetal death. A boxed warning says: “Because the available data are inadequate to evaluate the benefits-to-risks considerations, oxytocin is not indicated for elective induction of labor.”

However, “overall oxytocin is commonly used and very safe as long as careful protocols are followed,” David N. Hackney, MD, MS, of University Hospitals Cleveland, said in an interview. “The medication itself does not have many negative side effects. With very high doses there can be a concern for water intoxication, though this is clinically very uncommon. Some prior studies have raised concerns about the use of oxytocin and subsequent long-term neurodevelopmental outcomes, though these associations are likely confounders and the mainstream opinion is that these are not truly biologically causative associations.”

A 2021 study in The BMJ randomly assigned 1,200 women to continue or discontinue oxytocin. There was a slight increase in cesarean sections in the discontinuation group but significantly lower risks of uterine hyperstimulation and abnormal fetal heart rate.

Dr. Hackney, who didn’t take part in the new study, said the trial is “well conducted and well executed.” However, it needs peer review before any of its findings should change practice.

He added that differences in delivery protocols between the United States and France should be considered. As he noted, Dr. Girault mentioned in a Q&A after her presentation that delayed second-stage labor is more common in France than in the United States.

The study was funded by the French National Ministry of Health. Disclosures for the authors were not provided. Dr. Saade and Dr. Hackney have no disclosures.

A new randomized, open-label French trial offers more evidence that the discontinuation of oxytocin treatment after the earliest stages of labor may be safe. Stopping oxytocin didn’t appear to affect neonatal outcomes, compared with continual use of the medication. However, the first stage of labor lasted slightly longer – not surprisingly – in those in the intervention group, and many of those who stopped oxytocin treatment resumed it later.

“Our trial did not show any impact of oxytocin discontinuation in the active [labor] stage on neonatal morbidity cesarean delivery, postpartum hemorrhage, birth experience, and postpartum depression,” said Aude Girault, MD, PhD, of Paris Cité University, in a presentation in San Francisco at the meeting sponsored by the Society for Maternal-Fetal Medicine.

The goal of the STOPOXY study is to build upon previous research that found oxytocin discontinuation didn’t boost the risk of cesarean delivery rates, uterine hyperstimulation, and abnormal fetal heart rate, Dr. Girault said. “These studies were underpowered to show any effects on neonatal morbidity,” so she and colleagues decided to dig deeper into the issue by launching the new trial.

From 2020 to 2022, researchers assigned 2,367 women who received oxytocin before 4 centimeters dilation to either continue with the drug (n = 1,192) or discontinue it before reaching 6 centimeters dilation (n = 1,175). Overall, the women were pregnant for the first time (around 55%) with a median age around 32 years and body mass index around 24.1 kg/m². All had live, singleton, full-term babies.

More than a third – 37% – of those who discontinued oxytocin resumed treatment with the medication, while 5% of those in the control group stopped taking it.

The neonatal morbidity rate – defined via a composite variable based on umbilical arterial pH, umbilical arterial lactates, Apgar score, and/or neonatal ICU admission – was 10.0% in the intervention group and 10.1% in the control group (P = .94), the researchers reported. Cesarean delivery rates were similar (18.8% vs. 16.5%, respectively; P = .22). Apart from the duration of the active first stage, which was significantly higher in the intervention group (100 min [ interquartile range, 50-208 min] vs. 90 min [IQR, 45-150 min]; P = .001), there were no significant differences between the groups.

Dr. Girault said this increase in labor duration was “moderate and clinically debatable.”

In an interview, oncologist-gynecologist George Saade, MD, of the University of Texas Medical Branch, Galveston, noted that “oxytocin is frequently used for either induction or augmentation of labor ... with the goal of improving maternal and neonatal outcomes.”

Oxytocin itself is not expensive, Dr. Saade said. “However, when it is given, the patient requires more monitoring, which may increase cost.”

There’s debate over the proper use of oxytocin, which is available in a synthetic version as Pitocin, and researchers have been trying to understand whether it can safely be discontinued early in labor.

Potential side effects of oxytocin include heart disorders such as arrhythmia, asphyxia, neonatal seizure, and jaundice, low Apgar score, and fetal death. A boxed warning says: “Because the available data are inadequate to evaluate the benefits-to-risks considerations, oxytocin is not indicated for elective induction of labor.”

However, “overall oxytocin is commonly used and very safe as long as careful protocols are followed,” David N. Hackney, MD, MS, of University Hospitals Cleveland, said in an interview. “The medication itself does not have many negative side effects. With very high doses there can be a concern for water intoxication, though this is clinically very uncommon. Some prior studies have raised concerns about the use of oxytocin and subsequent long-term neurodevelopmental outcomes, though these associations are likely confounders and the mainstream opinion is that these are not truly biologically causative associations.”

A 2021 study in The BMJ randomly assigned 1,200 women to continue or discontinue oxytocin. There was a slight increase in cesarean sections in the discontinuation group but significantly lower risks of uterine hyperstimulation and abnormal fetal heart rate.

Dr. Hackney, who didn’t take part in the new study, said the trial is “well conducted and well executed.” However, it needs peer review before any of its findings should change practice.

He added that differences in delivery protocols between the United States and France should be considered. As he noted, Dr. Girault mentioned in a Q&A after her presentation that delayed second-stage labor is more common in France than in the United States.

The study was funded by the French National Ministry of Health. Disclosures for the authors were not provided. Dr. Saade and Dr. Hackney have no disclosures.

A new randomized, open-label French trial offers more evidence that the discontinuation of oxytocin treatment after the earliest stages of labor may be safe. Stopping oxytocin didn’t appear to affect neonatal outcomes, compared with continual use of the medication. However, the first stage of labor lasted slightly longer – not surprisingly – in those in the intervention group, and many of those who stopped oxytocin treatment resumed it later.

“Our trial did not show any impact of oxytocin discontinuation in the active [labor] stage on neonatal morbidity cesarean delivery, postpartum hemorrhage, birth experience, and postpartum depression,” said Aude Girault, MD, PhD, of Paris Cité University, in a presentation in San Francisco at the meeting sponsored by the Society for Maternal-Fetal Medicine.

The goal of the STOPOXY study is to build upon previous research that found oxytocin discontinuation didn’t boost the risk of cesarean delivery rates, uterine hyperstimulation, and abnormal fetal heart rate, Dr. Girault said. “These studies were underpowered to show any effects on neonatal morbidity,” so she and colleagues decided to dig deeper into the issue by launching the new trial.

From 2020 to 2022, researchers assigned 2,367 women who received oxytocin before 4 centimeters dilation to either continue with the drug (n = 1,192) or discontinue it before reaching 6 centimeters dilation (n = 1,175). Overall, the women were pregnant for the first time (around 55%) with a median age around 32 years and body mass index around 24.1 kg/m². All had live, singleton, full-term babies.

More than a third – 37% – of those who discontinued oxytocin resumed treatment with the medication, while 5% of those in the control group stopped taking it.

The neonatal morbidity rate – defined via a composite variable based on umbilical arterial pH, umbilical arterial lactates, Apgar score, and/or neonatal ICU admission – was 10.0% in the intervention group and 10.1% in the control group (P = .94), the researchers reported. Cesarean delivery rates were similar (18.8% vs. 16.5%, respectively; P = .22). Apart from the duration of the active first stage, which was significantly higher in the intervention group (100 min [ interquartile range, 50-208 min] vs. 90 min [IQR, 45-150 min]; P = .001), there were no significant differences between the groups.

Dr. Girault said this increase in labor duration was “moderate and clinically debatable.”

In an interview, oncologist-gynecologist George Saade, MD, of the University of Texas Medical Branch, Galveston, noted that “oxytocin is frequently used for either induction or augmentation of labor ... with the goal of improving maternal and neonatal outcomes.”

Oxytocin itself is not expensive, Dr. Saade said. “However, when it is given, the patient requires more monitoring, which may increase cost.”

There’s debate over the proper use of oxytocin, which is available in a synthetic version as Pitocin, and researchers have been trying to understand whether it can safely be discontinued early in labor.

Potential side effects of oxytocin include heart disorders such as arrhythmia, asphyxia, neonatal seizure, and jaundice, low Apgar score, and fetal death. A boxed warning says: “Because the available data are inadequate to evaluate the benefits-to-risks considerations, oxytocin is not indicated for elective induction of labor.”

However, “overall oxytocin is commonly used and very safe as long as careful protocols are followed,” David N. Hackney, MD, MS, of University Hospitals Cleveland, said in an interview. “The medication itself does not have many negative side effects. With very high doses there can be a concern for water intoxication, though this is clinically very uncommon. Some prior studies have raised concerns about the use of oxytocin and subsequent long-term neurodevelopmental outcomes, though these associations are likely confounders and the mainstream opinion is that these are not truly biologically causative associations.”

A 2021 study in The BMJ randomly assigned 1,200 women to continue or discontinue oxytocin. There was a slight increase in cesarean sections in the discontinuation group but significantly lower risks of uterine hyperstimulation and abnormal fetal heart rate.

Dr. Hackney, who didn’t take part in the new study, said the trial is “well conducted and well executed.” However, it needs peer review before any of its findings should change practice.

He added that differences in delivery protocols between the United States and France should be considered. As he noted, Dr. Girault mentioned in a Q&A after her presentation that delayed second-stage labor is more common in France than in the United States.

The study was funded by the French National Ministry of Health. Disclosures for the authors were not provided. Dr. Saade and Dr. Hackney have no disclosures.

The U.S. Preventive Services Task Force (USPSTF) recommends that clinicians screen for hypertensive disorders of pregnancy, which can cause serious and fatal complications, according to a new draft statement.

All pregnant people should have their blood pressure measured at each prenatal visit to identify and prevent serious health problems. The grade B recommendation expands on the task force’s 2017 recommendation on screening for preeclampsia to include all hypertensive disorders of pregnancy.

“Hypertensive disorders of pregnancy are some of the leading causes of serious complications and death for pregnant people,” Esa Davis, MD, a USPSTF member and associate professor of medicine and clinical and translational science at the University of Pittsburgh School of Medicine, told this news organization.

In the U.S., the rate of hypertensive disorders of pregnancy has increased in recent decades, jumping from about 500 cases per 10,000 deliveries in the early 1990s to more than 1,000 cases per 10,000 deliveries in the mid-2010s.

“The U.S. Preventive Services Task Force wants to help save the lives of pregnant people and their babies by ensuring that clinicians have the most up-to-date guidance on how to find these conditions early,” she said.

The draft recommendation statement was published online .
 

Screening recommendation

Hypertensive disorders of pregnancy, including gestational hypertension, preeclampsia, eclampsia, and chronic hypertension with and without superimposed preeclampsia, are marked by elevated blood pressure during pregnancy.

The disorders can lead to complications for the pregnant person, such as stroke, retinal detachment, organ damage or failure, and seizures, as well as for the baby, including restricted growth, low birth weight, and stillbirth. Many complications can lead to early induction of labor, cesarean delivery, and preterm birth.

After commissioning a systematic evidence review, the USPSTF provided a grade B recommendation for clinicians to offer or provide screening for hypertensive disorders of pregnancy. The recommendation concludes with “moderate certainty” that screening with blood pressure measurements has “substantial net benefit.”

The task force notes that it is “essential” for all pregnant women and pregnant people of all genders to be screened and that those who screen positive receive evidence-based management of their condition.

Risk factors include a history of eclampsia or preeclampsia, a family history of preeclampsia, a previous adverse pregnancy outcome, having gestational diabetes or chronic hypertension, being pregnant with more than one baby, having a first pregnancy, having a high body mass index prior to pregnancy, and being 35 years of age or older.

In addition, Black, American Indian, and Alaska Native people face higher risks and are more likely both to have and to die from a hypertensive disorder of pregnancy. In particular, Black people experience higher rates of maternal and infant morbidity and perinatal mortality than other racial and ethnic groups, and hypertensive disorders of pregnancy account for a larger proportion of these outcomes.

Although measuring blood pressure throughout pregnancy is an important first step, it’s not enough to improve inequities in health outcomes, the task force notes. Identifying hypertensive disorders of pregnancy requires adequate prenatal follow-up visits, surveillance, and evidence-based care, which can be a barrier for some pregnant people.

Follow-up visits with health care providers such as nurses, nurse midwives, pediatricians, and lactation consultants could help, as well as screening and monitoring during the postpartum period. Other approaches include telehealth, connections to community resources during the perinatal period, collaborative care provided in medical homes, and multilevel interventions to address underlying health inequities that increase health risks during pregnancy.

“Since screening is not enough to address the health disparities experienced by Black, American Indian, and Alaska Native people, health care professionals should also do what they can to help address these inequities,” Dr. Davis said. “For example, the task force identified a few promising approaches, including using standardized clinical bundles of best practices for disease management to help ensure that all pregnant persons receive appropriate, equitable care.”
 

Additional considerations

The USPSTF looked at the evidence on additional methods of screening but continued to find that measuring blood pressure at each prenatal visit is the best approach. Other evaluations, such as testing for proteinuria when preeclampsia is suspected, have low accuracy for detecting proteinuria in pregnancy.

Although there is no currently available treatment for preeclampsia except delivery, management strategies for diagnosed hypertensive disorders of pregnancy include close fetal and maternal monitoring, antihypertension medications, and magnesium sulfate for seizure prophylaxis when indicated.

Previously, the USPSTF also recommended that pregnant Black people be considered for treatment with low-dose aspirin to prevent preeclampsia, with aspirin use recommended for those with at least one additional moderate risk factor. Clinicians should also be aware of the complications of poor health outcomes among populations who face higher risks.

The USPSTF noted several gaps for future research, including the best approaches for blood pressure monitoring during pregnancy and the postpartum period, how to address health inequities through multilevel interventions, how to increase access to care through telehealth services, and how to mitigate cardiovascular complications later in life in patients diagnosed with hypertensive disorders of pregnancy.

“Continued research is needed in these promising areas,” Dr. Davis said. “We hope all clinicians will join us in helping ensure that all parents and babies have access to the care they need to be as healthy as possible.”

The draft recommendation statement and draft evidence review were posted for public comment on the USPSTF website. Comments can be submitted until March 6.

No relevant financial relationships have been disclosed.

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

The U.S. Preventive Services Task Force (USPSTF) recommends that clinicians screen for hypertensive disorders of pregnancy, which can cause serious and fatal complications, according to a new draft statement.

All pregnant people should have their blood pressure measured at each prenatal visit to identify and prevent serious health problems. The grade B recommendation expands on the task force’s 2017 recommendation on screening for preeclampsia to include all hypertensive disorders of pregnancy.

“Hypertensive disorders of pregnancy are some of the leading causes of serious complications and death for pregnant people,” Esa Davis, MD, a USPSTF member and associate professor of medicine and clinical and translational science at the University of Pittsburgh School of Medicine, told this news organization.

In the U.S., the rate of hypertensive disorders of pregnancy has increased in recent decades, jumping from about 500 cases per 10,000 deliveries in the early 1990s to more than 1,000 cases per 10,000 deliveries in the mid-2010s.

“The U.S. Preventive Services Task Force wants to help save the lives of pregnant people and their babies by ensuring that clinicians have the most up-to-date guidance on how to find these conditions early,” she said.

The draft recommendation statement was published online .
 

Screening recommendation

Hypertensive disorders of pregnancy, including gestational hypertension, preeclampsia, eclampsia, and chronic hypertension with and without superimposed preeclampsia, are marked by elevated blood pressure during pregnancy.

The disorders can lead to complications for the pregnant person, such as stroke, retinal detachment, organ damage or failure, and seizures, as well as for the baby, including restricted growth, low birth weight, and stillbirth. Many complications can lead to early induction of labor, cesarean delivery, and preterm birth.

After commissioning a systematic evidence review, the USPSTF provided a grade B recommendation for clinicians to offer or provide screening for hypertensive disorders of pregnancy. The recommendation concludes with “moderate certainty” that screening with blood pressure measurements has “substantial net benefit.”

The task force notes that it is “essential” for all pregnant women and pregnant people of all genders to be screened and that those who screen positive receive evidence-based management of their condition.

Risk factors include a history of eclampsia or preeclampsia, a family history of preeclampsia, a previous adverse pregnancy outcome, having gestational diabetes or chronic hypertension, being pregnant with more than one baby, having a first pregnancy, having a high body mass index prior to pregnancy, and being 35 years of age or older.

In addition, Black, American Indian, and Alaska Native people face higher risks and are more likely both to have and to die from a hypertensive disorder of pregnancy. In particular, Black people experience higher rates of maternal and infant morbidity and perinatal mortality than other racial and ethnic groups, and hypertensive disorders of pregnancy account for a larger proportion of these outcomes.

Although measuring blood pressure throughout pregnancy is an important first step, it’s not enough to improve inequities in health outcomes, the task force notes. Identifying hypertensive disorders of pregnancy requires adequate prenatal follow-up visits, surveillance, and evidence-based care, which can be a barrier for some pregnant people.

Follow-up visits with health care providers such as nurses, nurse midwives, pediatricians, and lactation consultants could help, as well as screening and monitoring during the postpartum period. Other approaches include telehealth, connections to community resources during the perinatal period, collaborative care provided in medical homes, and multilevel interventions to address underlying health inequities that increase health risks during pregnancy.

“Since screening is not enough to address the health disparities experienced by Black, American Indian, and Alaska Native people, health care professionals should also do what they can to help address these inequities,” Dr. Davis said. “For example, the task force identified a few promising approaches, including using standardized clinical bundles of best practices for disease management to help ensure that all pregnant persons receive appropriate, equitable care.”
 

Additional considerations

The USPSTF looked at the evidence on additional methods of screening but continued to find that measuring blood pressure at each prenatal visit is the best approach. Other evaluations, such as testing for proteinuria when preeclampsia is suspected, have low accuracy for detecting proteinuria in pregnancy.

Although there is no currently available treatment for preeclampsia except delivery, management strategies for diagnosed hypertensive disorders of pregnancy include close fetal and maternal monitoring, antihypertension medications, and magnesium sulfate for seizure prophylaxis when indicated.

Previously, the USPSTF also recommended that pregnant Black people be considered for treatment with low-dose aspirin to prevent preeclampsia, with aspirin use recommended for those with at least one additional moderate risk factor. Clinicians should also be aware of the complications of poor health outcomes among populations who face higher risks.

The USPSTF noted several gaps for future research, including the best approaches for blood pressure monitoring during pregnancy and the postpartum period, how to address health inequities through multilevel interventions, how to increase access to care through telehealth services, and how to mitigate cardiovascular complications later in life in patients diagnosed with hypertensive disorders of pregnancy.

“Continued research is needed in these promising areas,” Dr. Davis said. “We hope all clinicians will join us in helping ensure that all parents and babies have access to the care they need to be as healthy as possible.”

The draft recommendation statement and draft evidence review were posted for public comment on the USPSTF website. Comments can be submitted until March 6.

No relevant financial relationships have been disclosed.

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

The U.S. Preventive Services Task Force (USPSTF) recommends that clinicians screen for hypertensive disorders of pregnancy, which can cause serious and fatal complications, according to a new draft statement.

All pregnant people should have their blood pressure measured at each prenatal visit to identify and prevent serious health problems. The grade B recommendation expands on the task force’s 2017 recommendation on screening for preeclampsia to include all hypertensive disorders of pregnancy.

“Hypertensive disorders of pregnancy are some of the leading causes of serious complications and death for pregnant people,” Esa Davis, MD, a USPSTF member and associate professor of medicine and clinical and translational science at the University of Pittsburgh School of Medicine, told this news organization.

In the U.S., the rate of hypertensive disorders of pregnancy has increased in recent decades, jumping from about 500 cases per 10,000 deliveries in the early 1990s to more than 1,000 cases per 10,000 deliveries in the mid-2010s.

“The U.S. Preventive Services Task Force wants to help save the lives of pregnant people and their babies by ensuring that clinicians have the most up-to-date guidance on how to find these conditions early,” she said.

The draft recommendation statement was published online .
 

Screening recommendation

Hypertensive disorders of pregnancy, including gestational hypertension, preeclampsia, eclampsia, and chronic hypertension with and without superimposed preeclampsia, are marked by elevated blood pressure during pregnancy.

The disorders can lead to complications for the pregnant person, such as stroke, retinal detachment, organ damage or failure, and seizures, as well as for the baby, including restricted growth, low birth weight, and stillbirth. Many complications can lead to early induction of labor, cesarean delivery, and preterm birth.

After commissioning a systematic evidence review, the USPSTF provided a grade B recommendation for clinicians to offer or provide screening for hypertensive disorders of pregnancy. The recommendation concludes with “moderate certainty” that screening with blood pressure measurements has “substantial net benefit.”

The task force notes that it is “essential” for all pregnant women and pregnant people of all genders to be screened and that those who screen positive receive evidence-based management of their condition.

Risk factors include a history of eclampsia or preeclampsia, a family history of preeclampsia, a previous adverse pregnancy outcome, having gestational diabetes or chronic hypertension, being pregnant with more than one baby, having a first pregnancy, having a high body mass index prior to pregnancy, and being 35 years of age or older.

In addition, Black, American Indian, and Alaska Native people face higher risks and are more likely both to have and to die from a hypertensive disorder of pregnancy. In particular, Black people experience higher rates of maternal and infant morbidity and perinatal mortality than other racial and ethnic groups, and hypertensive disorders of pregnancy account for a larger proportion of these outcomes.

Although measuring blood pressure throughout pregnancy is an important first step, it’s not enough to improve inequities in health outcomes, the task force notes. Identifying hypertensive disorders of pregnancy requires adequate prenatal follow-up visits, surveillance, and evidence-based care, which can be a barrier for some pregnant people.

Follow-up visits with health care providers such as nurses, nurse midwives, pediatricians, and lactation consultants could help, as well as screening and monitoring during the postpartum period. Other approaches include telehealth, connections to community resources during the perinatal period, collaborative care provided in medical homes, and multilevel interventions to address underlying health inequities that increase health risks during pregnancy.

“Since screening is not enough to address the health disparities experienced by Black, American Indian, and Alaska Native people, health care professionals should also do what they can to help address these inequities,” Dr. Davis said. “For example, the task force identified a few promising approaches, including using standardized clinical bundles of best practices for disease management to help ensure that all pregnant persons receive appropriate, equitable care.”
 

Additional considerations

The USPSTF looked at the evidence on additional methods of screening but continued to find that measuring blood pressure at each prenatal visit is the best approach. Other evaluations, such as testing for proteinuria when preeclampsia is suspected, have low accuracy for detecting proteinuria in pregnancy.

Although there is no currently available treatment for preeclampsia except delivery, management strategies for diagnosed hypertensive disorders of pregnancy include close fetal and maternal monitoring, antihypertension medications, and magnesium sulfate for seizure prophylaxis when indicated.

Previously, the USPSTF also recommended that pregnant Black people be considered for treatment with low-dose aspirin to prevent preeclampsia, with aspirin use recommended for those with at least one additional moderate risk factor. Clinicians should also be aware of the complications of poor health outcomes among populations who face higher risks.

The USPSTF noted several gaps for future research, including the best approaches for blood pressure monitoring during pregnancy and the postpartum period, how to address health inequities through multilevel interventions, how to increase access to care through telehealth services, and how to mitigate cardiovascular complications later in life in patients diagnosed with hypertensive disorders of pregnancy.

“Continued research is needed in these promising areas,” Dr. Davis said. “We hope all clinicians will join us in helping ensure that all parents and babies have access to the care they need to be as healthy as possible.”

The draft recommendation statement and draft evidence review were posted for public comment on the USPSTF website. Comments can be submitted until March 6.

No relevant financial relationships have been disclosed.

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

When I was a child, I watched syndicated episodes of the original “Star Trek.” I was dazzled by the space travel, sure, but also the medical technology.

A handheld “tricorder” detected diseases, while an intramuscular injector (“hypospray”) could treat them. Sickbay “biobeds” came with real-time health monitors that looked futuristic at the time but seem primitive today.

Such visions inspired a lot of us kids to pursue science. Little did we know the real-life advances many of us would see in our lifetimes.

Artificial intelligence helping to spot disease, robots performing surgery, even video calls between doctor and patient – all these once sounded fantastical but now happen in clinical care.

Now, in the 23rd year of the 21st century, you might not believe wht we’ll be capable of next. Three especially wild examples are moving closer to clinical reality. 
 

Human hibernation

Captain America, Han Solo, and “Star Trek” villain Khan – all were preserved at low temperatures and then revived, waking up alive and well months, decades, or centuries later. These are fictional examples, to be sure, but the science they’re rooted in is real.

Rare cases of accidental hypothermia prove that full recovery is possible even after the heart stops beating. The drop in body temperature slows metabolism and reduces the need for oxygen, stalling brain damage for an hour or more. (In one extreme case, a climber survived after almost 9 hours of efforts to revive him.)

Useful for a space traveler? Maybe not. But it’s potentially huge for someone with life-threatening injuries from a car accident or a gunshot wound.

That’s the thinking behind a breakthrough procedure that came after decades of research on pigs and dogs, now in a clinical trial. The idea: A person with massive blood loss whose heart has stopped is injected with an ice-cold fluid, cooling them from the inside, down to about 50° F.

Doctors already induce more modest hypothermia to protect the brain and other organs after cardiac arrest and during surgery on the aortic arch (the main artery carrying blood from the heart).

But this experimental procedure – called emergency preservation and resuscitation (EPR) – goes far beyond that, dramatically “decreasing the body’s need for oxygen and blood flow,” says Samuel Tisherman, MD, a trauma surgeon at the University of Maryland Medical Center and the trial’s lead researcher. This puts the patient in a state of suspended animation that “could buy time for surgeons to stop the bleeding and save more of these patients.”

The technique has been done on at least six patients, though none were reported to survive. The trial is expected to include 20 people by the time it wraps up in December, according to the listing on the U.S. clinical trials database. Though given the strict requirements for candidates (emergency trauma victims who are not likely to survive), one can’t exactly rely on a set schedule.

Still, the technology is promising. Someday we may even use it to keep patients in suspended animation for months or years, experts predict, helping astronauts through decades-long spaceflights, or stalling death in sick patients awaiting a cure.
 

Artificial womb

Another sci-fi classic: growing human babies outside the womb. Think the fetus fields from “The Matrix,” or the frozen embryos in “Alien: Covenant.”

In 1923, British biologist J.B.S. Haldane coined a term for that – ectogenesis. He predicted that 70% of pregnancies would take place, from fertilization to birth, in artificial wombs by 2074. That many seems unlikely, but the timeline is on track.

Developing an embryo outside the womb is already routine in in vitro fertilization. And technology enables preterm babies to survive through much of the second half of gestation. Normal human pregnancy is 40 weeks, and the youngest preterm baby ever to survive was 21 weeks and 1 day old, just a few days younger than a smattering of others who lived.

The biggest obstacle for babies younger than that is lung viability. Mechanical ventilation can damage the lungs and lead to a chronic (sometimes fatal) lung disease known as bronchopulmonary dysplasia. Avoiding this would mean figuring out a way to maintain fetal circulation – the intricate system that delivers oxygenated blood from the placenta to the fetus via the umbilical cord. Researchers at Children’s Hospital of Philadelphia have done this using a fetal lamb.

The key to their invention is a substitute placenta: an oxygenator connected to the lamb’s umbilical cord. Tubes inserted through the umbilical vein and arteries carry oxygenated blood from the “placenta” to the fetus, and deoxygenated blood back out. The lamb resides in an artificial, fluid-filled amniotic sac until its lungs and other organs are developed.

Fertility treatment could benefit, too. “An artificial womb may substitute in situations in which a gestational carrier – surrogate – is indicated,” says Paula Amato, MD, a professor of obstetrics and gynecology at Oregon Health and Science University, Portland. (Dr. Amato is not involved in the CHOP research.) For example: when the mother is missing a uterus or can’t carry a pregnancy safely.

No date is set for clinical trials yet. But according to the research, the main difference between human and lamb may come down to size. A lamb’s umbilical vessels are larger, so feeding in a tube is easier. With today’s advances in miniaturizing surgical methods, that seems like a challenge scientists can overcome.
 

Messenger RNA therapeutics

Back to “Star Trek.” The hypospray injector’s contents could cure just about any disease, even one newly discovered on a strange planet. That’s not unlike messenger RNA (mRNA) technology, a breakthrough that enabled scientists to quickly develop some of the first COVID-19 vaccines.

But vaccines are just the beginning of what this technology can do.

A whole field of immunotherapy is emerging that uses mRNA to deliver instructions to produce chimeric antigen receptor–modified immune cells (CAR-modified immune cells). These cells are engineered to target diseased cells and tissues, like cancer cells and harmful fibroblasts (scar tissue) that promote fibrosis in, for example, the heart and lungs.

The field is bursting with rodent research, and clinical trials have started for treating some advanced-stage malignancies.

Actual clinical use may be years away, but if all goes well, these medicines could help treat or even cure the core medical problems facing humanity. We’re talking cancer, heart disease, neurodegenerative disease – transforming one therapy into another by simply changing the mRNA’s “nucleotide sequence,” the blueprint containing instructions telling it what to do, and what disease to attack.

As this technology matures, we may start to feel as if we’re really on “Star Trek,” where Dr. Leonard “Bones” McCoy pulls out the same device to treat just about every disease or injury.

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

When I was a child, I watched syndicated episodes of the original “Star Trek.” I was dazzled by the space travel, sure, but also the medical technology.

A handheld “tricorder” detected diseases, while an intramuscular injector (“hypospray”) could treat them. Sickbay “biobeds” came with real-time health monitors that looked futuristic at the time but seem primitive today.

Such visions inspired a lot of us kids to pursue science. Little did we know the real-life advances many of us would see in our lifetimes.

Artificial intelligence helping to spot disease, robots performing surgery, even video calls between doctor and patient – all these once sounded fantastical but now happen in clinical care.

Now, in the 23rd year of the 21st century, you might not believe wht we’ll be capable of next. Three especially wild examples are moving closer to clinical reality. 
 

Human hibernation

Captain America, Han Solo, and “Star Trek” villain Khan – all were preserved at low temperatures and then revived, waking up alive and well months, decades, or centuries later. These are fictional examples, to be sure, but the science they’re rooted in is real.

Rare cases of accidental hypothermia prove that full recovery is possible even after the heart stops beating. The drop in body temperature slows metabolism and reduces the need for oxygen, stalling brain damage for an hour or more. (In one extreme case, a climber survived after almost 9 hours of efforts to revive him.)

Useful for a space traveler? Maybe not. But it’s potentially huge for someone with life-threatening injuries from a car accident or a gunshot wound.

That’s the thinking behind a breakthrough procedure that came after decades of research on pigs and dogs, now in a clinical trial. The idea: A person with massive blood loss whose heart has stopped is injected with an ice-cold fluid, cooling them from the inside, down to about 50° F.

Doctors already induce more modest hypothermia to protect the brain and other organs after cardiac arrest and during surgery on the aortic arch (the main artery carrying blood from the heart).

But this experimental procedure – called emergency preservation and resuscitation (EPR) – goes far beyond that, dramatically “decreasing the body’s need for oxygen and blood flow,” says Samuel Tisherman, MD, a trauma surgeon at the University of Maryland Medical Center and the trial’s lead researcher. This puts the patient in a state of suspended animation that “could buy time for surgeons to stop the bleeding and save more of these patients.”

The technique has been done on at least six patients, though none were reported to survive. The trial is expected to include 20 people by the time it wraps up in December, according to the listing on the U.S. clinical trials database. Though given the strict requirements for candidates (emergency trauma victims who are not likely to survive), one can’t exactly rely on a set schedule.

Still, the technology is promising. Someday we may even use it to keep patients in suspended animation for months or years, experts predict, helping astronauts through decades-long spaceflights, or stalling death in sick patients awaiting a cure.
 

Artificial womb

Another sci-fi classic: growing human babies outside the womb. Think the fetus fields from “The Matrix,” or the frozen embryos in “Alien: Covenant.”

In 1923, British biologist J.B.S. Haldane coined a term for that – ectogenesis. He predicted that 70% of pregnancies would take place, from fertilization to birth, in artificial wombs by 2074. That many seems unlikely, but the timeline is on track.

Developing an embryo outside the womb is already routine in in vitro fertilization. And technology enables preterm babies to survive through much of the second half of gestation. Normal human pregnancy is 40 weeks, and the youngest preterm baby ever to survive was 21 weeks and 1 day old, just a few days younger than a smattering of others who lived.

The biggest obstacle for babies younger than that is lung viability. Mechanical ventilation can damage the lungs and lead to a chronic (sometimes fatal) lung disease known as bronchopulmonary dysplasia. Avoiding this would mean figuring out a way to maintain fetal circulation – the intricate system that delivers oxygenated blood from the placenta to the fetus via the umbilical cord. Researchers at Children’s Hospital of Philadelphia have done this using a fetal lamb.

The key to their invention is a substitute placenta: an oxygenator connected to the lamb’s umbilical cord. Tubes inserted through the umbilical vein and arteries carry oxygenated blood from the “placenta” to the fetus, and deoxygenated blood back out. The lamb resides in an artificial, fluid-filled amniotic sac until its lungs and other organs are developed.

Fertility treatment could benefit, too. “An artificial womb may substitute in situations in which a gestational carrier – surrogate – is indicated,” says Paula Amato, MD, a professor of obstetrics and gynecology at Oregon Health and Science University, Portland. (Dr. Amato is not involved in the CHOP research.) For example: when the mother is missing a uterus or can’t carry a pregnancy safely.

No date is set for clinical trials yet. But according to the research, the main difference between human and lamb may come down to size. A lamb’s umbilical vessels are larger, so feeding in a tube is easier. With today’s advances in miniaturizing surgical methods, that seems like a challenge scientists can overcome.
 

Messenger RNA therapeutics

Back to “Star Trek.” The hypospray injector’s contents could cure just about any disease, even one newly discovered on a strange planet. That’s not unlike messenger RNA (mRNA) technology, a breakthrough that enabled scientists to quickly develop some of the first COVID-19 vaccines.

But vaccines are just the beginning of what this technology can do.

A whole field of immunotherapy is emerging that uses mRNA to deliver instructions to produce chimeric antigen receptor–modified immune cells (CAR-modified immune cells). These cells are engineered to target diseased cells and tissues, like cancer cells and harmful fibroblasts (scar tissue) that promote fibrosis in, for example, the heart and lungs.

The field is bursting with rodent research, and clinical trials have started for treating some advanced-stage malignancies.

Actual clinical use may be years away, but if all goes well, these medicines could help treat or even cure the core medical problems facing humanity. We’re talking cancer, heart disease, neurodegenerative disease – transforming one therapy into another by simply changing the mRNA’s “nucleotide sequence,” the blueprint containing instructions telling it what to do, and what disease to attack.

As this technology matures, we may start to feel as if we’re really on “Star Trek,” where Dr. Leonard “Bones” McCoy pulls out the same device to treat just about every disease or injury.

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

When I was a child, I watched syndicated episodes of the original “Star Trek.” I was dazzled by the space travel, sure, but also the medical technology.

A handheld “tricorder” detected diseases, while an intramuscular injector (“hypospray”) could treat them. Sickbay “biobeds” came with real-time health monitors that looked futuristic at the time but seem primitive today.

Such visions inspired a lot of us kids to pursue science. Little did we know the real-life advances many of us would see in our lifetimes.

Artificial intelligence helping to spot disease, robots performing surgery, even video calls between doctor and patient – all these once sounded fantastical but now happen in clinical care.

Now, in the 23rd year of the 21st century, you might not believe wht we’ll be capable of next. Three especially wild examples are moving closer to clinical reality. 
 

Human hibernation

Captain America, Han Solo, and “Star Trek” villain Khan – all were preserved at low temperatures and then revived, waking up alive and well months, decades, or centuries later. These are fictional examples, to be sure, but the science they’re rooted in is real.

Rare cases of accidental hypothermia prove that full recovery is possible even after the heart stops beating. The drop in body temperature slows metabolism and reduces the need for oxygen, stalling brain damage for an hour or more. (In one extreme case, a climber survived after almost 9 hours of efforts to revive him.)

Useful for a space traveler? Maybe not. But it’s potentially huge for someone with life-threatening injuries from a car accident or a gunshot wound.

That’s the thinking behind a breakthrough procedure that came after decades of research on pigs and dogs, now in a clinical trial. The idea: A person with massive blood loss whose heart has stopped is injected with an ice-cold fluid, cooling them from the inside, down to about 50° F.

Doctors already induce more modest hypothermia to protect the brain and other organs after cardiac arrest and during surgery on the aortic arch (the main artery carrying blood from the heart).

But this experimental procedure – called emergency preservation and resuscitation (EPR) – goes far beyond that, dramatically “decreasing the body’s need for oxygen and blood flow,” says Samuel Tisherman, MD, a trauma surgeon at the University of Maryland Medical Center and the trial’s lead researcher. This puts the patient in a state of suspended animation that “could buy time for surgeons to stop the bleeding and save more of these patients.”

The technique has been done on at least six patients, though none were reported to survive. The trial is expected to include 20 people by the time it wraps up in December, according to the listing on the U.S. clinical trials database. Though given the strict requirements for candidates (emergency trauma victims who are not likely to survive), one can’t exactly rely on a set schedule.

Still, the technology is promising. Someday we may even use it to keep patients in suspended animation for months or years, experts predict, helping astronauts through decades-long spaceflights, or stalling death in sick patients awaiting a cure.
 

Artificial womb

Another sci-fi classic: growing human babies outside the womb. Think the fetus fields from “The Matrix,” or the frozen embryos in “Alien: Covenant.”

In 1923, British biologist J.B.S. Haldane coined a term for that – ectogenesis. He predicted that 70% of pregnancies would take place, from fertilization to birth, in artificial wombs by 2074. That many seems unlikely, but the timeline is on track.

Developing an embryo outside the womb is already routine in in vitro fertilization. And technology enables preterm babies to survive through much of the second half of gestation. Normal human pregnancy is 40 weeks, and the youngest preterm baby ever to survive was 21 weeks and 1 day old, just a few days younger than a smattering of others who lived.

The biggest obstacle for babies younger than that is lung viability. Mechanical ventilation can damage the lungs and lead to a chronic (sometimes fatal) lung disease known as bronchopulmonary dysplasia. Avoiding this would mean figuring out a way to maintain fetal circulation – the intricate system that delivers oxygenated blood from the placenta to the fetus via the umbilical cord. Researchers at Children’s Hospital of Philadelphia have done this using a fetal lamb.

The key to their invention is a substitute placenta: an oxygenator connected to the lamb’s umbilical cord. Tubes inserted through the umbilical vein and arteries carry oxygenated blood from the “placenta” to the fetus, and deoxygenated blood back out. The lamb resides in an artificial, fluid-filled amniotic sac until its lungs and other organs are developed.

Fertility treatment could benefit, too. “An artificial womb may substitute in situations in which a gestational carrier – surrogate – is indicated,” says Paula Amato, MD, a professor of obstetrics and gynecology at Oregon Health and Science University, Portland. (Dr. Amato is not involved in the CHOP research.) For example: when the mother is missing a uterus or can’t carry a pregnancy safely.

No date is set for clinical trials yet. But according to the research, the main difference between human and lamb may come down to size. A lamb’s umbilical vessels are larger, so feeding in a tube is easier. With today’s advances in miniaturizing surgical methods, that seems like a challenge scientists can overcome.
 

Messenger RNA therapeutics

Back to “Star Trek.” The hypospray injector’s contents could cure just about any disease, even one newly discovered on a strange planet. That’s not unlike messenger RNA (mRNA) technology, a breakthrough that enabled scientists to quickly develop some of the first COVID-19 vaccines.

But vaccines are just the beginning of what this technology can do.

A whole field of immunotherapy is emerging that uses mRNA to deliver instructions to produce chimeric antigen receptor–modified immune cells (CAR-modified immune cells). These cells are engineered to target diseased cells and tissues, like cancer cells and harmful fibroblasts (scar tissue) that promote fibrosis in, for example, the heart and lungs.

The field is bursting with rodent research, and clinical trials have started for treating some advanced-stage malignancies.

Actual clinical use may be years away, but if all goes well, these medicines could help treat or even cure the core medical problems facing humanity. We’re talking cancer, heart disease, neurodegenerative disease – transforming one therapy into another by simply changing the mRNA’s “nucleotide sequence,” the blueprint containing instructions telling it what to do, and what disease to attack.

As this technology matures, we may start to feel as if we’re really on “Star Trek,” where Dr. Leonard “Bones” McCoy pulls out the same device to treat just about every disease or injury.

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

Maternal vaccination with two doses of the mRNA COVID-19 vaccine was 95% effective against infant infection from the delta variant, and 45% effective against infant infection from the omicron variant, a new study shows.

Previous research has confirmed that COVID-19 neutralizing antibodies following maternal vaccination or maternal COVID-19 infection are present in umbilical cord blood, breast milk, and infant serum specimens, wrote Sarah C.J. Jorgensen, PharmD, MPH, of the University of Toronto, and colleagues in their article published in The BMJ.

In the study, the researchers identified maternal and newborn pairs using administrative databases from Canada. The study population included 8,809 infants aged younger than 6 months who were born between May 7, 2021, and March 31, 2022, and who underwent testing for COVID-19 between May 7, 2021, and September 5, 2022.

Maternal vaccination with the primary COVID-19 mRNA monovalent vaccine series was defined as two vaccine doses administered up to 14 days before delivery, with at least one of the doses after the conception date.

Maternal vaccination with the primary series plus one booster was defined as three doses administered up to 14 days before delivery, with at least one of these doses after the conception date.

The primary outcome was the presence of delta or omicron COVID-19 infection or hospital admission of the infants.

The study population included 99 COVID-19 cases with the delta variant (with 4,365 controls) and 1,501 cases with the omicron variant (with 4,847 controls).

Overall, the vaccine effectiveness of maternal doses was 95% against delta infection and 45% against omicron.

The effectiveness against hospital admission in cases of delta and omicron variants were 97% and 53%, respectively.

The effectiveness of three doses was 73% against omicron infant infection and 80% against omicron-related infant hospitalization. Data were not available for the effectiveness of three doses against the delta variant.

The effectiveness of two doses of vaccine against infant omicron infection was highest when mothers received the second dose during the third trimester of pregnancy, compared with during the first trimester or second trimester (53% vs. 47% and 53% vs. 37%, respectively).

Vaccine effectiveness with two doses against infant infection from omicron was highest in the first 8 weeks of life (57%), then decreased to 40% among infants after 16 weeks of age.

Although the study was not designed to assess the mechanism of action of the impact of maternal vaccination on infants, the current study results were consistent with other recent studies showing a reduction in infections and hospitalizations among infants whose mothers received COVID-19 vaccines during pregnancy, the researchers wrote in their discussion.

The findings were limited by several factors including the potential unmeasured confounders not available in databases, such as whether infants were breastfed, the researchers noted. Other limitations included a lack of data on home test results and the inability to assess the waning impact of the vaccine effectiveness against the delta variant because of the small number of delta cases, they said. However, the results suggest that the mRNA COVID-19 vaccine during pregnancy was moderately to highly effective for protection against omicron and delta infection and infection-related hospitalization – especially during the first 8 weeks of life.

Effectiveness is encouraging, but updates are needed

The effectiveness of maternal vaccination to prevent COVID-19 infection and related hospitalizations in infants is promising, especially since those younger than 6 months have no other source of vaccine protection against COVID-19 infection, wrote Dana Danino, MD, of Soroka University Medical Center, Israel, and Ilan Youngster, MD, of Shamir Medical Center, Israel, in an accompanying editorial also published in The BMJ.

They also noted that maternal vaccination during pregnancy is an established method of protecting infants from infections such as influenza and pertussis.

Data from previous studies show that most infants whose mothers were vaccinated against COVID-19 during pregnancy retained maternal antibodies at 6 months, “but evidence for protection against neonatal COVID-19 infection has been deficient,” they said.

The current study findings support the value of vaccination during pregnancy, and the findings were strengthened by the large study population, the editorialists wrote. However, whether the same effectiveness holds for other COVID-19 strains such as BQ.1, BQ.1.1, BF.7, XBB, and XBB.1 remains unknown, they said.

Other areas in need of exploration include the optimal timing of vaccination during pregnancy, the protective effects of a bivalent mRNA vaccine (vs. the primary monovalent vaccine in the current study), and the potential benefits of additional boosters, they added.

“Although Jorgenson and colleagues’ study reinforces the value of maternal vaccination against COVID-19 during pregnancy, more studies are needed to better inform vaccination recommendations in an evolving landscape of new SARS-CoV-2 strains and novel vaccines,” the editorialists concluded.

The study was supported by ICES, which is funded by an annual grant from the Ontario Ministry of Health and the Ministry of Long-term Care; the study also received funding from the Canadian Immunization Research Network and the Public Health Agency of Canada. Dr. Jorgensen and the editorialists had no financial conflicts to disclose.

*This article was updated on 3/2/2023.

Maternal vaccination with two doses of the mRNA COVID-19 vaccine was 95% effective against infant infection from the delta variant, and 45% effective against infant infection from the omicron variant, a new study shows.

Previous research has confirmed that COVID-19 neutralizing antibodies following maternal vaccination or maternal COVID-19 infection are present in umbilical cord blood, breast milk, and infant serum specimens, wrote Sarah C.J. Jorgensen, PharmD, MPH, of the University of Toronto, and colleagues in their article published in The BMJ.

In the study, the researchers identified maternal and newborn pairs using administrative databases from Canada. The study population included 8,809 infants aged younger than 6 months who were born between May 7, 2021, and March 31, 2022, and who underwent testing for COVID-19 between May 7, 2021, and September 5, 2022.

Maternal vaccination with the primary COVID-19 mRNA monovalent vaccine series was defined as two vaccine doses administered up to 14 days before delivery, with at least one of the doses after the conception date.

Maternal vaccination with the primary series plus one booster was defined as three doses administered up to 14 days before delivery, with at least one of these doses after the conception date.

The primary outcome was the presence of delta or omicron COVID-19 infection or hospital admission of the infants.

The study population included 99 COVID-19 cases with the delta variant (with 4,365 controls) and 1,501 cases with the omicron variant (with 4,847 controls).

Overall, the vaccine effectiveness of maternal doses was 95% against delta infection and 45% against omicron.

The effectiveness against hospital admission in cases of delta and omicron variants were 97% and 53%, respectively.

The effectiveness of three doses was 73% against omicron infant infection and 80% against omicron-related infant hospitalization. Data were not available for the effectiveness of three doses against the delta variant.

The effectiveness of two doses of vaccine against infant omicron infection was highest when mothers received the second dose during the third trimester of pregnancy, compared with during the first trimester or second trimester (53% vs. 47% and 53% vs. 37%, respectively).

Vaccine effectiveness with two doses against infant infection from omicron was highest in the first 8 weeks of life (57%), then decreased to 40% among infants after 16 weeks of age.

Although the study was not designed to assess the mechanism of action of the impact of maternal vaccination on infants, the current study results were consistent with other recent studies showing a reduction in infections and hospitalizations among infants whose mothers received COVID-19 vaccines during pregnancy, the researchers wrote in their discussion.

The findings were limited by several factors including the potential unmeasured confounders not available in databases, such as whether infants were breastfed, the researchers noted. Other limitations included a lack of data on home test results and the inability to assess the waning impact of the vaccine effectiveness against the delta variant because of the small number of delta cases, they said. However, the results suggest that the mRNA COVID-19 vaccine during pregnancy was moderately to highly effective for protection against omicron and delta infection and infection-related hospitalization – especially during the first 8 weeks of life.

Effectiveness is encouraging, but updates are needed

The effectiveness of maternal vaccination to prevent COVID-19 infection and related hospitalizations in infants is promising, especially since those younger than 6 months have no other source of vaccine protection against COVID-19 infection, wrote Dana Danino, MD, of Soroka University Medical Center, Israel, and Ilan Youngster, MD, of Shamir Medical Center, Israel, in an accompanying editorial also published in The BMJ.

They also noted that maternal vaccination during pregnancy is an established method of protecting infants from infections such as influenza and pertussis.

Data from previous studies show that most infants whose mothers were vaccinated against COVID-19 during pregnancy retained maternal antibodies at 6 months, “but evidence for protection against neonatal COVID-19 infection has been deficient,” they said.

The current study findings support the value of vaccination during pregnancy, and the findings were strengthened by the large study population, the editorialists wrote. However, whether the same effectiveness holds for other COVID-19 strains such as BQ.1, BQ.1.1, BF.7, XBB, and XBB.1 remains unknown, they said.

Other areas in need of exploration include the optimal timing of vaccination during pregnancy, the protective effects of a bivalent mRNA vaccine (vs. the primary monovalent vaccine in the current study), and the potential benefits of additional boosters, they added.

“Although Jorgenson and colleagues’ study reinforces the value of maternal vaccination against COVID-19 during pregnancy, more studies are needed to better inform vaccination recommendations in an evolving landscape of new SARS-CoV-2 strains and novel vaccines,” the editorialists concluded.

The study was supported by ICES, which is funded by an annual grant from the Ontario Ministry of Health and the Ministry of Long-term Care; the study also received funding from the Canadian Immunization Research Network and the Public Health Agency of Canada. Dr. Jorgensen and the editorialists had no financial conflicts to disclose.

*This article was updated on 3/2/2023.

Maternal vaccination with two doses of the mRNA COVID-19 vaccine was 95% effective against infant infection from the delta variant, and 45% effective against infant infection from the omicron variant, a new study shows.

Previous research has confirmed that COVID-19 neutralizing antibodies following maternal vaccination or maternal COVID-19 infection are present in umbilical cord blood, breast milk, and infant serum specimens, wrote Sarah C.J. Jorgensen, PharmD, MPH, of the University of Toronto, and colleagues in their article published in The BMJ.

In the study, the researchers identified maternal and newborn pairs using administrative databases from Canada. The study population included 8,809 infants aged younger than 6 months who were born between May 7, 2021, and March 31, 2022, and who underwent testing for COVID-19 between May 7, 2021, and September 5, 2022.

Maternal vaccination with the primary COVID-19 mRNA monovalent vaccine series was defined as two vaccine doses administered up to 14 days before delivery, with at least one of the doses after the conception date.

Maternal vaccination with the primary series plus one booster was defined as three doses administered up to 14 days before delivery, with at least one of these doses after the conception date.

The primary outcome was the presence of delta or omicron COVID-19 infection or hospital admission of the infants.

The study population included 99 COVID-19 cases with the delta variant (with 4,365 controls) and 1,501 cases with the omicron variant (with 4,847 controls).

Overall, the vaccine effectiveness of maternal doses was 95% against delta infection and 45% against omicron.

The effectiveness against hospital admission in cases of delta and omicron variants were 97% and 53%, respectively.

The effectiveness of three doses was 73% against omicron infant infection and 80% against omicron-related infant hospitalization. Data were not available for the effectiveness of three doses against the delta variant.

The effectiveness of two doses of vaccine against infant omicron infection was highest when mothers received the second dose during the third trimester of pregnancy, compared with during the first trimester or second trimester (53% vs. 47% and 53% vs. 37%, respectively).

Vaccine effectiveness with two doses against infant infection from omicron was highest in the first 8 weeks of life (57%), then decreased to 40% among infants after 16 weeks of age.

Although the study was not designed to assess the mechanism of action of the impact of maternal vaccination on infants, the current study results were consistent with other recent studies showing a reduction in infections and hospitalizations among infants whose mothers received COVID-19 vaccines during pregnancy, the researchers wrote in their discussion.

The findings were limited by several factors including the potential unmeasured confounders not available in databases, such as whether infants were breastfed, the researchers noted. Other limitations included a lack of data on home test results and the inability to assess the waning impact of the vaccine effectiveness against the delta variant because of the small number of delta cases, they said. However, the results suggest that the mRNA COVID-19 vaccine during pregnancy was moderately to highly effective for protection against omicron and delta infection and infection-related hospitalization – especially during the first 8 weeks of life.

Effectiveness is encouraging, but updates are needed

The effectiveness of maternal vaccination to prevent COVID-19 infection and related hospitalizations in infants is promising, especially since those younger than 6 months have no other source of vaccine protection against COVID-19 infection, wrote Dana Danino, MD, of Soroka University Medical Center, Israel, and Ilan Youngster, MD, of Shamir Medical Center, Israel, in an accompanying editorial also published in The BMJ.

They also noted that maternal vaccination during pregnancy is an established method of protecting infants from infections such as influenza and pertussis.

Data from previous studies show that most infants whose mothers were vaccinated against COVID-19 during pregnancy retained maternal antibodies at 6 months, “but evidence for protection against neonatal COVID-19 infection has been deficient,” they said.

The current study findings support the value of vaccination during pregnancy, and the findings were strengthened by the large study population, the editorialists wrote. However, whether the same effectiveness holds for other COVID-19 strains such as BQ.1, BQ.1.1, BF.7, XBB, and XBB.1 remains unknown, they said.

Other areas in need of exploration include the optimal timing of vaccination during pregnancy, the protective effects of a bivalent mRNA vaccine (vs. the primary monovalent vaccine in the current study), and the potential benefits of additional boosters, they added.

“Although Jorgenson and colleagues’ study reinforces the value of maternal vaccination against COVID-19 during pregnancy, more studies are needed to better inform vaccination recommendations in an evolving landscape of new SARS-CoV-2 strains and novel vaccines,” the editorialists concluded.

The study was supported by ICES, which is funded by an annual grant from the Ontario Ministry of Health and the Ministry of Long-term Care; the study also received funding from the Canadian Immunization Research Network and the Public Health Agency of Canada. Dr. Jorgensen and the editorialists had no financial conflicts to disclose.

*This article was updated on 3/2/2023.

HEGENBERGER RETRACTOR:  IS IT HELPFUL FOR PERINEAL REPAIR? 

The Hegenberger Retractor, manufactured by Hegenberger Medical (Abingdon, United Kingdom) is available for purchase in the United States through Rocket Medical. A video that I find particularly useful for explaining its use is available here: https://www.youtube.com /watch?v=p-jilXgXZLY

Background. About 85% of women having a vaginal birth experience some form of perineal trauma, and 60% to 70% receive stitches for those spontaneous tears or intentional incisions. As such, repairing perineal lacerations is a requisite skill for all obstetricians and midwives, and every provider has developed exposure techniques to perform their suturing with the goals of good tissue re-approximation, efficiency, minimized patient discomfort, reduced blood loss, and safety from needle sticks. For several millennia, the most commonly used tissue retractor for these repairs has been one’s own fingers, or those of a colleague. While cost-effective and readily available, fingers do have drawbacks as a vaginal retractor. First, their use as a retractor precludes their use for other tasks. Second, their frequent need to be inserted and replaced (see drawback #1) can be uncomfortable for patients. Third, their limited surface area is often insufficient to appropriately provide adequate tissue retraction for optimal surgical site visualization. Finally, they get tired and typically do not appreciate being stuck with needles. Given all this, it is surprising that so many centuries have passed with so little innovation for this ubiquitous procedure. Fortunately, Danish midwife Malene Hegenberger thought now was a good time to change the status quo.

Design/Functionality. The Hegenberger Retractor is brilliant in its simplicity. Its unique molded plastic design is smooth, ergonomic, nonconductive, and packaged as a single-use sterile device. Amazingly, it has a near-perfect pliability balance, making it simultaneously easy to compress for insertion while providing enough retraction tension for good visualization once it has been reexpanded. The subtle ridges on the compression points are just enough to allow for a good grip, and the notches on the sides are a convenient addition for holding extra suture if needed. The device has been cleared by the US Food and Drug Administration (FDA) as a Class 1 device and is approved for sale in the United States. In my experience with its use, I thought it was easy to place and provided excellent exposure for the repairs I was doing. In fact, I thought it provided as good if not better exposure than what I would expect from a Gelpi retractor without any of the trauma the Gelpi adds with its pointed ends. Smile emoji!

Innovation. In the early 1800s, French midwifery pioneer Marie Boivin introduced a novel pelvimeter and a revolutionary 2-part speculum to the technology of the day. Why it took more than 200 years for the ideas of another cutting-edge midwife to breach the walls of the obstetric technological establishment remains a mystery, but fortunately it has been done. While seemingly obvious, the Hegenberger Retractor is the culmination of years of work and 88 prototypes. It looks simple, but the secret to its functionality is the precision with which each dimension and every curve was designed. The device has been cleared by the FDA as a Class 1 device and is approved for sale in the United States. 

Summary. There are a lot of reasons to like the Hegenberger Retractor. I like it for its simplicity; I like it for its functionality; I like it for its ability to fill a real need. On the downside, I do not like that it is a single-use plastic device, and I am not happy about adding cost to obstetric care. Most of all, I hate that I did not invent it. 

Is the Hegenberger Retractor going to be needed to repair every obstetric laceration? No. Will it provide perfect exposure to repair every obstetric laceration? Of course not. But it is an incredibly clever device that will be very helpful in many situations, and I suspect it will soon become a mainstay on most maternity units as it gains recognition.

FOR MORE INFORMATION, VISIT www.rocketmedical.com

HEGENBERGER RETRACTOR:  IS IT HELPFUL FOR PERINEAL REPAIR? 

The Hegenberger Retractor, manufactured by Hegenberger Medical (Abingdon, United Kingdom) is available for purchase in the United States through Rocket Medical. A video that I find particularly useful for explaining its use is available here: https://www.youtube.com /watch?v=p-jilXgXZLY

Background. About 85% of women having a vaginal birth experience some form of perineal trauma, and 60% to 70% receive stitches for those spontaneous tears or intentional incisions. As such, repairing perineal lacerations is a requisite skill for all obstetricians and midwives, and every provider has developed exposure techniques to perform their suturing with the goals of good tissue re-approximation, efficiency, minimized patient discomfort, reduced blood loss, and safety from needle sticks. For several millennia, the most commonly used tissue retractor for these repairs has been one’s own fingers, or those of a colleague. While cost-effective and readily available, fingers do have drawbacks as a vaginal retractor. First, their use as a retractor precludes their use for other tasks. Second, their frequent need to be inserted and replaced (see drawback #1) can be uncomfortable for patients. Third, their limited surface area is often insufficient to appropriately provide adequate tissue retraction for optimal surgical site visualization. Finally, they get tired and typically do not appreciate being stuck with needles. Given all this, it is surprising that so many centuries have passed with so little innovation for this ubiquitous procedure. Fortunately, Danish midwife Malene Hegenberger thought now was a good time to change the status quo.

Design/Functionality. The Hegenberger Retractor is brilliant in its simplicity. Its unique molded plastic design is smooth, ergonomic, nonconductive, and packaged as a single-use sterile device. Amazingly, it has a near-perfect pliability balance, making it simultaneously easy to compress for insertion while providing enough retraction tension for good visualization once it has been reexpanded. The subtle ridges on the compression points are just enough to allow for a good grip, and the notches on the sides are a convenient addition for holding extra suture if needed. The device has been cleared by the US Food and Drug Administration (FDA) as a Class 1 device and is approved for sale in the United States. In my experience with its use, I thought it was easy to place and provided excellent exposure for the repairs I was doing. In fact, I thought it provided as good if not better exposure than what I would expect from a Gelpi retractor without any of the trauma the Gelpi adds with its pointed ends. Smile emoji!

Innovation. In the early 1800s, French midwifery pioneer Marie Boivin introduced a novel pelvimeter and a revolutionary 2-part speculum to the technology of the day. Why it took more than 200 years for the ideas of another cutting-edge midwife to breach the walls of the obstetric technological establishment remains a mystery, but fortunately it has been done. While seemingly obvious, the Hegenberger Retractor is the culmination of years of work and 88 prototypes. It looks simple, but the secret to its functionality is the precision with which each dimension and every curve was designed. The device has been cleared by the FDA as a Class 1 device and is approved for sale in the United States. 

Summary. There are a lot of reasons to like the Hegenberger Retractor. I like it for its simplicity; I like it for its functionality; I like it for its ability to fill a real need. On the downside, I do not like that it is a single-use plastic device, and I am not happy about adding cost to obstetric care. Most of all, I hate that I did not invent it. 

Is the Hegenberger Retractor going to be needed to repair every obstetric laceration? No. Will it provide perfect exposure to repair every obstetric laceration? Of course not. But it is an incredibly clever device that will be very helpful in many situations, and I suspect it will soon become a mainstay on most maternity units as it gains recognition.

FOR MORE INFORMATION, VISIT www.rocketmedical.com

HEGENBERGER RETRACTOR:  IS IT HELPFUL FOR PERINEAL REPAIR? 

The Hegenberger Retractor, manufactured by Hegenberger Medical (Abingdon, United Kingdom) is available for purchase in the United States through Rocket Medical. A video that I find particularly useful for explaining its use is available here: https://www.youtube.com /watch?v=p-jilXgXZLY

Background. About 85% of women having a vaginal birth experience some form of perineal trauma, and 60% to 70% receive stitches for those spontaneous tears or intentional incisions. As such, repairing perineal lacerations is a requisite skill for all obstetricians and midwives, and every provider has developed exposure techniques to perform their suturing with the goals of good tissue re-approximation, efficiency, minimized patient discomfort, reduced blood loss, and safety from needle sticks. For several millennia, the most commonly used tissue retractor for these repairs has been one’s own fingers, or those of a colleague. While cost-effective and readily available, fingers do have drawbacks as a vaginal retractor. First, their use as a retractor precludes their use for other tasks. Second, their frequent need to be inserted and replaced (see drawback #1) can be uncomfortable for patients. Third, their limited surface area is often insufficient to appropriately provide adequate tissue retraction for optimal surgical site visualization. Finally, they get tired and typically do not appreciate being stuck with needles. Given all this, it is surprising that so many centuries have passed with so little innovation for this ubiquitous procedure. Fortunately, Danish midwife Malene Hegenberger thought now was a good time to change the status quo.

Design/Functionality. The Hegenberger Retractor is brilliant in its simplicity. Its unique molded plastic design is smooth, ergonomic, nonconductive, and packaged as a single-use sterile device. Amazingly, it has a near-perfect pliability balance, making it simultaneously easy to compress for insertion while providing enough retraction tension for good visualization once it has been reexpanded. The subtle ridges on the compression points are just enough to allow for a good grip, and the notches on the sides are a convenient addition for holding extra suture if needed. The device has been cleared by the US Food and Drug Administration (FDA) as a Class 1 device and is approved for sale in the United States. In my experience with its use, I thought it was easy to place and provided excellent exposure for the repairs I was doing. In fact, I thought it provided as good if not better exposure than what I would expect from a Gelpi retractor without any of the trauma the Gelpi adds with its pointed ends. Smile emoji!

Innovation. In the early 1800s, French midwifery pioneer Marie Boivin introduced a novel pelvimeter and a revolutionary 2-part speculum to the technology of the day. Why it took more than 200 years for the ideas of another cutting-edge midwife to breach the walls of the obstetric technological establishment remains a mystery, but fortunately it has been done. While seemingly obvious, the Hegenberger Retractor is the culmination of years of work and 88 prototypes. It looks simple, but the secret to its functionality is the precision with which each dimension and every curve was designed. The device has been cleared by the FDA as a Class 1 device and is approved for sale in the United States. 

Summary. There are a lot of reasons to like the Hegenberger Retractor. I like it for its simplicity; I like it for its functionality; I like it for its ability to fill a real need. On the downside, I do not like that it is a single-use plastic device, and I am not happy about adding cost to obstetric care. Most of all, I hate that I did not invent it. 

Is the Hegenberger Retractor going to be needed to repair every obstetric laceration? No. Will it provide perfect exposure to repair every obstetric laceration? Of course not. But it is an incredibly clever device that will be very helpful in many situations, and I suspect it will soon become a mainstay on most maternity units as it gains recognition.

FOR MORE INFORMATION, VISIT www.rocketmedical.com

Should treatment be initiated for mild chronic hypertension in pregnancy to improve outcomes?

JAIMEY M. PAULI, MD (JUNE 2022)

Consider this, when it comes to treating chronic hypertension

I welcome the article by Dr. Jaimey Pauli, which focuses on initiating treatment for mild chronic hypertension in pregnancy to reach a goal blood pressure (BP) of <140/90 mm Hg to prevent adverse maternal and fetal outcomes.¹ I would like to offer 3 additional thoughts for your consideration. First, it is known that there is a physiological decrease in BP during the second trimester, which results in a normotensive presentation. Thus, it would be beneficial to see if pregnant women with high-normal BP levels before the third trimester be administered a lower dose of antihypertensives. However, there is also a concern that decreased maternal BP may compromise uteroplacental perfusion and fetal circulation, which also could be evaluated.²

Second, I would like to see how comorbidities affect the initiation of antihypertensives for mild chronic hypertension in pregnancy. Research incorporating pregnant women with borderline hypertension and comorbidities such as obesity, hyperlipidemia, and diabetes mellitus type 2 (DM) is likely to yield informative results. This is especially beneficial since, for example, chronic hypertension and DM are independent risk factors for adverse maternal and fetal outcomes; therefore, a mother with both these conditions may have additive effects on obstetric outcomes.³

Lastly, I would suggest you include a brief conversation about prepregnancy ways to manage women with chronic hypertension. Because many women who enter pregnancy with chronic hypertension have hypertension of unknown origin, it would be beneficial to optimize antihypertensive regimens before conception.⁴ Also, it should be further evaluated whether initiation of lifestyle modifications, such as weight reduction and the DASH diet before pregnancy, for women with chronic hypertension improves pregnancy outcomes.

Cassandra Maafoh, MD

Macon, Georgia

References

1. Pauli JM. Should treatment be initiated for mild chronic hypertension in pregnancy to improve outcomes? OBG Manag. 2022;34:14-15.
2. Brown CM, Garovic VD. Drug treatment of hypertension in pregnancy. Drugs. 2014;74:283-296. https://doi.org/10.1007/s40265-014-0187-7.
3. Yanit KE, Snowden JM, Cheng YW, et al. The impact of chronic hypertension and pregestational diabetes on pregnancy outcomes. Am J Obstet Gynecol. 2012;207. https://doi. org/10.1016/j.ajog.2012.06.066.
4. Seely EW, Ecker J. Chronic hypertension in pregnancy. Circulation. 2014;129:1254-1261. https:// doi.org/10.1161/circulationaha.113.003904. 

2022 UPDATE ON FEMALE SEXUAL HEALTH

BARBARA LEVY, MD (AUGUST 2022)

Are these new and rare syndromes’ pathophysiological mechanisms related?

I read with great interest Dr. Barbara Levy’s UPDATE in the August 2022 issue on testosterone therapy for women with hypoactive sexual desire disorder (HSDD), as well as her comments on persistent genital arousal disorder/genito-pelvic dysesthesia (PGAD/GPD) that was recently so coined by the International Society for the Study of Women’s Sexual Health (ISSWSH) as a 2-component syndrome.¹ The new syndrome, explains Dr. Levy, presents with “the perception of genital arousal that is involuntary, unrelated to sexual desire, without any identified cause, not relieved with orgasm, and distressing to the patient (the PGAD component),” combined with “itching, burning, tingling, or pain” (the GPD component).

Although agreeing with ISSWSH that diagnosis and management require a multidisciplinary biopsychosocial approach, in her practical advice, Dr. Levy mentioned: “neuropathic signaling” with “aberrant sensory processing” as the syndrome’s possible main pathophysiology. Interestingly, there are 2 other rare, chronic, and “poorly recognized source(s) of major distress to a small but significant group of patients.” Persistent idiopathic oro-facial pain (PIFP) disorder² after dental interventions and burning mouth syndrome (BMS),³ defined by the absence of any local or systemic contributing etiology, also present with continuous local burning and pain (as in GPD). Consequently, PGAD/GPD may indeed have the same pathophysiological explanation—as Dr. Levy suggested—of being a (genital) peripheral chronic neuropathic pain condition.

A potentially promising new therapeutic approach for PGAD/GPD would then be to use the same, or similar, antineuropathic medications (Clonazepam, Nortriptyline, Pregabalin, etc.) in the form of topical vaginal swishing solutions similar to the presently recommended antiepileptic and/or antidepressant oral swishing treatment for PIFP and BMS. As the topical approach works well for oral neuropathic pain, vaginal swishing could potentially be the answer for PGAD/GPD peripheral neuropathic pain. Moreover, such a novel topical approach would significantly increase patient motivation for treatment by avoiding the adverse effects of ingested antiepileptic or antidepressant drugs.

This is the first time that anticonvulsant and/or antidepressant vaginal swishing is proposed as topical therapy for GPD peripheral neuropathic pain, still pending scientific/clinical validation. ●

Zwi Hoch, MD

Newton, Massachusetts

1. Goldstein I, Komisaruk BR, Pukall CF, et al. International Society for the Study of Women’s Sexual Health (ISSWSH) Review of Epidemiology and Pathophysiology, and a Consensus Nomenclature and Process of Care for the Management of Persistent Genital Arousal Disorder/Genito-Pelvic Dysesthesia (PGAD/GPD). J Sex Med. 2021;18:665-697.
2. Baad-Hansen L, Benoliel R. Neuropathic orofacial pain: facts and fiction. Cephalgia. 2017;37:670-679.
3. Kuten-Shorer M, Treister NS, Stock S, et al. Safety and tolerability of topical clonazepam solution for management of oral dysesthesia. Oral Surg Oral Med Oral Pathol Oral Radiol. 2017;124: 146-151. 

Should treatment be initiated for mild chronic hypertension in pregnancy to improve outcomes?

JAIMEY M. PAULI, MD (JUNE 2022)

Consider this, when it comes to treating chronic hypertension

I welcome the article by Dr. Jaimey Pauli, which focuses on initiating treatment for mild chronic hypertension in pregnancy to reach a goal blood pressure (BP) of <140/90 mm Hg to prevent adverse maternal and fetal outcomes.¹ I would like to offer 3 additional thoughts for your consideration. First, it is known that there is a physiological decrease in BP during the second trimester, which results in a normotensive presentation. Thus, it would be beneficial to see if pregnant women with high-normal BP levels before the third trimester be administered a lower dose of antihypertensives. However, there is also a concern that decreased maternal BP may compromise uteroplacental perfusion and fetal circulation, which also could be evaluated.²

Second, I would like to see how comorbidities affect the initiation of antihypertensives for mild chronic hypertension in pregnancy. Research incorporating pregnant women with borderline hypertension and comorbidities such as obesity, hyperlipidemia, and diabetes mellitus type 2 (DM) is likely to yield informative results. This is especially beneficial since, for example, chronic hypertension and DM are independent risk factors for adverse maternal and fetal outcomes; therefore, a mother with both these conditions may have additive effects on obstetric outcomes.³

Lastly, I would suggest you include a brief conversation about prepregnancy ways to manage women with chronic hypertension. Because many women who enter pregnancy with chronic hypertension have hypertension of unknown origin, it would be beneficial to optimize antihypertensive regimens before conception.⁴ Also, it should be further evaluated whether initiation of lifestyle modifications, such as weight reduction and the DASH diet before pregnancy, for women with chronic hypertension improves pregnancy outcomes.

Cassandra Maafoh, MD

Macon, Georgia

References

1. Pauli JM. Should treatment be initiated for mild chronic hypertension in pregnancy to improve outcomes? OBG Manag. 2022;34:14-15.
2. Brown CM, Garovic VD. Drug treatment of hypertension in pregnancy. Drugs. 2014;74:283-296. https://doi.org/10.1007/s40265-014-0187-7.
3. Yanit KE, Snowden JM, Cheng YW, et al. The impact of chronic hypertension and pregestational diabetes on pregnancy outcomes. Am J Obstet Gynecol. 2012;207. https://doi. org/10.1016/j.ajog.2012.06.066.
4. Seely EW, Ecker J. Chronic hypertension in pregnancy. Circulation. 2014;129:1254-1261. https:// doi.org/10.1161/circulationaha.113.003904. 

2022 UPDATE ON FEMALE SEXUAL HEALTH

BARBARA LEVY, MD (AUGUST 2022)

Are these new and rare syndromes’ pathophysiological mechanisms related?

I read with great interest Dr. Barbara Levy’s UPDATE in the August 2022 issue on testosterone therapy for women with hypoactive sexual desire disorder (HSDD), as well as her comments on persistent genital arousal disorder/genito-pelvic dysesthesia (PGAD/GPD) that was recently so coined by the International Society for the Study of Women’s Sexual Health (ISSWSH) as a 2-component syndrome.¹ The new syndrome, explains Dr. Levy, presents with “the perception of genital arousal that is involuntary, unrelated to sexual desire, without any identified cause, not relieved with orgasm, and distressing to the patient (the PGAD component),” combined with “itching, burning, tingling, or pain” (the GPD component).

Although agreeing with ISSWSH that diagnosis and management require a multidisciplinary biopsychosocial approach, in her practical advice, Dr. Levy mentioned: “neuropathic signaling” with “aberrant sensory processing” as the syndrome’s possible main pathophysiology. Interestingly, there are 2 other rare, chronic, and “poorly recognized source(s) of major distress to a small but significant group of patients.” Persistent idiopathic oro-facial pain (PIFP) disorder² after dental interventions and burning mouth syndrome (BMS),³ defined by the absence of any local or systemic contributing etiology, also present with continuous local burning and pain (as in GPD). Consequently, PGAD/GPD may indeed have the same pathophysiological explanation—as Dr. Levy suggested—of being a (genital) peripheral chronic neuropathic pain condition.

A potentially promising new therapeutic approach for PGAD/GPD would then be to use the same, or similar, antineuropathic medications (Clonazepam, Nortriptyline, Pregabalin, etc.) in the form of topical vaginal swishing solutions similar to the presently recommended antiepileptic and/or antidepressant oral swishing treatment for PIFP and BMS. As the topical approach works well for oral neuropathic pain, vaginal swishing could potentially be the answer for PGAD/GPD peripheral neuropathic pain. Moreover, such a novel topical approach would significantly increase patient motivation for treatment by avoiding the adverse effects of ingested antiepileptic or antidepressant drugs.

This is the first time that anticonvulsant and/or antidepressant vaginal swishing is proposed as topical therapy for GPD peripheral neuropathic pain, still pending scientific/clinical validation. ●

Zwi Hoch, MD

Newton, Massachusetts

1. Goldstein I, Komisaruk BR, Pukall CF, et al. International Society for the Study of Women’s Sexual Health (ISSWSH) Review of Epidemiology and Pathophysiology, and a Consensus Nomenclature and Process of Care for the Management of Persistent Genital Arousal Disorder/Genito-Pelvic Dysesthesia (PGAD/GPD). J Sex Med. 2021;18:665-697.
2. Baad-Hansen L, Benoliel R. Neuropathic orofacial pain: facts and fiction. Cephalgia. 2017;37:670-679.
3. Kuten-Shorer M, Treister NS, Stock S, et al. Safety and tolerability of topical clonazepam solution for management of oral dysesthesia. Oral Surg Oral Med Oral Pathol Oral Radiol. 2017;124: 146-151. 

Should treatment be initiated for mild chronic hypertension in pregnancy to improve outcomes?

JAIMEY M. PAULI, MD (JUNE 2022)

Consider this, when it comes to treating chronic hypertension

I welcome the article by Dr. Jaimey Pauli, which focuses on initiating treatment for mild chronic hypertension in pregnancy to reach a goal blood pressure (BP) of <140/90 mm Hg to prevent adverse maternal and fetal outcomes.¹ I would like to offer 3 additional thoughts for your consideration. First, it is known that there is a physiological decrease in BP during the second trimester, which results in a normotensive presentation. Thus, it would be beneficial to see if pregnant women with high-normal BP levels before the third trimester be administered a lower dose of antihypertensives. However, there is also a concern that decreased maternal BP may compromise uteroplacental perfusion and fetal circulation, which also could be evaluated.²

Second, I would like to see how comorbidities affect the initiation of antihypertensives for mild chronic hypertension in pregnancy. Research incorporating pregnant women with borderline hypertension and comorbidities such as obesity, hyperlipidemia, and diabetes mellitus type 2 (DM) is likely to yield informative results. This is especially beneficial since, for example, chronic hypertension and DM are independent risk factors for adverse maternal and fetal outcomes; therefore, a mother with both these conditions may have additive effects on obstetric outcomes.³

Lastly, I would suggest you include a brief conversation about prepregnancy ways to manage women with chronic hypertension. Because many women who enter pregnancy with chronic hypertension have hypertension of unknown origin, it would be beneficial to optimize antihypertensive regimens before conception.⁴ Also, it should be further evaluated whether initiation of lifestyle modifications, such as weight reduction and the DASH diet before pregnancy, for women with chronic hypertension improves pregnancy outcomes.

Cassandra Maafoh, MD

Macon, Georgia

References

1. Pauli JM. Should treatment be initiated for mild chronic hypertension in pregnancy to improve outcomes? OBG Manag. 2022;34:14-15.
2. Brown CM, Garovic VD. Drug treatment of hypertension in pregnancy. Drugs. 2014;74:283-296. https://doi.org/10.1007/s40265-014-0187-7.
3. Yanit KE, Snowden JM, Cheng YW, et al. The impact of chronic hypertension and pregestational diabetes on pregnancy outcomes. Am J Obstet Gynecol. 2012;207. https://doi. org/10.1016/j.ajog.2012.06.066.
4. Seely EW, Ecker J. Chronic hypertension in pregnancy. Circulation. 2014;129:1254-1261. https:// doi.org/10.1161/circulationaha.113.003904. 

2022 UPDATE ON FEMALE SEXUAL HEALTH

BARBARA LEVY, MD (AUGUST 2022)

Are these new and rare syndromes’ pathophysiological mechanisms related?

I read with great interest Dr. Barbara Levy’s UPDATE in the August 2022 issue on testosterone therapy for women with hypoactive sexual desire disorder (HSDD), as well as her comments on persistent genital arousal disorder/genito-pelvic dysesthesia (PGAD/GPD) that was recently so coined by the International Society for the Study of Women’s Sexual Health (ISSWSH) as a 2-component syndrome.¹ The new syndrome, explains Dr. Levy, presents with “the perception of genital arousal that is involuntary, unrelated to sexual desire, without any identified cause, not relieved with orgasm, and distressing to the patient (the PGAD component),” combined with “itching, burning, tingling, or pain” (the GPD component).

Although agreeing with ISSWSH that diagnosis and management require a multidisciplinary biopsychosocial approach, in her practical advice, Dr. Levy mentioned: “neuropathic signaling” with “aberrant sensory processing” as the syndrome’s possible main pathophysiology. Interestingly, there are 2 other rare, chronic, and “poorly recognized source(s) of major distress to a small but significant group of patients.” Persistent idiopathic oro-facial pain (PIFP) disorder² after dental interventions and burning mouth syndrome (BMS),³ defined by the absence of any local or systemic contributing etiology, also present with continuous local burning and pain (as in GPD). Consequently, PGAD/GPD may indeed have the same pathophysiological explanation—as Dr. Levy suggested—of being a (genital) peripheral chronic neuropathic pain condition.

A potentially promising new therapeutic approach for PGAD/GPD would then be to use the same, or similar, antineuropathic medications (Clonazepam, Nortriptyline, Pregabalin, etc.) in the form of topical vaginal swishing solutions similar to the presently recommended antiepileptic and/or antidepressant oral swishing treatment for PIFP and BMS. As the topical approach works well for oral neuropathic pain, vaginal swishing could potentially be the answer for PGAD/GPD peripheral neuropathic pain. Moreover, such a novel topical approach would significantly increase patient motivation for treatment by avoiding the adverse effects of ingested antiepileptic or antidepressant drugs.

This is the first time that anticonvulsant and/or antidepressant vaginal swishing is proposed as topical therapy for GPD peripheral neuropathic pain, still pending scientific/clinical validation. ●

Zwi Hoch, MD

Newton, Massachusetts

1. Goldstein I, Komisaruk BR, Pukall CF, et al. International Society for the Study of Women’s Sexual Health (ISSWSH) Review of Epidemiology and Pathophysiology, and a Consensus Nomenclature and Process of Care for the Management of Persistent Genital Arousal Disorder/Genito-Pelvic Dysesthesia (PGAD/GPD). J Sex Med. 2021;18:665-697.
2. Baad-Hansen L, Benoliel R. Neuropathic orofacial pain: facts and fiction. Cephalgia. 2017;37:670-679.
3. Kuten-Shorer M, Treister NS, Stock S, et al. Safety and tolerability of topical clonazepam solution for management of oral dysesthesia. Oral Surg Oral Med Oral Pathol Oral Radiol. 2017;124: 146-151.