Preterm Birth

A federal advisory panel recommended the United States withdraw from the market an injection given to women at risk for giving birth prematurely. Many of its members argued this step is needed to allow further testing to see if this drug actually works.

The Food and Drug Administration has been seeking to pull the approval of hydroxyprogesterone caproate (17P) injection (Makena, Covis) since 2020, after the drug failed to show a benefit in the PROLONG study. This study was meant as a confirmatory trial for the accelerated approval the FDA granted Makena in 2011 based on promising results from an earlier small study, known as the Meis trial. The manufacturer, Covis, contends that the flaws in the PROLONG study made Makena appear ineffective.

The FDA asked its Obstetrics, Reproductive and Urologic Drugs Advisory Committee to review the evidence gathered to date on Makena at a hearing that ran from Oct. 17 to Oct. 19. At the conclusion, the FDA asked the committee to vote on whether the agency should allow Makena to remain on the market while an appropriate confirmatory study is designed and conducted.

The vote was 14-1 against this plan.

There needs to be another study as a “tiebreaker” to determine which of the previous Makena trials was correct, said FDA panelist Michael K. Lindsay, MD, MPH, who is also director of the division of maternal-fetal medicine for Grady and Emory University Hospital Midtown, Atlanta.

“I think there needs to be another trial,” Dr. Lindsay said. “If you can do the trial without the medication being FDA approved, then I am supportive of that.”

Members of the FDA panel noted the difficulties that would ensue if Covis attempted further study of Makena with the drug still approved, including difficulties in recruiting patients. Indeed, there were delays in recruiting patients for the PROLONG trial in part because Makena was perceived as the standard of care for pregnant women who had a prior spontaneous preterm birth. That led to efforts to enroll patients outside of the United States, particularly in Eastern European countries.

Panelist Cassandra E. Henderson, MD, of the New York-based Garden OB/GYN practice, was the dissenter in the 14-1 vote.

Withdrawing the approval of Makena may lead to increased use of pharmacy-compounded versions of this medicine, as women look for options to try to extend their pregnancies, she said.

“They may seek it in other ways and get something that we don’t have any control over, and we don’t know what the fetus may be exposed to,” Dr. Henderson said.

Dr. Henderson also said there should be greater discussion with patients about questions of potential “intergenerational risk” because of fetal exposure to the medicine. Covis could add a registry similar to the University of Chicago’s DES Program to its research program for Makena, she said.
 

Race-based argument

Covis has been fighting to keep the Makena approval by offering theories for why the PROLONG study failed to show a benefit for the drug.

Covis emphasizes the different racial make-up of patients in the two trials. Black women composed 59% of the Meis study population, compared with only 6.7% for the PROLONG study, Covis said in its briefing document for the hearing. The Luxembourg-based company also says that there may have been unreliable estimates of the gestational age in the PROLONG trial, which enrolled many subjects in Ukraine and Russia.

During deliberations among panelists on Oct. 19, Dr. Henderson emphasized a need to consider other factors that may have been involved and encouraged continued study of the drug in Black women. She dismissed the idea of a race-based difference being the explanation for the difference between the two trials, but instead stressed that race serves as a marker for inequities, which are known to increase risk for preterm birth.

“Targeting a population that is at risk, particularly Black women in the United States, may show something that would be beneficial” from Makena, Dr. Henderson said.

Other physicians have argued that this approach would actually put Black women and children at greater risk of an ineffective drug with potential side effects.

“The drug is not proven to work so keeping it on the market to be injected into Black women to see what subgroups it might work in essentially amounts to experimentation,” said Adam Urato, MD, chief of maternal-fetal medicine at MetroWest Medical Center in Framingham, Mass., during the public comment session of the hearing.

The vote marks the second time that the FDA’s advisers on reproductive health have told the agency that the evidence gathered on the drug does not support its use. An advisory committee also cast votes against the drug at a 2019 meeting.

The rate of preterm birth in Black women in 2020 was 14.4%, significantly higher than the rate of preterm birth in White or Hispanic women, 9.1% and 9.8%, respectively, according to the Centers for Disease Control and Prevention. The potential for harm to children from premature birth led the FDA to clear Makena through the accelerated approval pathway, said Patrizia Cavazzoni, MD, the director of FDA’s Center for Drug Evaluation and Research, in the opening session of the hearing.

“We once thought Makena was likely to be part of the answer to that problem,” Dr. Cavazzoni said. “Unfortunately we no longer do, based on the evidence available.”

A federal advisory panel recommended the United States withdraw from the market an injection given to women at risk for giving birth prematurely. Many of its members argued this step is needed to allow further testing to see if this drug actually works.

The Food and Drug Administration has been seeking to pull the approval of hydroxyprogesterone caproate (17P) injection (Makena, Covis) since 2020, after the drug failed to show a benefit in the PROLONG study. This study was meant as a confirmatory trial for the accelerated approval the FDA granted Makena in 2011 based on promising results from an earlier small study, known as the Meis trial. The manufacturer, Covis, contends that the flaws in the PROLONG study made Makena appear ineffective.

The FDA asked its Obstetrics, Reproductive and Urologic Drugs Advisory Committee to review the evidence gathered to date on Makena at a hearing that ran from Oct. 17 to Oct. 19. At the conclusion, the FDA asked the committee to vote on whether the agency should allow Makena to remain on the market while an appropriate confirmatory study is designed and conducted.

The vote was 14-1 against this plan.

There needs to be another study as a “tiebreaker” to determine which of the previous Makena trials was correct, said FDA panelist Michael K. Lindsay, MD, MPH, who is also director of the division of maternal-fetal medicine for Grady and Emory University Hospital Midtown, Atlanta.

“I think there needs to be another trial,” Dr. Lindsay said. “If you can do the trial without the medication being FDA approved, then I am supportive of that.”

Members of the FDA panel noted the difficulties that would ensue if Covis attempted further study of Makena with the drug still approved, including difficulties in recruiting patients. Indeed, there were delays in recruiting patients for the PROLONG trial in part because Makena was perceived as the standard of care for pregnant women who had a prior spontaneous preterm birth. That led to efforts to enroll patients outside of the United States, particularly in Eastern European countries.

Panelist Cassandra E. Henderson, MD, of the New York-based Garden OB/GYN practice, was the dissenter in the 14-1 vote.

Withdrawing the approval of Makena may lead to increased use of pharmacy-compounded versions of this medicine, as women look for options to try to extend their pregnancies, she said.

“They may seek it in other ways and get something that we don’t have any control over, and we don’t know what the fetus may be exposed to,” Dr. Henderson said.

Dr. Henderson also said there should be greater discussion with patients about questions of potential “intergenerational risk” because of fetal exposure to the medicine. Covis could add a registry similar to the University of Chicago’s DES Program to its research program for Makena, she said.
 

Race-based argument

Covis has been fighting to keep the Makena approval by offering theories for why the PROLONG study failed to show a benefit for the drug.

Covis emphasizes the different racial make-up of patients in the two trials. Black women composed 59% of the Meis study population, compared with only 6.7% for the PROLONG study, Covis said in its briefing document for the hearing. The Luxembourg-based company also says that there may have been unreliable estimates of the gestational age in the PROLONG trial, which enrolled many subjects in Ukraine and Russia.

During deliberations among panelists on Oct. 19, Dr. Henderson emphasized a need to consider other factors that may have been involved and encouraged continued study of the drug in Black women. She dismissed the idea of a race-based difference being the explanation for the difference between the two trials, but instead stressed that race serves as a marker for inequities, which are known to increase risk for preterm birth.

“Targeting a population that is at risk, particularly Black women in the United States, may show something that would be beneficial” from Makena, Dr. Henderson said.

Other physicians have argued that this approach would actually put Black women and children at greater risk of an ineffective drug with potential side effects.

“The drug is not proven to work so keeping it on the market to be injected into Black women to see what subgroups it might work in essentially amounts to experimentation,” said Adam Urato, MD, chief of maternal-fetal medicine at MetroWest Medical Center in Framingham, Mass., during the public comment session of the hearing.

The vote marks the second time that the FDA’s advisers on reproductive health have told the agency that the evidence gathered on the drug does not support its use. An advisory committee also cast votes against the drug at a 2019 meeting.

The rate of preterm birth in Black women in 2020 was 14.4%, significantly higher than the rate of preterm birth in White or Hispanic women, 9.1% and 9.8%, respectively, according to the Centers for Disease Control and Prevention. The potential for harm to children from premature birth led the FDA to clear Makena through the accelerated approval pathway, said Patrizia Cavazzoni, MD, the director of FDA’s Center for Drug Evaluation and Research, in the opening session of the hearing.

“We once thought Makena was likely to be part of the answer to that problem,” Dr. Cavazzoni said. “Unfortunately we no longer do, based on the evidence available.”

A federal advisory panel recommended the United States withdraw from the market an injection given to women at risk for giving birth prematurely. Many of its members argued this step is needed to allow further testing to see if this drug actually works.

The Food and Drug Administration has been seeking to pull the approval of hydroxyprogesterone caproate (17P) injection (Makena, Covis) since 2020, after the drug failed to show a benefit in the PROLONG study. This study was meant as a confirmatory trial for the accelerated approval the FDA granted Makena in 2011 based on promising results from an earlier small study, known as the Meis trial. The manufacturer, Covis, contends that the flaws in the PROLONG study made Makena appear ineffective.

The FDA asked its Obstetrics, Reproductive and Urologic Drugs Advisory Committee to review the evidence gathered to date on Makena at a hearing that ran from Oct. 17 to Oct. 19. At the conclusion, the FDA asked the committee to vote on whether the agency should allow Makena to remain on the market while an appropriate confirmatory study is designed and conducted.

The vote was 14-1 against this plan.

There needs to be another study as a “tiebreaker” to determine which of the previous Makena trials was correct, said FDA panelist Michael K. Lindsay, MD, MPH, who is also director of the division of maternal-fetal medicine for Grady and Emory University Hospital Midtown, Atlanta.

“I think there needs to be another trial,” Dr. Lindsay said. “If you can do the trial without the medication being FDA approved, then I am supportive of that.”

Members of the FDA panel noted the difficulties that would ensue if Covis attempted further study of Makena with the drug still approved, including difficulties in recruiting patients. Indeed, there were delays in recruiting patients for the PROLONG trial in part because Makena was perceived as the standard of care for pregnant women who had a prior spontaneous preterm birth. That led to efforts to enroll patients outside of the United States, particularly in Eastern European countries.

Panelist Cassandra E. Henderson, MD, of the New York-based Garden OB/GYN practice, was the dissenter in the 14-1 vote.

Withdrawing the approval of Makena may lead to increased use of pharmacy-compounded versions of this medicine, as women look for options to try to extend their pregnancies, she said.

“They may seek it in other ways and get something that we don’t have any control over, and we don’t know what the fetus may be exposed to,” Dr. Henderson said.

Dr. Henderson also said there should be greater discussion with patients about questions of potential “intergenerational risk” because of fetal exposure to the medicine. Covis could add a registry similar to the University of Chicago’s DES Program to its research program for Makena, she said.
 

Race-based argument

Covis has been fighting to keep the Makena approval by offering theories for why the PROLONG study failed to show a benefit for the drug.

Covis emphasizes the different racial make-up of patients in the two trials. Black women composed 59% of the Meis study population, compared with only 6.7% for the PROLONG study, Covis said in its briefing document for the hearing. The Luxembourg-based company also says that there may have been unreliable estimates of the gestational age in the PROLONG trial, which enrolled many subjects in Ukraine and Russia.

During deliberations among panelists on Oct. 19, Dr. Henderson emphasized a need to consider other factors that may have been involved and encouraged continued study of the drug in Black women. She dismissed the idea of a race-based difference being the explanation for the difference between the two trials, but instead stressed that race serves as a marker for inequities, which are known to increase risk for preterm birth.

“Targeting a population that is at risk, particularly Black women in the United States, may show something that would be beneficial” from Makena, Dr. Henderson said.

Other physicians have argued that this approach would actually put Black women and children at greater risk of an ineffective drug with potential side effects.

“The drug is not proven to work so keeping it on the market to be injected into Black women to see what subgroups it might work in essentially amounts to experimentation,” said Adam Urato, MD, chief of maternal-fetal medicine at MetroWest Medical Center in Framingham, Mass., during the public comment session of the hearing.

The vote marks the second time that the FDA’s advisers on reproductive health have told the agency that the evidence gathered on the drug does not support its use. An advisory committee also cast votes against the drug at a 2019 meeting.

The rate of preterm birth in Black women in 2020 was 14.4%, significantly higher than the rate of preterm birth in White or Hispanic women, 9.1% and 9.8%, respectively, according to the Centers for Disease Control and Prevention. The potential for harm to children from premature birth led the FDA to clear Makena through the accelerated approval pathway, said Patrizia Cavazzoni, MD, the director of FDA’s Center for Drug Evaluation and Research, in the opening session of the hearing.

“We once thought Makena was likely to be part of the answer to that problem,” Dr. Cavazzoni said. “Unfortunately we no longer do, based on the evidence available.”

A sweeping study of 85,000 infants found no link between mRNA COVID vaccination in pregnancy and greater risk of preterm birth, babies being born small for their gestational age, or stillbirth.

The research team wrote in the BMJ that their reassuring findings – drawn from a registry of all births in Ontario over an 8-month period – “can inform evidence-based decision-making” about COVID vaccination during pregnancy.

Previous research has found that pregnant patients are at higher risk of severe complications and death if they become infected with COVID and that vaccination before or during pregnancy prevents such outcomes and reduces the risk of newborn infection, noted Jeffrey Ecker, chief of obstetrics and gynecology at Massachusetts General Hospital, Boston.

This new study “adds to a growing body of information arguing clearly and reassuringly that vaccination during pregnancy is not associated with complications during pregnancy,” said Dr. Ecker, who was not involved in the new study.

He added that it “should help obstetric providers further reassure those who are hesitant that vaccination is safe and best both for the pregnant patient and their pregnancy.”
 

Methods and results

For the new study, researchers tapped a provincial registry of all live and stillborn infants with a gestational age of at least 20 weeks or birth weight of at least 500 g. Unique health card numbers were used to link birth records to a database of COVID vaccinations.

Of 85,162 infants born from May through December of 2021, 43,099 (50.6%) were born to individuals who received at least one vaccine dose during pregnancy. Among those, 99.7% received an mRNA vaccine such as Pfizer-BioNTech or Moderna.

Vaccination during pregnancy was not associated with greater risk of overall preterm birth (6.5% among vaccinated individuals versus 6.9% among unvaccinated; hazard ratio, 1.02; 95% confidence interval, 0.96-1.08), spontaneous preterm birth (3.7% versus 4.4%; hazard ratio, 0.96; 95% CI, 0.90-1.03) or very preterm birth (0.59% versus 0.89%; hazard ratio, 0.80; 95% CI, 0.67-0.95).

Likewise, no increase was observed in the risk of an infant being small for gestational age at birth (9.1% versus 9.2%; hazard ratio, 0.98; 95% CI, 0.93-1.03).

The researchers observed a reduction in the risk of stillbirth, even after adjusting for potential confounders. Stillbirths occurred in 0.25% of vaccinated individuals, compared with 0.44% of unvaccinated individuals (hazard ratio, 0.65; 95% CI, 0.51-0.84).

A reduced risk of stillbirth – albeit to a smaller degree – was also found in a Scandinavian registry study that included 28,506 babies born to individuals who were vaccinated during pregnancy.

“Collectively, the findings from these two studies are reassuring and are consistent with no increased risk of stillbirth after COVID-19 vaccination during pregnancy. In contrast, COVID-19 disease during pregnancy has been associated with an increased risk of stillbirth,” the researchers wrote.

Findings did not vary by which mRNA vaccine a mother received, the number of doses she received, or the trimester in which a vaccine was given, the researchers reported.
 

Stillbirth findings will be ‘very reassuring’ for patients

The lead investigator, Deshayne Fell, PhD, said in an interview, the fact that the study comprised the entire population of pregnant people in Ontario during the study period “increases our confidence” about the validity and relevance of the findings for other geographic settings.

Dr. Fell, an associate professor in epidemiology and public health at the University of Ottawa and a scientist at the Children’s Hospital of Eastern Ontario Research Institute, Ottawa, said the evaluation of stillbirth in particular, “a rare but devastating outcome,” will be “very reassuring and useful for clinical counseling.”

A limitation cited by the research team included a lack of data on vaccination prior to pregnancy.

In the new study, Dr, Ecker said, “Though the investigators were able to adjust for many variables they cannot be certain that some unmeasured variable that, accordingly, was not adjusted for does not hide a small risk. This seems very unlikely, however.”

The Canadian research team said similar studies of non-mRNA COVID vaccines “should be a research priority.” However, such studies are not underway in Canada, where only mRNA vaccines are used in pregnancy, Dr. Fell said.

This study was supported by the Public Health Agency of Canada.

Dr. Fell and Dr. Ecker reported no competing financial interests.

A sweeping study of 85,000 infants found no link between mRNA COVID vaccination in pregnancy and greater risk of preterm birth, babies being born small for their gestational age, or stillbirth.

The research team wrote in the BMJ that their reassuring findings – drawn from a registry of all births in Ontario over an 8-month period – “can inform evidence-based decision-making” about COVID vaccination during pregnancy.

Previous research has found that pregnant patients are at higher risk of severe complications and death if they become infected with COVID and that vaccination before or during pregnancy prevents such outcomes and reduces the risk of newborn infection, noted Jeffrey Ecker, chief of obstetrics and gynecology at Massachusetts General Hospital, Boston.

This new study “adds to a growing body of information arguing clearly and reassuringly that vaccination during pregnancy is not associated with complications during pregnancy,” said Dr. Ecker, who was not involved in the new study.

He added that it “should help obstetric providers further reassure those who are hesitant that vaccination is safe and best both for the pregnant patient and their pregnancy.”
 

Methods and results

For the new study, researchers tapped a provincial registry of all live and stillborn infants with a gestational age of at least 20 weeks or birth weight of at least 500 g. Unique health card numbers were used to link birth records to a database of COVID vaccinations.

Of 85,162 infants born from May through December of 2021, 43,099 (50.6%) were born to individuals who received at least one vaccine dose during pregnancy. Among those, 99.7% received an mRNA vaccine such as Pfizer-BioNTech or Moderna.

Vaccination during pregnancy was not associated with greater risk of overall preterm birth (6.5% among vaccinated individuals versus 6.9% among unvaccinated; hazard ratio, 1.02; 95% confidence interval, 0.96-1.08), spontaneous preterm birth (3.7% versus 4.4%; hazard ratio, 0.96; 95% CI, 0.90-1.03) or very preterm birth (0.59% versus 0.89%; hazard ratio, 0.80; 95% CI, 0.67-0.95).

Likewise, no increase was observed in the risk of an infant being small for gestational age at birth (9.1% versus 9.2%; hazard ratio, 0.98; 95% CI, 0.93-1.03).

The researchers observed a reduction in the risk of stillbirth, even after adjusting for potential confounders. Stillbirths occurred in 0.25% of vaccinated individuals, compared with 0.44% of unvaccinated individuals (hazard ratio, 0.65; 95% CI, 0.51-0.84).

A reduced risk of stillbirth – albeit to a smaller degree – was also found in a Scandinavian registry study that included 28,506 babies born to individuals who were vaccinated during pregnancy.

“Collectively, the findings from these two studies are reassuring and are consistent with no increased risk of stillbirth after COVID-19 vaccination during pregnancy. In contrast, COVID-19 disease during pregnancy has been associated with an increased risk of stillbirth,” the researchers wrote.

Findings did not vary by which mRNA vaccine a mother received, the number of doses she received, or the trimester in which a vaccine was given, the researchers reported.
 

Stillbirth findings will be ‘very reassuring’ for patients

The lead investigator, Deshayne Fell, PhD, said in an interview, the fact that the study comprised the entire population of pregnant people in Ontario during the study period “increases our confidence” about the validity and relevance of the findings for other geographic settings.

Dr. Fell, an associate professor in epidemiology and public health at the University of Ottawa and a scientist at the Children’s Hospital of Eastern Ontario Research Institute, Ottawa, said the evaluation of stillbirth in particular, “a rare but devastating outcome,” will be “very reassuring and useful for clinical counseling.”

A limitation cited by the research team included a lack of data on vaccination prior to pregnancy.

In the new study, Dr, Ecker said, “Though the investigators were able to adjust for many variables they cannot be certain that some unmeasured variable that, accordingly, was not adjusted for does not hide a small risk. This seems very unlikely, however.”

The Canadian research team said similar studies of non-mRNA COVID vaccines “should be a research priority.” However, such studies are not underway in Canada, where only mRNA vaccines are used in pregnancy, Dr. Fell said.

This study was supported by the Public Health Agency of Canada.

Dr. Fell and Dr. Ecker reported no competing financial interests.

A sweeping study of 85,000 infants found no link between mRNA COVID vaccination in pregnancy and greater risk of preterm birth, babies being born small for their gestational age, or stillbirth.

The research team wrote in the BMJ that their reassuring findings – drawn from a registry of all births in Ontario over an 8-month period – “can inform evidence-based decision-making” about COVID vaccination during pregnancy.

Previous research has found that pregnant patients are at higher risk of severe complications and death if they become infected with COVID and that vaccination before or during pregnancy prevents such outcomes and reduces the risk of newborn infection, noted Jeffrey Ecker, chief of obstetrics and gynecology at Massachusetts General Hospital, Boston.

This new study “adds to a growing body of information arguing clearly and reassuringly that vaccination during pregnancy is not associated with complications during pregnancy,” said Dr. Ecker, who was not involved in the new study.

He added that it “should help obstetric providers further reassure those who are hesitant that vaccination is safe and best both for the pregnant patient and their pregnancy.”
 

Methods and results

For the new study, researchers tapped a provincial registry of all live and stillborn infants with a gestational age of at least 20 weeks or birth weight of at least 500 g. Unique health card numbers were used to link birth records to a database of COVID vaccinations.

Of 85,162 infants born from May through December of 2021, 43,099 (50.6%) were born to individuals who received at least one vaccine dose during pregnancy. Among those, 99.7% received an mRNA vaccine such as Pfizer-BioNTech or Moderna.

Vaccination during pregnancy was not associated with greater risk of overall preterm birth (6.5% among vaccinated individuals versus 6.9% among unvaccinated; hazard ratio, 1.02; 95% confidence interval, 0.96-1.08), spontaneous preterm birth (3.7% versus 4.4%; hazard ratio, 0.96; 95% CI, 0.90-1.03) or very preterm birth (0.59% versus 0.89%; hazard ratio, 0.80; 95% CI, 0.67-0.95).

Likewise, no increase was observed in the risk of an infant being small for gestational age at birth (9.1% versus 9.2%; hazard ratio, 0.98; 95% CI, 0.93-1.03).

The researchers observed a reduction in the risk of stillbirth, even after adjusting for potential confounders. Stillbirths occurred in 0.25% of vaccinated individuals, compared with 0.44% of unvaccinated individuals (hazard ratio, 0.65; 95% CI, 0.51-0.84).

A reduced risk of stillbirth – albeit to a smaller degree – was also found in a Scandinavian registry study that included 28,506 babies born to individuals who were vaccinated during pregnancy.

“Collectively, the findings from these two studies are reassuring and are consistent with no increased risk of stillbirth after COVID-19 vaccination during pregnancy. In contrast, COVID-19 disease during pregnancy has been associated with an increased risk of stillbirth,” the researchers wrote.

Findings did not vary by which mRNA vaccine a mother received, the number of doses she received, or the trimester in which a vaccine was given, the researchers reported.
 

Stillbirth findings will be ‘very reassuring’ for patients

The lead investigator, Deshayne Fell, PhD, said in an interview, the fact that the study comprised the entire population of pregnant people in Ontario during the study period “increases our confidence” about the validity and relevance of the findings for other geographic settings.

Dr. Fell, an associate professor in epidemiology and public health at the University of Ottawa and a scientist at the Children’s Hospital of Eastern Ontario Research Institute, Ottawa, said the evaluation of stillbirth in particular, “a rare but devastating outcome,” will be “very reassuring and useful for clinical counseling.”

A limitation cited by the research team included a lack of data on vaccination prior to pregnancy.

In the new study, Dr, Ecker said, “Though the investigators were able to adjust for many variables they cannot be certain that some unmeasured variable that, accordingly, was not adjusted for does not hide a small risk. This seems very unlikely, however.”

The Canadian research team said similar studies of non-mRNA COVID vaccines “should be a research priority.” However, such studies are not underway in Canada, where only mRNA vaccines are used in pregnancy, Dr. Fell said.

This study was supported by the Public Health Agency of Canada.

Dr. Fell and Dr. Ecker reported no competing financial interests.

New research from the University of Birmingham, England, in collaboration with the World Health Organization, shows that tocolytic drugs used to delay preterm birth, and thus avert the ensuing associated mortality and morbidity, are all “probably effective in delaying preterm birth compared with placebo or no treatment.”

Expanded use of the drugs would be a safe means to reduce the global burden of neonatal death, the researchers suggest. Coauthor Victoria Hodgetts Morton, BMedSci, NIHR clinical lecturer in obstetrics at the University of Birmingham, said: “Preterm birth is the most common reason why a newborn baby may die, and the leading cause of death in children under 5 years of age.

“Tocolytics aim to delay preterm birth and allow time for the women to receive medicines that can help with baby’s breathing and feeding if born preterm, and medicines that lower the chance of cerebral palsy of the infant. Crucially, a short delay in preterm birth can enable women to reach specialist care.”
 

Network meta‐analysis drew on 122 trials

The new paper, published in Cochrane Reviews, aimed to find out which tocolytic was most effective in delaying preterm birth, safest, and with the fewest side effects. Researchers brought together data from 122 randomized clinical trials in a network meta‐analysis.

Unlike conventional Cochrane Reviews, this type of review simultaneously pools all direct and indirect evidence into one single coherent analysis. Indirect evidence is obtained by inferring the relative effectiveness of two competing drugs through a common comparator, even when these two drugs have not been directly compared. The method also enables researchers to calculate the probability for each competing drug to constitute the most effective drug with the least side effects. This thereby allowed the researchers to rank the available tocolytic drugs.

The trials, published between 1966 and 2021, involved 13,697 women across 39 countries and included high, middle and low-income states. The researchers looked for trials involving women with live fetus(es) who presented with signs and symptoms of preterm labor, defined as uterine activity with or without ruptured membranes; or ruptured membranes, with or without cervical dilatation or shortening or biomarkers consistent with a high risk of preterm birth.

Trials were eligible if they involved tocolytic drugs of any dosage, route, or regimen for delaying preterm birth, and compared them with other tocolytic drugs, placebo, or no treatment.

The team reported that overall, the evidence varied widely in quality, and their confidence in the effect estimates ranged from very low to high. Only 25 of the 122 studies (20%) were judged to be at “low risk of bias.” The effectiveness of different drugs was less clear in some of the studies considered.

Compared with the use of placebo or no tocolytic treatment, “all tocolytic drug classes assessed and their combinations were probably or possibly effective in delaying preterm birth for 48 hours, and 7 days,” the researchers found. “The most effective tocolytics for delaying preterm birth by 48 hours and 7 days were the nitric oxide donors, calcium channel blockers, oxytocin receptor antagonists, and combination tocolytics.”

Their figures showed:

• Betamimetics are possibly effective in delaying preterm birth by 48 hours (risk ratio [RR] 1.12), and 7 days (RR 1.14).
• Calcium channel blockers (for example, nifedipine) may be effective in delaying preterm birth by 48 hours (RR 1.16), and probably effective in delaying preterm birth by 7 days (RR 1.15), and prolong pregnancy by a mean of 5 days (0.1 to 9.2).
• Magnesium sulphate is probably effective in delaying preterm birth by 48 hours (RR 1.12).
• Oxytocin receptor antagonists (e.g., atosiban) are effective in delaying preterm birth by 7 days (RR 1.18), are probably effective in delaying preterm birth by 48 hours (RR 1.13), and possibly prolong pregnancy by an average of 10 days (95% confidence interval, 2.3 to 16.7).
• Nitric oxide donors (e.g., glyceryl trinitrate) are probably effective in delaying preterm birth by 48 hours (RR 1.17), and 7 days (RR 1.18).
• Cyclooxygenase-2 inhibitors (e.g., indomethacin) may be effective in delaying preterm birth by 48 hours (RR 1.11).
• Combination tocolytics – most common was magnesium sulphate with betamimetics - are probably effective effective in delaying preterm birth by 48 hours (RR 1.17), and 7 days (RR 1.19).

Uncertain mortality outcomes and a wide range of adverse effects

However, the effects of tocolytic use on neonatal and perinatal mortality, and on safety outcomes such as maternal and neonatal infection, were “uncertain,” the researchers said, and the drugs proved compatible with a wide range of effects compared with placebo or no tocolytic treatment for these outcomes.

“All tocolytics were compatible with a wide range of serious adverse effects (trials including 6,983 women) when compared with placebo or no treatment,” the researchers said. Betamimetics and combination tocolytics had the most side effects and were most likely to lead to cessation of treatment (results from 8,122 women).

Overall, “the findings show that the benefits of these drugs outweigh any risks associated with unwanted side effects,” said first author Amie Wilson, PhD, research fellow in global maternal health at the University of Birmingham. “These treatments are leading to a significant reduction in the number of deadly preterm births, and we now need to further understand the effectiveness of tocolytics for specific groups depending on pregnancy length,” she said.

“Our previous research has led to the improvement of guidelines for use of tocolysis drug use to delay preterm birth in the U.K. Knowing that this paper helped to inform the forthcoming recommendations of the World Health Organisation on the use of tocolytics, we hope that many more women around the globe will have access to these drugs, and have healthier births.”

A version of this article first appeared on Medscape UK.

New research from the University of Birmingham, England, in collaboration with the World Health Organization, shows that tocolytic drugs used to delay preterm birth, and thus avert the ensuing associated mortality and morbidity, are all “probably effective in delaying preterm birth compared with placebo or no treatment.”

Expanded use of the drugs would be a safe means to reduce the global burden of neonatal death, the researchers suggest. Coauthor Victoria Hodgetts Morton, BMedSci, NIHR clinical lecturer in obstetrics at the University of Birmingham, said: “Preterm birth is the most common reason why a newborn baby may die, and the leading cause of death in children under 5 years of age.

“Tocolytics aim to delay preterm birth and allow time for the women to receive medicines that can help with baby’s breathing and feeding if born preterm, and medicines that lower the chance of cerebral palsy of the infant. Crucially, a short delay in preterm birth can enable women to reach specialist care.”
 

Network meta‐analysis drew on 122 trials

The new paper, published in Cochrane Reviews, aimed to find out which tocolytic was most effective in delaying preterm birth, safest, and with the fewest side effects. Researchers brought together data from 122 randomized clinical trials in a network meta‐analysis.

Unlike conventional Cochrane Reviews, this type of review simultaneously pools all direct and indirect evidence into one single coherent analysis. Indirect evidence is obtained by inferring the relative effectiveness of two competing drugs through a common comparator, even when these two drugs have not been directly compared. The method also enables researchers to calculate the probability for each competing drug to constitute the most effective drug with the least side effects. This thereby allowed the researchers to rank the available tocolytic drugs.

The trials, published between 1966 and 2021, involved 13,697 women across 39 countries and included high, middle and low-income states. The researchers looked for trials involving women with live fetus(es) who presented with signs and symptoms of preterm labor, defined as uterine activity with or without ruptured membranes; or ruptured membranes, with or without cervical dilatation or shortening or biomarkers consistent with a high risk of preterm birth.

Trials were eligible if they involved tocolytic drugs of any dosage, route, or regimen for delaying preterm birth, and compared them with other tocolytic drugs, placebo, or no treatment.

The team reported that overall, the evidence varied widely in quality, and their confidence in the effect estimates ranged from very low to high. Only 25 of the 122 studies (20%) were judged to be at “low risk of bias.” The effectiveness of different drugs was less clear in some of the studies considered.

Compared with the use of placebo or no tocolytic treatment, “all tocolytic drug classes assessed and their combinations were probably or possibly effective in delaying preterm birth for 48 hours, and 7 days,” the researchers found. “The most effective tocolytics for delaying preterm birth by 48 hours and 7 days were the nitric oxide donors, calcium channel blockers, oxytocin receptor antagonists, and combination tocolytics.”

Their figures showed:

• Betamimetics are possibly effective in delaying preterm birth by 48 hours (risk ratio [RR] 1.12), and 7 days (RR 1.14).
• Calcium channel blockers (for example, nifedipine) may be effective in delaying preterm birth by 48 hours (RR 1.16), and probably effective in delaying preterm birth by 7 days (RR 1.15), and prolong pregnancy by a mean of 5 days (0.1 to 9.2).
• Magnesium sulphate is probably effective in delaying preterm birth by 48 hours (RR 1.12).
• Oxytocin receptor antagonists (e.g., atosiban) are effective in delaying preterm birth by 7 days (RR 1.18), are probably effective in delaying preterm birth by 48 hours (RR 1.13), and possibly prolong pregnancy by an average of 10 days (95% confidence interval, 2.3 to 16.7).
• Nitric oxide donors (e.g., glyceryl trinitrate) are probably effective in delaying preterm birth by 48 hours (RR 1.17), and 7 days (RR 1.18).
• Cyclooxygenase-2 inhibitors (e.g., indomethacin) may be effective in delaying preterm birth by 48 hours (RR 1.11).
• Combination tocolytics – most common was magnesium sulphate with betamimetics - are probably effective effective in delaying preterm birth by 48 hours (RR 1.17), and 7 days (RR 1.19).

Uncertain mortality outcomes and a wide range of adverse effects

However, the effects of tocolytic use on neonatal and perinatal mortality, and on safety outcomes such as maternal and neonatal infection, were “uncertain,” the researchers said, and the drugs proved compatible with a wide range of effects compared with placebo or no tocolytic treatment for these outcomes.

“All tocolytics were compatible with a wide range of serious adverse effects (trials including 6,983 women) when compared with placebo or no treatment,” the researchers said. Betamimetics and combination tocolytics had the most side effects and were most likely to lead to cessation of treatment (results from 8,122 women).

Overall, “the findings show that the benefits of these drugs outweigh any risks associated with unwanted side effects,” said first author Amie Wilson, PhD, research fellow in global maternal health at the University of Birmingham. “These treatments are leading to a significant reduction in the number of deadly preterm births, and we now need to further understand the effectiveness of tocolytics for specific groups depending on pregnancy length,” she said.

“Our previous research has led to the improvement of guidelines for use of tocolysis drug use to delay preterm birth in the U.K. Knowing that this paper helped to inform the forthcoming recommendations of the World Health Organisation on the use of tocolytics, we hope that many more women around the globe will have access to these drugs, and have healthier births.”

A version of this article first appeared on Medscape UK.

New research from the University of Birmingham, England, in collaboration with the World Health Organization, shows that tocolytic drugs used to delay preterm birth, and thus avert the ensuing associated mortality and morbidity, are all “probably effective in delaying preterm birth compared with placebo or no treatment.”

Expanded use of the drugs would be a safe means to reduce the global burden of neonatal death, the researchers suggest. Coauthor Victoria Hodgetts Morton, BMedSci, NIHR clinical lecturer in obstetrics at the University of Birmingham, said: “Preterm birth is the most common reason why a newborn baby may die, and the leading cause of death in children under 5 years of age.

“Tocolytics aim to delay preterm birth and allow time for the women to receive medicines that can help with baby’s breathing and feeding if born preterm, and medicines that lower the chance of cerebral palsy of the infant. Crucially, a short delay in preterm birth can enable women to reach specialist care.”
 

Network meta‐analysis drew on 122 trials

The new paper, published in Cochrane Reviews, aimed to find out which tocolytic was most effective in delaying preterm birth, safest, and with the fewest side effects. Researchers brought together data from 122 randomized clinical trials in a network meta‐analysis.

Unlike conventional Cochrane Reviews, this type of review simultaneously pools all direct and indirect evidence into one single coherent analysis. Indirect evidence is obtained by inferring the relative effectiveness of two competing drugs through a common comparator, even when these two drugs have not been directly compared. The method also enables researchers to calculate the probability for each competing drug to constitute the most effective drug with the least side effects. This thereby allowed the researchers to rank the available tocolytic drugs.

The trials, published between 1966 and 2021, involved 13,697 women across 39 countries and included high, middle and low-income states. The researchers looked for trials involving women with live fetus(es) who presented with signs and symptoms of preterm labor, defined as uterine activity with or without ruptured membranes; or ruptured membranes, with or without cervical dilatation or shortening or biomarkers consistent with a high risk of preterm birth.

Trials were eligible if they involved tocolytic drugs of any dosage, route, or regimen for delaying preterm birth, and compared them with other tocolytic drugs, placebo, or no treatment.

The team reported that overall, the evidence varied widely in quality, and their confidence in the effect estimates ranged from very low to high. Only 25 of the 122 studies (20%) were judged to be at “low risk of bias.” The effectiveness of different drugs was less clear in some of the studies considered.

Compared with the use of placebo or no tocolytic treatment, “all tocolytic drug classes assessed and their combinations were probably or possibly effective in delaying preterm birth for 48 hours, and 7 days,” the researchers found. “The most effective tocolytics for delaying preterm birth by 48 hours and 7 days were the nitric oxide donors, calcium channel blockers, oxytocin receptor antagonists, and combination tocolytics.”

Their figures showed:

• Betamimetics are possibly effective in delaying preterm birth by 48 hours (risk ratio [RR] 1.12), and 7 days (RR 1.14).
• Calcium channel blockers (for example, nifedipine) may be effective in delaying preterm birth by 48 hours (RR 1.16), and probably effective in delaying preterm birth by 7 days (RR 1.15), and prolong pregnancy by a mean of 5 days (0.1 to 9.2).
• Magnesium sulphate is probably effective in delaying preterm birth by 48 hours (RR 1.12).
• Oxytocin receptor antagonists (e.g., atosiban) are effective in delaying preterm birth by 7 days (RR 1.18), are probably effective in delaying preterm birth by 48 hours (RR 1.13), and possibly prolong pregnancy by an average of 10 days (95% confidence interval, 2.3 to 16.7).
• Nitric oxide donors (e.g., glyceryl trinitrate) are probably effective in delaying preterm birth by 48 hours (RR 1.17), and 7 days (RR 1.18).
• Cyclooxygenase-2 inhibitors (e.g., indomethacin) may be effective in delaying preterm birth by 48 hours (RR 1.11).
• Combination tocolytics – most common was magnesium sulphate with betamimetics - are probably effective effective in delaying preterm birth by 48 hours (RR 1.17), and 7 days (RR 1.19).

Uncertain mortality outcomes and a wide range of adverse effects

However, the effects of tocolytic use on neonatal and perinatal mortality, and on safety outcomes such as maternal and neonatal infection, were “uncertain,” the researchers said, and the drugs proved compatible with a wide range of effects compared with placebo or no tocolytic treatment for these outcomes.

“All tocolytics were compatible with a wide range of serious adverse effects (trials including 6,983 women) when compared with placebo or no treatment,” the researchers said. Betamimetics and combination tocolytics had the most side effects and were most likely to lead to cessation of treatment (results from 8,122 women).

Overall, “the findings show that the benefits of these drugs outweigh any risks associated with unwanted side effects,” said first author Amie Wilson, PhD, research fellow in global maternal health at the University of Birmingham. “These treatments are leading to a significant reduction in the number of deadly preterm births, and we now need to further understand the effectiveness of tocolytics for specific groups depending on pregnancy length,” she said.

“Our previous research has led to the improvement of guidelines for use of tocolysis drug use to delay preterm birth in the U.K. Knowing that this paper helped to inform the forthcoming recommendations of the World Health Organisation on the use of tocolytics, we hope that many more women around the globe will have access to these drugs, and have healthier births.”

A version of this article first appeared on Medscape UK.

It is time to reconsider the recommendation for practicing fetal kick counts. A meta-analysis demonstrated no decrease in the outcome of stillbirth, but instead an increased risk of iatrogenic delivery.¹

CASE 1 8 vs 10 fetal movements in 2 hours

Ms. M is 38 weeks pregnant with an uncomplicated pregnancy. She calls your practice with concerns about fetal kick counts. During her prenatal care, she was counseled to ensure that the baby moved 10 times over a period of 2 hours. This morning, however, she only perceived 8 movements in 2 hours. She is scheduled for evaluation with a nonstress test (NST) on the labor and delivery unit. The NST reveals a reassuring, reactive tracing. Ultrasonography evaluation demonstrates a normal amniotic fluid index and normal fetal growth. The patient is reassured, returns home, and goes on to deliver a healthy baby at 39 weeks and 5 days.

Perception of decreased movement triggers evaluation and monitoring

Maternal perception of normal fetal movement has conceivably been used throughout history as a means of reassurance of fetal well-being; it is highly predictive of fetal viability.^2,3 When fetal movement is lacking or decreased, it can be an alarm sign and may result in concerns by the mother that her baby is unwell. Maternal perception of decreased fetal movements affects 5% to 15% of all pregnancies.^2,4 While decreased fetal movement can be associated with poor perinatal outcomes such as fetal growth restriction, oligohydramnios, and neuro-developmental disability, it also can be reflective of more benign issues such as anterior placenta, maternal activity, maternal caffeine or sugar consumption, or maternal position.^4,5

However, the definition of decreased fetal movement is subject to significant variation, from a total absence of movement over an entire day or what has commonly become accepted as the definition of fetal kick counts with Pearson’s Cardiff chart (which was defined in the 1970s as 10 movements within 12 hours).^6,7 Today, women in the United States are commonly recommended to monitor their baby over a 2-hour period and to look for 10 movements during that time.⁸ Anything less is considered reduced fetal movement and results in recommendations to undergo assessment of previously known high-risk conditions or any possible underlying conditions, such as hypertension, gestational diabetes, or fetal growth restriction. Further evaluation with more objective measures such as electronic fetal monitoring or ultrasonography with biophysical profile are often recommended concurrently.⁹

It is estimated that up to 15% of women present reporting decreased fetal movement in the third trimester and, as such, require additional monitoring and evaluation. This is not without cost of time and money to the health care system and pregnant patients.

It is uncertain that fetal kick counting prevents stillbirth

Intrauterine fetal demise is neither an uncommon nor completely preventable outcome, despite advances in antenatal care. Many cases occur without evidence of fetal abnormality or other risk factors, and 30% to 55% of women who experience intrauterine fetal demise experience decreased fetal movement in the preceding week.¹⁰ It makes physiologic sense that a fetus’ adaptive response to decreased oxygenation is reduced fetal movement, resulting from the prioritization of blood to the fetal brain and other organs over skeletal muscle.^4,9,11 Results of a 1976 small study of 61 low-risk pregnancies seemed to confirm that a decrease in fetal movement preceded intrauterine death by 3 to 4 days. Conversely, they found that a normal fetal movement count was generally associated with a good neonatal outcome.⁶ Thus, experts have long extrapolated that decreased fetal movement can be an indicator for utero-placental insufficiency and, in turn, chronic or acute hypoxia.

However, in larger studies, the ability of fetal movement counting to predict fetal death and fetal compromise appears limited.^8,10,11 A meta-analysis of studies, including 5 randomized controlled trials and 468,000 fetuses, compared the incidence of stillbirth in women receiving instructions for fetal movement counting versus women who did not. Rates of stillbirth were the same for each group, demonstrating no advantage to fetal kick counts to prevent a poor perinatal outcome, including stillbirth.¹

CASE 2 Reported reduced fetal movement over 4 weeks

Ms. E is a 20-year-old nullipara at 36 weeks’ and 6 days gestation who has come in to triage weekly for the last 4 weeks with concerns about decreased fetal movement. She states that she goes for several hours each day without feeling 10 movements in 2 hours. Recent fetal growth recorded 3 weeks ago was in the 45th percentile, and the amniotic fluid index has been above 10 cm on each weekly ultrasound. Her weekly NSTs have been reactive, and she has been normotensive. However, because she has had several weeks of persistent decreased fetal movement, the labor and delivery team opts to keep her for induction as she is “close to term.”

Decreased kick count frequency may increase unnecessary interventions

Women with fewer kick counts are more likely to present with concerns about the well-being of their baby. In a survey of obstetricians and midwives, a large proportion of providers were more apt to recommend delivery or admission to the hospital for women presenting with decreased fetal movements.² It stands to reason that recommendations for delivery or admission can lead to outcomes like preterm delivery or recommendations for cesarean delivery (CD). However, using fetal kick counts to portend stillbirth or other poor fetal and neonatal outcomes has been shown to be limited in its value with the AFFIRM trial.¹⁰ The results of this large study, which included more than 400,000 pregnancies from 37 hospitals, show the challenges of any study to address the use of management strategies for recent change in the frequency of fetal movements in the reduction of and cause of stillbirth. Additionally, the relatively low risk of stillbirth overall (4.06 stillbirths per 1,000 livebirths during the intervention period and 4.40 per 1,000 livebirths during the control period) but higher incidence of other outcomes, such as prolonged (>48 hours) antepartum admission (6.7% in the intervention period and 6.2% in the control period), induction of labor (40.7% in the intervention period and 35.9% in the control period), and CD (28.4% and 25.5%, respectively) may result in increased harm for many women rather than the intended benefit of preventing stillbirth.^10,12

Mindfetalness may be a viable and valuable alternative to kick counts

Alternatives have been proposed as a measure of fetal movement without using kick counts specifically. Mindfetalness has been a method studied in Sweden; its purpose is to strengthen the mother’s awareness of her baby through developing an understanding of the fetal-movement pattern. It is practiced starting at 28 weeks’ gestation for 15 minutes a day, with the woman instructed to lie on her left side and discern the intensity and character of the movements, as well as frequency, without overtly counting the movements.¹² In one small study, women felt more connected to their babies and felt less worried.¹² In a much larger study of 13,000 women, the authors found no evidence of harm from generalized awareness of fetal movements in a population of pregnant women at or beyond 32 weeks; in fact, they did see significant reductions in iatrogenic outcomes such as CDs and labor inductions.¹³

The case for movement awareness over kick counts

Stillbirth risk does not appear to be modified by the use of methods to detect fetal movement.^10,12 However, a perceived decrease in fetal kick counts has been shown to result in increased interventions and preterm deliveries. A more prudent approach appears to be educating mothers about general fetal movement, which appears to reduce potentially unnecessary visits and interventions without sacrificing the ability to reassure mothers about the well-being of their babies in utero. ●

It is time to reconsider the recommendation for practicing fetal kick counts. A meta-analysis demonstrated no decrease in the outcome of stillbirth, but instead an increased risk of iatrogenic delivery.¹

CASE 1 8 vs 10 fetal movements in 2 hours

Ms. M is 38 weeks pregnant with an uncomplicated pregnancy. She calls your practice with concerns about fetal kick counts. During her prenatal care, she was counseled to ensure that the baby moved 10 times over a period of 2 hours. This morning, however, she only perceived 8 movements in 2 hours. She is scheduled for evaluation with a nonstress test (NST) on the labor and delivery unit. The NST reveals a reassuring, reactive tracing. Ultrasonography evaluation demonstrates a normal amniotic fluid index and normal fetal growth. The patient is reassured, returns home, and goes on to deliver a healthy baby at 39 weeks and 5 days.

Perception of decreased movement triggers evaluation and monitoring

Maternal perception of normal fetal movement has conceivably been used throughout history as a means of reassurance of fetal well-being; it is highly predictive of fetal viability.^2,3 When fetal movement is lacking or decreased, it can be an alarm sign and may result in concerns by the mother that her baby is unwell. Maternal perception of decreased fetal movements affects 5% to 15% of all pregnancies.^2,4 While decreased fetal movement can be associated with poor perinatal outcomes such as fetal growth restriction, oligohydramnios, and neuro-developmental disability, it also can be reflective of more benign issues such as anterior placenta, maternal activity, maternal caffeine or sugar consumption, or maternal position.^4,5

However, the definition of decreased fetal movement is subject to significant variation, from a total absence of movement over an entire day or what has commonly become accepted as the definition of fetal kick counts with Pearson’s Cardiff chart (which was defined in the 1970s as 10 movements within 12 hours).^6,7 Today, women in the United States are commonly recommended to monitor their baby over a 2-hour period and to look for 10 movements during that time.⁸ Anything less is considered reduced fetal movement and results in recommendations to undergo assessment of previously known high-risk conditions or any possible underlying conditions, such as hypertension, gestational diabetes, or fetal growth restriction. Further evaluation with more objective measures such as electronic fetal monitoring or ultrasonography with biophysical profile are often recommended concurrently.⁹

It is estimated that up to 15% of women present reporting decreased fetal movement in the third trimester and, as such, require additional monitoring and evaluation. This is not without cost of time and money to the health care system and pregnant patients.

It is uncertain that fetal kick counting prevents stillbirth

Intrauterine fetal demise is neither an uncommon nor completely preventable outcome, despite advances in antenatal care. Many cases occur without evidence of fetal abnormality or other risk factors, and 30% to 55% of women who experience intrauterine fetal demise experience decreased fetal movement in the preceding week.¹⁰ It makes physiologic sense that a fetus’ adaptive response to decreased oxygenation is reduced fetal movement, resulting from the prioritization of blood to the fetal brain and other organs over skeletal muscle.^4,9,11 Results of a 1976 small study of 61 low-risk pregnancies seemed to confirm that a decrease in fetal movement preceded intrauterine death by 3 to 4 days. Conversely, they found that a normal fetal movement count was generally associated with a good neonatal outcome.⁶ Thus, experts have long extrapolated that decreased fetal movement can be an indicator for utero-placental insufficiency and, in turn, chronic or acute hypoxia.

However, in larger studies, the ability of fetal movement counting to predict fetal death and fetal compromise appears limited.^8,10,11 A meta-analysis of studies, including 5 randomized controlled trials and 468,000 fetuses, compared the incidence of stillbirth in women receiving instructions for fetal movement counting versus women who did not. Rates of stillbirth were the same for each group, demonstrating no advantage to fetal kick counts to prevent a poor perinatal outcome, including stillbirth.¹

CASE 2 Reported reduced fetal movement over 4 weeks

Ms. E is a 20-year-old nullipara at 36 weeks’ and 6 days gestation who has come in to triage weekly for the last 4 weeks with concerns about decreased fetal movement. She states that she goes for several hours each day without feeling 10 movements in 2 hours. Recent fetal growth recorded 3 weeks ago was in the 45th percentile, and the amniotic fluid index has been above 10 cm on each weekly ultrasound. Her weekly NSTs have been reactive, and she has been normotensive. However, because she has had several weeks of persistent decreased fetal movement, the labor and delivery team opts to keep her for induction as she is “close to term.”

Decreased kick count frequency may increase unnecessary interventions

Women with fewer kick counts are more likely to present with concerns about the well-being of their baby. In a survey of obstetricians and midwives, a large proportion of providers were more apt to recommend delivery or admission to the hospital for women presenting with decreased fetal movements.² It stands to reason that recommendations for delivery or admission can lead to outcomes like preterm delivery or recommendations for cesarean delivery (CD). However, using fetal kick counts to portend stillbirth or other poor fetal and neonatal outcomes has been shown to be limited in its value with the AFFIRM trial.¹⁰ The results of this large study, which included more than 400,000 pregnancies from 37 hospitals, show the challenges of any study to address the use of management strategies for recent change in the frequency of fetal movements in the reduction of and cause of stillbirth. Additionally, the relatively low risk of stillbirth overall (4.06 stillbirths per 1,000 livebirths during the intervention period and 4.40 per 1,000 livebirths during the control period) but higher incidence of other outcomes, such as prolonged (>48 hours) antepartum admission (6.7% in the intervention period and 6.2% in the control period), induction of labor (40.7% in the intervention period and 35.9% in the control period), and CD (28.4% and 25.5%, respectively) may result in increased harm for many women rather than the intended benefit of preventing stillbirth.^10,12

Mindfetalness may be a viable and valuable alternative to kick counts

Alternatives have been proposed as a measure of fetal movement without using kick counts specifically. Mindfetalness has been a method studied in Sweden; its purpose is to strengthen the mother’s awareness of her baby through developing an understanding of the fetal-movement pattern. It is practiced starting at 28 weeks’ gestation for 15 minutes a day, with the woman instructed to lie on her left side and discern the intensity and character of the movements, as well as frequency, without overtly counting the movements.¹² In one small study, women felt more connected to their babies and felt less worried.¹² In a much larger study of 13,000 women, the authors found no evidence of harm from generalized awareness of fetal movements in a population of pregnant women at or beyond 32 weeks; in fact, they did see significant reductions in iatrogenic outcomes such as CDs and labor inductions.¹³

The case for movement awareness over kick counts

Stillbirth risk does not appear to be modified by the use of methods to detect fetal movement.^10,12 However, a perceived decrease in fetal kick counts has been shown to result in increased interventions and preterm deliveries. A more prudent approach appears to be educating mothers about general fetal movement, which appears to reduce potentially unnecessary visits and interventions without sacrificing the ability to reassure mothers about the well-being of their babies in utero. ●

It is time to reconsider the recommendation for practicing fetal kick counts. A meta-analysis demonstrated no decrease in the outcome of stillbirth, but instead an increased risk of iatrogenic delivery.¹

CASE 1 8 vs 10 fetal movements in 2 hours

Ms. M is 38 weeks pregnant with an uncomplicated pregnancy. She calls your practice with concerns about fetal kick counts. During her prenatal care, she was counseled to ensure that the baby moved 10 times over a period of 2 hours. This morning, however, she only perceived 8 movements in 2 hours. She is scheduled for evaluation with a nonstress test (NST) on the labor and delivery unit. The NST reveals a reassuring, reactive tracing. Ultrasonography evaluation demonstrates a normal amniotic fluid index and normal fetal growth. The patient is reassured, returns home, and goes on to deliver a healthy baby at 39 weeks and 5 days.

Perception of decreased movement triggers evaluation and monitoring

Maternal perception of normal fetal movement has conceivably been used throughout history as a means of reassurance of fetal well-being; it is highly predictive of fetal viability.^2,3 When fetal movement is lacking or decreased, it can be an alarm sign and may result in concerns by the mother that her baby is unwell. Maternal perception of decreased fetal movements affects 5% to 15% of all pregnancies.^2,4 While decreased fetal movement can be associated with poor perinatal outcomes such as fetal growth restriction, oligohydramnios, and neuro-developmental disability, it also can be reflective of more benign issues such as anterior placenta, maternal activity, maternal caffeine or sugar consumption, or maternal position.^4,5

However, the definition of decreased fetal movement is subject to significant variation, from a total absence of movement over an entire day or what has commonly become accepted as the definition of fetal kick counts with Pearson’s Cardiff chart (which was defined in the 1970s as 10 movements within 12 hours).^6,7 Today, women in the United States are commonly recommended to monitor their baby over a 2-hour period and to look for 10 movements during that time.⁸ Anything less is considered reduced fetal movement and results in recommendations to undergo assessment of previously known high-risk conditions or any possible underlying conditions, such as hypertension, gestational diabetes, or fetal growth restriction. Further evaluation with more objective measures such as electronic fetal monitoring or ultrasonography with biophysical profile are often recommended concurrently.⁹

It is estimated that up to 15% of women present reporting decreased fetal movement in the third trimester and, as such, require additional monitoring and evaluation. This is not without cost of time and money to the health care system and pregnant patients.

It is uncertain that fetal kick counting prevents stillbirth

Intrauterine fetal demise is neither an uncommon nor completely preventable outcome, despite advances in antenatal care. Many cases occur without evidence of fetal abnormality or other risk factors, and 30% to 55% of women who experience intrauterine fetal demise experience decreased fetal movement in the preceding week.¹⁰ It makes physiologic sense that a fetus’ adaptive response to decreased oxygenation is reduced fetal movement, resulting from the prioritization of blood to the fetal brain and other organs over skeletal muscle.^4,9,11 Results of a 1976 small study of 61 low-risk pregnancies seemed to confirm that a decrease in fetal movement preceded intrauterine death by 3 to 4 days. Conversely, they found that a normal fetal movement count was generally associated with a good neonatal outcome.⁶ Thus, experts have long extrapolated that decreased fetal movement can be an indicator for utero-placental insufficiency and, in turn, chronic or acute hypoxia.

However, in larger studies, the ability of fetal movement counting to predict fetal death and fetal compromise appears limited.^8,10,11 A meta-analysis of studies, including 5 randomized controlled trials and 468,000 fetuses, compared the incidence of stillbirth in women receiving instructions for fetal movement counting versus women who did not. Rates of stillbirth were the same for each group, demonstrating no advantage to fetal kick counts to prevent a poor perinatal outcome, including stillbirth.¹

CASE 2 Reported reduced fetal movement over 4 weeks

Ms. E is a 20-year-old nullipara at 36 weeks’ and 6 days gestation who has come in to triage weekly for the last 4 weeks with concerns about decreased fetal movement. She states that she goes for several hours each day without feeling 10 movements in 2 hours. Recent fetal growth recorded 3 weeks ago was in the 45th percentile, and the amniotic fluid index has been above 10 cm on each weekly ultrasound. Her weekly NSTs have been reactive, and she has been normotensive. However, because she has had several weeks of persistent decreased fetal movement, the labor and delivery team opts to keep her for induction as she is “close to term.”

Decreased kick count frequency may increase unnecessary interventions

Women with fewer kick counts are more likely to present with concerns about the well-being of their baby. In a survey of obstetricians and midwives, a large proportion of providers were more apt to recommend delivery or admission to the hospital for women presenting with decreased fetal movements.² It stands to reason that recommendations for delivery or admission can lead to outcomes like preterm delivery or recommendations for cesarean delivery (CD). However, using fetal kick counts to portend stillbirth or other poor fetal and neonatal outcomes has been shown to be limited in its value with the AFFIRM trial.¹⁰ The results of this large study, which included more than 400,000 pregnancies from 37 hospitals, show the challenges of any study to address the use of management strategies for recent change in the frequency of fetal movements in the reduction of and cause of stillbirth. Additionally, the relatively low risk of stillbirth overall (4.06 stillbirths per 1,000 livebirths during the intervention period and 4.40 per 1,000 livebirths during the control period) but higher incidence of other outcomes, such as prolonged (>48 hours) antepartum admission (6.7% in the intervention period and 6.2% in the control period), induction of labor (40.7% in the intervention period and 35.9% in the control period), and CD (28.4% and 25.5%, respectively) may result in increased harm for many women rather than the intended benefit of preventing stillbirth.^10,12

Mindfetalness may be a viable and valuable alternative to kick counts

Alternatives have been proposed as a measure of fetal movement without using kick counts specifically. Mindfetalness has been a method studied in Sweden; its purpose is to strengthen the mother’s awareness of her baby through developing an understanding of the fetal-movement pattern. It is practiced starting at 28 weeks’ gestation for 15 minutes a day, with the woman instructed to lie on her left side and discern the intensity and character of the movements, as well as frequency, without overtly counting the movements.¹² In one small study, women felt more connected to their babies and felt less worried.¹² In a much larger study of 13,000 women, the authors found no evidence of harm from generalized awareness of fetal movements in a population of pregnant women at or beyond 32 weeks; in fact, they did see significant reductions in iatrogenic outcomes such as CDs and labor inductions.¹³

The case for movement awareness over kick counts

Stillbirth risk does not appear to be modified by the use of methods to detect fetal movement.^10,12 However, a perceived decrease in fetal kick counts has been shown to result in increased interventions and preterm deliveries. A more prudent approach appears to be educating mothers about general fetal movement, which appears to reduce potentially unnecessary visits and interventions without sacrificing the ability to reassure mothers about the well-being of their babies in utero. ●

Pregnant women who get infected with SARS-CoV-2 in their third trimester are almost three times as likely to have a preterm birth, while infection after 34 weeks’ gestation raises this risk sevenfold, based on the largest matched population-based cohort study published to date.

These findings support previous studies, underscoring the need for pregnant women and their families to take preventive measures against infection, lead author Noga Fallach, MA, of the Kahn-Sagol-Maccabi Research and Innovation Center, Tel Aviv, and colleagues reported.

ArtMarie/E+/Getty Images

Past research has suggested that COVID-19 may cause low birth weights and preterm birth in pregnant women, but those studies didn’t report outcomes for each trimester, the investigators wrote in PLoS ONE, noting that “timing of viral infection during fetal development may affect birth and other health outcomes.”

To address this knowledge gap, the investigators looked back at data from 2,703 pregnant women in Israel who tested positive for SARS-CoV-2 from Feb. 21, 2020, to July 2, 2021. Pregnancy outcomes in these women were compared with outcomes in an equal number of uninfected pregnant women. Vaccination status was not reported.

Comparing the two groups showed that catching COVID-19 in the third trimester was linked with nearly triple the risk of preterm birth (odds ratio, 2.76; 95% confidence interval, 1.63-4.67), and more than quadruple the risk if COVID-19 symptoms were present (OR, 4.28; 95% CI, 1.94-9.41). Women who tested positive for SARS-CoV-2 after 34 weeks’ gestation were seven times more likely than uninfected women to deliver early (OR, 7.10; 95% CI, 2.44-20.61).

Pregnant women who caught COVID-19 in the first two trimesters were not significantly more likely to have a preterm birth. Infection was not associated with abnormally low birth rates, or pregnancy loss, in any trimester.

Tal Patalon, MD, coauthor and head of the Kahn-Sagol-Maccabi Research and Innovation Center, focused on these more optimistic findings in an interview.

“The results are encouraging, and reassuring that COVID-19 infection during pregnancy is not associated with any type of pregnancy loss,” Dr. Patalon said.

She also pointed out that the women in the study were infected with SARS-CoV-2 variants that are no longer common.

“It should be remembered that the research group tested the COVID-19 pre-Delta variants, and does not refer to the dominant variant today, which is Omicron,” Dr. Patalon said.

Still, the investigators concluded that the “results underline the importance of preventive measures taken against SARS-CoV-2 infection among pregnant women and their families.”

Sonja A. Rasmussen, MD, of the University of Florida, Gainesville, said that the issue with out-of-date variants in published research has been one of the “real challenges” in studying the ever-evolving COVID-19 pandemic; however, it’s not a good enough reason to dismiss this study.

“I think at this point, we need to assume that it applies to Omicron too,” Dr. Rasmussen said, noting that other respiratory viruses, like influenza, have also been shown to increase the risk of preterm birth when contracted in late pregnancy.

While the present findings highlight the risk of infection in the third trimester, Dr. Rasmussen advised women in all stages of pregnancy to protect themselves against COVID-19, based on the knowledge that illness in a mother can affect normal growth and development in a fetus, even if it doesn’t lead to preterm birth.

“A mom getting sick during pregnancy is not good for the baby,” Dr. Rasmussen said. “The baby’s really dependent on the mom. So you want that baby to have good nutrition throughout the pregnancy. It’s just as important earlier on as later. And you want that baby to get good oxygenation no matter what time [in the pregnancy]. I know that people want a little bit of a break [from preventive measures]. But I would emphasize that if you’re pregnant, we do all sorts of things during pregnancy to make sure that our babies are safe and healthy, and I would continue that for the whole pregnancy.”

Specifically, Dr. Rasmussen advised social distancing, use of an N95 mask, and vaccination. Getting vaccinated during pregnancy helps newborns fight off infection until 6 months of age, she added, when they become eligible for vaccination themselves. This added benefit was recently reported in a study published in the New England Journal of Medicine , for which Dr. Rasmussen cowrote an editorial .

“Vaccines have been approved for 6 months and older,” Dr. Rasmussen said. “But what do you do in those first 6 months of life? That’s a high-risk time for kids.”

Despite these risks, convincing pregnant women to get vaccinated remains a key challenge for health care providers, according to Dr. Rasmussen, even with an abundance of safety data. “Early on [in the pandemic], we said we didn’t know a lot about risks. We knew that other vaccines were safe during pregnancy, but we didn’t have a lot of information about a COVID-19 vaccine. But now we have a lot of data on safety during pregnancy, and these vaccines appear to be completely safe, based on the information we have. There have been many, many pregnant women vaccinated in the United States and in other countries.”

For reluctant expecting mothers, Dr. Rasmussen offered some words of advice: “I know that you worry about anything you do when you’re pregnant. But this is something that you can do to help your baby – now, to make a preterm birth less likely, and later, after the baby is born.

“The most important thing is for the pregnant person to hear this [vaccine recommendation] from their doctor,” she added. “If they’re going to listen to anybody, they’re going to listen to their physician. That’s what the data have shown for a long time.”

The investigators and Dr. Rasmussen disclosed no conflicts of interest.

Pregnant women who get infected with SARS-CoV-2 in their third trimester are almost three times as likely to have a preterm birth, while infection after 34 weeks’ gestation raises this risk sevenfold, based on the largest matched population-based cohort study published to date.

These findings support previous studies, underscoring the need for pregnant women and their families to take preventive measures against infection, lead author Noga Fallach, MA, of the Kahn-Sagol-Maccabi Research and Innovation Center, Tel Aviv, and colleagues reported.

ArtMarie/E+/Getty Images

Past research has suggested that COVID-19 may cause low birth weights and preterm birth in pregnant women, but those studies didn’t report outcomes for each trimester, the investigators wrote in PLoS ONE, noting that “timing of viral infection during fetal development may affect birth and other health outcomes.”

To address this knowledge gap, the investigators looked back at data from 2,703 pregnant women in Israel who tested positive for SARS-CoV-2 from Feb. 21, 2020, to July 2, 2021. Pregnancy outcomes in these women were compared with outcomes in an equal number of uninfected pregnant women. Vaccination status was not reported.

Comparing the two groups showed that catching COVID-19 in the third trimester was linked with nearly triple the risk of preterm birth (odds ratio, 2.76; 95% confidence interval, 1.63-4.67), and more than quadruple the risk if COVID-19 symptoms were present (OR, 4.28; 95% CI, 1.94-9.41). Women who tested positive for SARS-CoV-2 after 34 weeks’ gestation were seven times more likely than uninfected women to deliver early (OR, 7.10; 95% CI, 2.44-20.61).

Pregnant women who caught COVID-19 in the first two trimesters were not significantly more likely to have a preterm birth. Infection was not associated with abnormally low birth rates, or pregnancy loss, in any trimester.

Tal Patalon, MD, coauthor and head of the Kahn-Sagol-Maccabi Research and Innovation Center, focused on these more optimistic findings in an interview.

“The results are encouraging, and reassuring that COVID-19 infection during pregnancy is not associated with any type of pregnancy loss,” Dr. Patalon said.

She also pointed out that the women in the study were infected with SARS-CoV-2 variants that are no longer common.

“It should be remembered that the research group tested the COVID-19 pre-Delta variants, and does not refer to the dominant variant today, which is Omicron,” Dr. Patalon said.

Still, the investigators concluded that the “results underline the importance of preventive measures taken against SARS-CoV-2 infection among pregnant women and their families.”

Sonja A. Rasmussen, MD, of the University of Florida, Gainesville, said that the issue with out-of-date variants in published research has been one of the “real challenges” in studying the ever-evolving COVID-19 pandemic; however, it’s not a good enough reason to dismiss this study.

“I think at this point, we need to assume that it applies to Omicron too,” Dr. Rasmussen said, noting that other respiratory viruses, like influenza, have also been shown to increase the risk of preterm birth when contracted in late pregnancy.

While the present findings highlight the risk of infection in the third trimester, Dr. Rasmussen advised women in all stages of pregnancy to protect themselves against COVID-19, based on the knowledge that illness in a mother can affect normal growth and development in a fetus, even if it doesn’t lead to preterm birth.

“A mom getting sick during pregnancy is not good for the baby,” Dr. Rasmussen said. “The baby’s really dependent on the mom. So you want that baby to have good nutrition throughout the pregnancy. It’s just as important earlier on as later. And you want that baby to get good oxygenation no matter what time [in the pregnancy]. I know that people want a little bit of a break [from preventive measures]. But I would emphasize that if you’re pregnant, we do all sorts of things during pregnancy to make sure that our babies are safe and healthy, and I would continue that for the whole pregnancy.”

Specifically, Dr. Rasmussen advised social distancing, use of an N95 mask, and vaccination. Getting vaccinated during pregnancy helps newborns fight off infection until 6 months of age, she added, when they become eligible for vaccination themselves. This added benefit was recently reported in a study published in the New England Journal of Medicine , for which Dr. Rasmussen cowrote an editorial .

“Vaccines have been approved for 6 months and older,” Dr. Rasmussen said. “But what do you do in those first 6 months of life? That’s a high-risk time for kids.”

Despite these risks, convincing pregnant women to get vaccinated remains a key challenge for health care providers, according to Dr. Rasmussen, even with an abundance of safety data. “Early on [in the pandemic], we said we didn’t know a lot about risks. We knew that other vaccines were safe during pregnancy, but we didn’t have a lot of information about a COVID-19 vaccine. But now we have a lot of data on safety during pregnancy, and these vaccines appear to be completely safe, based on the information we have. There have been many, many pregnant women vaccinated in the United States and in other countries.”

For reluctant expecting mothers, Dr. Rasmussen offered some words of advice: “I know that you worry about anything you do when you’re pregnant. But this is something that you can do to help your baby – now, to make a preterm birth less likely, and later, after the baby is born.

“The most important thing is for the pregnant person to hear this [vaccine recommendation] from their doctor,” she added. “If they’re going to listen to anybody, they’re going to listen to their physician. That’s what the data have shown for a long time.”

The investigators and Dr. Rasmussen disclosed no conflicts of interest.

Pregnant women who get infected with SARS-CoV-2 in their third trimester are almost three times as likely to have a preterm birth, while infection after 34 weeks’ gestation raises this risk sevenfold, based on the largest matched population-based cohort study published to date.

These findings support previous studies, underscoring the need for pregnant women and their families to take preventive measures against infection, lead author Noga Fallach, MA, of the Kahn-Sagol-Maccabi Research and Innovation Center, Tel Aviv, and colleagues reported.

ArtMarie/E+/Getty Images

Past research has suggested that COVID-19 may cause low birth weights and preterm birth in pregnant women, but those studies didn’t report outcomes for each trimester, the investigators wrote in PLoS ONE, noting that “timing of viral infection during fetal development may affect birth and other health outcomes.”

To address this knowledge gap, the investigators looked back at data from 2,703 pregnant women in Israel who tested positive for SARS-CoV-2 from Feb. 21, 2020, to July 2, 2021. Pregnancy outcomes in these women were compared with outcomes in an equal number of uninfected pregnant women. Vaccination status was not reported.

Comparing the two groups showed that catching COVID-19 in the third trimester was linked with nearly triple the risk of preterm birth (odds ratio, 2.76; 95% confidence interval, 1.63-4.67), and more than quadruple the risk if COVID-19 symptoms were present (OR, 4.28; 95% CI, 1.94-9.41). Women who tested positive for SARS-CoV-2 after 34 weeks’ gestation were seven times more likely than uninfected women to deliver early (OR, 7.10; 95% CI, 2.44-20.61).

Pregnant women who caught COVID-19 in the first two trimesters were not significantly more likely to have a preterm birth. Infection was not associated with abnormally low birth rates, or pregnancy loss, in any trimester.

Tal Patalon, MD, coauthor and head of the Kahn-Sagol-Maccabi Research and Innovation Center, focused on these more optimistic findings in an interview.

“The results are encouraging, and reassuring that COVID-19 infection during pregnancy is not associated with any type of pregnancy loss,” Dr. Patalon said.

She also pointed out that the women in the study were infected with SARS-CoV-2 variants that are no longer common.

“It should be remembered that the research group tested the COVID-19 pre-Delta variants, and does not refer to the dominant variant today, which is Omicron,” Dr. Patalon said.

Still, the investigators concluded that the “results underline the importance of preventive measures taken against SARS-CoV-2 infection among pregnant women and their families.”

Sonja A. Rasmussen, MD, of the University of Florida, Gainesville, said that the issue with out-of-date variants in published research has been one of the “real challenges” in studying the ever-evolving COVID-19 pandemic; however, it’s not a good enough reason to dismiss this study.

“I think at this point, we need to assume that it applies to Omicron too,” Dr. Rasmussen said, noting that other respiratory viruses, like influenza, have also been shown to increase the risk of preterm birth when contracted in late pregnancy.

While the present findings highlight the risk of infection in the third trimester, Dr. Rasmussen advised women in all stages of pregnancy to protect themselves against COVID-19, based on the knowledge that illness in a mother can affect normal growth and development in a fetus, even if it doesn’t lead to preterm birth.

“A mom getting sick during pregnancy is not good for the baby,” Dr. Rasmussen said. “The baby’s really dependent on the mom. So you want that baby to have good nutrition throughout the pregnancy. It’s just as important earlier on as later. And you want that baby to get good oxygenation no matter what time [in the pregnancy]. I know that people want a little bit of a break [from preventive measures]. But I would emphasize that if you’re pregnant, we do all sorts of things during pregnancy to make sure that our babies are safe and healthy, and I would continue that for the whole pregnancy.”

Specifically, Dr. Rasmussen advised social distancing, use of an N95 mask, and vaccination. Getting vaccinated during pregnancy helps newborns fight off infection until 6 months of age, she added, when they become eligible for vaccination themselves. This added benefit was recently reported in a study published in the New England Journal of Medicine , for which Dr. Rasmussen cowrote an editorial .

“Vaccines have been approved for 6 months and older,” Dr. Rasmussen said. “But what do you do in those first 6 months of life? That’s a high-risk time for kids.”

Despite these risks, convincing pregnant women to get vaccinated remains a key challenge for health care providers, according to Dr. Rasmussen, even with an abundance of safety data. “Early on [in the pandemic], we said we didn’t know a lot about risks. We knew that other vaccines were safe during pregnancy, but we didn’t have a lot of information about a COVID-19 vaccine. But now we have a lot of data on safety during pregnancy, and these vaccines appear to be completely safe, based on the information we have. There have been many, many pregnant women vaccinated in the United States and in other countries.”

For reluctant expecting mothers, Dr. Rasmussen offered some words of advice: “I know that you worry about anything you do when you’re pregnant. But this is something that you can do to help your baby – now, to make a preterm birth less likely, and later, after the baby is born.

“The most important thing is for the pregnant person to hear this [vaccine recommendation] from their doctor,” she added. “If they’re going to listen to anybody, they’re going to listen to their physician. That’s what the data have shown for a long time.”

The investigators and Dr. Rasmussen disclosed no conflicts of interest.

A newly developed screening tool may help clinicians identify pregnant women with eating disorders.

The 12-question instrument is intended to be a quick way to help clinicians identify women who may need to be referred to a mental health expert for further evaluation, according to the researchers, who reported on the instrument in a study published in Archives of Women’s Mental Health.

“It would be most appropriate for clinical encounters so that women can get screened and referred,” said Elizabeth Claydon, MD, assistant professor in the department of social and behavioral sciences at West Virginia University’s School of Public Health, Morgantown, who led the study. “If you miss it, they may carry on their eating disorder throughout their pregnancy.”

Pregnant women who have an eating disorder are at increased risk for gestational diabetes, premature birth, labor complications, difficulties nursing, and postpartum depression, according to the National Eating Disorders Association. Their babies are at increased risk for premature birth, low birth weight, and poor development. However, clinicians have not had an accurate way of screening pregnant women who may have an eating disorder.

The American College of Obstetricians and Gynecologists offered its first clinical guidelines for managing anorexia in pregnancy in April 2022. The group’s recommendations include regular monitoring of cardiac and liver function, blood pressure, and heart rate, as well as tests to monitor iron, sodium, potassium, bone density, and blood sugar levels. Anorexia, bulimia, binge eating, and subthreshold disorders – also known as other specified feeding or eating disorders – are among the most common eating disorders among pregnant women.

There are no recent data on the incidence or prevalence of eating disorders among pregnant women, according to Lauren Smolar, vice president of mission and education at the National Eating Disorders Association.

“It’s hard to capture the number of pregnant women affected, since it so often goes undetected,” Ms. Smolar said.

Existing screening tools for eating disorders ask patients whether they’re currently pregnant; a questionnaire specifically tailored to pregnant women may help to better gather data on the prevalence within this group, Ms. Smolar said.

For the new study, Dr. Claydon and her colleagues tested the questionnaire among more than 400 mostly White women aged 25-34 years. They found that it could reliably identify women who may have an eating disorder. The questionnaire was validated for women to take during any trimester, according to the findings.

A score of 39 or above would serve as an indicator for follow-up. Women who score at least 39 were up to 16 times more likely to receive a diagnosis of an eating disorder, compared with women who scored less, the researchers found.
 

Eating disorders often escape the eye

Researchers developed the tool to screen all women, rather than just patients who present with recognizable symptoms, according to Dr. Claydon.

“Some people may relapse during pregnancy, some may develop [a disorder] while pregnant,” she said. “This makes sure there are no assumptions, because sometimes you can’t tell someone has an eating disorder just by looking at them.”

The researchers also worked to eliminate stigmatizing language to reduce the possibility of women withholding information about their symptoms.

The tool was developed following a qualitative study by Dr. Claydon and her colleagues that was published in 2018. In that study, the researchers analyzed self-perceptions and self-reported experiences of women going through pregnancy with an eating disorder.

“I heard a lot about how difficult it was to disclose eating disorders during pregnancy,” Dr. Claydon said. “It’s wonderful to do something applied to these findings. It’s very meaningful and personal work to me.”

Dr. Claydon said she and her colleagues now plan to test the tool by introducing it into clinics in West Virginia.

The Ophelia Fund/Rhode Island Foundation supported the creation of the tool and dissemination of the tool to clinicians. Research reported in the study was supported by the National Institute of General Medical Sciences of the National Institutes of Health.

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

A newly developed screening tool may help clinicians identify pregnant women with eating disorders.

The 12-question instrument is intended to be a quick way to help clinicians identify women who may need to be referred to a mental health expert for further evaluation, according to the researchers, who reported on the instrument in a study published in Archives of Women’s Mental Health.

“It would be most appropriate for clinical encounters so that women can get screened and referred,” said Elizabeth Claydon, MD, assistant professor in the department of social and behavioral sciences at West Virginia University’s School of Public Health, Morgantown, who led the study. “If you miss it, they may carry on their eating disorder throughout their pregnancy.”

Pregnant women who have an eating disorder are at increased risk for gestational diabetes, premature birth, labor complications, difficulties nursing, and postpartum depression, according to the National Eating Disorders Association. Their babies are at increased risk for premature birth, low birth weight, and poor development. However, clinicians have not had an accurate way of screening pregnant women who may have an eating disorder.

The American College of Obstetricians and Gynecologists offered its first clinical guidelines for managing anorexia in pregnancy in April 2022. The group’s recommendations include regular monitoring of cardiac and liver function, blood pressure, and heart rate, as well as tests to monitor iron, sodium, potassium, bone density, and blood sugar levels. Anorexia, bulimia, binge eating, and subthreshold disorders – also known as other specified feeding or eating disorders – are among the most common eating disorders among pregnant women.

There are no recent data on the incidence or prevalence of eating disorders among pregnant women, according to Lauren Smolar, vice president of mission and education at the National Eating Disorders Association.

“It’s hard to capture the number of pregnant women affected, since it so often goes undetected,” Ms. Smolar said.

Existing screening tools for eating disorders ask patients whether they’re currently pregnant; a questionnaire specifically tailored to pregnant women may help to better gather data on the prevalence within this group, Ms. Smolar said.

For the new study, Dr. Claydon and her colleagues tested the questionnaire among more than 400 mostly White women aged 25-34 years. They found that it could reliably identify women who may have an eating disorder. The questionnaire was validated for women to take during any trimester, according to the findings.

A score of 39 or above would serve as an indicator for follow-up. Women who score at least 39 were up to 16 times more likely to receive a diagnosis of an eating disorder, compared with women who scored less, the researchers found.
 

Eating disorders often escape the eye

Researchers developed the tool to screen all women, rather than just patients who present with recognizable symptoms, according to Dr. Claydon.

“Some people may relapse during pregnancy, some may develop [a disorder] while pregnant,” she said. “This makes sure there are no assumptions, because sometimes you can’t tell someone has an eating disorder just by looking at them.”

The researchers also worked to eliminate stigmatizing language to reduce the possibility of women withholding information about their symptoms.

The tool was developed following a qualitative study by Dr. Claydon and her colleagues that was published in 2018. In that study, the researchers analyzed self-perceptions and self-reported experiences of women going through pregnancy with an eating disorder.

“I heard a lot about how difficult it was to disclose eating disorders during pregnancy,” Dr. Claydon said. “It’s wonderful to do something applied to these findings. It’s very meaningful and personal work to me.”

Dr. Claydon said she and her colleagues now plan to test the tool by introducing it into clinics in West Virginia.

The Ophelia Fund/Rhode Island Foundation supported the creation of the tool and dissemination of the tool to clinicians. Research reported in the study was supported by the National Institute of General Medical Sciences of the National Institutes of Health.

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

A newly developed screening tool may help clinicians identify pregnant women with eating disorders.

The 12-question instrument is intended to be a quick way to help clinicians identify women who may need to be referred to a mental health expert for further evaluation, according to the researchers, who reported on the instrument in a study published in Archives of Women’s Mental Health.

“It would be most appropriate for clinical encounters so that women can get screened and referred,” said Elizabeth Claydon, MD, assistant professor in the department of social and behavioral sciences at West Virginia University’s School of Public Health, Morgantown, who led the study. “If you miss it, they may carry on their eating disorder throughout their pregnancy.”

Pregnant women who have an eating disorder are at increased risk for gestational diabetes, premature birth, labor complications, difficulties nursing, and postpartum depression, according to the National Eating Disorders Association. Their babies are at increased risk for premature birth, low birth weight, and poor development. However, clinicians have not had an accurate way of screening pregnant women who may have an eating disorder.

The American College of Obstetricians and Gynecologists offered its first clinical guidelines for managing anorexia in pregnancy in April 2022. The group’s recommendations include regular monitoring of cardiac and liver function, blood pressure, and heart rate, as well as tests to monitor iron, sodium, potassium, bone density, and blood sugar levels. Anorexia, bulimia, binge eating, and subthreshold disorders – also known as other specified feeding or eating disorders – are among the most common eating disorders among pregnant women.

There are no recent data on the incidence or prevalence of eating disorders among pregnant women, according to Lauren Smolar, vice president of mission and education at the National Eating Disorders Association.

“It’s hard to capture the number of pregnant women affected, since it so often goes undetected,” Ms. Smolar said.

Existing screening tools for eating disorders ask patients whether they’re currently pregnant; a questionnaire specifically tailored to pregnant women may help to better gather data on the prevalence within this group, Ms. Smolar said.

For the new study, Dr. Claydon and her colleagues tested the questionnaire among more than 400 mostly White women aged 25-34 years. They found that it could reliably identify women who may have an eating disorder. The questionnaire was validated for women to take during any trimester, according to the findings.

A score of 39 or above would serve as an indicator for follow-up. Women who score at least 39 were up to 16 times more likely to receive a diagnosis of an eating disorder, compared with women who scored less, the researchers found.
 

Eating disorders often escape the eye

Researchers developed the tool to screen all women, rather than just patients who present with recognizable symptoms, according to Dr. Claydon.

“Some people may relapse during pregnancy, some may develop [a disorder] while pregnant,” she said. “This makes sure there are no assumptions, because sometimes you can’t tell someone has an eating disorder just by looking at them.”

The researchers also worked to eliminate stigmatizing language to reduce the possibility of women withholding information about their symptoms.

The tool was developed following a qualitative study by Dr. Claydon and her colleagues that was published in 2018. In that study, the researchers analyzed self-perceptions and self-reported experiences of women going through pregnancy with an eating disorder.

“I heard a lot about how difficult it was to disclose eating disorders during pregnancy,” Dr. Claydon said. “It’s wonderful to do something applied to these findings. It’s very meaningful and personal work to me.”

Dr. Claydon said she and her colleagues now plan to test the tool by introducing it into clinics in West Virginia.

The Ophelia Fund/Rhode Island Foundation supported the creation of the tool and dissemination of the tool to clinicians. Research reported in the study was supported by the National Institute of General Medical Sciences of the National Institutes of Health.

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

Debra Katz, CNM, has noticed a shift in the number of teenagers coming to the teen obstetrics program at St. Joseph’s Medical Center in Paterson, N.J. A decade ago, about 30 adolescents gave birth in a given month; now, that figure is closer to 20, said Ms. Katz, chief of the nurse midwifery service at the center.

Ms. Katz’s observations mirror a national trend: The rate of teen births is falling in the United States, according to a study published in Obstetrics and Gynecology.

But, there’s a catch. The adolescents who are giving birth are more likely to have obesity, mental health problems, asthma, and other conditions that can complicate their pregnancies, the research shows. Rates of delivery complications have also increased in this age group.

Ms. Katz said that, compared with adult patients, teens tend to require longer medical visits. Most patients have limited knowledge of what prenatal care entails.

“Most of these patients have never even had a female [gynecologic] exam before,” Ms. Katz said. “They come in and they’re not used to the equipment. They’re not used to the terminology.”

Also consistent with the national trends, St. Joseph’s younger patients often have mental health problems or obesity. Many also lack stable housing and adequate food.

“Unfortunately, we are seeing a greater number of patients with morbid obesity; there’s a lot of bipolar disease; here’s a lot of depression; there’s a lot of anxiety,” Ms. Katz said. “And we also have a bit of PTSD [post traumatic stress disorder] as well.”

These factors make clinical practice more complex, according to the authors of the new study. “To optimize adolescent pregnancy outcomes, prenatal care will likely need to provide increasingly complex clinical management in addition to addressing outreach challenges of this population,” the authors of the new study write.

At St. Joseph’s, teens receive prenatal care in a group setting with other patients who are due to deliver in the same month. This model, called CenteringPregnancy, can increase self-esteem, build community, and may improve patient outcomes, Ms. Katz said. The program uses a team approach that includes a dietitian and social worker to address social support needs.
 

Shifting health status

To characterize delivery hospitalization trends for patients aged 11-19 years, Anna P. Staniczenko, MD, with Columbia University Irving Medical Center, New York, and her colleagues conducted a cross-sectional analysis of data from the 2000-2018 National Inpatient Sample.

Of more than 73 million estimated delivery hospitalizations during that period, 88,363 occurred in patients aged 11-14 years, and 6,359,331 were among patients aged 15-19 years.

Deliveries among patients aged 11-14 years decreased from 2.1 per 1,000 to 0.4 per 1,000 during the time frame. Deliveries among patients aged 15-19 years decreased from 11.5% of all deliveries to 4.8% over the study period.

Among patients aged 11-19 years, rates of comorbidities significantly increased from 2000 to 2018, the researchers found. The prevalence of obesity increased from 0.2% to 7.2%, asthma increased from 1.6% to 7%, while mental health conditions increased from 0.5% to 7.1%.

Severe maternal morbidity, defined as a patient having at least one of 20 conditions, including stroke, heart failure, and sepsis, increased from 0.5% to 0.7%. The rate of postpartum hemorrhage increased from 2.9% to 4.7%, the rate of cesarean delivery increased from 15.2% to 19.5%, and that of hypertensive disorders of pregnancy increased from 7.5% to 13.7%.
 

An often overlooked group

Adolescent pregnancies are more common in the United States than in other wealthy nations, and about 80% are unintended. In addition to the growth in comorbid conditions, adolescent mothers are at an increased risk of living under the poverty line, and children born to teen moms may be at increased risk for adverse pediatric outcomes.

Still, these pregnancies “may be planned and desired. ... It is unclear that there is an ‘ideal’ rate of pregnancy for this age group,” the study authors write.

Prior research has shown an increase in rates of chronic conditions among adults giving birth, but, “from what I could tell, this is really the first data” on chronic conditions in the pediatric obstetric population, said Lindsay K. Admon, MD, an ob.gyn. at the University of Michigan, Ann Arbor, who wrote an editorial accompanying the journal article.
 

Behind the decline

That there are fewer teen deliveries may be because the adolescent population is savvier about contraceptive methods. In addition, the Affordable Care Act expanded insurance coverage of contraception, said Stephanie Teal, MD, MPH, chair of obstetrics and gynecology and reproductive biology at University Hospitals Cleveland Medical Center and Case Western Reserve University School of Medicine, Cleveland.

Dr. Teal was involved in the Colorado Family Planning Initiative, a state effort that showed that long-acting reversible contraception was effective and acceptable to young people.

“We are definitely seeing more adolescents who use birth control the first time they have sex,” Dr. Teal told this news organization. “When I started in practice, it was fairly uncommon that I would see a teenager who was sexually active who was consistently using a birth control method. And now they just look at me, roll their eyes, and are, like, ‘Duh, of course. He uses condoms, and I have an IUD.’ ”

To the extent that these deliveries include unintended pregnancies, the data may point to a need for clinicians to provide contraceptive education to adolescents with chronic conditions, according to Dr. Admon.
 

Abortion shifts

If U.S. Supreme Court rulings and state laws further limit access to contraception or abortion, the result could lead to more teen deliveries, Dr. Admon said.

While the adolescent birth rate has plummeted, the teen abortion rate has not increased, Dr. Teal said.

“Pregnancy is a time of health risk for women, and it’s getting riskier,” she said. “Our concern is that if people are having to go through a pregnancy that they don’t feel physically or financially or emotionally prepared to go through, that we will see an increase in these kinds of adverse health outcomes with birth.”

One study author has a leadership role on an American College of Obstetricians and Gynecologists safe motherhood initiative that has received unrestricted funding from Merck for Mothers. Another author has ties to Delfina Care, and one is on the board of directors of Planned Parenthood of Greater New York. Dr. Admon receives funding from the Agency for Healthcare Research and Quality and the National Institutes of Health. Dr. Teal has received grants from Merck, Bayer Healthcare, Sebela, and Medicines360 and personal fees from Merck and from Bayer Healthcare. Ms. Katz has disclosed no relevant financial relationships.

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

Debra Katz, CNM, has noticed a shift in the number of teenagers coming to the teen obstetrics program at St. Joseph’s Medical Center in Paterson, N.J. A decade ago, about 30 adolescents gave birth in a given month; now, that figure is closer to 20, said Ms. Katz, chief of the nurse midwifery service at the center.

Ms. Katz’s observations mirror a national trend: The rate of teen births is falling in the United States, according to a study published in Obstetrics and Gynecology.

But, there’s a catch. The adolescents who are giving birth are more likely to have obesity, mental health problems, asthma, and other conditions that can complicate their pregnancies, the research shows. Rates of delivery complications have also increased in this age group.

Ms. Katz said that, compared with adult patients, teens tend to require longer medical visits. Most patients have limited knowledge of what prenatal care entails.

“Most of these patients have never even had a female [gynecologic] exam before,” Ms. Katz said. “They come in and they’re not used to the equipment. They’re not used to the terminology.”

Also consistent with the national trends, St. Joseph’s younger patients often have mental health problems or obesity. Many also lack stable housing and adequate food.

“Unfortunately, we are seeing a greater number of patients with morbid obesity; there’s a lot of bipolar disease; here’s a lot of depression; there’s a lot of anxiety,” Ms. Katz said. “And we also have a bit of PTSD [post traumatic stress disorder] as well.”

These factors make clinical practice more complex, according to the authors of the new study. “To optimize adolescent pregnancy outcomes, prenatal care will likely need to provide increasingly complex clinical management in addition to addressing outreach challenges of this population,” the authors of the new study write.

At St. Joseph’s, teens receive prenatal care in a group setting with other patients who are due to deliver in the same month. This model, called CenteringPregnancy, can increase self-esteem, build community, and may improve patient outcomes, Ms. Katz said. The program uses a team approach that includes a dietitian and social worker to address social support needs.
 

Shifting health status

To characterize delivery hospitalization trends for patients aged 11-19 years, Anna P. Staniczenko, MD, with Columbia University Irving Medical Center, New York, and her colleagues conducted a cross-sectional analysis of data from the 2000-2018 National Inpatient Sample.

Of more than 73 million estimated delivery hospitalizations during that period, 88,363 occurred in patients aged 11-14 years, and 6,359,331 were among patients aged 15-19 years.

Deliveries among patients aged 11-14 years decreased from 2.1 per 1,000 to 0.4 per 1,000 during the time frame. Deliveries among patients aged 15-19 years decreased from 11.5% of all deliveries to 4.8% over the study period.

Among patients aged 11-19 years, rates of comorbidities significantly increased from 2000 to 2018, the researchers found. The prevalence of obesity increased from 0.2% to 7.2%, asthma increased from 1.6% to 7%, while mental health conditions increased from 0.5% to 7.1%.

Severe maternal morbidity, defined as a patient having at least one of 20 conditions, including stroke, heart failure, and sepsis, increased from 0.5% to 0.7%. The rate of postpartum hemorrhage increased from 2.9% to 4.7%, the rate of cesarean delivery increased from 15.2% to 19.5%, and that of hypertensive disorders of pregnancy increased from 7.5% to 13.7%.
 

An often overlooked group

Adolescent pregnancies are more common in the United States than in other wealthy nations, and about 80% are unintended. In addition to the growth in comorbid conditions, adolescent mothers are at an increased risk of living under the poverty line, and children born to teen moms may be at increased risk for adverse pediatric outcomes.

Still, these pregnancies “may be planned and desired. ... It is unclear that there is an ‘ideal’ rate of pregnancy for this age group,” the study authors write.

Prior research has shown an increase in rates of chronic conditions among adults giving birth, but, “from what I could tell, this is really the first data” on chronic conditions in the pediatric obstetric population, said Lindsay K. Admon, MD, an ob.gyn. at the University of Michigan, Ann Arbor, who wrote an editorial accompanying the journal article.
 

Behind the decline

That there are fewer teen deliveries may be because the adolescent population is savvier about contraceptive methods. In addition, the Affordable Care Act expanded insurance coverage of contraception, said Stephanie Teal, MD, MPH, chair of obstetrics and gynecology and reproductive biology at University Hospitals Cleveland Medical Center and Case Western Reserve University School of Medicine, Cleveland.

Dr. Teal was involved in the Colorado Family Planning Initiative, a state effort that showed that long-acting reversible contraception was effective and acceptable to young people.

“We are definitely seeing more adolescents who use birth control the first time they have sex,” Dr. Teal told this news organization. “When I started in practice, it was fairly uncommon that I would see a teenager who was sexually active who was consistently using a birth control method. And now they just look at me, roll their eyes, and are, like, ‘Duh, of course. He uses condoms, and I have an IUD.’ ”

To the extent that these deliveries include unintended pregnancies, the data may point to a need for clinicians to provide contraceptive education to adolescents with chronic conditions, according to Dr. Admon.
 

Abortion shifts

If U.S. Supreme Court rulings and state laws further limit access to contraception or abortion, the result could lead to more teen deliveries, Dr. Admon said.

While the adolescent birth rate has plummeted, the teen abortion rate has not increased, Dr. Teal said.

“Pregnancy is a time of health risk for women, and it’s getting riskier,” she said. “Our concern is that if people are having to go through a pregnancy that they don’t feel physically or financially or emotionally prepared to go through, that we will see an increase in these kinds of adverse health outcomes with birth.”

One study author has a leadership role on an American College of Obstetricians and Gynecologists safe motherhood initiative that has received unrestricted funding from Merck for Mothers. Another author has ties to Delfina Care, and one is on the board of directors of Planned Parenthood of Greater New York. Dr. Admon receives funding from the Agency for Healthcare Research and Quality and the National Institutes of Health. Dr. Teal has received grants from Merck, Bayer Healthcare, Sebela, and Medicines360 and personal fees from Merck and from Bayer Healthcare. Ms. Katz has disclosed no relevant financial relationships.

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

Debra Katz, CNM, has noticed a shift in the number of teenagers coming to the teen obstetrics program at St. Joseph’s Medical Center in Paterson, N.J. A decade ago, about 30 adolescents gave birth in a given month; now, that figure is closer to 20, said Ms. Katz, chief of the nurse midwifery service at the center.

Ms. Katz’s observations mirror a national trend: The rate of teen births is falling in the United States, according to a study published in Obstetrics and Gynecology.

But, there’s a catch. The adolescents who are giving birth are more likely to have obesity, mental health problems, asthma, and other conditions that can complicate their pregnancies, the research shows. Rates of delivery complications have also increased in this age group.

Ms. Katz said that, compared with adult patients, teens tend to require longer medical visits. Most patients have limited knowledge of what prenatal care entails.

“Most of these patients have never even had a female [gynecologic] exam before,” Ms. Katz said. “They come in and they’re not used to the equipment. They’re not used to the terminology.”

Also consistent with the national trends, St. Joseph’s younger patients often have mental health problems or obesity. Many also lack stable housing and adequate food.

“Unfortunately, we are seeing a greater number of patients with morbid obesity; there’s a lot of bipolar disease; here’s a lot of depression; there’s a lot of anxiety,” Ms. Katz said. “And we also have a bit of PTSD [post traumatic stress disorder] as well.”

These factors make clinical practice more complex, according to the authors of the new study. “To optimize adolescent pregnancy outcomes, prenatal care will likely need to provide increasingly complex clinical management in addition to addressing outreach challenges of this population,” the authors of the new study write.

At St. Joseph’s, teens receive prenatal care in a group setting with other patients who are due to deliver in the same month. This model, called CenteringPregnancy, can increase self-esteem, build community, and may improve patient outcomes, Ms. Katz said. The program uses a team approach that includes a dietitian and social worker to address social support needs.
 

Shifting health status

To characterize delivery hospitalization trends for patients aged 11-19 years, Anna P. Staniczenko, MD, with Columbia University Irving Medical Center, New York, and her colleagues conducted a cross-sectional analysis of data from the 2000-2018 National Inpatient Sample.

Of more than 73 million estimated delivery hospitalizations during that period, 88,363 occurred in patients aged 11-14 years, and 6,359,331 were among patients aged 15-19 years.

Deliveries among patients aged 11-14 years decreased from 2.1 per 1,000 to 0.4 per 1,000 during the time frame. Deliveries among patients aged 15-19 years decreased from 11.5% of all deliveries to 4.8% over the study period.

Among patients aged 11-19 years, rates of comorbidities significantly increased from 2000 to 2018, the researchers found. The prevalence of obesity increased from 0.2% to 7.2%, asthma increased from 1.6% to 7%, while mental health conditions increased from 0.5% to 7.1%.

Severe maternal morbidity, defined as a patient having at least one of 20 conditions, including stroke, heart failure, and sepsis, increased from 0.5% to 0.7%. The rate of postpartum hemorrhage increased from 2.9% to 4.7%, the rate of cesarean delivery increased from 15.2% to 19.5%, and that of hypertensive disorders of pregnancy increased from 7.5% to 13.7%.
 

An often overlooked group

Adolescent pregnancies are more common in the United States than in other wealthy nations, and about 80% are unintended. In addition to the growth in comorbid conditions, adolescent mothers are at an increased risk of living under the poverty line, and children born to teen moms may be at increased risk for adverse pediatric outcomes.

Still, these pregnancies “may be planned and desired. ... It is unclear that there is an ‘ideal’ rate of pregnancy for this age group,” the study authors write.

Prior research has shown an increase in rates of chronic conditions among adults giving birth, but, “from what I could tell, this is really the first data” on chronic conditions in the pediatric obstetric population, said Lindsay K. Admon, MD, an ob.gyn. at the University of Michigan, Ann Arbor, who wrote an editorial accompanying the journal article.
 

Behind the decline

That there are fewer teen deliveries may be because the adolescent population is savvier about contraceptive methods. In addition, the Affordable Care Act expanded insurance coverage of contraception, said Stephanie Teal, MD, MPH, chair of obstetrics and gynecology and reproductive biology at University Hospitals Cleveland Medical Center and Case Western Reserve University School of Medicine, Cleveland.

Dr. Teal was involved in the Colorado Family Planning Initiative, a state effort that showed that long-acting reversible contraception was effective and acceptable to young people.

“We are definitely seeing more adolescents who use birth control the first time they have sex,” Dr. Teal told this news organization. “When I started in practice, it was fairly uncommon that I would see a teenager who was sexually active who was consistently using a birth control method. And now they just look at me, roll their eyes, and are, like, ‘Duh, of course. He uses condoms, and I have an IUD.’ ”

To the extent that these deliveries include unintended pregnancies, the data may point to a need for clinicians to provide contraceptive education to adolescents with chronic conditions, according to Dr. Admon.
 

Abortion shifts

If U.S. Supreme Court rulings and state laws further limit access to contraception or abortion, the result could lead to more teen deliveries, Dr. Admon said.

While the adolescent birth rate has plummeted, the teen abortion rate has not increased, Dr. Teal said.

“Pregnancy is a time of health risk for women, and it’s getting riskier,” she said. “Our concern is that if people are having to go through a pregnancy that they don’t feel physically or financially or emotionally prepared to go through, that we will see an increase in these kinds of adverse health outcomes with birth.”

One study author has a leadership role on an American College of Obstetricians and Gynecologists safe motherhood initiative that has received unrestricted funding from Merck for Mothers. Another author has ties to Delfina Care, and one is on the board of directors of Planned Parenthood of Greater New York. Dr. Admon receives funding from the Agency for Healthcare Research and Quality and the National Institutes of Health. Dr. Teal has received grants from Merck, Bayer Healthcare, Sebela, and Medicines360 and personal fees from Merck and from Bayer Healthcare. Ms. Katz has disclosed no relevant financial relationships.

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

The prospect of having a premature infant can be highly stressful. But a new study found that providing pregnant patients hospitalized for preterm labor with detailed information about what to expect with an early birth significantly reduced their anxiety about the process.

The study found that both printed handouts and a tablet app were associated with a 50% reduction in anxiety and appeared to be equally effective, although the handouts are likely easier to use in the high-stress environment of neonatal intensive care facilities, according to the researchers, who presented the findings April 25 at the annual meeting of the Pediatric Academic Societies.

“When patients get admitted for preterm labor a neonatologist comes to talk to parents about outcomes, short- and long-term, like bleeding in the baby’s brain and the possible need to have surgeries,” said Nicole Rau, MD, assistant professor of clinical pediatrics at University of Illinois at Peoria, who led the study. “Then parents are asked to make decisions during a high-stress time while they’re still processing everything. Everyone agrees that’s really not ideal.”

About 1 in 10 babies in the United States are born prematurely – or before 37 weeks of gestation – each year. That adds up to about 500,000 per year. Many spend days or weeks in neonatal intensive care units – watched from a distance by their anxious parents desperate for answers and reassurance. Potential complications for infants born prematurely include heart issues, trouble breathing, brain bleeds, and difficulty controlling their body temperature.

The American Academy of Pediatrics and the National Institute of Child Health and Human Development have warned that birth parents at risk for premature delivery may not be adequately prepared for what to expect. According to the groups, although clinicians may counsel these patients on admission to the hospital, factors such as stress, pain, and maternal medication can make the message difficult to comprehend.

For the study, Dr. Rau and her colleagues divided patients at the Medical College of Wisconsin and Children’s Hospital of Wisconsin who were hospitalized between 22 and 33 weeks of pregnancy into two groups: Some received a handout on preterm labor, and some were given a bedside tablet with an app called Preemie Prep for Parents.

Seventy-six women were randomized in gestational age blocks of 22-24 weeks and 25-33 weeks. After some opted not to complete the study, 59 participants remained – 32 of whom received handouts, and 27 who had access to tablets.

After distributing the materials, Dr. Rau’s group gave patients a questionnaire asking about delivery resuscitation, short-term problems, long-term problems, treatments, length of stay, and miscellaneous questions about their care. The two groups performed similarly – the tablet group’s median score was 20/30, and the handout group’s median score was 22/30.

Using the State-Trait Anxiety Inventory, researchers found both groups experienced a 50% reduction in anxiety after learning more from their respective materials.

Dr. Rau said she and her colleagues expected patients with access to the app would perform better based on cognition studies that have shown multimedia tools are more effective than tools that use visual or audio information but not both. However, both groups seemed to benefit comparably, which she said may reflect underuse of the app.

What was clear, though, is that patients absorbed more information and felt better prepared when they received it in ways beyond verbal communication.

“Well-written, parent-friendly information is a great tool to supplement counseling,” Dr. Rau told this news organization.

Because preterm labor is a relatively common occurrence, expectant parents should be well-prepared with proper information, said Erika Werner, MD, chair of obstetrics & gynecology at Tufts Medical Center, Boston, who was not involved in the study.

“Preterm labor is something that’s way more common than people think,” Dr. Werner told this news organization. “As long as it’s coming from a trusted source, additional information is a good thing. Knowing in advance some of the things that might be different from what you expect is always important. The more that we as providers have time to educate patients about potential risks, the better the outcomes will be.”

The authors reported no relevant financial conflicts of interest. The study was supported by grants from Children’s Research Institute and AMAG Pharmaceuticals.

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

The prospect of having a premature infant can be highly stressful. But a new study found that providing pregnant patients hospitalized for preterm labor with detailed information about what to expect with an early birth significantly reduced their anxiety about the process.

The study found that both printed handouts and a tablet app were associated with a 50% reduction in anxiety and appeared to be equally effective, although the handouts are likely easier to use in the high-stress environment of neonatal intensive care facilities, according to the researchers, who presented the findings April 25 at the annual meeting of the Pediatric Academic Societies.

“When patients get admitted for preterm labor a neonatologist comes to talk to parents about outcomes, short- and long-term, like bleeding in the baby’s brain and the possible need to have surgeries,” said Nicole Rau, MD, assistant professor of clinical pediatrics at University of Illinois at Peoria, who led the study. “Then parents are asked to make decisions during a high-stress time while they’re still processing everything. Everyone agrees that’s really not ideal.”

About 1 in 10 babies in the United States are born prematurely – or before 37 weeks of gestation – each year. That adds up to about 500,000 per year. Many spend days or weeks in neonatal intensive care units – watched from a distance by their anxious parents desperate for answers and reassurance. Potential complications for infants born prematurely include heart issues, trouble breathing, brain bleeds, and difficulty controlling their body temperature.

The American Academy of Pediatrics and the National Institute of Child Health and Human Development have warned that birth parents at risk for premature delivery may not be adequately prepared for what to expect. According to the groups, although clinicians may counsel these patients on admission to the hospital, factors such as stress, pain, and maternal medication can make the message difficult to comprehend.

For the study, Dr. Rau and her colleagues divided patients at the Medical College of Wisconsin and Children’s Hospital of Wisconsin who were hospitalized between 22 and 33 weeks of pregnancy into two groups: Some received a handout on preterm labor, and some were given a bedside tablet with an app called Preemie Prep for Parents.

Seventy-six women were randomized in gestational age blocks of 22-24 weeks and 25-33 weeks. After some opted not to complete the study, 59 participants remained – 32 of whom received handouts, and 27 who had access to tablets.

After distributing the materials, Dr. Rau’s group gave patients a questionnaire asking about delivery resuscitation, short-term problems, long-term problems, treatments, length of stay, and miscellaneous questions about their care. The two groups performed similarly – the tablet group’s median score was 20/30, and the handout group’s median score was 22/30.

Using the State-Trait Anxiety Inventory, researchers found both groups experienced a 50% reduction in anxiety after learning more from their respective materials.

Dr. Rau said she and her colleagues expected patients with access to the app would perform better based on cognition studies that have shown multimedia tools are more effective than tools that use visual or audio information but not both. However, both groups seemed to benefit comparably, which she said may reflect underuse of the app.

What was clear, though, is that patients absorbed more information and felt better prepared when they received it in ways beyond verbal communication.

“Well-written, parent-friendly information is a great tool to supplement counseling,” Dr. Rau told this news organization.

Because preterm labor is a relatively common occurrence, expectant parents should be well-prepared with proper information, said Erika Werner, MD, chair of obstetrics & gynecology at Tufts Medical Center, Boston, who was not involved in the study.

“Preterm labor is something that’s way more common than people think,” Dr. Werner told this news organization. “As long as it’s coming from a trusted source, additional information is a good thing. Knowing in advance some of the things that might be different from what you expect is always important. The more that we as providers have time to educate patients about potential risks, the better the outcomes will be.”

The authors reported no relevant financial conflicts of interest. The study was supported by grants from Children’s Research Institute and AMAG Pharmaceuticals.

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

The prospect of having a premature infant can be highly stressful. But a new study found that providing pregnant patients hospitalized for preterm labor with detailed information about what to expect with an early birth significantly reduced their anxiety about the process.

The study found that both printed handouts and a tablet app were associated with a 50% reduction in anxiety and appeared to be equally effective, although the handouts are likely easier to use in the high-stress environment of neonatal intensive care facilities, according to the researchers, who presented the findings April 25 at the annual meeting of the Pediatric Academic Societies.

“When patients get admitted for preterm labor a neonatologist comes to talk to parents about outcomes, short- and long-term, like bleeding in the baby’s brain and the possible need to have surgeries,” said Nicole Rau, MD, assistant professor of clinical pediatrics at University of Illinois at Peoria, who led the study. “Then parents are asked to make decisions during a high-stress time while they’re still processing everything. Everyone agrees that’s really not ideal.”

About 1 in 10 babies in the United States are born prematurely – or before 37 weeks of gestation – each year. That adds up to about 500,000 per year. Many spend days or weeks in neonatal intensive care units – watched from a distance by their anxious parents desperate for answers and reassurance. Potential complications for infants born prematurely include heart issues, trouble breathing, brain bleeds, and difficulty controlling their body temperature.

The American Academy of Pediatrics and the National Institute of Child Health and Human Development have warned that birth parents at risk for premature delivery may not be adequately prepared for what to expect. According to the groups, although clinicians may counsel these patients on admission to the hospital, factors such as stress, pain, and maternal medication can make the message difficult to comprehend.

For the study, Dr. Rau and her colleagues divided patients at the Medical College of Wisconsin and Children’s Hospital of Wisconsin who were hospitalized between 22 and 33 weeks of pregnancy into two groups: Some received a handout on preterm labor, and some were given a bedside tablet with an app called Preemie Prep for Parents.

Seventy-six women were randomized in gestational age blocks of 22-24 weeks and 25-33 weeks. After some opted not to complete the study, 59 participants remained – 32 of whom received handouts, and 27 who had access to tablets.

After distributing the materials, Dr. Rau’s group gave patients a questionnaire asking about delivery resuscitation, short-term problems, long-term problems, treatments, length of stay, and miscellaneous questions about their care. The two groups performed similarly – the tablet group’s median score was 20/30, and the handout group’s median score was 22/30.

Using the State-Trait Anxiety Inventory, researchers found both groups experienced a 50% reduction in anxiety after learning more from their respective materials.

Dr. Rau said she and her colleagues expected patients with access to the app would perform better based on cognition studies that have shown multimedia tools are more effective than tools that use visual or audio information but not both. However, both groups seemed to benefit comparably, which she said may reflect underuse of the app.

What was clear, though, is that patients absorbed more information and felt better prepared when they received it in ways beyond verbal communication.

“Well-written, parent-friendly information is a great tool to supplement counseling,” Dr. Rau told this news organization.

Because preterm labor is a relatively common occurrence, expectant parents should be well-prepared with proper information, said Erika Werner, MD, chair of obstetrics & gynecology at Tufts Medical Center, Boston, who was not involved in the study.

“Preterm labor is something that’s way more common than people think,” Dr. Werner told this news organization. “As long as it’s coming from a trusted source, additional information is a good thing. Knowing in advance some of the things that might be different from what you expect is always important. The more that we as providers have time to educate patients about potential risks, the better the outcomes will be.”

The authors reported no relevant financial conflicts of interest. The study was supported by grants from Children’s Research Institute and AMAG Pharmaceuticals.

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

A new blood test performed in the second trimester could help identify pregnancies at risk of early and very early spontaneous preterm birth (sPTB), based on a prospective cohort trial.

The cell-free RNA (cfRNA) profiling tool could guide patient and provider decision-making, while the underlying research illuminates biological pathways that may facilitate novel interventions, reported lead author Joan Camunas-Soler, PhD, of Mirvie, South San Francisco, and colleagues.

“Given the complex etiology of this heterogeneous syndrome, it would be advantageous to develop predictive tests that provide insight on the specific pathophysiology leading to preterm birth for each particular pregnancy,” Dr. Camunas-Soler and colleagues wrote in the American Journal of Obstetrics and Gynecology. “Such an approach could inform the development of preventive treatments and targeted therapeutics that are currently lacking/difficult to implement due to the heterogeneous etiology of sPTB.”

Currently, the best predictor of sPTB is previous sPTB, according to the investigators. Although a combination approach that incorporates cervical length and fetal fibronectin in cervicovaginal fluid is “of use,” they noted, “this is not standard of care in the U.S.A. nor recommended by the American College of Obstetricians and Gynecologists or the Society for Maternal-Fetal Medicine.” Existing molecular tests lack clinical data and may be inaccurate across diverse patient populations, they added.

The present study aimed to address these shortcomings by creating a second-trimester blood test for predicting sPTB. To identify relevant biomarkers, the investigators compared RNA profiles that were differentially expressed in three types of cases: term birth, early sPTB, and very early sPTB.

Among 242 women who contributed second-trimester blood samples for analysis, 194 went on to have a term birth. Of the remaining 48 women who gave birth spontaneously before 35 weeks’ gestation, 32 delivered between 25 and 35 weeks (early sPTB), while 16 delivered before 25 weeks’ gestation (very early sPTB). Slightly more than half of the patients were White, about one-third were Black, approximately 10% were Asian, and the remainder were of unknown race/ethnicity. Cases of preeclampsia were excluded.

The gene discovery and modeling process revealed 25 distinct genes that were significantly associated with early sPTB, offering a risk model with a sensitivity of 76% and a specificity of 72% (area under the curve, 0.80; 95% confidence interval, 0.72-0.87). Very early sPTB was associated with a set of 39 genes, giving a model with a sensitivity of 64% and a specificity of 80% (area under the curve = 0.76; 95% CI, 0.63-0.87).

Characterization of the two RNA profiles offered a glimpse into the underlying biological processes driving preterm birth. The genes predicting early sPTB are largely responsible for extracellular matrix degradation and remodeling, which could, “in terms of mechanism, reflect ongoing processes associated with cervical shortening, a feature often detected some weeks prior to sPTB,” the investigators wrote. In contrast, genes associated with very early sPTB are linked with insulinlike growth factor transport, which drives fetal growth and placentation. These findings could lead to development of pathway-specific interventions, Dr. Camunas-Soler and colleagues suggested.

According to coauthor Michal A. Elovitz, MD, the Hilarie L. Morgan and Mitchell L. Morgan President’s Distinguished Professor in Women’s Health at the University of Pennsylvania, Philadelphia, and chief medical advisor at Mirvie, the proprietary RNA platform moves beyond “unreliable and at times biased clinical factors such as race, BMI, and maternal age” to offer a “precision-based approach to pregnancy health.”

Excluding traditional risk factors also “promises more equitable care than the use of broad sociodemographic factors that often result in bias,” she added, noting that this may help address the higher rate of pregnancy complications among Black patients.

When asked about the potential for false-positive results, considering reported specificity rates of 72%-80%, Dr. Elovitz suggested that such concerns among pregnant women are an “unfortunate misconception.”

“It is not reflective of what women want regarding knowledge about the health of their pregnancy,” she said in a written comment. “Rather than be left in the dark, women want to be prepared for what is to come in their pregnancy journey.”

In support of this statement, Dr. Elovitz cited a recent study involving women with preeclampsia and other hypertensive disorders in pregnancy. A questionnaire showed that women appreciated pregnancy risk models when making decisions, and reported that they would have greater peace of mind if such tests were available.

*This story was updated on 4/26/2022. 

A new blood test performed in the second trimester could help identify pregnancies at risk of early and very early spontaneous preterm birth (sPTB), based on a prospective cohort trial.

The cell-free RNA (cfRNA) profiling tool could guide patient and provider decision-making, while the underlying research illuminates biological pathways that may facilitate novel interventions, reported lead author Joan Camunas-Soler, PhD, of Mirvie, South San Francisco, and colleagues.

“Given the complex etiology of this heterogeneous syndrome, it would be advantageous to develop predictive tests that provide insight on the specific pathophysiology leading to preterm birth for each particular pregnancy,” Dr. Camunas-Soler and colleagues wrote in the American Journal of Obstetrics and Gynecology. “Such an approach could inform the development of preventive treatments and targeted therapeutics that are currently lacking/difficult to implement due to the heterogeneous etiology of sPTB.”

Currently, the best predictor of sPTB is previous sPTB, according to the investigators. Although a combination approach that incorporates cervical length and fetal fibronectin in cervicovaginal fluid is “of use,” they noted, “this is not standard of care in the U.S.A. nor recommended by the American College of Obstetricians and Gynecologists or the Society for Maternal-Fetal Medicine.” Existing molecular tests lack clinical data and may be inaccurate across diverse patient populations, they added.

The present study aimed to address these shortcomings by creating a second-trimester blood test for predicting sPTB. To identify relevant biomarkers, the investigators compared RNA profiles that were differentially expressed in three types of cases: term birth, early sPTB, and very early sPTB.

Among 242 women who contributed second-trimester blood samples for analysis, 194 went on to have a term birth. Of the remaining 48 women who gave birth spontaneously before 35 weeks’ gestation, 32 delivered between 25 and 35 weeks (early sPTB), while 16 delivered before 25 weeks’ gestation (very early sPTB). Slightly more than half of the patients were White, about one-third were Black, approximately 10% were Asian, and the remainder were of unknown race/ethnicity. Cases of preeclampsia were excluded.

The gene discovery and modeling process revealed 25 distinct genes that were significantly associated with early sPTB, offering a risk model with a sensitivity of 76% and a specificity of 72% (area under the curve, 0.80; 95% confidence interval, 0.72-0.87). Very early sPTB was associated with a set of 39 genes, giving a model with a sensitivity of 64% and a specificity of 80% (area under the curve = 0.76; 95% CI, 0.63-0.87).

Characterization of the two RNA profiles offered a glimpse into the underlying biological processes driving preterm birth. The genes predicting early sPTB are largely responsible for extracellular matrix degradation and remodeling, which could, “in terms of mechanism, reflect ongoing processes associated with cervical shortening, a feature often detected some weeks prior to sPTB,” the investigators wrote. In contrast, genes associated with very early sPTB are linked with insulinlike growth factor transport, which drives fetal growth and placentation. These findings could lead to development of pathway-specific interventions, Dr. Camunas-Soler and colleagues suggested.

According to coauthor Michal A. Elovitz, MD, the Hilarie L. Morgan and Mitchell L. Morgan President’s Distinguished Professor in Women’s Health at the University of Pennsylvania, Philadelphia, and chief medical advisor at Mirvie, the proprietary RNA platform moves beyond “unreliable and at times biased clinical factors such as race, BMI, and maternal age” to offer a “precision-based approach to pregnancy health.”

Excluding traditional risk factors also “promises more equitable care than the use of broad sociodemographic factors that often result in bias,” she added, noting that this may help address the higher rate of pregnancy complications among Black patients.

When asked about the potential for false-positive results, considering reported specificity rates of 72%-80%, Dr. Elovitz suggested that such concerns among pregnant women are an “unfortunate misconception.”

“It is not reflective of what women want regarding knowledge about the health of their pregnancy,” she said in a written comment. “Rather than be left in the dark, women want to be prepared for what is to come in their pregnancy journey.”

In support of this statement, Dr. Elovitz cited a recent study involving women with preeclampsia and other hypertensive disorders in pregnancy. A questionnaire showed that women appreciated pregnancy risk models when making decisions, and reported that they would have greater peace of mind if such tests were available.

*This story was updated on 4/26/2022. 

A new blood test performed in the second trimester could help identify pregnancies at risk of early and very early spontaneous preterm birth (sPTB), based on a prospective cohort trial.

The cell-free RNA (cfRNA) profiling tool could guide patient and provider decision-making, while the underlying research illuminates biological pathways that may facilitate novel interventions, reported lead author Joan Camunas-Soler, PhD, of Mirvie, South San Francisco, and colleagues.

“Given the complex etiology of this heterogeneous syndrome, it would be advantageous to develop predictive tests that provide insight on the specific pathophysiology leading to preterm birth for each particular pregnancy,” Dr. Camunas-Soler and colleagues wrote in the American Journal of Obstetrics and Gynecology. “Such an approach could inform the development of preventive treatments and targeted therapeutics that are currently lacking/difficult to implement due to the heterogeneous etiology of sPTB.”

Currently, the best predictor of sPTB is previous sPTB, according to the investigators. Although a combination approach that incorporates cervical length and fetal fibronectin in cervicovaginal fluid is “of use,” they noted, “this is not standard of care in the U.S.A. nor recommended by the American College of Obstetricians and Gynecologists or the Society for Maternal-Fetal Medicine.” Existing molecular tests lack clinical data and may be inaccurate across diverse patient populations, they added.

The present study aimed to address these shortcomings by creating a second-trimester blood test for predicting sPTB. To identify relevant biomarkers, the investigators compared RNA profiles that were differentially expressed in three types of cases: term birth, early sPTB, and very early sPTB.

Among 242 women who contributed second-trimester blood samples for analysis, 194 went on to have a term birth. Of the remaining 48 women who gave birth spontaneously before 35 weeks’ gestation, 32 delivered between 25 and 35 weeks (early sPTB), while 16 delivered before 25 weeks’ gestation (very early sPTB). Slightly more than half of the patients were White, about one-third were Black, approximately 10% were Asian, and the remainder were of unknown race/ethnicity. Cases of preeclampsia were excluded.

The gene discovery and modeling process revealed 25 distinct genes that were significantly associated with early sPTB, offering a risk model with a sensitivity of 76% and a specificity of 72% (area under the curve, 0.80; 95% confidence interval, 0.72-0.87). Very early sPTB was associated with a set of 39 genes, giving a model with a sensitivity of 64% and a specificity of 80% (area under the curve = 0.76; 95% CI, 0.63-0.87).

Characterization of the two RNA profiles offered a glimpse into the underlying biological processes driving preterm birth. The genes predicting early sPTB are largely responsible for extracellular matrix degradation and remodeling, which could, “in terms of mechanism, reflect ongoing processes associated with cervical shortening, a feature often detected some weeks prior to sPTB,” the investigators wrote. In contrast, genes associated with very early sPTB are linked with insulinlike growth factor transport, which drives fetal growth and placentation. These findings could lead to development of pathway-specific interventions, Dr. Camunas-Soler and colleagues suggested.

According to coauthor Michal A. Elovitz, MD, the Hilarie L. Morgan and Mitchell L. Morgan President’s Distinguished Professor in Women’s Health at the University of Pennsylvania, Philadelphia, and chief medical advisor at Mirvie, the proprietary RNA platform moves beyond “unreliable and at times biased clinical factors such as race, BMI, and maternal age” to offer a “precision-based approach to pregnancy health.”

Excluding traditional risk factors also “promises more equitable care than the use of broad sociodemographic factors that often result in bias,” she added, noting that this may help address the higher rate of pregnancy complications among Black patients.

When asked about the potential for false-positive results, considering reported specificity rates of 72%-80%, Dr. Elovitz suggested that such concerns among pregnant women are an “unfortunate misconception.”

“It is not reflective of what women want regarding knowledge about the health of their pregnancy,” she said in a written comment. “Rather than be left in the dark, women want to be prepared for what is to come in their pregnancy journey.”

In support of this statement, Dr. Elovitz cited a recent study involving women with preeclampsia and other hypertensive disorders in pregnancy. A questionnaire showed that women appreciated pregnancy risk models when making decisions, and reported that they would have greater peace of mind if such tests were available.

*This story was updated on 4/26/2022. 

Premature births from cesarean (C-section) and induced deliveries dropped abruptly by 6.5% from the projected number in the first month of the COVID-19 pandemic and stayed at the lower rate consistently throughout the year, researchers have found.

Results of the study, led by Daniel Dench, PhD, assistant professor at the Georgia Institute of Technology School of Economics in Atlanta, were published online in Pediatrics.

The authors say their findings help answer the question of whether numbers of preterm (less than 37 weeks gestation) C-sections and induced deliveries would change if women didn’t see their physicians during pregnancy as often, especially in person, and raise the question of whether some birth interventions by physicians may not be necessary. The pandemic gave researchers a natural, ethical way to study the question.

The researchers found that in March 2020 – the start of business closures and stay-at-home orders around the country – preterm births from C-sections or induced deliveries immediately fell from the forecast number for the month by 0.4 percentage points. For the rest of 2020, the number remained on average 0.35 percentage points below the numbers predicted.

That means 350 fewer preterm C-sections and induced deliveries per 100,000 live births, or 10,000 fewer overall, the authors said.

Dr. Dench told this publication the numbers for those births had been steady from January 2010 to February 2020, but the pattern “diverges from this trend very clearly beginning exactly in March 2020 and does not return to trend by December 2020.”

Meanwhile, during the study period, the number of full-term cesarean and induced deliveries stayed steady and started to increase slightly in 2020. Researchers also adjusted for seasonality as, for example, preterm births are higher on average in February than in March.

So far, Dr. Dench said in a press release, it’s not clear whether the lower numbers mean physicians didn’t deliver babies that ended up surviving in the womb anyway or if they missed some that would die in the womb without intervention.

To better understand those implications, Dr. Dench says he is turning to fetal death records for March-December 2020 and he said he expects to have those results analyzed by the end of the year.

If there was no change in fetal deaths at the same time as the drop in preterm births, Dr. Dench said, that could point to physician interventions that may not have been necessary.

Mya R. Zapata, MD, an obstetrician-gynecologist with UCLA Health, who was not involved with the study, told this publication that checking the fetal deaths is a good start and an objective outcome in answering the question, but she points out there are other outcomes that will take a deeper analysis, such as whether there are differences later in developmental outcomes after fewer physician visits.

“It’s always a good question for health care,” she said, “are we doing more than we need to?”

Dr. Zapata is the obstetrics service chief for UCLA’s labor and delivery unit and was an integral part of decision-making as to what services were essential and for which patients. She said the fewer visits and fewer ultrasounds the researchers describe fit with what ob.gyns. at UCLA experienced as the pandemic hit.

“We really tried to hone in on people who were at highest risk for an adverse outcome,” she said. “I still have the question of whether there were things we missed in low-risk people. It will take time to get the entire answer. But it does make us reflect that perhaps less intervention could be better for patients and easier. It’s our job in medicine to keep asking the question of what is essential and safe and not just continue with current practice because that’s what we’ve always done.”

The amount of data gave the researchers an unusual view. They studied 38,891,271 singleton births in the United States from 2010 to 2020 with data from the National Center for Health Statistics.

“If you look at 1,000 births in a single hospital, or even at 30,000 births across a hospital system, you wouldn’t be able to see the drop as clearly,” Dr. Dench said. “The drop we detected is a huge change, but you might miss it in a small sample.”

The researchers acknowledge a limitation of the study is that half of all preterm C-sections and induced deliveries happen because of a ruptured membrane, a spontaneous cause. Those instances can’t be distinguished from the ones caused by doctors’ interventions in this study.

“Still, these findings are significant because the causes for preterm births are not always known,” the authors wrote in the press release.

The study authors and Dr. Zapata reported no relevant financial relationships.

Premature births from cesarean (C-section) and induced deliveries dropped abruptly by 6.5% from the projected number in the first month of the COVID-19 pandemic and stayed at the lower rate consistently throughout the year, researchers have found.

Results of the study, led by Daniel Dench, PhD, assistant professor at the Georgia Institute of Technology School of Economics in Atlanta, were published online in Pediatrics.

The authors say their findings help answer the question of whether numbers of preterm (less than 37 weeks gestation) C-sections and induced deliveries would change if women didn’t see their physicians during pregnancy as often, especially in person, and raise the question of whether some birth interventions by physicians may not be necessary. The pandemic gave researchers a natural, ethical way to study the question.

The researchers found that in March 2020 – the start of business closures and stay-at-home orders around the country – preterm births from C-sections or induced deliveries immediately fell from the forecast number for the month by 0.4 percentage points. For the rest of 2020, the number remained on average 0.35 percentage points below the numbers predicted.

That means 350 fewer preterm C-sections and induced deliveries per 100,000 live births, or 10,000 fewer overall, the authors said.

Dr. Dench told this publication the numbers for those births had been steady from January 2010 to February 2020, but the pattern “diverges from this trend very clearly beginning exactly in March 2020 and does not return to trend by December 2020.”

Meanwhile, during the study period, the number of full-term cesarean and induced deliveries stayed steady and started to increase slightly in 2020. Researchers also adjusted for seasonality as, for example, preterm births are higher on average in February than in March.

So far, Dr. Dench said in a press release, it’s not clear whether the lower numbers mean physicians didn’t deliver babies that ended up surviving in the womb anyway or if they missed some that would die in the womb without intervention.

To better understand those implications, Dr. Dench says he is turning to fetal death records for March-December 2020 and he said he expects to have those results analyzed by the end of the year.

If there was no change in fetal deaths at the same time as the drop in preterm births, Dr. Dench said, that could point to physician interventions that may not have been necessary.

Mya R. Zapata, MD, an obstetrician-gynecologist with UCLA Health, who was not involved with the study, told this publication that checking the fetal deaths is a good start and an objective outcome in answering the question, but she points out there are other outcomes that will take a deeper analysis, such as whether there are differences later in developmental outcomes after fewer physician visits.

“It’s always a good question for health care,” she said, “are we doing more than we need to?”

Dr. Zapata is the obstetrics service chief for UCLA’s labor and delivery unit and was an integral part of decision-making as to what services were essential and for which patients. She said the fewer visits and fewer ultrasounds the researchers describe fit with what ob.gyns. at UCLA experienced as the pandemic hit.

“We really tried to hone in on people who were at highest risk for an adverse outcome,” she said. “I still have the question of whether there were things we missed in low-risk people. It will take time to get the entire answer. But it does make us reflect that perhaps less intervention could be better for patients and easier. It’s our job in medicine to keep asking the question of what is essential and safe and not just continue with current practice because that’s what we’ve always done.”

The amount of data gave the researchers an unusual view. They studied 38,891,271 singleton births in the United States from 2010 to 2020 with data from the National Center for Health Statistics.

“If you look at 1,000 births in a single hospital, or even at 30,000 births across a hospital system, you wouldn’t be able to see the drop as clearly,” Dr. Dench said. “The drop we detected is a huge change, but you might miss it in a small sample.”

The researchers acknowledge a limitation of the study is that half of all preterm C-sections and induced deliveries happen because of a ruptured membrane, a spontaneous cause. Those instances can’t be distinguished from the ones caused by doctors’ interventions in this study.

“Still, these findings are significant because the causes for preterm births are not always known,” the authors wrote in the press release.

The study authors and Dr. Zapata reported no relevant financial relationships.

Premature births from cesarean (C-section) and induced deliveries dropped abruptly by 6.5% from the projected number in the first month of the COVID-19 pandemic and stayed at the lower rate consistently throughout the year, researchers have found.

Results of the study, led by Daniel Dench, PhD, assistant professor at the Georgia Institute of Technology School of Economics in Atlanta, were published online in Pediatrics.

The authors say their findings help answer the question of whether numbers of preterm (less than 37 weeks gestation) C-sections and induced deliveries would change if women didn’t see their physicians during pregnancy as often, especially in person, and raise the question of whether some birth interventions by physicians may not be necessary. The pandemic gave researchers a natural, ethical way to study the question.

The researchers found that in March 2020 – the start of business closures and stay-at-home orders around the country – preterm births from C-sections or induced deliveries immediately fell from the forecast number for the month by 0.4 percentage points. For the rest of 2020, the number remained on average 0.35 percentage points below the numbers predicted.

That means 350 fewer preterm C-sections and induced deliveries per 100,000 live births, or 10,000 fewer overall, the authors said.

Dr. Dench told this publication the numbers for those births had been steady from January 2010 to February 2020, but the pattern “diverges from this trend very clearly beginning exactly in March 2020 and does not return to trend by December 2020.”

Meanwhile, during the study period, the number of full-term cesarean and induced deliveries stayed steady and started to increase slightly in 2020. Researchers also adjusted for seasonality as, for example, preterm births are higher on average in February than in March.

So far, Dr. Dench said in a press release, it’s not clear whether the lower numbers mean physicians didn’t deliver babies that ended up surviving in the womb anyway or if they missed some that would die in the womb without intervention.

To better understand those implications, Dr. Dench says he is turning to fetal death records for March-December 2020 and he said he expects to have those results analyzed by the end of the year.

If there was no change in fetal deaths at the same time as the drop in preterm births, Dr. Dench said, that could point to physician interventions that may not have been necessary.

Mya R. Zapata, MD, an obstetrician-gynecologist with UCLA Health, who was not involved with the study, told this publication that checking the fetal deaths is a good start and an objective outcome in answering the question, but she points out there are other outcomes that will take a deeper analysis, such as whether there are differences later in developmental outcomes after fewer physician visits.

“It’s always a good question for health care,” she said, “are we doing more than we need to?”

Dr. Zapata is the obstetrics service chief for UCLA’s labor and delivery unit and was an integral part of decision-making as to what services were essential and for which patients. She said the fewer visits and fewer ultrasounds the researchers describe fit with what ob.gyns. at UCLA experienced as the pandemic hit.

“We really tried to hone in on people who were at highest risk for an adverse outcome,” she said. “I still have the question of whether there were things we missed in low-risk people. It will take time to get the entire answer. But it does make us reflect that perhaps less intervention could be better for patients and easier. It’s our job in medicine to keep asking the question of what is essential and safe and not just continue with current practice because that’s what we’ve always done.”

The amount of data gave the researchers an unusual view. They studied 38,891,271 singleton births in the United States from 2010 to 2020 with data from the National Center for Health Statistics.

“If you look at 1,000 births in a single hospital, or even at 30,000 births across a hospital system, you wouldn’t be able to see the drop as clearly,” Dr. Dench said. “The drop we detected is a huge change, but you might miss it in a small sample.”

The researchers acknowledge a limitation of the study is that half of all preterm C-sections and induced deliveries happen because of a ruptured membrane, a spontaneous cause. Those instances can’t be distinguished from the ones caused by doctors’ interventions in this study.

“Still, these findings are significant because the causes for preterm births are not always known,” the authors wrote in the press release.

The study authors and Dr. Zapata reported no relevant financial relationships.