SMFM Annual Meeting 2015

SAN DIEGO – The prevalence of sleep-disordered breathing during pregnancy is low, but a large prospective study links it to both hypertensive disorders of pregnancy and gestational diabetes.

In an analysis of 3,702 nulliparous women, researchers found that the prevalence of sleep-disordered breathing (SDB) was 3.3% during early pregnancy (weeks 6-15) and 8.1% in midpregnancy (weeks 22-31).

SDB in midpregnancy was significantly associated with hypertensive disorders of pregnancy, while having SDB in both early and midpregnncy was significantly associated with gestational diabetes mellitus (GDM).

While the majority of sleep-disordered breathing cases in the study were mild, “clinical experience tells us that these women are not routinely being diagnosed and treated for SDB,” Dr. Francesca L. Facco said at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine. “Our data demonstrate that even modest elevations of apnea-hypopnea index scores in pregnancy are associated with cardiometabolic morbidity. These findings are important because SDB, unlike many other risk factors, is potentially modifiable.”

In a study that Dr. Facco presented on behalf of the National Institute of Child Health and Human Development NuMoM2b Network, researchers at eight clinical sites in the United States set out to determine if SDB during pregnancy is a risk factor for adverse pregnancy outcomes.

Obstructive sleep apnea is the most common type of sleep disorder, said Dr. Facco of the department of obstetrics and gynecology at Magee-Women’s Hospital at the University of Pittsburgh Medical Center. In adults, an apnea-hypopnea index (AHI) of greater than or equal to 5 is the minimum criterion for establishing a sleep-disordered breathing diagnosis, while severity is classified by the number of events per hour.

“The prevalence, incidence, and severity of SDB and its impact on pregnancy remain undetermined,” Dr. Facco said. “This is despite the fact that pregnant women may be particularly disposed to SDB, given the physiologic changes associated with the gravid state, such as rapid weight gain and edema.”

Researchers recruited 3,702 women from a prospective cohort of 10,000 nulliparous women. The subjects underwent overnight in-home assessments of SDB during early pregnancy and midpregnancy. All studies were scored by a central sleep reading center.

“Currently there are no pregnancy-specific guidelines for SDB treatment and no data on which to base fetal and maternal parameters for treatment,” Dr. Facco noted. “Given the clinical equipoise that surrounds the issue, all participants and care providers were blinded to the sleep study results unless a study was identified as an urgent alert study.”

The primary outcome measures were hypertensive disorders of pregnancy and gestational diabetes. Hypertensive disorders included mild, severe, or superimposed preeclampsia, eclampsia, and gestational hypertension diagnosed in the antepartum period. The Embletta Portable Diagnostic System was used to perform the home sleep test.

Data were analyzed using multivariable logistic regression adjusted for age, body mass index, and the presence of chronic hypertension in early pregnancy analyses, as well as weight gain between visits for the midpregnancy analyses. All of the women included in the study had singleton pregnancies.

The researchers obtained complete data from 3,261 women in early pregnancy and from 2,511 women in midpregnancy. Among the 3,132 women with hypertension data, there was a 12.4% incidence of hypertensive disorders at baseline, with a 5.5% incidence of preeclampsia. Among 3,076 women with gestational diabetes mellitus data (cases of pregestational diabetes were excluded), the rate of GDM was 3.9%.

The mean age of study participants was 27 years; 60% were non-Hispanic white, 18% were Hispanic, 14% were non-Hispanic black, and the remainder were from other ethnic groups. At baseline, about half (49%) were normal weight, 25% were overweight, 23% were obese or morbidly obese, and the remainder were underweight.

SDB in midpregnancy was significantly associated with hypertensive disorders of pregnancy (an adjusted odds ratio of 1.62; P = .0156). A similar trend was seen in early pregnancy, but the association did not reach statistical significance in adjusted analyses (aOR, 1.44; P = .1434), according to Dr. Facco.

SDB in both early and midpregnancy was significantly associated with GDM (aOR, 3.62; P < .0001 and aOR, 2.79; P = .0002, respectively).

The study was funded by the NICHD. Dr. Facco reported having no relevant financial conflicts.

[email protected]

On Twitter @dougbrunk

SAN DIEGO – The prevalence of sleep-disordered breathing during pregnancy is low, but a large prospective study links it to both hypertensive disorders of pregnancy and gestational diabetes.

In an analysis of 3,702 nulliparous women, researchers found that the prevalence of sleep-disordered breathing (SDB) was 3.3% during early pregnancy (weeks 6-15) and 8.1% in midpregnancy (weeks 22-31).

SDB in midpregnancy was significantly associated with hypertensive disorders of pregnancy, while having SDB in both early and midpregnncy was significantly associated with gestational diabetes mellitus (GDM).

While the majority of sleep-disordered breathing cases in the study were mild, “clinical experience tells us that these women are not routinely being diagnosed and treated for SDB,” Dr. Francesca L. Facco said at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine. “Our data demonstrate that even modest elevations of apnea-hypopnea index scores in pregnancy are associated with cardiometabolic morbidity. These findings are important because SDB, unlike many other risk factors, is potentially modifiable.”

In a study that Dr. Facco presented on behalf of the National Institute of Child Health and Human Development NuMoM2b Network, researchers at eight clinical sites in the United States set out to determine if SDB during pregnancy is a risk factor for adverse pregnancy outcomes.

Obstructive sleep apnea is the most common type of sleep disorder, said Dr. Facco of the department of obstetrics and gynecology at Magee-Women’s Hospital at the University of Pittsburgh Medical Center. In adults, an apnea-hypopnea index (AHI) of greater than or equal to 5 is the minimum criterion for establishing a sleep-disordered breathing diagnosis, while severity is classified by the number of events per hour.

“The prevalence, incidence, and severity of SDB and its impact on pregnancy remain undetermined,” Dr. Facco said. “This is despite the fact that pregnant women may be particularly disposed to SDB, given the physiologic changes associated with the gravid state, such as rapid weight gain and edema.”

Researchers recruited 3,702 women from a prospective cohort of 10,000 nulliparous women. The subjects underwent overnight in-home assessments of SDB during early pregnancy and midpregnancy. All studies were scored by a central sleep reading center.

“Currently there are no pregnancy-specific guidelines for SDB treatment and no data on which to base fetal and maternal parameters for treatment,” Dr. Facco noted. “Given the clinical equipoise that surrounds the issue, all participants and care providers were blinded to the sleep study results unless a study was identified as an urgent alert study.”

The primary outcome measures were hypertensive disorders of pregnancy and gestational diabetes. Hypertensive disorders included mild, severe, or superimposed preeclampsia, eclampsia, and gestational hypertension diagnosed in the antepartum period. The Embletta Portable Diagnostic System was used to perform the home sleep test.

Data were analyzed using multivariable logistic regression adjusted for age, body mass index, and the presence of chronic hypertension in early pregnancy analyses, as well as weight gain between visits for the midpregnancy analyses. All of the women included in the study had singleton pregnancies.

The researchers obtained complete data from 3,261 women in early pregnancy and from 2,511 women in midpregnancy. Among the 3,132 women with hypertension data, there was a 12.4% incidence of hypertensive disorders at baseline, with a 5.5% incidence of preeclampsia. Among 3,076 women with gestational diabetes mellitus data (cases of pregestational diabetes were excluded), the rate of GDM was 3.9%.

The mean age of study participants was 27 years; 60% were non-Hispanic white, 18% were Hispanic, 14% were non-Hispanic black, and the remainder were from other ethnic groups. At baseline, about half (49%) were normal weight, 25% were overweight, 23% were obese or morbidly obese, and the remainder were underweight.

SDB in midpregnancy was significantly associated with hypertensive disorders of pregnancy (an adjusted odds ratio of 1.62; P = .0156). A similar trend was seen in early pregnancy, but the association did not reach statistical significance in adjusted analyses (aOR, 1.44; P = .1434), according to Dr. Facco.

SDB in both early and midpregnancy was significantly associated with GDM (aOR, 3.62; P < .0001 and aOR, 2.79; P = .0002, respectively).

The study was funded by the NICHD. Dr. Facco reported having no relevant financial conflicts.

[email protected]

On Twitter @dougbrunk

SAN DIEGO – The prevalence of sleep-disordered breathing during pregnancy is low, but a large prospective study links it to both hypertensive disorders of pregnancy and gestational diabetes.

In an analysis of 3,702 nulliparous women, researchers found that the prevalence of sleep-disordered breathing (SDB) was 3.3% during early pregnancy (weeks 6-15) and 8.1% in midpregnancy (weeks 22-31).

SDB in midpregnancy was significantly associated with hypertensive disorders of pregnancy, while having SDB in both early and midpregnncy was significantly associated with gestational diabetes mellitus (GDM).

While the majority of sleep-disordered breathing cases in the study were mild, “clinical experience tells us that these women are not routinely being diagnosed and treated for SDB,” Dr. Francesca L. Facco said at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine. “Our data demonstrate that even modest elevations of apnea-hypopnea index scores in pregnancy are associated with cardiometabolic morbidity. These findings are important because SDB, unlike many other risk factors, is potentially modifiable.”

In a study that Dr. Facco presented on behalf of the National Institute of Child Health and Human Development NuMoM2b Network, researchers at eight clinical sites in the United States set out to determine if SDB during pregnancy is a risk factor for adverse pregnancy outcomes.

Obstructive sleep apnea is the most common type of sleep disorder, said Dr. Facco of the department of obstetrics and gynecology at Magee-Women’s Hospital at the University of Pittsburgh Medical Center. In adults, an apnea-hypopnea index (AHI) of greater than or equal to 5 is the minimum criterion for establishing a sleep-disordered breathing diagnosis, while severity is classified by the number of events per hour.

“The prevalence, incidence, and severity of SDB and its impact on pregnancy remain undetermined,” Dr. Facco said. “This is despite the fact that pregnant women may be particularly disposed to SDB, given the physiologic changes associated with the gravid state, such as rapid weight gain and edema.”

Researchers recruited 3,702 women from a prospective cohort of 10,000 nulliparous women. The subjects underwent overnight in-home assessments of SDB during early pregnancy and midpregnancy. All studies were scored by a central sleep reading center.

“Currently there are no pregnancy-specific guidelines for SDB treatment and no data on which to base fetal and maternal parameters for treatment,” Dr. Facco noted. “Given the clinical equipoise that surrounds the issue, all participants and care providers were blinded to the sleep study results unless a study was identified as an urgent alert study.”

The primary outcome measures were hypertensive disorders of pregnancy and gestational diabetes. Hypertensive disorders included mild, severe, or superimposed preeclampsia, eclampsia, and gestational hypertension diagnosed in the antepartum period. The Embletta Portable Diagnostic System was used to perform the home sleep test.

Data were analyzed using multivariable logistic regression adjusted for age, body mass index, and the presence of chronic hypertension in early pregnancy analyses, as well as weight gain between visits for the midpregnancy analyses. All of the women included in the study had singleton pregnancies.

The researchers obtained complete data from 3,261 women in early pregnancy and from 2,511 women in midpregnancy. Among the 3,132 women with hypertension data, there was a 12.4% incidence of hypertensive disorders at baseline, with a 5.5% incidence of preeclampsia. Among 3,076 women with gestational diabetes mellitus data (cases of pregestational diabetes were excluded), the rate of GDM was 3.9%.

The mean age of study participants was 27 years; 60% were non-Hispanic white, 18% were Hispanic, 14% were non-Hispanic black, and the remainder were from other ethnic groups. At baseline, about half (49%) were normal weight, 25% were overweight, 23% were obese or morbidly obese, and the remainder were underweight.

SDB in midpregnancy was significantly associated with hypertensive disorders of pregnancy (an adjusted odds ratio of 1.62; P = .0156). A similar trend was seen in early pregnancy, but the association did not reach statistical significance in adjusted analyses (aOR, 1.44; P = .1434), according to Dr. Facco.

SDB in both early and midpregnancy was significantly associated with GDM (aOR, 3.62; P < .0001 and aOR, 2.79; P = .0002, respectively).

The study was funded by the NICHD. Dr. Facco reported having no relevant financial conflicts.

[email protected]

On Twitter @dougbrunk

SAN DIEGO – When it comes to reducing the risk of infant death and stillbirth in twin pregnancies, the ideal delivery date is somewhere around 37 weeks’ gestation.

That’s the key finding from a retrospective cohort study using national data that was presented by Dr. Jessica Page at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.

The study aimed to better characterize the optimal delivery timing in twin pregnancies by quantifying the risk of stillbirth during each week of gestation, along with the risk of infant death following delivery at each week between 32 and 40 weeks.

“There is an existing body of work examining this question in the obstetric literature and debate persists as to the ideal delivery timing,” Dr. Page of the department of obstetrics and gynecology at the University of Utah, Salt Lake City, said in an interview. “This is somewhat difficult to study given the low frequency of twin gestations and rarity of fetal and infant mortality.”

Using nationally linked birth and death certificate data involving 454,625 twin pregnancies from 2006 to 2008, the researchers determined the incidence of stillbirth (defined as fetal death after 20 weeks’ gestation) and infant death (defined as death within the first year of life) for each week of pregnancy from 32 weeks’ through 40 weeks’ and 6 days gestation. Pregnancies complicated by fetal anomalies were excluded from the analysis.

The researchers next estimated the risk associated with continued pregnancy by combining the stillbirth risk during the additional week of pregnancy with the risk of infant death following delivery at the conclusion of that week. This composite risk was compared to the infant death risk associated with delivery at the corresponding gestational age.

Dr. Page and her associates found that the risk of stillbirth increased between 37 and 38 weeks’ gestation (12.5 per 10,000 vs. 22.5 per 10,000, respectively; P less than .05) as well as between 39 and 40 weeks’ gestation. The risk of infant death following delivery gradually decreased as pregnancies approached term gestation with statistically significant decreases in mortality risk with each additional week of pregnancy from 32 through 36 weeks’ gestation.

The composite risk of stillbirth and infant death associated with an additional week of pregnancy had a significant increase from 37 to 38 weeks’ gestation (43.9 per 10,000 vs. 59.2 per 10,000; P less than .05). This rise in fetal/infant death risk continued through 40 weeks’ gestation with significant differences between both 38 and 39 weeks’ and 39 and 40 weeks’ gestation.

“We found that mortality risk was minimized at 37 weeks’ gestation,” Dr. Page said. “This finding corresponds with prior work regarding delivery timing for twins. We did observe a significantly increased risk of mortality following 38 weeks’ gestation due to increased stillbirth risk. However, since we could not control for chorionicity, we cannot make recommendations based solely on these data.”

The study’s main limitation is that chorionicity is not included in birth certificate data and so the researchers were unable to compare monochorionic versus dichorionic pregnancies.

“This is a very important risk factor in the management of twin pregnancies and additional work is needed in this regard,” Dr. Page said. “We additionally could not study specific neonatal morbidities, which also adds to the risk stratification regarding preterm delivery.”

Dr. Page reported having no relevant financial conflicts.

[email protected]

On Twitter @dougbrunk

SAN DIEGO – When it comes to reducing the risk of infant death and stillbirth in twin pregnancies, the ideal delivery date is somewhere around 37 weeks’ gestation.

That’s the key finding from a retrospective cohort study using national data that was presented by Dr. Jessica Page at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.

The study aimed to better characterize the optimal delivery timing in twin pregnancies by quantifying the risk of stillbirth during each week of gestation, along with the risk of infant death following delivery at each week between 32 and 40 weeks.

“There is an existing body of work examining this question in the obstetric literature and debate persists as to the ideal delivery timing,” Dr. Page of the department of obstetrics and gynecology at the University of Utah, Salt Lake City, said in an interview. “This is somewhat difficult to study given the low frequency of twin gestations and rarity of fetal and infant mortality.”

Using nationally linked birth and death certificate data involving 454,625 twin pregnancies from 2006 to 2008, the researchers determined the incidence of stillbirth (defined as fetal death after 20 weeks’ gestation) and infant death (defined as death within the first year of life) for each week of pregnancy from 32 weeks’ through 40 weeks’ and 6 days gestation. Pregnancies complicated by fetal anomalies were excluded from the analysis.

The researchers next estimated the risk associated with continued pregnancy by combining the stillbirth risk during the additional week of pregnancy with the risk of infant death following delivery at the conclusion of that week. This composite risk was compared to the infant death risk associated with delivery at the corresponding gestational age.

Dr. Page and her associates found that the risk of stillbirth increased between 37 and 38 weeks’ gestation (12.5 per 10,000 vs. 22.5 per 10,000, respectively; P less than .05) as well as between 39 and 40 weeks’ gestation. The risk of infant death following delivery gradually decreased as pregnancies approached term gestation with statistically significant decreases in mortality risk with each additional week of pregnancy from 32 through 36 weeks’ gestation.

The composite risk of stillbirth and infant death associated with an additional week of pregnancy had a significant increase from 37 to 38 weeks’ gestation (43.9 per 10,000 vs. 59.2 per 10,000; P less than .05). This rise in fetal/infant death risk continued through 40 weeks’ gestation with significant differences between both 38 and 39 weeks’ and 39 and 40 weeks’ gestation.

“We found that mortality risk was minimized at 37 weeks’ gestation,” Dr. Page said. “This finding corresponds with prior work regarding delivery timing for twins. We did observe a significantly increased risk of mortality following 38 weeks’ gestation due to increased stillbirth risk. However, since we could not control for chorionicity, we cannot make recommendations based solely on these data.”

The study’s main limitation is that chorionicity is not included in birth certificate data and so the researchers were unable to compare monochorionic versus dichorionic pregnancies.

“This is a very important risk factor in the management of twin pregnancies and additional work is needed in this regard,” Dr. Page said. “We additionally could not study specific neonatal morbidities, which also adds to the risk stratification regarding preterm delivery.”

Dr. Page reported having no relevant financial conflicts.

[email protected]

On Twitter @dougbrunk

SAN DIEGO – When it comes to reducing the risk of infant death and stillbirth in twin pregnancies, the ideal delivery date is somewhere around 37 weeks’ gestation.

That’s the key finding from a retrospective cohort study using national data that was presented by Dr. Jessica Page at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.

The study aimed to better characterize the optimal delivery timing in twin pregnancies by quantifying the risk of stillbirth during each week of gestation, along with the risk of infant death following delivery at each week between 32 and 40 weeks.

“There is an existing body of work examining this question in the obstetric literature and debate persists as to the ideal delivery timing,” Dr. Page of the department of obstetrics and gynecology at the University of Utah, Salt Lake City, said in an interview. “This is somewhat difficult to study given the low frequency of twin gestations and rarity of fetal and infant mortality.”

Using nationally linked birth and death certificate data involving 454,625 twin pregnancies from 2006 to 2008, the researchers determined the incidence of stillbirth (defined as fetal death after 20 weeks’ gestation) and infant death (defined as death within the first year of life) for each week of pregnancy from 32 weeks’ through 40 weeks’ and 6 days gestation. Pregnancies complicated by fetal anomalies were excluded from the analysis.

The researchers next estimated the risk associated with continued pregnancy by combining the stillbirth risk during the additional week of pregnancy with the risk of infant death following delivery at the conclusion of that week. This composite risk was compared to the infant death risk associated with delivery at the corresponding gestational age.

Dr. Page and her associates found that the risk of stillbirth increased between 37 and 38 weeks’ gestation (12.5 per 10,000 vs. 22.5 per 10,000, respectively; P less than .05) as well as between 39 and 40 weeks’ gestation. The risk of infant death following delivery gradually decreased as pregnancies approached term gestation with statistically significant decreases in mortality risk with each additional week of pregnancy from 32 through 36 weeks’ gestation.

The composite risk of stillbirth and infant death associated with an additional week of pregnancy had a significant increase from 37 to 38 weeks’ gestation (43.9 per 10,000 vs. 59.2 per 10,000; P less than .05). This rise in fetal/infant death risk continued through 40 weeks’ gestation with significant differences between both 38 and 39 weeks’ and 39 and 40 weeks’ gestation.

“We found that mortality risk was minimized at 37 weeks’ gestation,” Dr. Page said. “This finding corresponds with prior work regarding delivery timing for twins. We did observe a significantly increased risk of mortality following 38 weeks’ gestation due to increased stillbirth risk. However, since we could not control for chorionicity, we cannot make recommendations based solely on these data.”

The study’s main limitation is that chorionicity is not included in birth certificate data and so the researchers were unable to compare monochorionic versus dichorionic pregnancies.

“This is a very important risk factor in the management of twin pregnancies and additional work is needed in this regard,” Dr. Page said. “We additionally could not study specific neonatal morbidities, which also adds to the risk stratification regarding preterm delivery.”

Dr. Page reported having no relevant financial conflicts.

[email protected]

On Twitter @dougbrunk

SAN DIEGO – A lack of consensus exists regarding optimal criteria for diagnosing gestational diabetes mellitus, noted Dr. Linda Barbour.

“The biggest question is, if we are to diagnose many more women and increase the prevalence [of gestational diabetes mellitus] by two- to threefold by diagnosing them and treating them, will we see improved outcomes?” asked Dr. Barbour, professor of medicine and obstetrics and gynecology at the University of Colorado, Aurora.

In an interview at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine, Dr. Barbour discussed the challenges that have prevented a consensus from emerging.

She reported having no financial disclosures.

[email protected]


On Twitter @dougbrunk

SAN DIEGO – A lack of consensus exists regarding optimal criteria for diagnosing gestational diabetes mellitus, noted Dr. Linda Barbour.

“The biggest question is, if we are to diagnose many more women and increase the prevalence [of gestational diabetes mellitus] by two- to threefold by diagnosing them and treating them, will we see improved outcomes?” asked Dr. Barbour, professor of medicine and obstetrics and gynecology at the University of Colorado, Aurora.

In an interview at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine, Dr. Barbour discussed the challenges that have prevented a consensus from emerging.

She reported having no financial disclosures.

[email protected]


On Twitter @dougbrunk

SAN DIEGO – A lack of consensus exists regarding optimal criteria for diagnosing gestational diabetes mellitus, noted Dr. Linda Barbour.

“The biggest question is, if we are to diagnose many more women and increase the prevalence [of gestational diabetes mellitus] by two- to threefold by diagnosing them and treating them, will we see improved outcomes?” asked Dr. Barbour, professor of medicine and obstetrics and gynecology at the University of Colorado, Aurora.

In an interview at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine, Dr. Barbour discussed the challenges that have prevented a consensus from emerging.

She reported having no financial disclosures.

[email protected]


On Twitter @dougbrunk

SAN DIEGO – Fetal growth rates vary significantly among racial and ethnic groups, according to findings from a prospective cohort study.

The findings, which suggest that a single standard is not appropriate for all population subgroups, have implications for the development of fetal growth standards in the United States, Dr. Katherine Laughon Grantz reported at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.

“There is potential for significant misclassification if standards are used that are based on either one race or that use a pooled racial ethnic group, and a single standard is not appropriate for fetal growth in contemporary U.S. obstetrical calculations,” she said.

Of 2,334 healthy women with low-risk singleton pregnancies who participated in the trial – a National Institute of Child Health and Human Development (NICHD) growth study – 26% were Caucasian, 26% were African American, 28% were Hispanic, and 20% were Asian. After exclusion of those who developed pregnancy complications or were lost to follow-up, 1,737 remained.

The growth curves began to differ between the groups beginning at 16 weeks gestation, and extended to delivery, said Dr. Grantz of the NICHD in Rockville, Md.

After 20 weeks’ gestation, highly significant differences were seen between the groups in estimated fetal weight. At 35 weeks’ gestation, the 10th, 50th, and 90th estimated fetal weight percentiles were 2,305 g, 2,727 g, and 3,227 g for Caucasians; 2,179 g, 2,607 g, and 3,121 g for Hispanics; 2,140 g, 2,530 g, and 2,987 g for Asians; and 2,140 g, 2,528 g, and 2,987 g for African Americans.

Differences in abdominal circumference paralleled the differences in estimated fetal weight, Dr. Grantz said.

After 25 weeks’ gestation, statistically significant differences in head circumference emerged, and at 35 weeks, median head circumference was 320 cm in Caucasians, 317 cm in Hispanics, 316 cm in Asians, and 314 cm in African Americans, she said.

Other differences included humerus and femur length, which were longer throughout gestation in African Americans than in the other racial/ethnic groups – similar to adult proportions.

The women were recruited between 2010 and 2013 from 12 clinical sites. They were screened between 8 weeks and 13 weeks plus 6 days for low-risk status associated with optimal fetal growth. The women were then randomized to one of four serial 2D/3D ultrasonology schedules with quality assurance for longitudinal fetal measurements. This approach was taken to allow for adequate representation of each gestational week without subjecting the women to too many ultrasounds, Dr. Grantz said.

The differences remained statistically significant after adjustment for various demographic differences between the groups.

“Optimal fetal growth is the foundation of long-term health,” Dr. Grantz said, noting that despite this understanding, identifying normal fetal growth remains a pressing challenge.

The current findings suggest that fetuses growing in optimal conditions, with normal maternal size and normal pregnancy outcomes, differ in proportion and size by race/ethnicity, she said.

Dr. Grantz is an employee of the NICHD, which supported the study.

SAN DIEGO – Fetal growth rates vary significantly among racial and ethnic groups, according to findings from a prospective cohort study.

The findings, which suggest that a single standard is not appropriate for all population subgroups, have implications for the development of fetal growth standards in the United States, Dr. Katherine Laughon Grantz reported at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.

“There is potential for significant misclassification if standards are used that are based on either one race or that use a pooled racial ethnic group, and a single standard is not appropriate for fetal growth in contemporary U.S. obstetrical calculations,” she said.

Of 2,334 healthy women with low-risk singleton pregnancies who participated in the trial – a National Institute of Child Health and Human Development (NICHD) growth study – 26% were Caucasian, 26% were African American, 28% were Hispanic, and 20% were Asian. After exclusion of those who developed pregnancy complications or were lost to follow-up, 1,737 remained.

The growth curves began to differ between the groups beginning at 16 weeks gestation, and extended to delivery, said Dr. Grantz of the NICHD in Rockville, Md.

After 20 weeks’ gestation, highly significant differences were seen between the groups in estimated fetal weight. At 35 weeks’ gestation, the 10th, 50th, and 90th estimated fetal weight percentiles were 2,305 g, 2,727 g, and 3,227 g for Caucasians; 2,179 g, 2,607 g, and 3,121 g for Hispanics; 2,140 g, 2,530 g, and 2,987 g for Asians; and 2,140 g, 2,528 g, and 2,987 g for African Americans.

Differences in abdominal circumference paralleled the differences in estimated fetal weight, Dr. Grantz said.

After 25 weeks’ gestation, statistically significant differences in head circumference emerged, and at 35 weeks, median head circumference was 320 cm in Caucasians, 317 cm in Hispanics, 316 cm in Asians, and 314 cm in African Americans, she said.

Other differences included humerus and femur length, which were longer throughout gestation in African Americans than in the other racial/ethnic groups – similar to adult proportions.

The women were recruited between 2010 and 2013 from 12 clinical sites. They were screened between 8 weeks and 13 weeks plus 6 days for low-risk status associated with optimal fetal growth. The women were then randomized to one of four serial 2D/3D ultrasonology schedules with quality assurance for longitudinal fetal measurements. This approach was taken to allow for adequate representation of each gestational week without subjecting the women to too many ultrasounds, Dr. Grantz said.

The differences remained statistically significant after adjustment for various demographic differences between the groups.

“Optimal fetal growth is the foundation of long-term health,” Dr. Grantz said, noting that despite this understanding, identifying normal fetal growth remains a pressing challenge.

The current findings suggest that fetuses growing in optimal conditions, with normal maternal size and normal pregnancy outcomes, differ in proportion and size by race/ethnicity, she said.

Dr. Grantz is an employee of the NICHD, which supported the study.

SAN DIEGO – Fetal growth rates vary significantly among racial and ethnic groups, according to findings from a prospective cohort study.

The findings, which suggest that a single standard is not appropriate for all population subgroups, have implications for the development of fetal growth standards in the United States, Dr. Katherine Laughon Grantz reported at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.

“There is potential for significant misclassification if standards are used that are based on either one race or that use a pooled racial ethnic group, and a single standard is not appropriate for fetal growth in contemporary U.S. obstetrical calculations,” she said.

Of 2,334 healthy women with low-risk singleton pregnancies who participated in the trial – a National Institute of Child Health and Human Development (NICHD) growth study – 26% were Caucasian, 26% were African American, 28% were Hispanic, and 20% were Asian. After exclusion of those who developed pregnancy complications or were lost to follow-up, 1,737 remained.

The growth curves began to differ between the groups beginning at 16 weeks gestation, and extended to delivery, said Dr. Grantz of the NICHD in Rockville, Md.

After 20 weeks’ gestation, highly significant differences were seen between the groups in estimated fetal weight. At 35 weeks’ gestation, the 10th, 50th, and 90th estimated fetal weight percentiles were 2,305 g, 2,727 g, and 3,227 g for Caucasians; 2,179 g, 2,607 g, and 3,121 g for Hispanics; 2,140 g, 2,530 g, and 2,987 g for Asians; and 2,140 g, 2,528 g, and 2,987 g for African Americans.

Differences in abdominal circumference paralleled the differences in estimated fetal weight, Dr. Grantz said.

After 25 weeks’ gestation, statistically significant differences in head circumference emerged, and at 35 weeks, median head circumference was 320 cm in Caucasians, 317 cm in Hispanics, 316 cm in Asians, and 314 cm in African Americans, she said.

Other differences included humerus and femur length, which were longer throughout gestation in African Americans than in the other racial/ethnic groups – similar to adult proportions.

The women were recruited between 2010 and 2013 from 12 clinical sites. They were screened between 8 weeks and 13 weeks plus 6 days for low-risk status associated with optimal fetal growth. The women were then randomized to one of four serial 2D/3D ultrasonology schedules with quality assurance for longitudinal fetal measurements. This approach was taken to allow for adequate representation of each gestational week without subjecting the women to too many ultrasounds, Dr. Grantz said.

The differences remained statistically significant after adjustment for various demographic differences between the groups.

“Optimal fetal growth is the foundation of long-term health,” Dr. Grantz said, noting that despite this understanding, identifying normal fetal growth remains a pressing challenge.

The current findings suggest that fetuses growing in optimal conditions, with normal maternal size and normal pregnancy outcomes, differ in proportion and size by race/ethnicity, she said.

Dr. Grantz is an employee of the NICHD, which supported the study.

SAN DIEGO– Early treatment of pregnant women with prediabetes led to lower hemoglobin A_1C (HbA_1C) levels during the second trimester and at delivery in a randomized, controlled trial.

Study subjects were 83 women with a first trimester HbA_1C of 5.7%-6.4% (median of 5.8%) indicative of prediabetes. HbA_1C levels during the second trimester were 5.2% and 5.3% in the 42 women who were randomized to receive early treatment and in the 41 who received routine care, respectively, and the levels at delivery were 5.5% and 5.8%, respectively, Dr. Sarah Osmundson reported at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.

The overall rate of positive glucose tolerance tests (GTT) or insulin use prior to the GTT – the primary study outcome – did not differ significantly between the groups but did trend toward lower in the early treatment group (45.2% vs. 55%; relative risk, 0.82), said Dr. Osmundson of Stanford (Calif.) University.

Further, although no difference was seen in the rate of gestational diabetes mellitus (GDM) among women with prepregnancy obesity in the early treatment and routine care groups, early treatment was associated with a 50% lower rate of GDM in nonobese women (29.6% vs. 59.1%, relative risk, 0.50), she said.

The participants had a singleton pregnancy, no chronic steroid use, and no preexisting diabetes. They were enrolled between May 2012 and June 2014, and all met with a certified diabetes educator at study entry to discuss healthy weight gain strategies in pregnancy and to set personalized weight gain goals.

Those in the early treatment group also were counseled to keep a diary to track food intake, were advised to monitor portion size, and limit carbohydrate intake to no more than 45% of total diet, and were seen by a dietitian or obstetrician every 2 weeks. They self-monitored blood glucose levels four times daily, and insulin was initiated if more than 20% of values were elevated.

The routine care group received usual prenatal care, including a visit with a provider every 4 weeks.

Patients in both groups underwent an oral GTT between 26 and 28 weeks of gestation.

Patients in the early treatment group with a positive GTT continued treatment, and those with a negative GTT continued treatment, but reduced monitoring to twice daily – returning to four times daily testing if levels increased. Those in the routine care group initiated treatment if the GTT was positive, and continued usual care if it was negative.

The groups gained a similar amount of weight during the study and did not differ in terms of insulin use, but the early treatment group started insulin at an earlier gestational age, and nonsignificant trends were seen toward a decrease in the primary outcome and toward lower GTT values in that group. The early treatment group patients also had a lower cesarean delivery rate (29.4% vs. 47,2%; RR, 0.63), but the difference did not reach statistical significance, Dr. Osmundson said.

Similarly, nonsignificant trends were seen toward lower infant birth weight, less macrosomia, and lower umbilical cord C-peptide levels in the early treatment group.

Glycosylated HbA_1C is widely used for monitoring glycemic control, but was only recently adopted as an additional method of screening for diabetes. The measure has several advantages over the oral GTT, as it can be performed in a nonfasting state, requires only one blood draw, and provides information about average glucose exposure over time, she said.

The American Diabetes Association accepted HbA_1C as an additional method for diagnosing type 2 diabetes in 2009, and classified those with levels between 5.7% and 6.4% as having prediabetes. That same year, an International Association of Diabetes in Pregnancy study group recommended that HbA_1C of 6.5% or greater in pregnancy be considered overt diabetes, but made no recommendations regarding the management of those with prediabetic HbA_1C, Dr. Osmundson said.

Prediabetes predicts a 50% cumulative incidence of type 2 diabetes within 5 years in nonpregnant patients, but much less is known about the condition in pregnant women, she added, noting that recent studies suggest a threefold increased risk for gestational diabetes in the second trimester – and perhaps even greater risk in obese women – among those with prediabetes.

The addition of HbA_1C to the prenatal panel in California, along with a recommendation that those with prediabetes be diagnosed with and treated for gestational diabetes, provided the opportunity to evaluate whether such treatment affected the incidence of gestational diabetes as compared with usual care, she noted.

“We hypothesized that treatment would lower the risk of GDM, especially among obese women,” she said.

Though limited by the sample size and the fact that providers were not blinded to patients’ treatment group, the randomized, controlled study design is a strength, and the findings add to the limited data on HbA_1C in pregnancy and the management of prediabetes in pregnant patients, she said.

The study was underpowered to determine whether early treatment reduces the risk of GDM in women with prediabetes, but the findings suggest that such treatment may reduce the risk among nonobese women.

“While this finding is unexpected, we think the findings are consistent with literature suggesting that women with prepregnancy obesity remain at higher risk of adverse perinatal outcomes even in absence of GDM or excessive weight gain. We hypothesize that any small effect may be attenuated by the morbidity associated with prepregnancy adiposity. Larger studies powered to examine the primary outcomes and perinatal outcomes are required,” she concluded.

This study was funded by the American College of Obstetricians and Gynecologists Abbott Nutrition Research Fellowship, the Stanford Child Health Institute, and the Valley Foundation for the California Institute of Medical Research. Dr. Osmundson reported having no disclosures.

SAN DIEGO– Early treatment of pregnant women with prediabetes led to lower hemoglobin A_1C (HbA_1C) levels during the second trimester and at delivery in a randomized, controlled trial.

Study subjects were 83 women with a first trimester HbA_1C of 5.7%-6.4% (median of 5.8%) indicative of prediabetes. HbA_1C levels during the second trimester were 5.2% and 5.3% in the 42 women who were randomized to receive early treatment and in the 41 who received routine care, respectively, and the levels at delivery were 5.5% and 5.8%, respectively, Dr. Sarah Osmundson reported at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.

The overall rate of positive glucose tolerance tests (GTT) or insulin use prior to the GTT – the primary study outcome – did not differ significantly between the groups but did trend toward lower in the early treatment group (45.2% vs. 55%; relative risk, 0.82), said Dr. Osmundson of Stanford (Calif.) University.

Further, although no difference was seen in the rate of gestational diabetes mellitus (GDM) among women with prepregnancy obesity in the early treatment and routine care groups, early treatment was associated with a 50% lower rate of GDM in nonobese women (29.6% vs. 59.1%, relative risk, 0.50), she said.

The participants had a singleton pregnancy, no chronic steroid use, and no preexisting diabetes. They were enrolled between May 2012 and June 2014, and all met with a certified diabetes educator at study entry to discuss healthy weight gain strategies in pregnancy and to set personalized weight gain goals.

Those in the early treatment group also were counseled to keep a diary to track food intake, were advised to monitor portion size, and limit carbohydrate intake to no more than 45% of total diet, and were seen by a dietitian or obstetrician every 2 weeks. They self-monitored blood glucose levels four times daily, and insulin was initiated if more than 20% of values were elevated.

The routine care group received usual prenatal care, including a visit with a provider every 4 weeks.

Patients in both groups underwent an oral GTT between 26 and 28 weeks of gestation.

Patients in the early treatment group with a positive GTT continued treatment, and those with a negative GTT continued treatment, but reduced monitoring to twice daily – returning to four times daily testing if levels increased. Those in the routine care group initiated treatment if the GTT was positive, and continued usual care if it was negative.

The groups gained a similar amount of weight during the study and did not differ in terms of insulin use, but the early treatment group started insulin at an earlier gestational age, and nonsignificant trends were seen toward a decrease in the primary outcome and toward lower GTT values in that group. The early treatment group patients also had a lower cesarean delivery rate (29.4% vs. 47,2%; RR, 0.63), but the difference did not reach statistical significance, Dr. Osmundson said.

Similarly, nonsignificant trends were seen toward lower infant birth weight, less macrosomia, and lower umbilical cord C-peptide levels in the early treatment group.

Glycosylated HbA_1C is widely used for monitoring glycemic control, but was only recently adopted as an additional method of screening for diabetes. The measure has several advantages over the oral GTT, as it can be performed in a nonfasting state, requires only one blood draw, and provides information about average glucose exposure over time, she said.

The American Diabetes Association accepted HbA_1C as an additional method for diagnosing type 2 diabetes in 2009, and classified those with levels between 5.7% and 6.4% as having prediabetes. That same year, an International Association of Diabetes in Pregnancy study group recommended that HbA_1C of 6.5% or greater in pregnancy be considered overt diabetes, but made no recommendations regarding the management of those with prediabetic HbA_1C, Dr. Osmundson said.

Prediabetes predicts a 50% cumulative incidence of type 2 diabetes within 5 years in nonpregnant patients, but much less is known about the condition in pregnant women, she added, noting that recent studies suggest a threefold increased risk for gestational diabetes in the second trimester – and perhaps even greater risk in obese women – among those with prediabetes.

The addition of HbA_1C to the prenatal panel in California, along with a recommendation that those with prediabetes be diagnosed with and treated for gestational diabetes, provided the opportunity to evaluate whether such treatment affected the incidence of gestational diabetes as compared with usual care, she noted.

“We hypothesized that treatment would lower the risk of GDM, especially among obese women,” she said.

Though limited by the sample size and the fact that providers were not blinded to patients’ treatment group, the randomized, controlled study design is a strength, and the findings add to the limited data on HbA_1C in pregnancy and the management of prediabetes in pregnant patients, she said.

The study was underpowered to determine whether early treatment reduces the risk of GDM in women with prediabetes, but the findings suggest that such treatment may reduce the risk among nonobese women.

“While this finding is unexpected, we think the findings are consistent with literature suggesting that women with prepregnancy obesity remain at higher risk of adverse perinatal outcomes even in absence of GDM or excessive weight gain. We hypothesize that any small effect may be attenuated by the morbidity associated with prepregnancy adiposity. Larger studies powered to examine the primary outcomes and perinatal outcomes are required,” she concluded.

This study was funded by the American College of Obstetricians and Gynecologists Abbott Nutrition Research Fellowship, the Stanford Child Health Institute, and the Valley Foundation for the California Institute of Medical Research. Dr. Osmundson reported having no disclosures.

SAN DIEGO– Early treatment of pregnant women with prediabetes led to lower hemoglobin A_1C (HbA_1C) levels during the second trimester and at delivery in a randomized, controlled trial.

Study subjects were 83 women with a first trimester HbA_1C of 5.7%-6.4% (median of 5.8%) indicative of prediabetes. HbA_1C levels during the second trimester were 5.2% and 5.3% in the 42 women who were randomized to receive early treatment and in the 41 who received routine care, respectively, and the levels at delivery were 5.5% and 5.8%, respectively, Dr. Sarah Osmundson reported at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.

The overall rate of positive glucose tolerance tests (GTT) or insulin use prior to the GTT – the primary study outcome – did not differ significantly between the groups but did trend toward lower in the early treatment group (45.2% vs. 55%; relative risk, 0.82), said Dr. Osmundson of Stanford (Calif.) University.

Further, although no difference was seen in the rate of gestational diabetes mellitus (GDM) among women with prepregnancy obesity in the early treatment and routine care groups, early treatment was associated with a 50% lower rate of GDM in nonobese women (29.6% vs. 59.1%, relative risk, 0.50), she said.

The participants had a singleton pregnancy, no chronic steroid use, and no preexisting diabetes. They were enrolled between May 2012 and June 2014, and all met with a certified diabetes educator at study entry to discuss healthy weight gain strategies in pregnancy and to set personalized weight gain goals.

Those in the early treatment group also were counseled to keep a diary to track food intake, were advised to monitor portion size, and limit carbohydrate intake to no more than 45% of total diet, and were seen by a dietitian or obstetrician every 2 weeks. They self-monitored blood glucose levels four times daily, and insulin was initiated if more than 20% of values were elevated.

The routine care group received usual prenatal care, including a visit with a provider every 4 weeks.

Patients in both groups underwent an oral GTT between 26 and 28 weeks of gestation.

Patients in the early treatment group with a positive GTT continued treatment, and those with a negative GTT continued treatment, but reduced monitoring to twice daily – returning to four times daily testing if levels increased. Those in the routine care group initiated treatment if the GTT was positive, and continued usual care if it was negative.

The groups gained a similar amount of weight during the study and did not differ in terms of insulin use, but the early treatment group started insulin at an earlier gestational age, and nonsignificant trends were seen toward a decrease in the primary outcome and toward lower GTT values in that group. The early treatment group patients also had a lower cesarean delivery rate (29.4% vs. 47,2%; RR, 0.63), but the difference did not reach statistical significance, Dr. Osmundson said.

Similarly, nonsignificant trends were seen toward lower infant birth weight, less macrosomia, and lower umbilical cord C-peptide levels in the early treatment group.

Glycosylated HbA_1C is widely used for monitoring glycemic control, but was only recently adopted as an additional method of screening for diabetes. The measure has several advantages over the oral GTT, as it can be performed in a nonfasting state, requires only one blood draw, and provides information about average glucose exposure over time, she said.

The American Diabetes Association accepted HbA_1C as an additional method for diagnosing type 2 diabetes in 2009, and classified those with levels between 5.7% and 6.4% as having prediabetes. That same year, an International Association of Diabetes in Pregnancy study group recommended that HbA_1C of 6.5% or greater in pregnancy be considered overt diabetes, but made no recommendations regarding the management of those with prediabetic HbA_1C, Dr. Osmundson said.

Prediabetes predicts a 50% cumulative incidence of type 2 diabetes within 5 years in nonpregnant patients, but much less is known about the condition in pregnant women, she added, noting that recent studies suggest a threefold increased risk for gestational diabetes in the second trimester – and perhaps even greater risk in obese women – among those with prediabetes.

The addition of HbA_1C to the prenatal panel in California, along with a recommendation that those with prediabetes be diagnosed with and treated for gestational diabetes, provided the opportunity to evaluate whether such treatment affected the incidence of gestational diabetes as compared with usual care, she noted.

“We hypothesized that treatment would lower the risk of GDM, especially among obese women,” she said.

Though limited by the sample size and the fact that providers were not blinded to patients’ treatment group, the randomized, controlled study design is a strength, and the findings add to the limited data on HbA_1C in pregnancy and the management of prediabetes in pregnant patients, she said.

The study was underpowered to determine whether early treatment reduces the risk of GDM in women with prediabetes, but the findings suggest that such treatment may reduce the risk among nonobese women.

“While this finding is unexpected, we think the findings are consistent with literature suggesting that women with prepregnancy obesity remain at higher risk of adverse perinatal outcomes even in absence of GDM or excessive weight gain. We hypothesize that any small effect may be attenuated by the morbidity associated with prepregnancy adiposity. Larger studies powered to examine the primary outcomes and perinatal outcomes are required,” she concluded.

This study was funded by the American College of Obstetricians and Gynecologists Abbott Nutrition Research Fellowship, the Stanford Child Health Institute, and the Valley Foundation for the California Institute of Medical Research. Dr. Osmundson reported having no disclosures.

SAN DIEGO – A shift from a conventional private practice model to a 24-hour obstetrician and midwifery model was associated with a dramatic decrease in the nulliparous term single vertex cesarean delivery rate, and an increase in the vaginal birth after cesarean delivery (VBAC) rate among privately insured women who delivered at a single community hospital.

The nulliparous term single vertex cesarean delivery (NTSV CD) rate among privately insured women prior to the model change was 32.2%, compared with 25% after the change, with a 5% decrease at the time of the change, and a nearly 2% decrease per year thereafter. Prior to the change, the rate had been increasing by 0.6% annually, which was similar to national trends. The odds ratio for NTSV CD was 0.56 after adjustment for maternal age, race/ethnicity, induction , epidural use, birth weight, gestational age, maternal medical problems, and birth year, Dr. Melissa Rosenstein reported at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.

Further, the VBAC rate, which was decreasing slightly each year before the change, increased from 13% to 22% after the change (adjusted odds ratio, 1.94), and increased by about 8% per year thereafter, said Dr. Rosenstein of the University of California, San Francisco.

Prior to the change, privately insured women were managed by their individual obstetricians; only publicly insured women utilized the hospitalist model. The rates of NTSV CD and VBAC in the publicly insured women did not change significantly during the study period – the NTSV CD rates were 15.7% and 15.8% before and after the change, and VBAC rates were 33.9% and 27.9% before and after the change (aOR, 0.84 and 0.76, respectively), she said.

Interrupted time series analyses showed that the change in VBAC rates among the publicly insured women represented a persistent trend rather than any change from the intervention and also showed no significant adverse effect of the intervention on short-term neonatal outcomes, she noted.

The prospective cohort study included all singleton term deliveries at the community hospital between January 2005 and April 2014. The model shift occurred in April 2011. Overall, 3,684 NTSV deliveries and 1,375 deliveries in women with a prior cesarean delivery were included in the analysis.

The pre- and post-model change cohorts were similar with respect to delivery volume, gestational age, maternal age, and ethnic makeup.

The findings are notable, because the practice of obstetrics in the United States faces multiple challenges, Dr. Rosenstein said, noting that nearly a third of all births are by cesarean section, while VBAC rates continue to decline.

“These trends are accompanied by increasing maternal complications and rising costs,” she said.

Additionally, work force concerns are leading to decreased provider satisfaction and burnout among those who perform deliveries – due in part to the inherent conflict between labor and delivery responsibilities and office practice – and the difficulty of balancing these demands.

“At the same time, there have been increasing calls for expanding the availability of 24-hour in-house obstetric coverage to improve patient safety and decrease liability,” she said.

A potential solution to the problem of a shrinking workforce and rising cesarean delivery rates is increased use of midwives, whose involvement in deliveries is associated with excellent maternal and neonatal outcomes, Dr. Rosenstein noted.

Additionally, the employment of laborists, who provide in-house labor and delivery coverage without competing clinical duties, is increasing, and has been endorsed by the American College of Obstetricians and Gynecologists as a potential solution to improve provider satisfaction and patient safety. Data on outcomes associated with such a model are sparse, but encouraging, she said.

The shift from the private practice model to the laborist and midwifery model at a community hospital that provides services for an equal number of privately and publicly insured women posed an opportunity for University of California, San Francisco, researchers to prospectively study the effects of the model.

“We observed that the expansion of midwifery and laborist services in a collaborative practice model, was associated with decreased rate of primary cesarean delivery and an increased rate of VBAC, with cesarean rates continuing to decline during the 3 years after the practice change,” Dr Rosenstein said, noting that “the changes were seen to a statistically significant degree only in the group of women exposed to the practice change, suggesting causation rather than secular trends for other hospital-wide interventions.”

“We believe that this model could be instituted at other U.S. hospitals that are seeking to decrease their cesarean delivery rates,” she concluded.

This study was funded by the National Institutes of Health and the Prima Medical Foundation. Dr. Rosenstein reported having no disclosures.

SAN DIEGO – A shift from a conventional private practice model to a 24-hour obstetrician and midwifery model was associated with a dramatic decrease in the nulliparous term single vertex cesarean delivery rate, and an increase in the vaginal birth after cesarean delivery (VBAC) rate among privately insured women who delivered at a single community hospital.

The nulliparous term single vertex cesarean delivery (NTSV CD) rate among privately insured women prior to the model change was 32.2%, compared with 25% after the change, with a 5% decrease at the time of the change, and a nearly 2% decrease per year thereafter. Prior to the change, the rate had been increasing by 0.6% annually, which was similar to national trends. The odds ratio for NTSV CD was 0.56 after adjustment for maternal age, race/ethnicity, induction , epidural use, birth weight, gestational age, maternal medical problems, and birth year, Dr. Melissa Rosenstein reported at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.

Further, the VBAC rate, which was decreasing slightly each year before the change, increased from 13% to 22% after the change (adjusted odds ratio, 1.94), and increased by about 8% per year thereafter, said Dr. Rosenstein of the University of California, San Francisco.

Prior to the change, privately insured women were managed by their individual obstetricians; only publicly insured women utilized the hospitalist model. The rates of NTSV CD and VBAC in the publicly insured women did not change significantly during the study period – the NTSV CD rates were 15.7% and 15.8% before and after the change, and VBAC rates were 33.9% and 27.9% before and after the change (aOR, 0.84 and 0.76, respectively), she said.

Interrupted time series analyses showed that the change in VBAC rates among the publicly insured women represented a persistent trend rather than any change from the intervention and also showed no significant adverse effect of the intervention on short-term neonatal outcomes, she noted.

The prospective cohort study included all singleton term deliveries at the community hospital between January 2005 and April 2014. The model shift occurred in April 2011. Overall, 3,684 NTSV deliveries and 1,375 deliveries in women with a prior cesarean delivery were included in the analysis.

The pre- and post-model change cohorts were similar with respect to delivery volume, gestational age, maternal age, and ethnic makeup.

The findings are notable, because the practice of obstetrics in the United States faces multiple challenges, Dr. Rosenstein said, noting that nearly a third of all births are by cesarean section, while VBAC rates continue to decline.

“These trends are accompanied by increasing maternal complications and rising costs,” she said.

Additionally, work force concerns are leading to decreased provider satisfaction and burnout among those who perform deliveries – due in part to the inherent conflict between labor and delivery responsibilities and office practice – and the difficulty of balancing these demands.

“At the same time, there have been increasing calls for expanding the availability of 24-hour in-house obstetric coverage to improve patient safety and decrease liability,” she said.

A potential solution to the problem of a shrinking workforce and rising cesarean delivery rates is increased use of midwives, whose involvement in deliveries is associated with excellent maternal and neonatal outcomes, Dr. Rosenstein noted.

Additionally, the employment of laborists, who provide in-house labor and delivery coverage without competing clinical duties, is increasing, and has been endorsed by the American College of Obstetricians and Gynecologists as a potential solution to improve provider satisfaction and patient safety. Data on outcomes associated with such a model are sparse, but encouraging, she said.

The shift from the private practice model to the laborist and midwifery model at a community hospital that provides services for an equal number of privately and publicly insured women posed an opportunity for University of California, San Francisco, researchers to prospectively study the effects of the model.

“We observed that the expansion of midwifery and laborist services in a collaborative practice model, was associated with decreased rate of primary cesarean delivery and an increased rate of VBAC, with cesarean rates continuing to decline during the 3 years after the practice change,” Dr Rosenstein said, noting that “the changes were seen to a statistically significant degree only in the group of women exposed to the practice change, suggesting causation rather than secular trends for other hospital-wide interventions.”

“We believe that this model could be instituted at other U.S. hospitals that are seeking to decrease their cesarean delivery rates,” she concluded.

This study was funded by the National Institutes of Health and the Prima Medical Foundation. Dr. Rosenstein reported having no disclosures.

SAN DIEGO – A shift from a conventional private practice model to a 24-hour obstetrician and midwifery model was associated with a dramatic decrease in the nulliparous term single vertex cesarean delivery rate, and an increase in the vaginal birth after cesarean delivery (VBAC) rate among privately insured women who delivered at a single community hospital.

The nulliparous term single vertex cesarean delivery (NTSV CD) rate among privately insured women prior to the model change was 32.2%, compared with 25% after the change, with a 5% decrease at the time of the change, and a nearly 2% decrease per year thereafter. Prior to the change, the rate had been increasing by 0.6% annually, which was similar to national trends. The odds ratio for NTSV CD was 0.56 after adjustment for maternal age, race/ethnicity, induction , epidural use, birth weight, gestational age, maternal medical problems, and birth year, Dr. Melissa Rosenstein reported at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.

Further, the VBAC rate, which was decreasing slightly each year before the change, increased from 13% to 22% after the change (adjusted odds ratio, 1.94), and increased by about 8% per year thereafter, said Dr. Rosenstein of the University of California, San Francisco.

Prior to the change, privately insured women were managed by their individual obstetricians; only publicly insured women utilized the hospitalist model. The rates of NTSV CD and VBAC in the publicly insured women did not change significantly during the study period – the NTSV CD rates were 15.7% and 15.8% before and after the change, and VBAC rates were 33.9% and 27.9% before and after the change (aOR, 0.84 and 0.76, respectively), she said.

Interrupted time series analyses showed that the change in VBAC rates among the publicly insured women represented a persistent trend rather than any change from the intervention and also showed no significant adverse effect of the intervention on short-term neonatal outcomes, she noted.

The prospective cohort study included all singleton term deliveries at the community hospital between January 2005 and April 2014. The model shift occurred in April 2011. Overall, 3,684 NTSV deliveries and 1,375 deliveries in women with a prior cesarean delivery were included in the analysis.

The pre- and post-model change cohorts were similar with respect to delivery volume, gestational age, maternal age, and ethnic makeup.

The findings are notable, because the practice of obstetrics in the United States faces multiple challenges, Dr. Rosenstein said, noting that nearly a third of all births are by cesarean section, while VBAC rates continue to decline.

“These trends are accompanied by increasing maternal complications and rising costs,” she said.

Additionally, work force concerns are leading to decreased provider satisfaction and burnout among those who perform deliveries – due in part to the inherent conflict between labor and delivery responsibilities and office practice – and the difficulty of balancing these demands.

“At the same time, there have been increasing calls for expanding the availability of 24-hour in-house obstetric coverage to improve patient safety and decrease liability,” she said.

A potential solution to the problem of a shrinking workforce and rising cesarean delivery rates is increased use of midwives, whose involvement in deliveries is associated with excellent maternal and neonatal outcomes, Dr. Rosenstein noted.

Additionally, the employment of laborists, who provide in-house labor and delivery coverage without competing clinical duties, is increasing, and has been endorsed by the American College of Obstetricians and Gynecologists as a potential solution to improve provider satisfaction and patient safety. Data on outcomes associated with such a model are sparse, but encouraging, she said.

The shift from the private practice model to the laborist and midwifery model at a community hospital that provides services for an equal number of privately and publicly insured women posed an opportunity for University of California, San Francisco, researchers to prospectively study the effects of the model.

“We observed that the expansion of midwifery and laborist services in a collaborative practice model, was associated with decreased rate of primary cesarean delivery and an increased rate of VBAC, with cesarean rates continuing to decline during the 3 years after the practice change,” Dr Rosenstein said, noting that “the changes were seen to a statistically significant degree only in the group of women exposed to the practice change, suggesting causation rather than secular trends for other hospital-wide interventions.”

“We believe that this model could be instituted at other U.S. hospitals that are seeking to decrease their cesarean delivery rates,” she concluded.

This study was funded by the National Institutes of Health and the Prima Medical Foundation. Dr. Rosenstein reported having no disclosures.

SAN DIEGO – Fetal electrocardiogram ST segment analysis, or STAN, is commonly used in Europe as an adjunct to conventional intrapartum fetal heart rate monitoring, but adding STAN did not improve perinatal outcomes or decrease operative deliveries in a large, multicenter U.S. study.

Of 11,108 patients included in the 26-center study, 149 women experienced the composite primary outcome of at least one of the following: intrapartum fetal death, neonatal death, Apgar score of 3 or less at 5 minutes, neonatal seizure, cord artery pH of 7.05 or less plus base deficit of at least 12 mmol/L, intubation for ventilation at delivery, and neonatal encephalopathy, Dr. George R. Saade reported at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.

The number of patients experiencing the composite outcome did not differ between those randomized to open or masked STAN fetal heart rate monitoring, with 79 of 5,532 in the open monitoring group (1.43%) and 70 of 5,576 in the masked monitoring group (1.26%) experiencing one or more events (relative risk, 1.14), said Dr. Saade, a professor at the University of Texas, Galveston, who presented the findings on behalf of the National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network in Bethesda, Md.

The open group monitors displayed relevant information used for decision making in the event of uncertain fetal heart rate patterns; the masked monitors functioned as normal monitors, he explained.

Study participants were women attempting vaginal singleton delivery at gestation of 36 weeks and 1 day or greater with cervical dilation of 2-7 cm between November 2010 and March 2014. The open and masked STAN monitoring groups did not differ with respect to baseline characteristics or with respect to parity, type of labor, cervical dilation at study entry, and study period.

The groups also did not differ in secondary study outcomes, including the type of delivery and measures of morbidity.

For example, operative vaginal delivery occurred in 5.9% of patients in both groups (relative risk, 1.02), and cesarean delivery occurred in 16.9% and 16.2% of the open and masked group patients, respectively (RR, 1.05). Additionally, intermediate/NICU stay was required in 9.0% and 8.4% of patients in the groups, respectively (RR, 1.07), meconium aspiration occurred in 0.4% of patients of both groups (RR, 1.01), and shoulder dystocia occurred in 2.5% and 2.8% (RR, 0.90).

All participating providers were trained and certified per approved management guidelines for STAN, and a training pilot study involving 1,527 women from 31 centers was conducted at each site prior to the randomized controlled trial.

“This is the largest fetal ECG randomized trial conducted to date, with the highest rate of available cord gasses. We feel that our study is more applicable to U.S. practice than [are] all other prior studies,” Dr. Saade said, concluding that the validity of the results is strengthened by the “intensive training and rigorous certification,” of providers, as well as by the inclusion of real-time review feedback after training, central review of outcomes, and the use of an independent data coordinating center.

Many community and university hospitals were represented in the study, as were a variety of providers – including residents and midwives – and types of practices.

Even in subgroup analyses, and after controlling for site of service, there were no differences in outcomes observed between the study groups. This suggests that the findings are generalizable across the United States, Dr. Saade said.

When asked why European studies have shown a benefit with STAN monitoring, Dr. Saade said that the main difference seen in systematic reviews was a lower rate of fetal scalp sampling with STAN monitoring. “In the United States, we don’t do fetal scalp sampling, so that won’t help us here,” he said.

Dr. Saade reported having no financial disclosures.

SAN DIEGO – Fetal electrocardiogram ST segment analysis, or STAN, is commonly used in Europe as an adjunct to conventional intrapartum fetal heart rate monitoring, but adding STAN did not improve perinatal outcomes or decrease operative deliveries in a large, multicenter U.S. study.

Of 11,108 patients included in the 26-center study, 149 women experienced the composite primary outcome of at least one of the following: intrapartum fetal death, neonatal death, Apgar score of 3 or less at 5 minutes, neonatal seizure, cord artery pH of 7.05 or less plus base deficit of at least 12 mmol/L, intubation for ventilation at delivery, and neonatal encephalopathy, Dr. George R. Saade reported at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.

The number of patients experiencing the composite outcome did not differ between those randomized to open or masked STAN fetal heart rate monitoring, with 79 of 5,532 in the open monitoring group (1.43%) and 70 of 5,576 in the masked monitoring group (1.26%) experiencing one or more events (relative risk, 1.14), said Dr. Saade, a professor at the University of Texas, Galveston, who presented the findings on behalf of the National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network in Bethesda, Md.

The open group monitors displayed relevant information used for decision making in the event of uncertain fetal heart rate patterns; the masked monitors functioned as normal monitors, he explained.

Study participants were women attempting vaginal singleton delivery at gestation of 36 weeks and 1 day or greater with cervical dilation of 2-7 cm between November 2010 and March 2014. The open and masked STAN monitoring groups did not differ with respect to baseline characteristics or with respect to parity, type of labor, cervical dilation at study entry, and study period.

The groups also did not differ in secondary study outcomes, including the type of delivery and measures of morbidity.

For example, operative vaginal delivery occurred in 5.9% of patients in both groups (relative risk, 1.02), and cesarean delivery occurred in 16.9% and 16.2% of the open and masked group patients, respectively (RR, 1.05). Additionally, intermediate/NICU stay was required in 9.0% and 8.4% of patients in the groups, respectively (RR, 1.07), meconium aspiration occurred in 0.4% of patients of both groups (RR, 1.01), and shoulder dystocia occurred in 2.5% and 2.8% (RR, 0.90).

All participating providers were trained and certified per approved management guidelines for STAN, and a training pilot study involving 1,527 women from 31 centers was conducted at each site prior to the randomized controlled trial.

“This is the largest fetal ECG randomized trial conducted to date, with the highest rate of available cord gasses. We feel that our study is more applicable to U.S. practice than [are] all other prior studies,” Dr. Saade said, concluding that the validity of the results is strengthened by the “intensive training and rigorous certification,” of providers, as well as by the inclusion of real-time review feedback after training, central review of outcomes, and the use of an independent data coordinating center.

Many community and university hospitals were represented in the study, as were a variety of providers – including residents and midwives – and types of practices.

Even in subgroup analyses, and after controlling for site of service, there were no differences in outcomes observed between the study groups. This suggests that the findings are generalizable across the United States, Dr. Saade said.

When asked why European studies have shown a benefit with STAN monitoring, Dr. Saade said that the main difference seen in systematic reviews was a lower rate of fetal scalp sampling with STAN monitoring. “In the United States, we don’t do fetal scalp sampling, so that won’t help us here,” he said.

Dr. Saade reported having no financial disclosures.

SAN DIEGO – Fetal electrocardiogram ST segment analysis, or STAN, is commonly used in Europe as an adjunct to conventional intrapartum fetal heart rate monitoring, but adding STAN did not improve perinatal outcomes or decrease operative deliveries in a large, multicenter U.S. study.

Of 11,108 patients included in the 26-center study, 149 women experienced the composite primary outcome of at least one of the following: intrapartum fetal death, neonatal death, Apgar score of 3 or less at 5 minutes, neonatal seizure, cord artery pH of 7.05 or less plus base deficit of at least 12 mmol/L, intubation for ventilation at delivery, and neonatal encephalopathy, Dr. George R. Saade reported at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.

The number of patients experiencing the composite outcome did not differ between those randomized to open or masked STAN fetal heart rate monitoring, with 79 of 5,532 in the open monitoring group (1.43%) and 70 of 5,576 in the masked monitoring group (1.26%) experiencing one or more events (relative risk, 1.14), said Dr. Saade, a professor at the University of Texas, Galveston, who presented the findings on behalf of the National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network in Bethesda, Md.

The open group monitors displayed relevant information used for decision making in the event of uncertain fetal heart rate patterns; the masked monitors functioned as normal monitors, he explained.

Study participants were women attempting vaginal singleton delivery at gestation of 36 weeks and 1 day or greater with cervical dilation of 2-7 cm between November 2010 and March 2014. The open and masked STAN monitoring groups did not differ with respect to baseline characteristics or with respect to parity, type of labor, cervical dilation at study entry, and study period.

The groups also did not differ in secondary study outcomes, including the type of delivery and measures of morbidity.

For example, operative vaginal delivery occurred in 5.9% of patients in both groups (relative risk, 1.02), and cesarean delivery occurred in 16.9% and 16.2% of the open and masked group patients, respectively (RR, 1.05). Additionally, intermediate/NICU stay was required in 9.0% and 8.4% of patients in the groups, respectively (RR, 1.07), meconium aspiration occurred in 0.4% of patients of both groups (RR, 1.01), and shoulder dystocia occurred in 2.5% and 2.8% (RR, 0.90).

All participating providers were trained and certified per approved management guidelines for STAN, and a training pilot study involving 1,527 women from 31 centers was conducted at each site prior to the randomized controlled trial.

“This is the largest fetal ECG randomized trial conducted to date, with the highest rate of available cord gasses. We feel that our study is more applicable to U.S. practice than [are] all other prior studies,” Dr. Saade said, concluding that the validity of the results is strengthened by the “intensive training and rigorous certification,” of providers, as well as by the inclusion of real-time review feedback after training, central review of outcomes, and the use of an independent data coordinating center.

Many community and university hospitals were represented in the study, as were a variety of providers – including residents and midwives – and types of practices.

Even in subgroup analyses, and after controlling for site of service, there were no differences in outcomes observed between the study groups. This suggests that the findings are generalizable across the United States, Dr. Saade said.

When asked why European studies have shown a benefit with STAN monitoring, Dr. Saade said that the main difference seen in systematic reviews was a lower rate of fetal scalp sampling with STAN monitoring. “In the United States, we don’t do fetal scalp sampling, so that won’t help us here,” he said.

Dr. Saade reported having no financial disclosures.

SAN DIEGO – Fetal growth ultrasound does not identify fetuses destined to be small for gestational age at birth, but it does identify fetuses with increased risk of significant morbidity and mortality in the postnatal period.

Those are key findings from a large retrospective study presented by Dr. Jacob C. Larkin at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.

“Small for gestational age (SGA) newborns and fetuses are known to be at increased risk of stillbirth, neonatal morbidity and mortality, and adult disease,” Dr. Larkin said in an interview in advance of the meeting. “We show that ultrasound is not a good tool for identifying fetuses that are destined to be SGA at birth. However, for those babies that are SGA when they’re born (the smaller 10% of newborns) fetal growth ultrasound appears to be an effective tool for stratifying risk in the neonatal period.”

In a study led by Dr. Larkin of the division of maternal-fetal medicine in the department of obstetrics, gynecology, and reproductive sciences at the University of Pittsburgh, researchers retrospectively evaluated 125,069 nonanomalous singletons, delivered beyond 24 weeks at the university’s Magee-Womens Hospital between 1995 and 2011. Using Alexander’s nomogram, newborns were classified as appropriate for gestational age (AGA; weight at 10%-89% for GA) or SGA, which were categorized into three groups: no growth ultrasound (US) in third trimester; US in the third trimester but no diagnosis of fetal growth restriction (FGR); and diagnosed as FGR antenatally. An Apgar score of less than 4 at 5 minutes and neonatal mortality were adjusted for nulliparity, maternal education, tobacco use, race, marital status, and neonatal gender.

Of the 125,069 newborns evaluated, 10% (12,474) were SGA. Of these, 81% (10,140) did not have US after 24 weeks, a finding that surprised Dr. Larkin. Of those 2,334 SGA who had a growth US, 81% were not identified as FGR. Overall, only 3% (431) of SGA were detected antenatally as FGR. SGA newborns who were found to have an estimated fetal weight below the 10th percentile, and thus labeled as growth restricted, were at significantly increased risk of neonatal death (adjusted odds ratio, 15.39). On the other hand, newborns with birth weights below the 10th percentile who had an ultrasound before birth that found them to be appropriately grown were at no greater risk of neonatal death or low Apgar score than were newborns with normal birth weights (aOR, 1.19 and 1.34, respectively).

A key strength of the study, Dr. Larkin said, was its large sample size and the fact that US data was linked to neonatal outcomes. Limitations of the study include the absence of stillbirths in the cohort. “Also, the data used was not collected as part of a protocol, and all ultrasounds were obtained for clinical indications, which makes it difficult to compare outcomes in patient that had ultrasound and those that didn’t without bias,” he said.

Dr. Larkin reported having no relevant financial conflicts.

[email protected]

On Twitter @dougbrunk

SAN DIEGO – Fetal growth ultrasound does not identify fetuses destined to be small for gestational age at birth, but it does identify fetuses with increased risk of significant morbidity and mortality in the postnatal period.

Those are key findings from a large retrospective study presented by Dr. Jacob C. Larkin at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.

“Small for gestational age (SGA) newborns and fetuses are known to be at increased risk of stillbirth, neonatal morbidity and mortality, and adult disease,” Dr. Larkin said in an interview in advance of the meeting. “We show that ultrasound is not a good tool for identifying fetuses that are destined to be SGA at birth. However, for those babies that are SGA when they’re born (the smaller 10% of newborns) fetal growth ultrasound appears to be an effective tool for stratifying risk in the neonatal period.”

In a study led by Dr. Larkin of the division of maternal-fetal medicine in the department of obstetrics, gynecology, and reproductive sciences at the University of Pittsburgh, researchers retrospectively evaluated 125,069 nonanomalous singletons, delivered beyond 24 weeks at the university’s Magee-Womens Hospital between 1995 and 2011. Using Alexander’s nomogram, newborns were classified as appropriate for gestational age (AGA; weight at 10%-89% for GA) or SGA, which were categorized into three groups: no growth ultrasound (US) in third trimester; US in the third trimester but no diagnosis of fetal growth restriction (FGR); and diagnosed as FGR antenatally. An Apgar score of less than 4 at 5 minutes and neonatal mortality were adjusted for nulliparity, maternal education, tobacco use, race, marital status, and neonatal gender.

Of the 125,069 newborns evaluated, 10% (12,474) were SGA. Of these, 81% (10,140) did not have US after 24 weeks, a finding that surprised Dr. Larkin. Of those 2,334 SGA who had a growth US, 81% were not identified as FGR. Overall, only 3% (431) of SGA were detected antenatally as FGR. SGA newborns who were found to have an estimated fetal weight below the 10th percentile, and thus labeled as growth restricted, were at significantly increased risk of neonatal death (adjusted odds ratio, 15.39). On the other hand, newborns with birth weights below the 10th percentile who had an ultrasound before birth that found them to be appropriately grown were at no greater risk of neonatal death or low Apgar score than were newborns with normal birth weights (aOR, 1.19 and 1.34, respectively).

A key strength of the study, Dr. Larkin said, was its large sample size and the fact that US data was linked to neonatal outcomes. Limitations of the study include the absence of stillbirths in the cohort. “Also, the data used was not collected as part of a protocol, and all ultrasounds were obtained for clinical indications, which makes it difficult to compare outcomes in patient that had ultrasound and those that didn’t without bias,” he said.

Dr. Larkin reported having no relevant financial conflicts.

[email protected]

On Twitter @dougbrunk

SAN DIEGO – Fetal growth ultrasound does not identify fetuses destined to be small for gestational age at birth, but it does identify fetuses with increased risk of significant morbidity and mortality in the postnatal period.

Those are key findings from a large retrospective study presented by Dr. Jacob C. Larkin at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.

“Small for gestational age (SGA) newborns and fetuses are known to be at increased risk of stillbirth, neonatal morbidity and mortality, and adult disease,” Dr. Larkin said in an interview in advance of the meeting. “We show that ultrasound is not a good tool for identifying fetuses that are destined to be SGA at birth. However, for those babies that are SGA when they’re born (the smaller 10% of newborns) fetal growth ultrasound appears to be an effective tool for stratifying risk in the neonatal period.”

In a study led by Dr. Larkin of the division of maternal-fetal medicine in the department of obstetrics, gynecology, and reproductive sciences at the University of Pittsburgh, researchers retrospectively evaluated 125,069 nonanomalous singletons, delivered beyond 24 weeks at the university’s Magee-Womens Hospital between 1995 and 2011. Using Alexander’s nomogram, newborns were classified as appropriate for gestational age (AGA; weight at 10%-89% for GA) or SGA, which were categorized into three groups: no growth ultrasound (US) in third trimester; US in the third trimester but no diagnosis of fetal growth restriction (FGR); and diagnosed as FGR antenatally. An Apgar score of less than 4 at 5 minutes and neonatal mortality were adjusted for nulliparity, maternal education, tobacco use, race, marital status, and neonatal gender.

Of the 125,069 newborns evaluated, 10% (12,474) were SGA. Of these, 81% (10,140) did not have US after 24 weeks, a finding that surprised Dr. Larkin. Of those 2,334 SGA who had a growth US, 81% were not identified as FGR. Overall, only 3% (431) of SGA were detected antenatally as FGR. SGA newborns who were found to have an estimated fetal weight below the 10th percentile, and thus labeled as growth restricted, were at significantly increased risk of neonatal death (adjusted odds ratio, 15.39). On the other hand, newborns with birth weights below the 10th percentile who had an ultrasound before birth that found them to be appropriately grown were at no greater risk of neonatal death or low Apgar score than were newborns with normal birth weights (aOR, 1.19 and 1.34, respectively).

A key strength of the study, Dr. Larkin said, was its large sample size and the fact that US data was linked to neonatal outcomes. Limitations of the study include the absence of stillbirths in the cohort. “Also, the data used was not collected as part of a protocol, and all ultrasounds were obtained for clinical indications, which makes it difficult to compare outcomes in patient that had ultrasound and those that didn’t without bias,” he said.

Dr. Larkin reported having no relevant financial conflicts.

[email protected]

On Twitter @dougbrunk

SAN DIEGO – The combination of povidone-iodine with chlorhexidine with alcohol reduced the rate of surgical site infections by 83% in obese women undergoing nonemergency cesarean deliveries, according to the results of a large randomized trial.

But among women with a lower body mass index (BMI < 40 kg/m²), there were no overall differences in surgical site infection (SSI) rates using either povidone-iodine with alcohol, chlorhexidine with alcohol, or a combination of both agents for the preparation of cesarean delivery.

“Body surface area is greater in this subset of patients, so the volume of prep solution could have played a role,” Dr. Ivan Ngai, one of the researchers, said in an interview. “Also, it’s known that the organism that colonizes skin in obese persons, compared with nonobese persons, is different, especially increased colonization by fungus. We think that’s why the prep combination played a role, because iodine is better against fungi than chlorhexidine.”

In what Dr. Ngai said is among the largest studies of its kind for cesarean deliveries, he and his associates randomized 1,404 women at greater than 37 weeks’ gestational age undergoing a nonemergent cesarean section between January 2013 and July 2014 to receive one of three preparations: povidone-iodine plus alcohol (povidone group); chlorhexidine plus alcohol (chlorhexidine group), or povidone-iodine plus alcohol and chlorhexidine plus alcohol (combination group).

The primary outcome was the rate of SSI within 30 days of the cesarean delivery. The researchers used univariate and multivariable regression models to determine whether specific prep groups and other clinical variables were independent predictors of SSI. They presented their findings at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.

The mean age of the study participants was 30 years old. Dr. Ngai reported that 457 women in the povidone group completed follow-up, compared with 454 in the chlorhexidine group and 454 patients in the combination group.

There were 60 (4.3%) SSIs, with no differences between skin prep groups in demographics, medical disorders, indications for cesarean, operative time, blood loss, or SSI rates. The SSI rate of 4.3% “was much lower than the 9%-14% usually reported in cesarean birth,” Dr. Ngai said. “We think it’s lower because we did not include cases of emergent cesarean delivery.”

Multivariable analysis revealed that increasing maternal BMI, excessive blood loss (greater than 1,000 mL), and preeclampsia were independent predictors of SSIs. Women in the combination group who had a BMI of 40 kg/m² or greater had an 83% reduction in SSI (odds ratio, 0.17; P = .02).

While a formal cost analysis was not conducted, each surgical site infection averages about $3,500 extra health care dollars per event, said Dr. Ngai of the department of obstetrics and gynecology and women’s health at Albert Einstein College of Medicine, New York.

In the subgroup of patients with a BMI of 40 kg/m² or greater, the researchers estimated that they would have to use combination prep on about 12 patients to prevent one SSI infection. This compared with using chlorhexidine prep alone on 21 patients to prevent one SSI infection.

“In a nonobese population, the difference between povidone-iodine or chlorhexidine or combination of the two with alcohol makes no difference in preventing SSI,” Dr. Ngai concluded. “But in the obese population, the combination of povidone-iodine with chlorhexidine with alcohol plays a significant role in reducing the SSI rate.”

The researchers reported having no relevant financial conflicts.

[email protected]

On Twitter @dougbrunk

SAN DIEGO – The combination of povidone-iodine with chlorhexidine with alcohol reduced the rate of surgical site infections by 83% in obese women undergoing nonemergency cesarean deliveries, according to the results of a large randomized trial.

But among women with a lower body mass index (BMI < 40 kg/m²), there were no overall differences in surgical site infection (SSI) rates using either povidone-iodine with alcohol, chlorhexidine with alcohol, or a combination of both agents for the preparation of cesarean delivery.

“Body surface area is greater in this subset of patients, so the volume of prep solution could have played a role,” Dr. Ivan Ngai, one of the researchers, said in an interview. “Also, it’s known that the organism that colonizes skin in obese persons, compared with nonobese persons, is different, especially increased colonization by fungus. We think that’s why the prep combination played a role, because iodine is better against fungi than chlorhexidine.”

In what Dr. Ngai said is among the largest studies of its kind for cesarean deliveries, he and his associates randomized 1,404 women at greater than 37 weeks’ gestational age undergoing a nonemergent cesarean section between January 2013 and July 2014 to receive one of three preparations: povidone-iodine plus alcohol (povidone group); chlorhexidine plus alcohol (chlorhexidine group), or povidone-iodine plus alcohol and chlorhexidine plus alcohol (combination group).

The primary outcome was the rate of SSI within 30 days of the cesarean delivery. The researchers used univariate and multivariable regression models to determine whether specific prep groups and other clinical variables were independent predictors of SSI. They presented their findings at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.

The mean age of the study participants was 30 years old. Dr. Ngai reported that 457 women in the povidone group completed follow-up, compared with 454 in the chlorhexidine group and 454 patients in the combination group.

There were 60 (4.3%) SSIs, with no differences between skin prep groups in demographics, medical disorders, indications for cesarean, operative time, blood loss, or SSI rates. The SSI rate of 4.3% “was much lower than the 9%-14% usually reported in cesarean birth,” Dr. Ngai said. “We think it’s lower because we did not include cases of emergent cesarean delivery.”

Multivariable analysis revealed that increasing maternal BMI, excessive blood loss (greater than 1,000 mL), and preeclampsia were independent predictors of SSIs. Women in the combination group who had a BMI of 40 kg/m² or greater had an 83% reduction in SSI (odds ratio, 0.17; P = .02).

While a formal cost analysis was not conducted, each surgical site infection averages about $3,500 extra health care dollars per event, said Dr. Ngai of the department of obstetrics and gynecology and women’s health at Albert Einstein College of Medicine, New York.

In the subgroup of patients with a BMI of 40 kg/m² or greater, the researchers estimated that they would have to use combination prep on about 12 patients to prevent one SSI infection. This compared with using chlorhexidine prep alone on 21 patients to prevent one SSI infection.

“In a nonobese population, the difference between povidone-iodine or chlorhexidine or combination of the two with alcohol makes no difference in preventing SSI,” Dr. Ngai concluded. “But in the obese population, the combination of povidone-iodine with chlorhexidine with alcohol plays a significant role in reducing the SSI rate.”

The researchers reported having no relevant financial conflicts.

[email protected]

On Twitter @dougbrunk

SAN DIEGO – The combination of povidone-iodine with chlorhexidine with alcohol reduced the rate of surgical site infections by 83% in obese women undergoing nonemergency cesarean deliveries, according to the results of a large randomized trial.

But among women with a lower body mass index (BMI < 40 kg/m²), there were no overall differences in surgical site infection (SSI) rates using either povidone-iodine with alcohol, chlorhexidine with alcohol, or a combination of both agents for the preparation of cesarean delivery.

“Body surface area is greater in this subset of patients, so the volume of prep solution could have played a role,” Dr. Ivan Ngai, one of the researchers, said in an interview. “Also, it’s known that the organism that colonizes skin in obese persons, compared with nonobese persons, is different, especially increased colonization by fungus. We think that’s why the prep combination played a role, because iodine is better against fungi than chlorhexidine.”

In what Dr. Ngai said is among the largest studies of its kind for cesarean deliveries, he and his associates randomized 1,404 women at greater than 37 weeks’ gestational age undergoing a nonemergent cesarean section between January 2013 and July 2014 to receive one of three preparations: povidone-iodine plus alcohol (povidone group); chlorhexidine plus alcohol (chlorhexidine group), or povidone-iodine plus alcohol and chlorhexidine plus alcohol (combination group).

The primary outcome was the rate of SSI within 30 days of the cesarean delivery. The researchers used univariate and multivariable regression models to determine whether specific prep groups and other clinical variables were independent predictors of SSI. They presented their findings at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.

The mean age of the study participants was 30 years old. Dr. Ngai reported that 457 women in the povidone group completed follow-up, compared with 454 in the chlorhexidine group and 454 patients in the combination group.

There were 60 (4.3%) SSIs, with no differences between skin prep groups in demographics, medical disorders, indications for cesarean, operative time, blood loss, or SSI rates. The SSI rate of 4.3% “was much lower than the 9%-14% usually reported in cesarean birth,” Dr. Ngai said. “We think it’s lower because we did not include cases of emergent cesarean delivery.”

Multivariable analysis revealed that increasing maternal BMI, excessive blood loss (greater than 1,000 mL), and preeclampsia were independent predictors of SSIs. Women in the combination group who had a BMI of 40 kg/m² or greater had an 83% reduction in SSI (odds ratio, 0.17; P = .02).

While a formal cost analysis was not conducted, each surgical site infection averages about $3,500 extra health care dollars per event, said Dr. Ngai of the department of obstetrics and gynecology and women’s health at Albert Einstein College of Medicine, New York.

In the subgroup of patients with a BMI of 40 kg/m² or greater, the researchers estimated that they would have to use combination prep on about 12 patients to prevent one SSI infection. This compared with using chlorhexidine prep alone on 21 patients to prevent one SSI infection.

“In a nonobese population, the difference between povidone-iodine or chlorhexidine or combination of the two with alcohol makes no difference in preventing SSI,” Dr. Ngai concluded. “But in the obese population, the combination of povidone-iodine with chlorhexidine with alcohol plays a significant role in reducing the SSI rate.”

The researchers reported having no relevant financial conflicts.

[email protected]

On Twitter @dougbrunk

SAN DIEGO – In women with an unfavorable cervix at term, induction of labor with oral misoprostol was comparable to the Foley catheter in terms of effectiveness and safety, results from a multicenter Dutch study demonstrated.

Between 20% and 30% of pregnant women are induced in Western countries, and around 10% in the developing world, Dr. Mieke L.G. ten Eikelder said at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.

“When cervical ripening is necessary, the safest method is still unclear. Current guidelines suggest prostaglandin E analogues and [note that] the Foley catheter is a reasonable and effective alternative.”

Doug Brunk/Frontline Medical News

In 2011, researchers published results from the PROBAAT trial, which found that induction with a Foley catheter was just as effective as prostaglandins, with less neonatal and maternal morbidity (Lancet 2011;378:2095-2103). For the current noninferiority trial, known as PROBAAT-II, the researchers set out to study the safety and effectiveness of labor induction using oral misoprostol, compared with transcervical catheter in term pregnant women with an unfavorable cervix.

Between July 2012 and October 2013, Dr. ten Eikelder of the department of obstetrics and gynecology at Leiden University Medical Center, the Netherlands, and her associates in 28 other Dutch hospitals, enrolled 1,845 women with a term singleton pregnancy in cephalic presentation, intact membranes, an unfavorable cervix, without prior cesarean section.

The researchers randomly assigned 924 women to 50 mcg oral misoprostol administered every 4 hours (for a maximum of three times in a 24-hour period) and 921 women to 30 mL Foley catheter. The primary outcome was a composite of asphyxia (an arterial umbilical cord pH of 7.05 or lower, and/or a 5-minute Apgar score of less than 7) and/or postpartum hemorrhage (greater than or equal to 1,000 mL). Secondary outcomes were maternal and neonatal morbidity and time from intervention to birth. Analyses were done by intention to treat.

The primary composite outcome occurred in 12% of patients in both the oral misoprostol and Foley catheter groups, for a risk ratio of 1.1, Dr. ten Eikelder reported. Spontaneous vaginal delivery did not differ between the two groups (70% vs. 70%; relative risk 0.99), nor did the rates of delivery by cesarean section (17% vs. 20%; RR 0.84) or by vaginal instrument (14% vs. 10%; RR 1.4).

However, cesarean section for failure to progress occurred less frequently in the oral misoprostol group, compared with the Foley catheter group (6% vs. 11%, RR 0.58). The time from the start of induction to delivery was comparable between the two groups and there were no cases of serious maternal or neonatal morbidity.

“In women with an unfavorable cervix at term, induction of labor with oral misoprostol and Foley catheter are comparable in terms of safety and effectiveness,” Dr. ten Eikelder said.

The study was funded by Fonds NutsOhra, a Dutch health research and development organization. Dr. ten Eikelder reported that she and the other researchers had no relevant financial disclosures.

[email protected]

On Twitter @dougbrunk

SAN DIEGO – In women with an unfavorable cervix at term, induction of labor with oral misoprostol was comparable to the Foley catheter in terms of effectiveness and safety, results from a multicenter Dutch study demonstrated.

Between 20% and 30% of pregnant women are induced in Western countries, and around 10% in the developing world, Dr. Mieke L.G. ten Eikelder said at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.

“When cervical ripening is necessary, the safest method is still unclear. Current guidelines suggest prostaglandin E analogues and [note that] the Foley catheter is a reasonable and effective alternative.”

Doug Brunk/Frontline Medical News

In 2011, researchers published results from the PROBAAT trial, which found that induction with a Foley catheter was just as effective as prostaglandins, with less neonatal and maternal morbidity (Lancet 2011;378:2095-2103). For the current noninferiority trial, known as PROBAAT-II, the researchers set out to study the safety and effectiveness of labor induction using oral misoprostol, compared with transcervical catheter in term pregnant women with an unfavorable cervix.

Between July 2012 and October 2013, Dr. ten Eikelder of the department of obstetrics and gynecology at Leiden University Medical Center, the Netherlands, and her associates in 28 other Dutch hospitals, enrolled 1,845 women with a term singleton pregnancy in cephalic presentation, intact membranes, an unfavorable cervix, without prior cesarean section.

The researchers randomly assigned 924 women to 50 mcg oral misoprostol administered every 4 hours (for a maximum of three times in a 24-hour period) and 921 women to 30 mL Foley catheter. The primary outcome was a composite of asphyxia (an arterial umbilical cord pH of 7.05 or lower, and/or a 5-minute Apgar score of less than 7) and/or postpartum hemorrhage (greater than or equal to 1,000 mL). Secondary outcomes were maternal and neonatal morbidity and time from intervention to birth. Analyses were done by intention to treat.

The primary composite outcome occurred in 12% of patients in both the oral misoprostol and Foley catheter groups, for a risk ratio of 1.1, Dr. ten Eikelder reported. Spontaneous vaginal delivery did not differ between the two groups (70% vs. 70%; relative risk 0.99), nor did the rates of delivery by cesarean section (17% vs. 20%; RR 0.84) or by vaginal instrument (14% vs. 10%; RR 1.4).

However, cesarean section for failure to progress occurred less frequently in the oral misoprostol group, compared with the Foley catheter group (6% vs. 11%, RR 0.58). The time from the start of induction to delivery was comparable between the two groups and there were no cases of serious maternal or neonatal morbidity.

“In women with an unfavorable cervix at term, induction of labor with oral misoprostol and Foley catheter are comparable in terms of safety and effectiveness,” Dr. ten Eikelder said.

The study was funded by Fonds NutsOhra, a Dutch health research and development organization. Dr. ten Eikelder reported that she and the other researchers had no relevant financial disclosures.

[email protected]

On Twitter @dougbrunk

SAN DIEGO – In women with an unfavorable cervix at term, induction of labor with oral misoprostol was comparable to the Foley catheter in terms of effectiveness and safety, results from a multicenter Dutch study demonstrated.

Between 20% and 30% of pregnant women are induced in Western countries, and around 10% in the developing world, Dr. Mieke L.G. ten Eikelder said at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.

“When cervical ripening is necessary, the safest method is still unclear. Current guidelines suggest prostaglandin E analogues and [note that] the Foley catheter is a reasonable and effective alternative.”

Doug Brunk/Frontline Medical News

In 2011, researchers published results from the PROBAAT trial, which found that induction with a Foley catheter was just as effective as prostaglandins, with less neonatal and maternal morbidity (Lancet 2011;378:2095-2103). For the current noninferiority trial, known as PROBAAT-II, the researchers set out to study the safety and effectiveness of labor induction using oral misoprostol, compared with transcervical catheter in term pregnant women with an unfavorable cervix.

Between July 2012 and October 2013, Dr. ten Eikelder of the department of obstetrics and gynecology at Leiden University Medical Center, the Netherlands, and her associates in 28 other Dutch hospitals, enrolled 1,845 women with a term singleton pregnancy in cephalic presentation, intact membranes, an unfavorable cervix, without prior cesarean section.

The researchers randomly assigned 924 women to 50 mcg oral misoprostol administered every 4 hours (for a maximum of three times in a 24-hour period) and 921 women to 30 mL Foley catheter. The primary outcome was a composite of asphyxia (an arterial umbilical cord pH of 7.05 or lower, and/or a 5-minute Apgar score of less than 7) and/or postpartum hemorrhage (greater than or equal to 1,000 mL). Secondary outcomes were maternal and neonatal morbidity and time from intervention to birth. Analyses were done by intention to treat.

The primary composite outcome occurred in 12% of patients in both the oral misoprostol and Foley catheter groups, for a risk ratio of 1.1, Dr. ten Eikelder reported. Spontaneous vaginal delivery did not differ between the two groups (70% vs. 70%; relative risk 0.99), nor did the rates of delivery by cesarean section (17% vs. 20%; RR 0.84) or by vaginal instrument (14% vs. 10%; RR 1.4).

However, cesarean section for failure to progress occurred less frequently in the oral misoprostol group, compared with the Foley catheter group (6% vs. 11%, RR 0.58). The time from the start of induction to delivery was comparable between the two groups and there were no cases of serious maternal or neonatal morbidity.

“In women with an unfavorable cervix at term, induction of labor with oral misoprostol and Foley catheter are comparable in terms of safety and effectiveness,” Dr. ten Eikelder said.

The study was funded by Fonds NutsOhra, a Dutch health research and development organization. Dr. ten Eikelder reported that she and the other researchers had no relevant financial disclosures.

[email protected]

On Twitter @dougbrunk