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Aspirin reduces recurrent preeclampsia in real-world study
LAS VEGAS – Using low-dose aspirin during pregnancy significantly reduced the risk of recurrent preeclampsia, according to results of a new study.
“The net benefit of aspirin is substantial,” Mary Catherine Tolcher, MD, the study’s lead author said. “The number needed to treat to prevent one case of recurrent preeclampsia is six... The cost of daily low-dose aspirin for the duration of one pregnancy is about $4.00. Comparatively, the cost to prevent one case of eclampsia is approximately $21,000.”
Dr. Tolcher, a postdoctorate fellow in ob.gyn. at Baylor College of Medicine, Houston, and her colleagues found a total of 417 at-risk women in the institution’s labor and delivery database during the August 2011–June 2016 study period; 284 were identified before the guidelines were implemented in 2014, while 133 women were identified as high-risk after guideline implementation.
While nearly one-third (32.4%) of women with a history of preeclampsia had a recurrence in the before group, the recurrence rate fell to 16.5% in the after group, who had been instructed to take low-dose aspirin in accordance with the guidelines. When the investigators calculated the fully adjusted odds ratio for recurrent preeclampsia, they found a reduction of about 30% in recurrent preeclampsia [aOR, 0.71; 95% confidence interval, 0.52-0.95].
“This decrease is greater than the approximately 10 to 15 percent reduction that has been previously reported in clinical trials, and different from the meta-analysis that prompted the national recommendations,” Dr. Tolcher said at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.
She and her colleagues hypothesize that the greater effect size may be attributable to limiting the study population to the higher-risk group of women with a history of preeclampsia. Alternatively, she said, aspirin’s pharmacodynamics can differ by race, so racial differences between study populations may also be at play.
One of the causative mechanisms for preeclampsia is thought to be impaired trophoblastic remodeling that impedes development of the low-resistance vascular system of the maternal-fetal unit. “The resulting pathophysiology is multisystemic and includes vascular and endothelial dysfunction, placental ischemia, and an inflammatory and stress response,” Dr. Tolcher said. Overproduction of thromboxanes, she said, plays a role in this process. Aspirin’s inhibition of cyclooxygenase-2 (COX-2) enzymes and thromboxanes is thought to mitigate the vasoconstriction and endothelial dysfunction seen in preeclampsia, she said.
A secondary outcome measure in the study was use of magnesium sulfate, and after guideline implementation “there was a trend toward reduced use of magnesium sulfate, which we reserved for preeclampsia with severe features,” Dr. Tolcher said.
There was no difference in the incidence of preterm deliveries, another secondary outcome measure, after the aspirin guidelines were implemented.
There were some differences in characteristics between the before and after groups: the ratio of Hispanic women with preeclampsia was significantly lower in the after group (P less than .0001). The distribution of method of payment shifted, with more private pay patients, fewer Children’s Health Insurance Program (CHIP) patients, and fewer “other” payment method patients in the after group. Though Dr. Tolcher reported that type 1 diabetes was seen more often in the after group, the rates of any kind of pre-pregnancy diabetes were similar between the groups (6.33% before; 4.26% after).
Potentially confounding variables were controlled by means of logistic regression analysis. Women with multiple gestations were excluded, and only the first pregnancy after a previous episode of preeclampsia was studied.
Otherwise, demographics and other patient characteristics – including rates of chronic hypertension, were similar between the before and after groups. About a quarter of the patients in each group had a history of preterm delivery, and the median age at delivery for both was 38 years.
Within the total group that had recurrent preeclampsia, “maternal age greater than 35, type 2 diabetes, chronic hypertension, and a history of preterm preeclampsia were significantly associated with recurrent preeclampsia,” Dr. Tolcher said.
Study limitations included the retrospective nature, the inclusion of only women who had a prior history of preeclampsia, and the investigators’ inability to determine whether patients were adherent to recommendations for aspirin use. However, the study represents actual clinical use, Dr. Tolcher said, and addresses a real need. “Preeclampsia is responsible for 75,000 maternal deaths annually, and accounts for 15% of the preterm births in the U.S.,” she said.
Dr. Tolcher reported having no relevant financial disclosures.
[email protected]
On Twitter @karioakes
LAS VEGAS – Using low-dose aspirin during pregnancy significantly reduced the risk of recurrent preeclampsia, according to results of a new study.
“The net benefit of aspirin is substantial,” Mary Catherine Tolcher, MD, the study’s lead author said. “The number needed to treat to prevent one case of recurrent preeclampsia is six... The cost of daily low-dose aspirin for the duration of one pregnancy is about $4.00. Comparatively, the cost to prevent one case of eclampsia is approximately $21,000.”
Dr. Tolcher, a postdoctorate fellow in ob.gyn. at Baylor College of Medicine, Houston, and her colleagues found a total of 417 at-risk women in the institution’s labor and delivery database during the August 2011–June 2016 study period; 284 were identified before the guidelines were implemented in 2014, while 133 women were identified as high-risk after guideline implementation.
While nearly one-third (32.4%) of women with a history of preeclampsia had a recurrence in the before group, the recurrence rate fell to 16.5% in the after group, who had been instructed to take low-dose aspirin in accordance with the guidelines. When the investigators calculated the fully adjusted odds ratio for recurrent preeclampsia, they found a reduction of about 30% in recurrent preeclampsia [aOR, 0.71; 95% confidence interval, 0.52-0.95].
“This decrease is greater than the approximately 10 to 15 percent reduction that has been previously reported in clinical trials, and different from the meta-analysis that prompted the national recommendations,” Dr. Tolcher said at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.
She and her colleagues hypothesize that the greater effect size may be attributable to limiting the study population to the higher-risk group of women with a history of preeclampsia. Alternatively, she said, aspirin’s pharmacodynamics can differ by race, so racial differences between study populations may also be at play.
One of the causative mechanisms for preeclampsia is thought to be impaired trophoblastic remodeling that impedes development of the low-resistance vascular system of the maternal-fetal unit. “The resulting pathophysiology is multisystemic and includes vascular and endothelial dysfunction, placental ischemia, and an inflammatory and stress response,” Dr. Tolcher said. Overproduction of thromboxanes, she said, plays a role in this process. Aspirin’s inhibition of cyclooxygenase-2 (COX-2) enzymes and thromboxanes is thought to mitigate the vasoconstriction and endothelial dysfunction seen in preeclampsia, she said.
A secondary outcome measure in the study was use of magnesium sulfate, and after guideline implementation “there was a trend toward reduced use of magnesium sulfate, which we reserved for preeclampsia with severe features,” Dr. Tolcher said.
There was no difference in the incidence of preterm deliveries, another secondary outcome measure, after the aspirin guidelines were implemented.
There were some differences in characteristics between the before and after groups: the ratio of Hispanic women with preeclampsia was significantly lower in the after group (P less than .0001). The distribution of method of payment shifted, with more private pay patients, fewer Children’s Health Insurance Program (CHIP) patients, and fewer “other” payment method patients in the after group. Though Dr. Tolcher reported that type 1 diabetes was seen more often in the after group, the rates of any kind of pre-pregnancy diabetes were similar between the groups (6.33% before; 4.26% after).
Potentially confounding variables were controlled by means of logistic regression analysis. Women with multiple gestations were excluded, and only the first pregnancy after a previous episode of preeclampsia was studied.
Otherwise, demographics and other patient characteristics – including rates of chronic hypertension, were similar between the before and after groups. About a quarter of the patients in each group had a history of preterm delivery, and the median age at delivery for both was 38 years.
Within the total group that had recurrent preeclampsia, “maternal age greater than 35, type 2 diabetes, chronic hypertension, and a history of preterm preeclampsia were significantly associated with recurrent preeclampsia,” Dr. Tolcher said.
Study limitations included the retrospective nature, the inclusion of only women who had a prior history of preeclampsia, and the investigators’ inability to determine whether patients were adherent to recommendations for aspirin use. However, the study represents actual clinical use, Dr. Tolcher said, and addresses a real need. “Preeclampsia is responsible for 75,000 maternal deaths annually, and accounts for 15% of the preterm births in the U.S.,” she said.
Dr. Tolcher reported having no relevant financial disclosures.
[email protected]
On Twitter @karioakes
LAS VEGAS – Using low-dose aspirin during pregnancy significantly reduced the risk of recurrent preeclampsia, according to results of a new study.
“The net benefit of aspirin is substantial,” Mary Catherine Tolcher, MD, the study’s lead author said. “The number needed to treat to prevent one case of recurrent preeclampsia is six... The cost of daily low-dose aspirin for the duration of one pregnancy is about $4.00. Comparatively, the cost to prevent one case of eclampsia is approximately $21,000.”
Dr. Tolcher, a postdoctorate fellow in ob.gyn. at Baylor College of Medicine, Houston, and her colleagues found a total of 417 at-risk women in the institution’s labor and delivery database during the August 2011–June 2016 study period; 284 were identified before the guidelines were implemented in 2014, while 133 women were identified as high-risk after guideline implementation.
While nearly one-third (32.4%) of women with a history of preeclampsia had a recurrence in the before group, the recurrence rate fell to 16.5% in the after group, who had been instructed to take low-dose aspirin in accordance with the guidelines. When the investigators calculated the fully adjusted odds ratio for recurrent preeclampsia, they found a reduction of about 30% in recurrent preeclampsia [aOR, 0.71; 95% confidence interval, 0.52-0.95].
“This decrease is greater than the approximately 10 to 15 percent reduction that has been previously reported in clinical trials, and different from the meta-analysis that prompted the national recommendations,” Dr. Tolcher said at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.
She and her colleagues hypothesize that the greater effect size may be attributable to limiting the study population to the higher-risk group of women with a history of preeclampsia. Alternatively, she said, aspirin’s pharmacodynamics can differ by race, so racial differences between study populations may also be at play.
One of the causative mechanisms for preeclampsia is thought to be impaired trophoblastic remodeling that impedes development of the low-resistance vascular system of the maternal-fetal unit. “The resulting pathophysiology is multisystemic and includes vascular and endothelial dysfunction, placental ischemia, and an inflammatory and stress response,” Dr. Tolcher said. Overproduction of thromboxanes, she said, plays a role in this process. Aspirin’s inhibition of cyclooxygenase-2 (COX-2) enzymes and thromboxanes is thought to mitigate the vasoconstriction and endothelial dysfunction seen in preeclampsia, she said.
A secondary outcome measure in the study was use of magnesium sulfate, and after guideline implementation “there was a trend toward reduced use of magnesium sulfate, which we reserved for preeclampsia with severe features,” Dr. Tolcher said.
There was no difference in the incidence of preterm deliveries, another secondary outcome measure, after the aspirin guidelines were implemented.
There were some differences in characteristics between the before and after groups: the ratio of Hispanic women with preeclampsia was significantly lower in the after group (P less than .0001). The distribution of method of payment shifted, with more private pay patients, fewer Children’s Health Insurance Program (CHIP) patients, and fewer “other” payment method patients in the after group. Though Dr. Tolcher reported that type 1 diabetes was seen more often in the after group, the rates of any kind of pre-pregnancy diabetes were similar between the groups (6.33% before; 4.26% after).
Potentially confounding variables were controlled by means of logistic regression analysis. Women with multiple gestations were excluded, and only the first pregnancy after a previous episode of preeclampsia was studied.
Otherwise, demographics and other patient characteristics – including rates of chronic hypertension, were similar between the before and after groups. About a quarter of the patients in each group had a history of preterm delivery, and the median age at delivery for both was 38 years.
Within the total group that had recurrent preeclampsia, “maternal age greater than 35, type 2 diabetes, chronic hypertension, and a history of preterm preeclampsia were significantly associated with recurrent preeclampsia,” Dr. Tolcher said.
Study limitations included the retrospective nature, the inclusion of only women who had a prior history of preeclampsia, and the investigators’ inability to determine whether patients were adherent to recommendations for aspirin use. However, the study represents actual clinical use, Dr. Tolcher said, and addresses a real need. “Preeclampsia is responsible for 75,000 maternal deaths annually, and accounts for 15% of the preterm births in the U.S.,” she said.
Dr. Tolcher reported having no relevant financial disclosures.
[email protected]
On Twitter @karioakes
AT THE PREGNANCY MEETING
Key clinical point:
Major finding: The adjusted odds ratio for recurrent preeclampsia was 0.71 after implementing U.S. Preventive Services Task Force (USPSTF) guidelines for aspirin administration.
Data source: Retrospective cohort study of 17,256 deliveries at a single academic medical center before and after implementation of USPSTF aspirin guidelines, with 417 cases of recurrent preeclampsia identified.
Disclosures: Dr. Tolcher reported having no relevant financial disclosures.
Toddlers’ neurodevelopmental deficits linked with maternal diabetes
LAS VEGAS – Children born to obese women with insulin resistance during pregnancy showed significantly impaired neurodevelopment at 2 years of age, compared with children born to obese mothers without insulin resistance in a prospective observational study with 75 pregnant women.
The neurodevelopmental deficits were specific for the domains of motor function and attention, and the deficits correlated with several markers of abnormal glucose and fat metabolism in the insulin-resistant women, Alison G. Cahill, MD, said at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.
“The differences in neurodevelopment appear to not be global but instead specifically affect domains of motor development and attention,” said Dr. Cahill, chief of maternal fetal medicine at Washington University in St. Louis. “These findings are consistent with results from animal studies that suggest certain brain regions are more sensitive than others to metabolic abnormalities” while in utero.
“These are among the first data in humans to characterize the impact of metabolic abnormalities on brain development,” she added.
Dr. Cahill said that results from the lean mothers uniformly matched those from the obese mothers without insulin resistance, and so for brevity she only reported results from the obese control group.
Average gestational age at birth was 37 weeks in the insulin-resistant mothers and 38.7 weeks among the obese mothers without insulin resistance, a significant difference. Birth weight averaged 3,617 g in the mothers with insulin resistance and 3,373 g in the mothers without insulin resistance, a difference that was not statistically significant.
Dr. Cahill and her associates assessed the 2-year-olds with a battery of behavioral and functional assessments. They measured motor function, cognition, and language with the Bayley Scales of Infant and Toddler Development, prespecified as the study’s primary endpoint. They also applied the Modified Checklist for Autism in Toddlers (M-CHAT), as well as the Infant-Toddler Social and Emotional Assessment (ITSEA) to assess competence, externalizing, internalizing, and dysregulation.
The results of these analyses showed statistically significant deficits for the motor composite score on the Bayley assessment and for the competence component of the ITSEA assessment, Dr. Cahill reported. The average composite Bayley motor score was 88 in children from mothers with insulin resistance and 98 in the control children, a statistically significant difference.
Further analyses showed that the motor deficit was primarily in fine motor function, and that motor scores were depressed throughout the entire cohort of children born to mothers with insulin resistance.
Depressed competence scores on the ITSEA assessment reflect attention abnormalities, she explained.
A final analysis examined the correlation between the motor deficits identified and various metabolic tests of fat, glucose, and protein metabolism run on the enrolled mothers during the last weeks of gestation. This showed significant links between depressed motor development and maternal lipolytic rate, plasma free fatty acids, and hepatic glucose output.
This finding “suggests an association between abnormal lipid and glucose metabolism in mothers and aspects of neurodevelopment” in their children, Dr. Cahill said.
Dr. Cahill had no disclosures.
[email protected] On Twitter @mitchelzoler
LAS VEGAS – Children born to obese women with insulin resistance during pregnancy showed significantly impaired neurodevelopment at 2 years of age, compared with children born to obese mothers without insulin resistance in a prospective observational study with 75 pregnant women.
The neurodevelopmental deficits were specific for the domains of motor function and attention, and the deficits correlated with several markers of abnormal glucose and fat metabolism in the insulin-resistant women, Alison G. Cahill, MD, said at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.
“The differences in neurodevelopment appear to not be global but instead specifically affect domains of motor development and attention,” said Dr. Cahill, chief of maternal fetal medicine at Washington University in St. Louis. “These findings are consistent with results from animal studies that suggest certain brain regions are more sensitive than others to metabolic abnormalities” while in utero.
“These are among the first data in humans to characterize the impact of metabolic abnormalities on brain development,” she added.
Dr. Cahill said that results from the lean mothers uniformly matched those from the obese mothers without insulin resistance, and so for brevity she only reported results from the obese control group.
Average gestational age at birth was 37 weeks in the insulin-resistant mothers and 38.7 weeks among the obese mothers without insulin resistance, a significant difference. Birth weight averaged 3,617 g in the mothers with insulin resistance and 3,373 g in the mothers without insulin resistance, a difference that was not statistically significant.
Dr. Cahill and her associates assessed the 2-year-olds with a battery of behavioral and functional assessments. They measured motor function, cognition, and language with the Bayley Scales of Infant and Toddler Development, prespecified as the study’s primary endpoint. They also applied the Modified Checklist for Autism in Toddlers (M-CHAT), as well as the Infant-Toddler Social and Emotional Assessment (ITSEA) to assess competence, externalizing, internalizing, and dysregulation.
The results of these analyses showed statistically significant deficits for the motor composite score on the Bayley assessment and for the competence component of the ITSEA assessment, Dr. Cahill reported. The average composite Bayley motor score was 88 in children from mothers with insulin resistance and 98 in the control children, a statistically significant difference.
Further analyses showed that the motor deficit was primarily in fine motor function, and that motor scores were depressed throughout the entire cohort of children born to mothers with insulin resistance.
Depressed competence scores on the ITSEA assessment reflect attention abnormalities, she explained.
A final analysis examined the correlation between the motor deficits identified and various metabolic tests of fat, glucose, and protein metabolism run on the enrolled mothers during the last weeks of gestation. This showed significant links between depressed motor development and maternal lipolytic rate, plasma free fatty acids, and hepatic glucose output.
This finding “suggests an association between abnormal lipid and glucose metabolism in mothers and aspects of neurodevelopment” in their children, Dr. Cahill said.
Dr. Cahill had no disclosures.
[email protected] On Twitter @mitchelzoler
LAS VEGAS – Children born to obese women with insulin resistance during pregnancy showed significantly impaired neurodevelopment at 2 years of age, compared with children born to obese mothers without insulin resistance in a prospective observational study with 75 pregnant women.
The neurodevelopmental deficits were specific for the domains of motor function and attention, and the deficits correlated with several markers of abnormal glucose and fat metabolism in the insulin-resistant women, Alison G. Cahill, MD, said at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.
“The differences in neurodevelopment appear to not be global but instead specifically affect domains of motor development and attention,” said Dr. Cahill, chief of maternal fetal medicine at Washington University in St. Louis. “These findings are consistent with results from animal studies that suggest certain brain regions are more sensitive than others to metabolic abnormalities” while in utero.
“These are among the first data in humans to characterize the impact of metabolic abnormalities on brain development,” she added.
Dr. Cahill said that results from the lean mothers uniformly matched those from the obese mothers without insulin resistance, and so for brevity she only reported results from the obese control group.
Average gestational age at birth was 37 weeks in the insulin-resistant mothers and 38.7 weeks among the obese mothers without insulin resistance, a significant difference. Birth weight averaged 3,617 g in the mothers with insulin resistance and 3,373 g in the mothers without insulin resistance, a difference that was not statistically significant.
Dr. Cahill and her associates assessed the 2-year-olds with a battery of behavioral and functional assessments. They measured motor function, cognition, and language with the Bayley Scales of Infant and Toddler Development, prespecified as the study’s primary endpoint. They also applied the Modified Checklist for Autism in Toddlers (M-CHAT), as well as the Infant-Toddler Social and Emotional Assessment (ITSEA) to assess competence, externalizing, internalizing, and dysregulation.
The results of these analyses showed statistically significant deficits for the motor composite score on the Bayley assessment and for the competence component of the ITSEA assessment, Dr. Cahill reported. The average composite Bayley motor score was 88 in children from mothers with insulin resistance and 98 in the control children, a statistically significant difference.
Further analyses showed that the motor deficit was primarily in fine motor function, and that motor scores were depressed throughout the entire cohort of children born to mothers with insulin resistance.
Depressed competence scores on the ITSEA assessment reflect attention abnormalities, she explained.
A final analysis examined the correlation between the motor deficits identified and various metabolic tests of fat, glucose, and protein metabolism run on the enrolled mothers during the last weeks of gestation. This showed significant links between depressed motor development and maternal lipolytic rate, plasma free fatty acids, and hepatic glucose output.
This finding “suggests an association between abnormal lipid and glucose metabolism in mothers and aspects of neurodevelopment” in their children, Dr. Cahill said.
Dr. Cahill had no disclosures.
[email protected] On Twitter @mitchelzoler
Key clinical point:
Major finding: The Bayley motor scale score averaged 88 in children from insulin-resistant mothers and 98 when no insulin resistance existed.
Data source: Prospective, single-center observational study with 75 pregnant women.
Disclosures: Dr. Cahill had no disclosures.
Capping gestational weight gain didn’t deliver better pregnancy outcomes
LAS VEGAS – Two similar behavioral interventions during pregnancy both succeeded in capping gestational weight gain in two independent randomized trials, but neither intervention produced improvements in obstetrical outcomes.
Results from several prior studies linked excess gestational weight gain (GWG) with adverse outcomes, including gestational diabetes, hypertension, macrosomia, and cesarean delivery. But none of the rates of these complications fell among women in the study groups that received intervention and had reduced GWG, compared with controls.
“The clinical significance of the difference in GWG we saw is not known,” said Alison G. Cahill, MD, who presented one of the two reports at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine. In the study she led, women who received a behavioral intervention averaged about 3.5 pounds less GWG through 36 weeks of pregnancy.
“Our findings call into question the association between GWG and adverse pregnancy outcomes,” said Alan M. Peaceman, MD, who presented the second study, in which women receiving the behavioral intervention averaged 4 pounds less in GWG, compared with control women.
Dr. Peaceman reported results from the Maternal Offspring Metabolics: Family Intervention Trial (MOMFIT), a trial run at Northwestern University in Chicago that randomized 263 pregnant women. The women had to be at less than 16 weeks singleton gestation with a body mass index of 25-40 kg/m2, no pregestational diabetes, and a first trimester weight gain of no more than 15 pounds.
The researchers randomized participants to receive either an intervention that included an individualized diet, Internet-based self monitoring of diet adherence, recommendations on physical activity, and weekly coaching calls and opportunities for group meetings, webinars and podcasts; or a control regimen of electronic newsletters and website access that dispensed pregnancy information without mentioning diet. The participants averaged 33 years old, their average body mass index was 31 kg/m2, and about 55% were obese, with a body mass index of 30 kg/m2 or greater.
The study’s primary outcome was weight gain from enrollment through 36 weeks of gestation, which averaged 19.1 pounds among women who received the intervention and 23.7 pounds among controls, an average 4.6 pounds difference that was statistically significant, Dr. Peaceman reported.
The percentage of patients exceeding the GWG recommendations made in 2009 by the Institute of Medicine (IOM) was 68% in the intervention group and 86% among the controls, an 18 percentage-point difference that was statistically significant.
Despite these differences, the two groups showed very similar rates for the incidence of gestational diabetes, preeclampsia or hypertension, birth weight above 4,000 g, and gestational age at delivery (39 weeks on average for both subgroups).
The rate of cesarean delivery (40%) was higher in the women who received the intervention and had less GWG, compared with 27% among the control women. Despite meeting the statistical test for significance, it is most likely a chance result, said Dr. Peaceman, chief of maternal fetal medicine at Northwestern.
He stressed that while no benefit from reduced GWG has yet been found in the MOMFIT results, additional endpoints are under study, such as neonatal metabolism, infant metabolism at 1 year, and maternal weight retention.
Dr. Cahill reported very similar findings from her study, run as part of the Weight Management in Obese Pregnant Underserved African American Women (LIFE-Moms) trial. She enrolled 267 socioeconomically disadvantaged African American women with singleton, normal-anatomy pregnancies who presented for prenatal care at her clinic at less than 16 weeks gestation and were overweight or obese.
The study randomized these women to receive either an exercise and lifestyle intervention along with home visits from the Parents as Teachers program, or just home visits without the exercise and lifestyle component. The enrolled women averaged about 25 years old, and their average body mass index was about 32 kg/m2, with two-thirds of patients being obese.
The study’s primary endpoint, the percentage of women who exceeded the IOM’s 2009 recommendations on GWG, was 37% among women who received the exercise and lifestyle intervention and 46% among those who did not, a difference that was not statistically significant in the full intention-to-treat analysis, Dr. Cahill reported.
A subgroup analysis showed that most of the benefit focused in obese participants, where 34% of women who received the extra intervention had a GWG greater than the IOM recommendation, compared with a 49% rate among controls, a 15 percentage-point difference that fell just short of statistical significance.
For the secondary endpoint of average amount of GWG, women in the intervention arm had a 8.05 kg average, compared with 9.64 kg among the controls, an average GWG reduction of 1.59 kg (3.5 pounds) in the intervention arm. This difference was statistically significant, said Dr. Cahill, chief of maternal fetal medicine at Washington University in St. Louis.
Dr. Cahill also ran a modified intention-to-treat analysis that excluded women with missing GWG data at term, those with fetal death or miscarriage, and one women mistakenly enrolled who was of normal weight. Among the remaining 240 women, the impact of the exercise and lifestyle intervention was even more pronounced, resulting in an average reduction in GWG of 4 pounds and a 12 percentage-point reduction in women exceeding the IOM’s GWG recommendations.
Despite these favorable effects on GWG, the two study arms showed no significant differences in the incidence of gestational diabetes, gestational hypertension, preterm births, or cesarean delivery.
Dr. Cahill said that she too planned to look at additional outcomes that might be affected by controlling GWG, including maternal weight retention and neurodevelopment in the children.
[email protected] On Twitter @mitchelzoler
LAS VEGAS – Two similar behavioral interventions during pregnancy both succeeded in capping gestational weight gain in two independent randomized trials, but neither intervention produced improvements in obstetrical outcomes.
Results from several prior studies linked excess gestational weight gain (GWG) with adverse outcomes, including gestational diabetes, hypertension, macrosomia, and cesarean delivery. But none of the rates of these complications fell among women in the study groups that received intervention and had reduced GWG, compared with controls.
“The clinical significance of the difference in GWG we saw is not known,” said Alison G. Cahill, MD, who presented one of the two reports at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine. In the study she led, women who received a behavioral intervention averaged about 3.5 pounds less GWG through 36 weeks of pregnancy.
“Our findings call into question the association between GWG and adverse pregnancy outcomes,” said Alan M. Peaceman, MD, who presented the second study, in which women receiving the behavioral intervention averaged 4 pounds less in GWG, compared with control women.
Dr. Peaceman reported results from the Maternal Offspring Metabolics: Family Intervention Trial (MOMFIT), a trial run at Northwestern University in Chicago that randomized 263 pregnant women. The women had to be at less than 16 weeks singleton gestation with a body mass index of 25-40 kg/m2, no pregestational diabetes, and a first trimester weight gain of no more than 15 pounds.
The researchers randomized participants to receive either an intervention that included an individualized diet, Internet-based self monitoring of diet adherence, recommendations on physical activity, and weekly coaching calls and opportunities for group meetings, webinars and podcasts; or a control regimen of electronic newsletters and website access that dispensed pregnancy information without mentioning diet. The participants averaged 33 years old, their average body mass index was 31 kg/m2, and about 55% were obese, with a body mass index of 30 kg/m2 or greater.
The study’s primary outcome was weight gain from enrollment through 36 weeks of gestation, which averaged 19.1 pounds among women who received the intervention and 23.7 pounds among controls, an average 4.6 pounds difference that was statistically significant, Dr. Peaceman reported.
The percentage of patients exceeding the GWG recommendations made in 2009 by the Institute of Medicine (IOM) was 68% in the intervention group and 86% among the controls, an 18 percentage-point difference that was statistically significant.
Despite these differences, the two groups showed very similar rates for the incidence of gestational diabetes, preeclampsia or hypertension, birth weight above 4,000 g, and gestational age at delivery (39 weeks on average for both subgroups).
The rate of cesarean delivery (40%) was higher in the women who received the intervention and had less GWG, compared with 27% among the control women. Despite meeting the statistical test for significance, it is most likely a chance result, said Dr. Peaceman, chief of maternal fetal medicine at Northwestern.
He stressed that while no benefit from reduced GWG has yet been found in the MOMFIT results, additional endpoints are under study, such as neonatal metabolism, infant metabolism at 1 year, and maternal weight retention.
Dr. Cahill reported very similar findings from her study, run as part of the Weight Management in Obese Pregnant Underserved African American Women (LIFE-Moms) trial. She enrolled 267 socioeconomically disadvantaged African American women with singleton, normal-anatomy pregnancies who presented for prenatal care at her clinic at less than 16 weeks gestation and were overweight or obese.
The study randomized these women to receive either an exercise and lifestyle intervention along with home visits from the Parents as Teachers program, or just home visits without the exercise and lifestyle component. The enrolled women averaged about 25 years old, and their average body mass index was about 32 kg/m2, with two-thirds of patients being obese.
The study’s primary endpoint, the percentage of women who exceeded the IOM’s 2009 recommendations on GWG, was 37% among women who received the exercise and lifestyle intervention and 46% among those who did not, a difference that was not statistically significant in the full intention-to-treat analysis, Dr. Cahill reported.
A subgroup analysis showed that most of the benefit focused in obese participants, where 34% of women who received the extra intervention had a GWG greater than the IOM recommendation, compared with a 49% rate among controls, a 15 percentage-point difference that fell just short of statistical significance.
For the secondary endpoint of average amount of GWG, women in the intervention arm had a 8.05 kg average, compared with 9.64 kg among the controls, an average GWG reduction of 1.59 kg (3.5 pounds) in the intervention arm. This difference was statistically significant, said Dr. Cahill, chief of maternal fetal medicine at Washington University in St. Louis.
Dr. Cahill also ran a modified intention-to-treat analysis that excluded women with missing GWG data at term, those with fetal death or miscarriage, and one women mistakenly enrolled who was of normal weight. Among the remaining 240 women, the impact of the exercise and lifestyle intervention was even more pronounced, resulting in an average reduction in GWG of 4 pounds and a 12 percentage-point reduction in women exceeding the IOM’s GWG recommendations.
Despite these favorable effects on GWG, the two study arms showed no significant differences in the incidence of gestational diabetes, gestational hypertension, preterm births, or cesarean delivery.
Dr. Cahill said that she too planned to look at additional outcomes that might be affected by controlling GWG, including maternal weight retention and neurodevelopment in the children.
[email protected] On Twitter @mitchelzoler
LAS VEGAS – Two similar behavioral interventions during pregnancy both succeeded in capping gestational weight gain in two independent randomized trials, but neither intervention produced improvements in obstetrical outcomes.
Results from several prior studies linked excess gestational weight gain (GWG) with adverse outcomes, including gestational diabetes, hypertension, macrosomia, and cesarean delivery. But none of the rates of these complications fell among women in the study groups that received intervention and had reduced GWG, compared with controls.
“The clinical significance of the difference in GWG we saw is not known,” said Alison G. Cahill, MD, who presented one of the two reports at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine. In the study she led, women who received a behavioral intervention averaged about 3.5 pounds less GWG through 36 weeks of pregnancy.
“Our findings call into question the association between GWG and adverse pregnancy outcomes,” said Alan M. Peaceman, MD, who presented the second study, in which women receiving the behavioral intervention averaged 4 pounds less in GWG, compared with control women.
Dr. Peaceman reported results from the Maternal Offspring Metabolics: Family Intervention Trial (MOMFIT), a trial run at Northwestern University in Chicago that randomized 263 pregnant women. The women had to be at less than 16 weeks singleton gestation with a body mass index of 25-40 kg/m2, no pregestational diabetes, and a first trimester weight gain of no more than 15 pounds.
The researchers randomized participants to receive either an intervention that included an individualized diet, Internet-based self monitoring of diet adherence, recommendations on physical activity, and weekly coaching calls and opportunities for group meetings, webinars and podcasts; or a control regimen of electronic newsletters and website access that dispensed pregnancy information without mentioning diet. The participants averaged 33 years old, their average body mass index was 31 kg/m2, and about 55% were obese, with a body mass index of 30 kg/m2 or greater.
The study’s primary outcome was weight gain from enrollment through 36 weeks of gestation, which averaged 19.1 pounds among women who received the intervention and 23.7 pounds among controls, an average 4.6 pounds difference that was statistically significant, Dr. Peaceman reported.
The percentage of patients exceeding the GWG recommendations made in 2009 by the Institute of Medicine (IOM) was 68% in the intervention group and 86% among the controls, an 18 percentage-point difference that was statistically significant.
Despite these differences, the two groups showed very similar rates for the incidence of gestational diabetes, preeclampsia or hypertension, birth weight above 4,000 g, and gestational age at delivery (39 weeks on average for both subgroups).
The rate of cesarean delivery (40%) was higher in the women who received the intervention and had less GWG, compared with 27% among the control women. Despite meeting the statistical test for significance, it is most likely a chance result, said Dr. Peaceman, chief of maternal fetal medicine at Northwestern.
He stressed that while no benefit from reduced GWG has yet been found in the MOMFIT results, additional endpoints are under study, such as neonatal metabolism, infant metabolism at 1 year, and maternal weight retention.
Dr. Cahill reported very similar findings from her study, run as part of the Weight Management in Obese Pregnant Underserved African American Women (LIFE-Moms) trial. She enrolled 267 socioeconomically disadvantaged African American women with singleton, normal-anatomy pregnancies who presented for prenatal care at her clinic at less than 16 weeks gestation and were overweight or obese.
The study randomized these women to receive either an exercise and lifestyle intervention along with home visits from the Parents as Teachers program, or just home visits without the exercise and lifestyle component. The enrolled women averaged about 25 years old, and their average body mass index was about 32 kg/m2, with two-thirds of patients being obese.
The study’s primary endpoint, the percentage of women who exceeded the IOM’s 2009 recommendations on GWG, was 37% among women who received the exercise and lifestyle intervention and 46% among those who did not, a difference that was not statistically significant in the full intention-to-treat analysis, Dr. Cahill reported.
A subgroup analysis showed that most of the benefit focused in obese participants, where 34% of women who received the extra intervention had a GWG greater than the IOM recommendation, compared with a 49% rate among controls, a 15 percentage-point difference that fell just short of statistical significance.
For the secondary endpoint of average amount of GWG, women in the intervention arm had a 8.05 kg average, compared with 9.64 kg among the controls, an average GWG reduction of 1.59 kg (3.5 pounds) in the intervention arm. This difference was statistically significant, said Dr. Cahill, chief of maternal fetal medicine at Washington University in St. Louis.
Dr. Cahill also ran a modified intention-to-treat analysis that excluded women with missing GWG data at term, those with fetal death or miscarriage, and one women mistakenly enrolled who was of normal weight. Among the remaining 240 women, the impact of the exercise and lifestyle intervention was even more pronounced, resulting in an average reduction in GWG of 4 pounds and a 12 percentage-point reduction in women exceeding the IOM’s GWG recommendations.
Despite these favorable effects on GWG, the two study arms showed no significant differences in the incidence of gestational diabetes, gestational hypertension, preterm births, or cesarean delivery.
Dr. Cahill said that she too planned to look at additional outcomes that might be affected by controlling GWG, including maternal weight retention and neurodevelopment in the children.
[email protected] On Twitter @mitchelzoler
Key clinical point:
Major finding: Behavioral interventions linked with average reductions in gestational weight gain of 4.6 pounds in MOMFIT and 3.5 pounds in LIFE-Moms.
Data source: MOMFIT and LIFE-Moms, two single-center randomized trials with 263 and 267 mothers, respectively.
Disclosures: Neither trial had commercial support. Dr. Peaceman and Dr. Cahill had no relevant disclosures.
Fewer infant deaths during ‘39-week rule’ era
LAS VEGAS – Closer adherence by U.S. physicians to the “39-week rule” for elective deliveries appears to have cut net neonatal mortality in an analysis of more than 14 million deliveries during 2008-2012.
This net drop in mortality occurred despite a concurrent rise in stillbirths, Rachel A. Pilliod, MD, said at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine. The increase in stillbirths was more than counterbalanced by a larger drop in infant deaths during the same period.
“It’s not a one-to-one trade, where each stillbirth corresponds to an infant death that is subsequently avoided. It’s hard to make this trade-off when counseling parents,” she said. “We think that there has been some effect from increasing gestational age on reducing overall mortality, but we need to do even better on identifying high risk [deliveries].”
What is “unacceptable,” Dr. Pilliod said, is if a woman needs an earlier delivery but it gets pushed back because of a poorly informed application of the 39-week rule.
Her study used data collected by the National Center for Health Statistics on U.S. deliveries each year, focusing on pregnancies that were singletons and nonanomalous.
She compared the 7,388,782 deliveries during 2008 and 2009 and 6,980,962 births during 2011 and 2012, selecting the 2-year time periods on either side of the Joint Commission’s 2010 adoption of a quality measure aimed at decreasing elective deliveries prior to 39 weeks gestation.
The Joint Commission’s action had its desired effect. Deliveries at 39 weeks jumped from 36% of all elective births in 2008 and 2009 to 43% in 2011 and 2012, while deliveries at 38 weeks show the biggest drop, from 22% to 20%, Dr. Pilliod reported (Am J Obstet Gynecol. 2017 Jan. doi: 10.1016/j.ajog.2016.11.959).
Concurrent with the rise in 39-week births and a drop in neonates with shorter gestation times, the incidence of stillbirths rose from 9.32 per 10,000 births in 2008 and 2009 to 10.15, an increase of 0.83 per 10,000 births.
But during the same periods the incidence of infant deaths fell, from 20.63 per 10,000 births in 2008 and 2009 to 19.0 in 2011 and 2012, a reduction of 1.63 per 10,000. Overall the stillbirth and infant death data combined for a net mortality reduction of 0.8 per 10,000 births.
[email protected]
On Twitter @mitchelzoler
LAS VEGAS – Closer adherence by U.S. physicians to the “39-week rule” for elective deliveries appears to have cut net neonatal mortality in an analysis of more than 14 million deliveries during 2008-2012.
This net drop in mortality occurred despite a concurrent rise in stillbirths, Rachel A. Pilliod, MD, said at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine. The increase in stillbirths was more than counterbalanced by a larger drop in infant deaths during the same period.
“It’s not a one-to-one trade, where each stillbirth corresponds to an infant death that is subsequently avoided. It’s hard to make this trade-off when counseling parents,” she said. “We think that there has been some effect from increasing gestational age on reducing overall mortality, but we need to do even better on identifying high risk [deliveries].”
What is “unacceptable,” Dr. Pilliod said, is if a woman needs an earlier delivery but it gets pushed back because of a poorly informed application of the 39-week rule.
Her study used data collected by the National Center for Health Statistics on U.S. deliveries each year, focusing on pregnancies that were singletons and nonanomalous.
She compared the 7,388,782 deliveries during 2008 and 2009 and 6,980,962 births during 2011 and 2012, selecting the 2-year time periods on either side of the Joint Commission’s 2010 adoption of a quality measure aimed at decreasing elective deliveries prior to 39 weeks gestation.
The Joint Commission’s action had its desired effect. Deliveries at 39 weeks jumped from 36% of all elective births in 2008 and 2009 to 43% in 2011 and 2012, while deliveries at 38 weeks show the biggest drop, from 22% to 20%, Dr. Pilliod reported (Am J Obstet Gynecol. 2017 Jan. doi: 10.1016/j.ajog.2016.11.959).
Concurrent with the rise in 39-week births and a drop in neonates with shorter gestation times, the incidence of stillbirths rose from 9.32 per 10,000 births in 2008 and 2009 to 10.15, an increase of 0.83 per 10,000 births.
But during the same periods the incidence of infant deaths fell, from 20.63 per 10,000 births in 2008 and 2009 to 19.0 in 2011 and 2012, a reduction of 1.63 per 10,000. Overall the stillbirth and infant death data combined for a net mortality reduction of 0.8 per 10,000 births.
[email protected]
On Twitter @mitchelzoler
LAS VEGAS – Closer adherence by U.S. physicians to the “39-week rule” for elective deliveries appears to have cut net neonatal mortality in an analysis of more than 14 million deliveries during 2008-2012.
This net drop in mortality occurred despite a concurrent rise in stillbirths, Rachel A. Pilliod, MD, said at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine. The increase in stillbirths was more than counterbalanced by a larger drop in infant deaths during the same period.
“It’s not a one-to-one trade, where each stillbirth corresponds to an infant death that is subsequently avoided. It’s hard to make this trade-off when counseling parents,” she said. “We think that there has been some effect from increasing gestational age on reducing overall mortality, but we need to do even better on identifying high risk [deliveries].”
What is “unacceptable,” Dr. Pilliod said, is if a woman needs an earlier delivery but it gets pushed back because of a poorly informed application of the 39-week rule.
Her study used data collected by the National Center for Health Statistics on U.S. deliveries each year, focusing on pregnancies that were singletons and nonanomalous.
She compared the 7,388,782 deliveries during 2008 and 2009 and 6,980,962 births during 2011 and 2012, selecting the 2-year time periods on either side of the Joint Commission’s 2010 adoption of a quality measure aimed at decreasing elective deliveries prior to 39 weeks gestation.
The Joint Commission’s action had its desired effect. Deliveries at 39 weeks jumped from 36% of all elective births in 2008 and 2009 to 43% in 2011 and 2012, while deliveries at 38 weeks show the biggest drop, from 22% to 20%, Dr. Pilliod reported (Am J Obstet Gynecol. 2017 Jan. doi: 10.1016/j.ajog.2016.11.959).
Concurrent with the rise in 39-week births and a drop in neonates with shorter gestation times, the incidence of stillbirths rose from 9.32 per 10,000 births in 2008 and 2009 to 10.15, an increase of 0.83 per 10,000 births.
But during the same periods the incidence of infant deaths fell, from 20.63 per 10,000 births in 2008 and 2009 to 19.0 in 2011 and 2012, a reduction of 1.63 per 10,000. Overall the stillbirth and infant death data combined for a net mortality reduction of 0.8 per 10,000 births.
[email protected]
On Twitter @mitchelzoler
AT THE PREGNANCY MEETING
Key clinical point:
Major finding: Net mortality dropped by 0.8 per 10,000 births from 2008 and 2009 to 2011 and 2012.
Data source: Review of U.S. birth records from the National Center for Health Statistics during 2008-2012.
Disclosures: Dr. Pilliod reported having no financial disclosures.
More risk factors boost mortality in home births
LAS VEGAS – Analysis of nearly 13 million U.S. deliveries during 2009-2013 identified two new, significant dangers posed to neonates delivered by planned home births: nulliparous pregnancies and deliveries at 41 weeks gestational age or older.
Both conditions linked with a substantially increased risk for neonatal mortality, compared with babies delivered at a hospital, either by a nurse midwife or a physician, said Amos Grünebaum, MD, at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.
The critical difference between a home birth–like setting at a hospital and home birth in the field is distance from a hospital when emergency care is needed, he said.
“Women want less intervention during delivery and should get less intervention,” but a midwife run, home birth–like clinic should operate adjacent to a hospital able to handle obstetrical and neonatal emergencies, Dr. Grünebaum said in an interview. “Women need to understand the risks of home births.”
He and his associates used data collected by the Centers for Disease Control and Prevention on 12,953,671 U.S. deliveries during 2009-2013 for singleton, nonanomalous neonates with at least 37 weeks gestation at birth and weighing at least 2,500 grams. The total included 91% hospital deliveries by a physician, 8% hospital deliveries by a nurse-midwife, and 96,815 home births or 0.75% of U.S. deliveries during this period. Despite that low percentage, the number of U.S. home births nearly tripled from 2007 to 2015, he noted.
The rate of neonatal deaths for each 10,000 live births was 3 among infants delivered by nurse midwives at hospitals, 5 for infants delivered by physicians at hospitals, and 12 for infants delivered by home births. The standard mortality ratio was 66% higher for physicians at hospitals, compared with nurse-midwives at hospitals, because physicians handle higher-risk deliveries, and more than fourfold higher for home births, compared with hospital deliveries by nurse-midwives, Dr. Grünebaum reported.
Further analysis showed that the death rate per 10,000 neonates for pregnancies that continued to a gestational age of 41 weeks or more was 17.2, and for deliveries among nulliparous women, neonatal mortality was 22.5 deaths per 10,000 births. These rates were in the same ballpark as three conditions cited by an ACOG committee in a 2016 report as contraindications for home birth: prior cesarean delivery, which had home birth mortality of 18.9 per 10,000 neonates in the current study, multiple gestations, and breach presentation, with home birth mortality in the current study of 127.5 per 10,000.Maternal age of 35 years or greater at the time of delivery linked with a death rate of 13.6 per 10,000 births, a rate that Dr. Grünebaum did not consider high enough to specifically label it a contraindication to home birth. But Dr. Grünebaum took a dim view of home births in general. For any type of pregnancy, a birth center not adjacent to a hospital is “unprofessional,” he declared.
A journal article with this report also appeared online (Am J Ob Gyn. 2017 Jan 29. doi: 10.1016/j.ajog.2017.01.012).
[email protected]
On Twitter @mitchelzoler
LAS VEGAS – Analysis of nearly 13 million U.S. deliveries during 2009-2013 identified two new, significant dangers posed to neonates delivered by planned home births: nulliparous pregnancies and deliveries at 41 weeks gestational age or older.
Both conditions linked with a substantially increased risk for neonatal mortality, compared with babies delivered at a hospital, either by a nurse midwife or a physician, said Amos Grünebaum, MD, at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.
The critical difference between a home birth–like setting at a hospital and home birth in the field is distance from a hospital when emergency care is needed, he said.
“Women want less intervention during delivery and should get less intervention,” but a midwife run, home birth–like clinic should operate adjacent to a hospital able to handle obstetrical and neonatal emergencies, Dr. Grünebaum said in an interview. “Women need to understand the risks of home births.”
He and his associates used data collected by the Centers for Disease Control and Prevention on 12,953,671 U.S. deliveries during 2009-2013 for singleton, nonanomalous neonates with at least 37 weeks gestation at birth and weighing at least 2,500 grams. The total included 91% hospital deliveries by a physician, 8% hospital deliveries by a nurse-midwife, and 96,815 home births or 0.75% of U.S. deliveries during this period. Despite that low percentage, the number of U.S. home births nearly tripled from 2007 to 2015, he noted.
The rate of neonatal deaths for each 10,000 live births was 3 among infants delivered by nurse midwives at hospitals, 5 for infants delivered by physicians at hospitals, and 12 for infants delivered by home births. The standard mortality ratio was 66% higher for physicians at hospitals, compared with nurse-midwives at hospitals, because physicians handle higher-risk deliveries, and more than fourfold higher for home births, compared with hospital deliveries by nurse-midwives, Dr. Grünebaum reported.
Further analysis showed that the death rate per 10,000 neonates for pregnancies that continued to a gestational age of 41 weeks or more was 17.2, and for deliveries among nulliparous women, neonatal mortality was 22.5 deaths per 10,000 births. These rates were in the same ballpark as three conditions cited by an ACOG committee in a 2016 report as contraindications for home birth: prior cesarean delivery, which had home birth mortality of 18.9 per 10,000 neonates in the current study, multiple gestations, and breach presentation, with home birth mortality in the current study of 127.5 per 10,000.Maternal age of 35 years or greater at the time of delivery linked with a death rate of 13.6 per 10,000 births, a rate that Dr. Grünebaum did not consider high enough to specifically label it a contraindication to home birth. But Dr. Grünebaum took a dim view of home births in general. For any type of pregnancy, a birth center not adjacent to a hospital is “unprofessional,” he declared.
A journal article with this report also appeared online (Am J Ob Gyn. 2017 Jan 29. doi: 10.1016/j.ajog.2017.01.012).
[email protected]
On Twitter @mitchelzoler
LAS VEGAS – Analysis of nearly 13 million U.S. deliveries during 2009-2013 identified two new, significant dangers posed to neonates delivered by planned home births: nulliparous pregnancies and deliveries at 41 weeks gestational age or older.
Both conditions linked with a substantially increased risk for neonatal mortality, compared with babies delivered at a hospital, either by a nurse midwife or a physician, said Amos Grünebaum, MD, at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.
The critical difference between a home birth–like setting at a hospital and home birth in the field is distance from a hospital when emergency care is needed, he said.
“Women want less intervention during delivery and should get less intervention,” but a midwife run, home birth–like clinic should operate adjacent to a hospital able to handle obstetrical and neonatal emergencies, Dr. Grünebaum said in an interview. “Women need to understand the risks of home births.”
He and his associates used data collected by the Centers for Disease Control and Prevention on 12,953,671 U.S. deliveries during 2009-2013 for singleton, nonanomalous neonates with at least 37 weeks gestation at birth and weighing at least 2,500 grams. The total included 91% hospital deliveries by a physician, 8% hospital deliveries by a nurse-midwife, and 96,815 home births or 0.75% of U.S. deliveries during this period. Despite that low percentage, the number of U.S. home births nearly tripled from 2007 to 2015, he noted.
The rate of neonatal deaths for each 10,000 live births was 3 among infants delivered by nurse midwives at hospitals, 5 for infants delivered by physicians at hospitals, and 12 for infants delivered by home births. The standard mortality ratio was 66% higher for physicians at hospitals, compared with nurse-midwives at hospitals, because physicians handle higher-risk deliveries, and more than fourfold higher for home births, compared with hospital deliveries by nurse-midwives, Dr. Grünebaum reported.
Further analysis showed that the death rate per 10,000 neonates for pregnancies that continued to a gestational age of 41 weeks or more was 17.2, and for deliveries among nulliparous women, neonatal mortality was 22.5 deaths per 10,000 births. These rates were in the same ballpark as three conditions cited by an ACOG committee in a 2016 report as contraindications for home birth: prior cesarean delivery, which had home birth mortality of 18.9 per 10,000 neonates in the current study, multiple gestations, and breach presentation, with home birth mortality in the current study of 127.5 per 10,000.Maternal age of 35 years or greater at the time of delivery linked with a death rate of 13.6 per 10,000 births, a rate that Dr. Grünebaum did not consider high enough to specifically label it a contraindication to home birth. But Dr. Grünebaum took a dim view of home births in general. For any type of pregnancy, a birth center not adjacent to a hospital is “unprofessional,” he declared.
A journal article with this report also appeared online (Am J Ob Gyn. 2017 Jan 29. doi: 10.1016/j.ajog.2017.01.012).
[email protected]
On Twitter @mitchelzoler
AT THE PREGNANCY MEETING
Key clinical point:
Major finding: Home birth neonatal mortality per 10,000 births was 22.5 from nulliparous pregnancies and 17.2 with 41 weeks gestational age or greater.
Data source: Analysis of data from 12,953,671 selected full-term U.S. deliveries during 2009-2013, collected by the Centers for Disease Control and Prevention.
Disclosures: Dr. Grünebaum had no disclosures.
Puerperal NSAIDs show no hypertension risk
LAS VEGAS – Puerperal NSAID treatment appeared safe for women with severe preeclampsia and hypertension postpartum in a single-center, retrospective analysis with 324 women.
Given that an opioid is generally the alternative to analgesia with a nonsteroidal anti-inflammatory drug, these new data help refute a recent call to limit puerperal NSAID use, Oscar A. Viteri, MD, said at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.
Given the apparent safety of NSAIDs in this new analysis, their safety for nursing women, and concerns about opiates, it makes sense to defer any recommendations about avoiding NSAIDs in women with hypertension postpartum until their harm is proven in a adequately powered randomized trial, said Dr. Viteri, a maternal fetal medicine specialist at the University of Texas, Houston. “Opiates are a public health problem,” he stressed.
His analysis used data collected from all women who delivered at Children’s Memorial Hermann Hospital in Houston during 2013-2015. In that group he identified 399 mothers with preeclampsia with severe features that had been diagnosed prior to delivery, and among them 324 mothers had hypertension (a systolic blood pressure of at least 140 mm Hg, a diastolic pressure of at least 90 mm Hg, or both) at or after 24 hours following delivery. Within this subgroup of 324 mothers, 243 (75%) received puerperal NSAID treatment and 81 women (25%) did not. Dr. Viteri highlighted that three-quarters of the women in the study subgroup had received NSAIDs “despite” the 2013 Task Force recommendation.
“Many units” continue to use puerperal NSAIDs in women with hypertension postpartum, commented Mary E. D’Alton, MD, professor and chair of ob.gyn. at Columbia University, New York.
Dr. Viteri defined persistent hypertension in these women as a systolic blood pressure of at least 150 mm Hg, a diastolic pressure of at least 100 mm Hg, or both measured after delivery at least twice at an interval of at least 4 hours. This primary endpoint occurred in 70% of the women treated with an NSAID and in 73% of those who received no NSAID, a difference that was not statistically significant after adjustment for laboratory abnormalities, gestational age, and mode of delivery, Dr. Viteri reported. The women who received NSAIDs also showed a numerically lower rate of receiving new or additional antihypertensive drugs of 20%, compared with 31% among those not on NSAIDs, a nonsignificant difference.
The analysis also showed no differences between the women on NSAIDs and those who did not take them for all the other parameters examined, including highest, average, and discharge systolic and diastolic blood pressures. In addition, among the women who received NSAIDs the results showed no differences in blood pressures regardless of whether the women also were receiving antihypertensive treatment with labetalol or nifedipine. This is the largest study yet reported to examine the effect of puerperal NSAID treatment on women with hypertension, and also the first data on the impact of NSAID treatment on blood pressure in women taking various types of antihypertensive drugs, Dr. Viteri noted.
Despite this reassuring data “it is important to be cautious” when using NSAIDs to treat the type of women enrolled in this study, Dr. D’Alton said in an interview. One concern to keep in mind is the risk for renal injury from NSAID use in women with a history of severe hypertension. Although Dr. D’Alton believed that it is not necessary to monitor renal function routinely in hypertensive women receiving puerperal NSAID treatment, the impact of this practice on the kidneys was worth further investigation, she said.
Dr. Viteri and Dr. D’Alton had no disclosures.
[email protected]
On Twitter @mitchelzoler
LAS VEGAS – Puerperal NSAID treatment appeared safe for women with severe preeclampsia and hypertension postpartum in a single-center, retrospective analysis with 324 women.
Given that an opioid is generally the alternative to analgesia with a nonsteroidal anti-inflammatory drug, these new data help refute a recent call to limit puerperal NSAID use, Oscar A. Viteri, MD, said at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.
Given the apparent safety of NSAIDs in this new analysis, their safety for nursing women, and concerns about opiates, it makes sense to defer any recommendations about avoiding NSAIDs in women with hypertension postpartum until their harm is proven in a adequately powered randomized trial, said Dr. Viteri, a maternal fetal medicine specialist at the University of Texas, Houston. “Opiates are a public health problem,” he stressed.
His analysis used data collected from all women who delivered at Children’s Memorial Hermann Hospital in Houston during 2013-2015. In that group he identified 399 mothers with preeclampsia with severe features that had been diagnosed prior to delivery, and among them 324 mothers had hypertension (a systolic blood pressure of at least 140 mm Hg, a diastolic pressure of at least 90 mm Hg, or both) at or after 24 hours following delivery. Within this subgroup of 324 mothers, 243 (75%) received puerperal NSAID treatment and 81 women (25%) did not. Dr. Viteri highlighted that three-quarters of the women in the study subgroup had received NSAIDs “despite” the 2013 Task Force recommendation.
“Many units” continue to use puerperal NSAIDs in women with hypertension postpartum, commented Mary E. D’Alton, MD, professor and chair of ob.gyn. at Columbia University, New York.
Dr. Viteri defined persistent hypertension in these women as a systolic blood pressure of at least 150 mm Hg, a diastolic pressure of at least 100 mm Hg, or both measured after delivery at least twice at an interval of at least 4 hours. This primary endpoint occurred in 70% of the women treated with an NSAID and in 73% of those who received no NSAID, a difference that was not statistically significant after adjustment for laboratory abnormalities, gestational age, and mode of delivery, Dr. Viteri reported. The women who received NSAIDs also showed a numerically lower rate of receiving new or additional antihypertensive drugs of 20%, compared with 31% among those not on NSAIDs, a nonsignificant difference.
The analysis also showed no differences between the women on NSAIDs and those who did not take them for all the other parameters examined, including highest, average, and discharge systolic and diastolic blood pressures. In addition, among the women who received NSAIDs the results showed no differences in blood pressures regardless of whether the women also were receiving antihypertensive treatment with labetalol or nifedipine. This is the largest study yet reported to examine the effect of puerperal NSAID treatment on women with hypertension, and also the first data on the impact of NSAID treatment on blood pressure in women taking various types of antihypertensive drugs, Dr. Viteri noted.
Despite this reassuring data “it is important to be cautious” when using NSAIDs to treat the type of women enrolled in this study, Dr. D’Alton said in an interview. One concern to keep in mind is the risk for renal injury from NSAID use in women with a history of severe hypertension. Although Dr. D’Alton believed that it is not necessary to monitor renal function routinely in hypertensive women receiving puerperal NSAID treatment, the impact of this practice on the kidneys was worth further investigation, she said.
Dr. Viteri and Dr. D’Alton had no disclosures.
[email protected]
On Twitter @mitchelzoler
LAS VEGAS – Puerperal NSAID treatment appeared safe for women with severe preeclampsia and hypertension postpartum in a single-center, retrospective analysis with 324 women.
Given that an opioid is generally the alternative to analgesia with a nonsteroidal anti-inflammatory drug, these new data help refute a recent call to limit puerperal NSAID use, Oscar A. Viteri, MD, said at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.
Given the apparent safety of NSAIDs in this new analysis, their safety for nursing women, and concerns about opiates, it makes sense to defer any recommendations about avoiding NSAIDs in women with hypertension postpartum until their harm is proven in a adequately powered randomized trial, said Dr. Viteri, a maternal fetal medicine specialist at the University of Texas, Houston. “Opiates are a public health problem,” he stressed.
His analysis used data collected from all women who delivered at Children’s Memorial Hermann Hospital in Houston during 2013-2015. In that group he identified 399 mothers with preeclampsia with severe features that had been diagnosed prior to delivery, and among them 324 mothers had hypertension (a systolic blood pressure of at least 140 mm Hg, a diastolic pressure of at least 90 mm Hg, or both) at or after 24 hours following delivery. Within this subgroup of 324 mothers, 243 (75%) received puerperal NSAID treatment and 81 women (25%) did not. Dr. Viteri highlighted that three-quarters of the women in the study subgroup had received NSAIDs “despite” the 2013 Task Force recommendation.
“Many units” continue to use puerperal NSAIDs in women with hypertension postpartum, commented Mary E. D’Alton, MD, professor and chair of ob.gyn. at Columbia University, New York.
Dr. Viteri defined persistent hypertension in these women as a systolic blood pressure of at least 150 mm Hg, a diastolic pressure of at least 100 mm Hg, or both measured after delivery at least twice at an interval of at least 4 hours. This primary endpoint occurred in 70% of the women treated with an NSAID and in 73% of those who received no NSAID, a difference that was not statistically significant after adjustment for laboratory abnormalities, gestational age, and mode of delivery, Dr. Viteri reported. The women who received NSAIDs also showed a numerically lower rate of receiving new or additional antihypertensive drugs of 20%, compared with 31% among those not on NSAIDs, a nonsignificant difference.
The analysis also showed no differences between the women on NSAIDs and those who did not take them for all the other parameters examined, including highest, average, and discharge systolic and diastolic blood pressures. In addition, among the women who received NSAIDs the results showed no differences in blood pressures regardless of whether the women also were receiving antihypertensive treatment with labetalol or nifedipine. This is the largest study yet reported to examine the effect of puerperal NSAID treatment on women with hypertension, and also the first data on the impact of NSAID treatment on blood pressure in women taking various types of antihypertensive drugs, Dr. Viteri noted.
Despite this reassuring data “it is important to be cautious” when using NSAIDs to treat the type of women enrolled in this study, Dr. D’Alton said in an interview. One concern to keep in mind is the risk for renal injury from NSAID use in women with a history of severe hypertension. Although Dr. D’Alton believed that it is not necessary to monitor renal function routinely in hypertensive women receiving puerperal NSAID treatment, the impact of this practice on the kidneys was worth further investigation, she said.
Dr. Viteri and Dr. D’Alton had no disclosures.
[email protected]
On Twitter @mitchelzoler
AT THE PREGNANCY MEETING
Key clinical point:
Major finding: The incidence of persistent hypertension was 70% in women who received NSAIDs and 73% in women not on NSAISDs.
Data source: Retrospective analysis of data from 324 women at a single U.S. center.
Disclosures: Dr. Viteri and Dr. D’Alton had no disclosures.
5% dextrose speeds induced-labor delivery
LAS VEGAS – Adding 5% dextrose to the hydrating solution given to women undergoing induced labor safely led to a median 76-minute decrease in labor duration in a single-center randomized study.
Normal saline with 5% dextrose “should be considered the default solute during labor induction in nulliparous women,” Josianne Paré, MD, said at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine. “The uterus is a muscle, and glucose is its main energy substrate.”
During January 2013 to January 2015, women who met these criteria and required induction received either normal saline or normal saline plus 5% dextrose when they began their oxytocin drip, at a rate of 250 mL/hour.
Treatment with the assigned hydrating solutions continued until delivery or C-section. Participants averaged 28 years old, their average body mass index was 26 kg/m2 and average birth weight was about 3,450 g.
The study’s primary outcome was total duration of labor. This was a median of 423 minutes in 96 women who received dextrose and were available for analysis, and a median of 499 minutes in 97 evaluable women who received the saline control, a median difference of 76 minutes that was statistically significant, Dr. Paré reported. Most of the difference in labor duration happened during the first stage, which showed a median 70-minute reduction between the control group and the women receiving dextrose.
“These results support findings from prior studies. Women need glucose during labor,” Elliott Main, MD, commented in an interview. “There is no evidence for a need to exclude glucose from intravenous fluids. Adding some form of glucose is not standard practice today, but the time has come to do it, either by adding glucose to hydrating fluid or have women in labor eat and drink more,” said Dr. Main, medical director of the California Maternal Quality Care Collaborative in Stanford.
Dr. Paré reported having no financial disclosures.
[email protected]
On Twitter @mitchelzoler
LAS VEGAS – Adding 5% dextrose to the hydrating solution given to women undergoing induced labor safely led to a median 76-minute decrease in labor duration in a single-center randomized study.
Normal saline with 5% dextrose “should be considered the default solute during labor induction in nulliparous women,” Josianne Paré, MD, said at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine. “The uterus is a muscle, and glucose is its main energy substrate.”
During January 2013 to January 2015, women who met these criteria and required induction received either normal saline or normal saline plus 5% dextrose when they began their oxytocin drip, at a rate of 250 mL/hour.
Treatment with the assigned hydrating solutions continued until delivery or C-section. Participants averaged 28 years old, their average body mass index was 26 kg/m2 and average birth weight was about 3,450 g.
The study’s primary outcome was total duration of labor. This was a median of 423 minutes in 96 women who received dextrose and were available for analysis, and a median of 499 minutes in 97 evaluable women who received the saline control, a median difference of 76 minutes that was statistically significant, Dr. Paré reported. Most of the difference in labor duration happened during the first stage, which showed a median 70-minute reduction between the control group and the women receiving dextrose.
“These results support findings from prior studies. Women need glucose during labor,” Elliott Main, MD, commented in an interview. “There is no evidence for a need to exclude glucose from intravenous fluids. Adding some form of glucose is not standard practice today, but the time has come to do it, either by adding glucose to hydrating fluid or have women in labor eat and drink more,” said Dr. Main, medical director of the California Maternal Quality Care Collaborative in Stanford.
Dr. Paré reported having no financial disclosures.
[email protected]
On Twitter @mitchelzoler
LAS VEGAS – Adding 5% dextrose to the hydrating solution given to women undergoing induced labor safely led to a median 76-minute decrease in labor duration in a single-center randomized study.
Normal saline with 5% dextrose “should be considered the default solute during labor induction in nulliparous women,” Josianne Paré, MD, said at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine. “The uterus is a muscle, and glucose is its main energy substrate.”
During January 2013 to January 2015, women who met these criteria and required induction received either normal saline or normal saline plus 5% dextrose when they began their oxytocin drip, at a rate of 250 mL/hour.
Treatment with the assigned hydrating solutions continued until delivery or C-section. Participants averaged 28 years old, their average body mass index was 26 kg/m2 and average birth weight was about 3,450 g.
The study’s primary outcome was total duration of labor. This was a median of 423 minutes in 96 women who received dextrose and were available for analysis, and a median of 499 minutes in 97 evaluable women who received the saline control, a median difference of 76 minutes that was statistically significant, Dr. Paré reported. Most of the difference in labor duration happened during the first stage, which showed a median 70-minute reduction between the control group and the women receiving dextrose.
“These results support findings from prior studies. Women need glucose during labor,” Elliott Main, MD, commented in an interview. “There is no evidence for a need to exclude glucose from intravenous fluids. Adding some form of glucose is not standard practice today, but the time has come to do it, either by adding glucose to hydrating fluid or have women in labor eat and drink more,” said Dr. Main, medical director of the California Maternal Quality Care Collaborative in Stanford.
Dr. Paré reported having no financial disclosures.
[email protected]
On Twitter @mitchelzoler
AT THE PREGNANCY MEETING
Key clinical point:
Major finding: Median labor duration fell by 76 minutes among women who received 5% dextrose, compared with controls.
Data source: DEXTRONS, a single-center, randomized study that enrolled 200 pregnant women.
Disclosures: Dr. Paré reported having no financial disclosures.
Universal cervical length screening reduces preterm birth rate
LAS VEGAS – Universal cervical length screening by transvaginal ultrasound in a low-risk cohort resulted in a significant reduction in spontaneous preterm births.
In a single-center retrospective cohort study of more than 13,000 deliveries, the overall preterm birth rate decreased from 3.8% to 2.4% on implementation of universal cervical length screening (P less than .001).
Screening reduced the numbers of both early and late preterm birth rates. Preterm births occurring earlier than 28 weeks’ gestation dropped from 0.3% to 0.1% (P = .04); preterm births before 34 weeks dropped from 1% to 0.5% (P less than .001); and preterm births before 37 weeks dropped from 2.5% to 1.8% (P = .004).
The data were presented by Alex Argyelan, MD, an ob.gyn. resident at St. Joseph Mercy Hospital–Ann Arbor, Mich., at the Annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine. Dr. Argyelan noted that the current Society for Maternal-Fetal Medicine (SMFM) position regarding cervical length screening is that it should not yet be universally mandated for singleton pregnancies without a prior history of preterm birth. However, a 2016 SMFM guideline stated, “Nonetheless, implementation of such a screening strategy can be viewed as reasonable and can be considered by individual practitioners.” This statement was made, he said, in recognition of the fact that “a sonographic short cervix is a powerful predictor of spontaneous preterm birth,” and that progesterone administration for gravid women with shortening cervixes can, for many, forestall spontaneous preterm labor.
First author Pooja Mittal Green, MD, a maternal-fetal medicine specialist at St. Joseph Mercy Hospital, and her associates looked at preterm delivery data before and after implementation of a universal cervical length screening protocol at a single tertiary referral center. The data collection period spanned from January 2013 to May 2014, with implementation of universal cervical length screening in October 2014.
A total of 13,396 women were included in the study, with a small minority of just 0.5% having experienced a prior spontaneous preterm birth. The mean patient age was just under 30 years; most patients were white, mirroring the demographics of the county where the study took place. Pre- and postintervention patient characteristics did not vary significantly.
Almost all patients agreed to cervical length screening by ultrasound, with the numbers climbing from 93% during the first year after implementing the universal screening protocol, to 99.2% in 2016.
All of the sonographers participating in the study were Cervical Length Education and Review (CLEAR) certified, and the institution’s lead sonographer carried out a ongoing quality assurance program.
A shortened cervix (25 mm or less) was found in a total of 114 women (1.7%) who underwent cervical length screening. According to the protocol, if maternal cervical length was 25 mm or less, women were offered treatment to attempt to stave off preterm delivery, according to the usual standard of care.
For women with no prior history of preterm delivery, treatment was vaginal progesterone. For women who had a prior preterm birth, cervical cerclage was offered, as well as vaginal progesterone if the patient was not already on 17-alpha-hydroxyprogesterone caproate.
The determination whether spontaneous preterm birth had occurred was made by reviewing labor and delivery birth logs, with a subsequent individual chart review to make sure that the delivery happened after either spontaneous labor or preterm premature rupture of membranes.
Only women who received prenatal care at the study institution were included in the study, and women who had not received any prenatal care were excluded.
Dr. Argyelan and his colleagues did not see any significant differences between the preterm and term delivery groups in maternal age, body mass index, or ethnicity.
“Among spontaneous preterm deliveries in low-risk women, the proportion of deliveries before 34 weeks was decreased” after the intervention, said Dr. Argyelan, who reported seeing a decrease from 28% early (less than 34 weeks’ gestation) preterm births before the intervention to 17% after the intervention.
In response to an audience question, Dr. Argyelan noted that his institution charges $186 for an ultrasound examination that includes assessment of cervical length, saying, “We have not had significant issues being reimbursed.”
Another audience member asked what the institution policy had been before the universal screening program was implemented. “Before the universal screening study, there was a policy of screening those with a history of preterm birth; also, if sonographers saw what looked like a short cervix on transabdominal exam, then they would do a transvaginal scan to further assess the cervix,” Dr. Argyelan said.
Dr. Argyelan reported having no financial disclosures.
[email protected]
On Twitter @karioakes
LAS VEGAS – Universal cervical length screening by transvaginal ultrasound in a low-risk cohort resulted in a significant reduction in spontaneous preterm births.
In a single-center retrospective cohort study of more than 13,000 deliveries, the overall preterm birth rate decreased from 3.8% to 2.4% on implementation of universal cervical length screening (P less than .001).
Screening reduced the numbers of both early and late preterm birth rates. Preterm births occurring earlier than 28 weeks’ gestation dropped from 0.3% to 0.1% (P = .04); preterm births before 34 weeks dropped from 1% to 0.5% (P less than .001); and preterm births before 37 weeks dropped from 2.5% to 1.8% (P = .004).
The data were presented by Alex Argyelan, MD, an ob.gyn. resident at St. Joseph Mercy Hospital–Ann Arbor, Mich., at the Annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine. Dr. Argyelan noted that the current Society for Maternal-Fetal Medicine (SMFM) position regarding cervical length screening is that it should not yet be universally mandated for singleton pregnancies without a prior history of preterm birth. However, a 2016 SMFM guideline stated, “Nonetheless, implementation of such a screening strategy can be viewed as reasonable and can be considered by individual practitioners.” This statement was made, he said, in recognition of the fact that “a sonographic short cervix is a powerful predictor of spontaneous preterm birth,” and that progesterone administration for gravid women with shortening cervixes can, for many, forestall spontaneous preterm labor.
First author Pooja Mittal Green, MD, a maternal-fetal medicine specialist at St. Joseph Mercy Hospital, and her associates looked at preterm delivery data before and after implementation of a universal cervical length screening protocol at a single tertiary referral center. The data collection period spanned from January 2013 to May 2014, with implementation of universal cervical length screening in October 2014.
A total of 13,396 women were included in the study, with a small minority of just 0.5% having experienced a prior spontaneous preterm birth. The mean patient age was just under 30 years; most patients were white, mirroring the demographics of the county where the study took place. Pre- and postintervention patient characteristics did not vary significantly.
Almost all patients agreed to cervical length screening by ultrasound, with the numbers climbing from 93% during the first year after implementing the universal screening protocol, to 99.2% in 2016.
All of the sonographers participating in the study were Cervical Length Education and Review (CLEAR) certified, and the institution’s lead sonographer carried out a ongoing quality assurance program.
A shortened cervix (25 mm or less) was found in a total of 114 women (1.7%) who underwent cervical length screening. According to the protocol, if maternal cervical length was 25 mm or less, women were offered treatment to attempt to stave off preterm delivery, according to the usual standard of care.
For women with no prior history of preterm delivery, treatment was vaginal progesterone. For women who had a prior preterm birth, cervical cerclage was offered, as well as vaginal progesterone if the patient was not already on 17-alpha-hydroxyprogesterone caproate.
The determination whether spontaneous preterm birth had occurred was made by reviewing labor and delivery birth logs, with a subsequent individual chart review to make sure that the delivery happened after either spontaneous labor or preterm premature rupture of membranes.
Only women who received prenatal care at the study institution were included in the study, and women who had not received any prenatal care were excluded.
Dr. Argyelan and his colleagues did not see any significant differences between the preterm and term delivery groups in maternal age, body mass index, or ethnicity.
“Among spontaneous preterm deliveries in low-risk women, the proportion of deliveries before 34 weeks was decreased” after the intervention, said Dr. Argyelan, who reported seeing a decrease from 28% early (less than 34 weeks’ gestation) preterm births before the intervention to 17% after the intervention.
In response to an audience question, Dr. Argyelan noted that his institution charges $186 for an ultrasound examination that includes assessment of cervical length, saying, “We have not had significant issues being reimbursed.”
Another audience member asked what the institution policy had been before the universal screening program was implemented. “Before the universal screening study, there was a policy of screening those with a history of preterm birth; also, if sonographers saw what looked like a short cervix on transabdominal exam, then they would do a transvaginal scan to further assess the cervix,” Dr. Argyelan said.
Dr. Argyelan reported having no financial disclosures.
[email protected]
On Twitter @karioakes
LAS VEGAS – Universal cervical length screening by transvaginal ultrasound in a low-risk cohort resulted in a significant reduction in spontaneous preterm births.
In a single-center retrospective cohort study of more than 13,000 deliveries, the overall preterm birth rate decreased from 3.8% to 2.4% on implementation of universal cervical length screening (P less than .001).
Screening reduced the numbers of both early and late preterm birth rates. Preterm births occurring earlier than 28 weeks’ gestation dropped from 0.3% to 0.1% (P = .04); preterm births before 34 weeks dropped from 1% to 0.5% (P less than .001); and preterm births before 37 weeks dropped from 2.5% to 1.8% (P = .004).
The data were presented by Alex Argyelan, MD, an ob.gyn. resident at St. Joseph Mercy Hospital–Ann Arbor, Mich., at the Annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine. Dr. Argyelan noted that the current Society for Maternal-Fetal Medicine (SMFM) position regarding cervical length screening is that it should not yet be universally mandated for singleton pregnancies without a prior history of preterm birth. However, a 2016 SMFM guideline stated, “Nonetheless, implementation of such a screening strategy can be viewed as reasonable and can be considered by individual practitioners.” This statement was made, he said, in recognition of the fact that “a sonographic short cervix is a powerful predictor of spontaneous preterm birth,” and that progesterone administration for gravid women with shortening cervixes can, for many, forestall spontaneous preterm labor.
First author Pooja Mittal Green, MD, a maternal-fetal medicine specialist at St. Joseph Mercy Hospital, and her associates looked at preterm delivery data before and after implementation of a universal cervical length screening protocol at a single tertiary referral center. The data collection period spanned from January 2013 to May 2014, with implementation of universal cervical length screening in October 2014.
A total of 13,396 women were included in the study, with a small minority of just 0.5% having experienced a prior spontaneous preterm birth. The mean patient age was just under 30 years; most patients were white, mirroring the demographics of the county where the study took place. Pre- and postintervention patient characteristics did not vary significantly.
Almost all patients agreed to cervical length screening by ultrasound, with the numbers climbing from 93% during the first year after implementing the universal screening protocol, to 99.2% in 2016.
All of the sonographers participating in the study were Cervical Length Education and Review (CLEAR) certified, and the institution’s lead sonographer carried out a ongoing quality assurance program.
A shortened cervix (25 mm or less) was found in a total of 114 women (1.7%) who underwent cervical length screening. According to the protocol, if maternal cervical length was 25 mm or less, women were offered treatment to attempt to stave off preterm delivery, according to the usual standard of care.
For women with no prior history of preterm delivery, treatment was vaginal progesterone. For women who had a prior preterm birth, cervical cerclage was offered, as well as vaginal progesterone if the patient was not already on 17-alpha-hydroxyprogesterone caproate.
The determination whether spontaneous preterm birth had occurred was made by reviewing labor and delivery birth logs, with a subsequent individual chart review to make sure that the delivery happened after either spontaneous labor or preterm premature rupture of membranes.
Only women who received prenatal care at the study institution were included in the study, and women who had not received any prenatal care were excluded.
Dr. Argyelan and his colleagues did not see any significant differences between the preterm and term delivery groups in maternal age, body mass index, or ethnicity.
“Among spontaneous preterm deliveries in low-risk women, the proportion of deliveries before 34 weeks was decreased” after the intervention, said Dr. Argyelan, who reported seeing a decrease from 28% early (less than 34 weeks’ gestation) preterm births before the intervention to 17% after the intervention.
In response to an audience question, Dr. Argyelan noted that his institution charges $186 for an ultrasound examination that includes assessment of cervical length, saying, “We have not had significant issues being reimbursed.”
Another audience member asked what the institution policy had been before the universal screening program was implemented. “Before the universal screening study, there was a policy of screening those with a history of preterm birth; also, if sonographers saw what looked like a short cervix on transabdominal exam, then they would do a transvaginal scan to further assess the cervix,” Dr. Argyelan said.
Dr. Argyelan reported having no financial disclosures.
[email protected]
On Twitter @karioakes
AT THE ANNUAL PREGNANCY MEETING
Key clinical point:
Major finding: Preterm births dropped from 3.8% to 2.4% (P less than .001) after implementing a universal cervical length screening program.
Data source: Retrospective single-site cohort study of 13,396 singleton pregnancies.
Disclosures: Dr. Argyelan reported having no financial disclosures.