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Mitchel is a reporter for MDedge based in the Philadelphia area. He started with the company in 1992, when it was International Medical News Group (IMNG), and has since covered a range of medical specialties. Mitchel trained as a virologist at Roswell Park Memorial Institute in Buffalo, and then worked briefly as a researcher at Boston Children's Hospital before pivoting to journalism as a AAAS Mass Media Fellow in 1980. His first reporting job was with Science Digest magazine, and from the mid-1980s to early-1990s he was a reporter with Medical World News. @mitchelzoler
Hypertensive disease of pregnancy linked to earlier mortality
LAS VEGAS – Women who develop any form of hypertensive disease during pregnancy have a significantly increased mortality rate until they reach age 50, compared with women without the condition.
The findings, presented at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine, are based on a review of more than 2 million mothers who delivered babies in Utah during 1939-2012.
The relatively increased mortality rate linked with hypertensive disease of pregnancy (HDP) reached its peak during the first decade immediately following the index delivery and was dramatically higher in women for whom the index HDP was preceded by at least one earlier HDP. Increased mortality was especially elevated for certain types of deaths including stroke, diabetes, circulatory disease, and ischemic heart disease, said Lauren Theilen, MD, a maternal-fetal medicine researcher at the University of Utah in Salt Lake City.
She calculated that during the decade following an index case of HDP, life expectancy among mothers who had two or more HDP-affected pregnancies was about 49 years, life expectancy among women with a history of one HDP was 52 years, and postpartum women without HDP had a life expectancy of 55 years.
The data came from 2,083,331 singleton pregnancies delivered in Utah during 1939-2012 where the mother remained in Utah for at least 1 year following delivery. From this group, Dr. Theilen and her associates identified 67,384 women (3%) with HDP, including 49,598 women without a prior history of HDP and 7,786 with at least one prior HDP pregnancy. They included four different diagnoses as HDP: gestational hypertension, preeclampsia, HELLP syndrome (hemolysis, elevated liver enzymes, and low platelet count), or eclampsia.
The analysis excluded women with chronic hypertension, antiphospholipid syndrome, pregestational diabetes, or chronic kidney disease. It also excluded women who died within a year of the index delivery. For each of the included 67,384 cases with HDP, the researchers selected two controls with a delivery unaffected by HDP and matched them to a case by age, year of childbirth, and parity.
The women in the study were 26 years old on average. Gestational age at delivery among the HDP cases averaged 1 week less than among the controls, 37.8 weeks compared with 38.9 weeks, a statistically significant difference. Average birth weight also differed by a significant amount, 3,079 grams in the HDP neonates and 3,319 grams in the control newborns. During follow-up, 8% of the HDP women died, compared with 6% of the control women.
Analysis showed that relative mortality rates in HDP women were especially elevated for certain types of death: endocrine and metabolic, circulatory, genitourinary, infectious disease, and digestive. In most types of death, the increased risk linked with HDP was markedly higher in the women with recurrent HDP.
Dr. Theilen reported the relative risks of death for certain specific mortality causes (Am J Obstet Gynecol. 2017 Jan;216[1][suppl]:S32-3). In women with a single index case of HDP, the mortality rate compared to women with no HDP was threefold higher for diabetes, twofold higher for ischemic heart disease, and 85% higher for stroke. In women with recurrent HDP, the relative mortality risks were fourfold higher for diabetes, threefold higher for ischemic heart disease, and fivefold higher for stroke.
For all causes of death except stroke, the increased relative risk from HDP existed only for women younger than 51 years. Once HDP women passed the age of 50, their excess mortality risk was substantially muted, even in women with recurrent HDP. But for stroke mortality, the added risk persisted among older women with a history of at least two HDPs. In this subgroup, stroke deaths were nearly fourfold higher than in the matched controls.
Dr. Theilen reported having no financial disclosures.
mzoler@frontlinemedcom.com
On Twitter @mitchelzoler
The findings Dr. Theilen and her associates made in this study confirm results reported several decades ago that first established a link between hypertensive disease of pregnancy (HDP) and significantly reduced life expectancy. We have known for some time that HDP identifies women with a long-term mortality risk. The real question is: Can we ameliorate the risk linked with HDP?
We know that HDP requires acute management, but we are not sure how to best manage these women once they have delivered. To address that, we need prospective studies.
Not all women who experience HDP receive appropriate follow-up after delivery. We need to ensure a better handoff of women who developed HDP from the physicians who cared for these women during pregnancy to the physicians who care for these women postpartum and during the balance of their life. Ideally, a primary care physician should closely follow and manage blood pressure and other risk factors of HDP women once they are no longer pregnant.
Mary E. D’Alton, MD , is professor and chair of ob.gyn. at Columbia University Medical Center in New York City. She is on the advisory board of Merck for Mothers. She made these comments in an interview.
The findings Dr. Theilen and her associates made in this study confirm results reported several decades ago that first established a link between hypertensive disease of pregnancy (HDP) and significantly reduced life expectancy. We have known for some time that HDP identifies women with a long-term mortality risk. The real question is: Can we ameliorate the risk linked with HDP?
We know that HDP requires acute management, but we are not sure how to best manage these women once they have delivered. To address that, we need prospective studies.
Not all women who experience HDP receive appropriate follow-up after delivery. We need to ensure a better handoff of women who developed HDP from the physicians who cared for these women during pregnancy to the physicians who care for these women postpartum and during the balance of their life. Ideally, a primary care physician should closely follow and manage blood pressure and other risk factors of HDP women once they are no longer pregnant.
Mary E. D’Alton, MD , is professor and chair of ob.gyn. at Columbia University Medical Center in New York City. She is on the advisory board of Merck for Mothers. She made these comments in an interview.
The findings Dr. Theilen and her associates made in this study confirm results reported several decades ago that first established a link between hypertensive disease of pregnancy (HDP) and significantly reduced life expectancy. We have known for some time that HDP identifies women with a long-term mortality risk. The real question is: Can we ameliorate the risk linked with HDP?
We know that HDP requires acute management, but we are not sure how to best manage these women once they have delivered. To address that, we need prospective studies.
Not all women who experience HDP receive appropriate follow-up after delivery. We need to ensure a better handoff of women who developed HDP from the physicians who cared for these women during pregnancy to the physicians who care for these women postpartum and during the balance of their life. Ideally, a primary care physician should closely follow and manage blood pressure and other risk factors of HDP women once they are no longer pregnant.
Mary E. D’Alton, MD , is professor and chair of ob.gyn. at Columbia University Medical Center in New York City. She is on the advisory board of Merck for Mothers. She made these comments in an interview.
LAS VEGAS – Women who develop any form of hypertensive disease during pregnancy have a significantly increased mortality rate until they reach age 50, compared with women without the condition.
The findings, presented at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine, are based on a review of more than 2 million mothers who delivered babies in Utah during 1939-2012.
The relatively increased mortality rate linked with hypertensive disease of pregnancy (HDP) reached its peak during the first decade immediately following the index delivery and was dramatically higher in women for whom the index HDP was preceded by at least one earlier HDP. Increased mortality was especially elevated for certain types of deaths including stroke, diabetes, circulatory disease, and ischemic heart disease, said Lauren Theilen, MD, a maternal-fetal medicine researcher at the University of Utah in Salt Lake City.
She calculated that during the decade following an index case of HDP, life expectancy among mothers who had two or more HDP-affected pregnancies was about 49 years, life expectancy among women with a history of one HDP was 52 years, and postpartum women without HDP had a life expectancy of 55 years.
The data came from 2,083,331 singleton pregnancies delivered in Utah during 1939-2012 where the mother remained in Utah for at least 1 year following delivery. From this group, Dr. Theilen and her associates identified 67,384 women (3%) with HDP, including 49,598 women without a prior history of HDP and 7,786 with at least one prior HDP pregnancy. They included four different diagnoses as HDP: gestational hypertension, preeclampsia, HELLP syndrome (hemolysis, elevated liver enzymes, and low platelet count), or eclampsia.
The analysis excluded women with chronic hypertension, antiphospholipid syndrome, pregestational diabetes, or chronic kidney disease. It also excluded women who died within a year of the index delivery. For each of the included 67,384 cases with HDP, the researchers selected two controls with a delivery unaffected by HDP and matched them to a case by age, year of childbirth, and parity.
The women in the study were 26 years old on average. Gestational age at delivery among the HDP cases averaged 1 week less than among the controls, 37.8 weeks compared with 38.9 weeks, a statistically significant difference. Average birth weight also differed by a significant amount, 3,079 grams in the HDP neonates and 3,319 grams in the control newborns. During follow-up, 8% of the HDP women died, compared with 6% of the control women.
Analysis showed that relative mortality rates in HDP women were especially elevated for certain types of death: endocrine and metabolic, circulatory, genitourinary, infectious disease, and digestive. In most types of death, the increased risk linked with HDP was markedly higher in the women with recurrent HDP.
Dr. Theilen reported the relative risks of death for certain specific mortality causes (Am J Obstet Gynecol. 2017 Jan;216[1][suppl]:S32-3). In women with a single index case of HDP, the mortality rate compared to women with no HDP was threefold higher for diabetes, twofold higher for ischemic heart disease, and 85% higher for stroke. In women with recurrent HDP, the relative mortality risks were fourfold higher for diabetes, threefold higher for ischemic heart disease, and fivefold higher for stroke.
For all causes of death except stroke, the increased relative risk from HDP existed only for women younger than 51 years. Once HDP women passed the age of 50, their excess mortality risk was substantially muted, even in women with recurrent HDP. But for stroke mortality, the added risk persisted among older women with a history of at least two HDPs. In this subgroup, stroke deaths were nearly fourfold higher than in the matched controls.
Dr. Theilen reported having no financial disclosures.
mzoler@frontlinemedcom.com
On Twitter @mitchelzoler
LAS VEGAS – Women who develop any form of hypertensive disease during pregnancy have a significantly increased mortality rate until they reach age 50, compared with women without the condition.
The findings, presented at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine, are based on a review of more than 2 million mothers who delivered babies in Utah during 1939-2012.
The relatively increased mortality rate linked with hypertensive disease of pregnancy (HDP) reached its peak during the first decade immediately following the index delivery and was dramatically higher in women for whom the index HDP was preceded by at least one earlier HDP. Increased mortality was especially elevated for certain types of deaths including stroke, diabetes, circulatory disease, and ischemic heart disease, said Lauren Theilen, MD, a maternal-fetal medicine researcher at the University of Utah in Salt Lake City.
She calculated that during the decade following an index case of HDP, life expectancy among mothers who had two or more HDP-affected pregnancies was about 49 years, life expectancy among women with a history of one HDP was 52 years, and postpartum women without HDP had a life expectancy of 55 years.
The data came from 2,083,331 singleton pregnancies delivered in Utah during 1939-2012 where the mother remained in Utah for at least 1 year following delivery. From this group, Dr. Theilen and her associates identified 67,384 women (3%) with HDP, including 49,598 women without a prior history of HDP and 7,786 with at least one prior HDP pregnancy. They included four different diagnoses as HDP: gestational hypertension, preeclampsia, HELLP syndrome (hemolysis, elevated liver enzymes, and low platelet count), or eclampsia.
The analysis excluded women with chronic hypertension, antiphospholipid syndrome, pregestational diabetes, or chronic kidney disease. It also excluded women who died within a year of the index delivery. For each of the included 67,384 cases with HDP, the researchers selected two controls with a delivery unaffected by HDP and matched them to a case by age, year of childbirth, and parity.
The women in the study were 26 years old on average. Gestational age at delivery among the HDP cases averaged 1 week less than among the controls, 37.8 weeks compared with 38.9 weeks, a statistically significant difference. Average birth weight also differed by a significant amount, 3,079 grams in the HDP neonates and 3,319 grams in the control newborns. During follow-up, 8% of the HDP women died, compared with 6% of the control women.
Analysis showed that relative mortality rates in HDP women were especially elevated for certain types of death: endocrine and metabolic, circulatory, genitourinary, infectious disease, and digestive. In most types of death, the increased risk linked with HDP was markedly higher in the women with recurrent HDP.
Dr. Theilen reported the relative risks of death for certain specific mortality causes (Am J Obstet Gynecol. 2017 Jan;216[1][suppl]:S32-3). In women with a single index case of HDP, the mortality rate compared to women with no HDP was threefold higher for diabetes, twofold higher for ischemic heart disease, and 85% higher for stroke. In women with recurrent HDP, the relative mortality risks were fourfold higher for diabetes, threefold higher for ischemic heart disease, and fivefold higher for stroke.
For all causes of death except stroke, the increased relative risk from HDP existed only for women younger than 51 years. Once HDP women passed the age of 50, their excess mortality risk was substantially muted, even in women with recurrent HDP. But for stroke mortality, the added risk persisted among older women with a history of at least two HDPs. In this subgroup, stroke deaths were nearly fourfold higher than in the matched controls.
Dr. Theilen reported having no financial disclosures.
mzoler@frontlinemedcom.com
On Twitter @mitchelzoler
AT THE PREGNANCY MEETING
Key clinical point:
Major finding: Postpartum life expectancy was 49 years in women with two or more hypertensive pregnancies and 55 years in women without hypertension.
Data source: Retrospective, case-control study of 2,083,331 singleton pregnancies delivered in Utah during 1939-2012.
Disclosures: Dr. Theilen reported having no 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.
mzoler@frontlinemedcom.com 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.
mzoler@frontlinemedcom.com 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.
mzoler@frontlinemedcom.com 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.
mzoler@frontlinemedcom.com 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.
mzoler@frontlinemedcom.com 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.
mzoler@frontlinemedcom.com 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.
mzoler@frontlinemedcom.com
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.
mzoler@frontlinemedcom.com
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.
mzoler@frontlinemedcom.com
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).
mzoler@frontlinemedcom.com
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).
mzoler@frontlinemedcom.com
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).
mzoler@frontlinemedcom.com
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.
Strokes cut by extended NOAC prophylaxis in hospitalized, medically ill patients
NEW ORLEANS – Thromboprophylaxis for 35-42 days with the new oral anticoagulant betrixaban led to a significant reduction in all-cause and ischemic strokes in medically ill patients who required hospitalization as compared with conventional prophylaxis for 10 days, based on a post-hoc analysis of data from a randomized trial with more than 7,500 patients.
But the trial’s unusual design left it unclear whether the incremental benefit seen from prolonged prophylaxis with a NOAC resulted primarily from a longer period of treatment, the drug used, or both.
The safety analysis showed that prolonged treatment with betrixaban roughly doubled the rate of major or clinically relevant nonmajor bleeding events during the period of treatment and for the first 7 days after treatment stopped. The incidence of these bleeds was 1.6% among control patients on 10 days of enoxaparin treatment and 3.1% among patients who received extended treatment with betrixaban, a statistically significant difference. The rates of fatal bleeds and intracranial hemorrhages in the two study groups did not significantly differ.
The data Dr. Gibson reported came from the Multicenter, Randomized, Active-Controlled Efficacy And Safety Study Comparing Extended Duration Betrixaban With Standard Of Care Enoxaparin For The Prevention Of Venous Thromboembolism In Acute Medically Ill Patients (APEX). The study’s primary aim was testing in 7,513 hospitalized medically ill patients the safety and efficacy of prolonged prophylaxis with the oral, factor Xa inhibitor betrixaban, compared with 10 days of prophylaxis with the low molecular weight heparin enoxaparin. The primary endpoint was the rate of venous thromboembolic events and deaths from venous thromboembolism (VTE) out to 47 days after the start of treatment.
APEX enrolled patients hospitalized for acute decompensated heart failure, chronic respiratory failure, acute infection without septic shock, acute rheumatic disorders or acute ischemic stroke. All enrolled patients had to be expected to be immobilized for at least 24 hours following randomization and to be hospitalized for at least 3 days. Patients also had to have an additional risk marker for high thrombotic risk: They had to be at least 75 years old, or 60-74 years old with a D-dimer level at least twice the upper limit of normal, or 40-59 years old with a D-dimer level at least twice the upper limit of normal and a history of either VTE or cancer.
Results for the primary endpoint, reported in 2016, showed that prolonged betrixaban prophylaxis linked with an absolute 1.6% reduction in the combined endpoint, which resulted in a 19% relative risk reduction that fell just short of the trial’s prespecified definition of statistical significance. The study’s primary safety endpoint was the occurrence of major bleeding events through 7 days after the stop of treatment, which occurred in 0.7% of the betrixaban patients and in 0.6% of those on enoxaparin (N Engl J Med. 2016 Aug 11;375[6]:534-44).
Even thought the primary results from this pivotal trial failed to meet the prespecified threshold for statistical significance, the company developing betrixaban, Portola, submitted an application to the Food and Drug Administration to approve marketing of extended-duration betrixaban for VTE prophylaxis in acute medically-ill patients with VTE risk factors. In December 2016, Portola announced that the FDA had given the application priority status for a decision.
The post-hoc analysis that Dr. Gibson presented at the meeting looked at the impact of betrixaban compared with enoxaparin on the incidence of all-cause and ischemic stroke during 77 days of follow-up after the start of treatment in the 7,432 patients who received at least one dose of their assigned drug, two endpoints that weren’t even secondary outcomes in APEX’s original design.
Among the 3,716 treated with betrixaban, the all-cause stroke incidence was 0.54%; among the 3,716 patients treated with enoxaparin, the all-cause stroke incidence was 0.97%. The 56% relative risk reduction was statistically significant. The incidence of ischemic strokes was 0.48% with betrixaban and 0.91% with enoxaparin, a 53% relative risk reduction that was also statistically significant.
The post-hoc analysis also looked specifically at the comparison between betrixaban and enoxaparin for stroke prevention in a subgroup of patients who had the highest stroke rate, the patients who were hospitalized because of an index stroke or an index heart failure episode. In this high-risk subgroup, prophylaxis with betrixaban cut the all-cause stroke rate compared with enoxaparin by 49% and the ischemic stroke rate by 45%, both statistically significant effects. When the high-risk subgroup also included patients hospitalized for an index episode of atrial fibrillation, betrixaban cut the rate of all-cause strokes by a relative 48% and ischemic strokes by a relative 44%.
Concurrently with Dr. Gibson’s report at the meeting, the results also appeared online (Circulation. 2016 Nov 14. doi: 10.1161/CIRCULATIONAHA.116.025427).
APEX was sponsored by Portola, the company developing betrixaban. Dr. Gibson has been a consultant to Eli Lilly, Gilead, The Medicines Company, Novo Nordisk, Pfizer, and St. Jude. He has received research support from Portola and several other companies.
mzoler@frontlinemedcom.com
On Twitter @mitchelzoler
The APEX study identified a group of patients hospitalized for medical reasons who were at high risk for both venous thromboembolism and for stroke. We are comfortable with the concept of thromboprophylaxis for hospitalized patients who are at high risk for venous thromboembolism, but we have generally not paid attention to prophylaxis against stroke during and immediately after hospitalization.
The results suggest that extending thromboprophylaxis beyond the standard period of 10 days may be a good idea. Because patients in the two treatment arms of the study differed in both the drugs they received and in the duration of prophylaxis, the results cannot distinguish which of these two variables was more important. Treating patients with enoxaparin for 35-42 days may provide a similar benefit to what was seen with extended-duration betrixaban.
The findings are a wake-up call to the high thromboembolic risk faced by the types of patients enrolled in APEX, and they point to a new way to manage these patients. Guidelines already call for putting high-risk patients, such as those with heart failure, on anticoagulant prophylaxis if they have no contraindications. These new data suggest that thromboprophylaxis in appropriate patients should extend beyond 10 days and beyond acute hospitalization.
Steven R. Lentz, MD, is a professor of medicine and a hematologist oncologist at the University of Iowa in Iowa City. He has been a consultant to Novo Nordisk and Opko, has an ownership interest in Celgene, and has received research grants from Novo Nordisk. He made these comments in an interview.
The APEX study identified a group of patients hospitalized for medical reasons who were at high risk for both venous thromboembolism and for stroke. We are comfortable with the concept of thromboprophylaxis for hospitalized patients who are at high risk for venous thromboembolism, but we have generally not paid attention to prophylaxis against stroke during and immediately after hospitalization.
The results suggest that extending thromboprophylaxis beyond the standard period of 10 days may be a good idea. Because patients in the two treatment arms of the study differed in both the drugs they received and in the duration of prophylaxis, the results cannot distinguish which of these two variables was more important. Treating patients with enoxaparin for 35-42 days may provide a similar benefit to what was seen with extended-duration betrixaban.
The findings are a wake-up call to the high thromboembolic risk faced by the types of patients enrolled in APEX, and they point to a new way to manage these patients. Guidelines already call for putting high-risk patients, such as those with heart failure, on anticoagulant prophylaxis if they have no contraindications. These new data suggest that thromboprophylaxis in appropriate patients should extend beyond 10 days and beyond acute hospitalization.
Steven R. Lentz, MD, is a professor of medicine and a hematologist oncologist at the University of Iowa in Iowa City. He has been a consultant to Novo Nordisk and Opko, has an ownership interest in Celgene, and has received research grants from Novo Nordisk. He made these comments in an interview.
The APEX study identified a group of patients hospitalized for medical reasons who were at high risk for both venous thromboembolism and for stroke. We are comfortable with the concept of thromboprophylaxis for hospitalized patients who are at high risk for venous thromboembolism, but we have generally not paid attention to prophylaxis against stroke during and immediately after hospitalization.
The results suggest that extending thromboprophylaxis beyond the standard period of 10 days may be a good idea. Because patients in the two treatment arms of the study differed in both the drugs they received and in the duration of prophylaxis, the results cannot distinguish which of these two variables was more important. Treating patients with enoxaparin for 35-42 days may provide a similar benefit to what was seen with extended-duration betrixaban.
The findings are a wake-up call to the high thromboembolic risk faced by the types of patients enrolled in APEX, and they point to a new way to manage these patients. Guidelines already call for putting high-risk patients, such as those with heart failure, on anticoagulant prophylaxis if they have no contraindications. These new data suggest that thromboprophylaxis in appropriate patients should extend beyond 10 days and beyond acute hospitalization.
Steven R. Lentz, MD, is a professor of medicine and a hematologist oncologist at the University of Iowa in Iowa City. He has been a consultant to Novo Nordisk and Opko, has an ownership interest in Celgene, and has received research grants from Novo Nordisk. He made these comments in an interview.
NEW ORLEANS – Thromboprophylaxis for 35-42 days with the new oral anticoagulant betrixaban led to a significant reduction in all-cause and ischemic strokes in medically ill patients who required hospitalization as compared with conventional prophylaxis for 10 days, based on a post-hoc analysis of data from a randomized trial with more than 7,500 patients.
But the trial’s unusual design left it unclear whether the incremental benefit seen from prolonged prophylaxis with a NOAC resulted primarily from a longer period of treatment, the drug used, or both.
The safety analysis showed that prolonged treatment with betrixaban roughly doubled the rate of major or clinically relevant nonmajor bleeding events during the period of treatment and for the first 7 days after treatment stopped. The incidence of these bleeds was 1.6% among control patients on 10 days of enoxaparin treatment and 3.1% among patients who received extended treatment with betrixaban, a statistically significant difference. The rates of fatal bleeds and intracranial hemorrhages in the two study groups did not significantly differ.
The data Dr. Gibson reported came from the Multicenter, Randomized, Active-Controlled Efficacy And Safety Study Comparing Extended Duration Betrixaban With Standard Of Care Enoxaparin For The Prevention Of Venous Thromboembolism In Acute Medically Ill Patients (APEX). The study’s primary aim was testing in 7,513 hospitalized medically ill patients the safety and efficacy of prolonged prophylaxis with the oral, factor Xa inhibitor betrixaban, compared with 10 days of prophylaxis with the low molecular weight heparin enoxaparin. The primary endpoint was the rate of venous thromboembolic events and deaths from venous thromboembolism (VTE) out to 47 days after the start of treatment.
APEX enrolled patients hospitalized for acute decompensated heart failure, chronic respiratory failure, acute infection without septic shock, acute rheumatic disorders or acute ischemic stroke. All enrolled patients had to be expected to be immobilized for at least 24 hours following randomization and to be hospitalized for at least 3 days. Patients also had to have an additional risk marker for high thrombotic risk: They had to be at least 75 years old, or 60-74 years old with a D-dimer level at least twice the upper limit of normal, or 40-59 years old with a D-dimer level at least twice the upper limit of normal and a history of either VTE or cancer.
Results for the primary endpoint, reported in 2016, showed that prolonged betrixaban prophylaxis linked with an absolute 1.6% reduction in the combined endpoint, which resulted in a 19% relative risk reduction that fell just short of the trial’s prespecified definition of statistical significance. The study’s primary safety endpoint was the occurrence of major bleeding events through 7 days after the stop of treatment, which occurred in 0.7% of the betrixaban patients and in 0.6% of those on enoxaparin (N Engl J Med. 2016 Aug 11;375[6]:534-44).
Even thought the primary results from this pivotal trial failed to meet the prespecified threshold for statistical significance, the company developing betrixaban, Portola, submitted an application to the Food and Drug Administration to approve marketing of extended-duration betrixaban for VTE prophylaxis in acute medically-ill patients with VTE risk factors. In December 2016, Portola announced that the FDA had given the application priority status for a decision.
The post-hoc analysis that Dr. Gibson presented at the meeting looked at the impact of betrixaban compared with enoxaparin on the incidence of all-cause and ischemic stroke during 77 days of follow-up after the start of treatment in the 7,432 patients who received at least one dose of their assigned drug, two endpoints that weren’t even secondary outcomes in APEX’s original design.
Among the 3,716 treated with betrixaban, the all-cause stroke incidence was 0.54%; among the 3,716 patients treated with enoxaparin, the all-cause stroke incidence was 0.97%. The 56% relative risk reduction was statistically significant. The incidence of ischemic strokes was 0.48% with betrixaban and 0.91% with enoxaparin, a 53% relative risk reduction that was also statistically significant.
The post-hoc analysis also looked specifically at the comparison between betrixaban and enoxaparin for stroke prevention in a subgroup of patients who had the highest stroke rate, the patients who were hospitalized because of an index stroke or an index heart failure episode. In this high-risk subgroup, prophylaxis with betrixaban cut the all-cause stroke rate compared with enoxaparin by 49% and the ischemic stroke rate by 45%, both statistically significant effects. When the high-risk subgroup also included patients hospitalized for an index episode of atrial fibrillation, betrixaban cut the rate of all-cause strokes by a relative 48% and ischemic strokes by a relative 44%.
Concurrently with Dr. Gibson’s report at the meeting, the results also appeared online (Circulation. 2016 Nov 14. doi: 10.1161/CIRCULATIONAHA.116.025427).
APEX was sponsored by Portola, the company developing betrixaban. Dr. Gibson has been a consultant to Eli Lilly, Gilead, The Medicines Company, Novo Nordisk, Pfizer, and St. Jude. He has received research support from Portola and several other companies.
mzoler@frontlinemedcom.com
On Twitter @mitchelzoler
NEW ORLEANS – Thromboprophylaxis for 35-42 days with the new oral anticoagulant betrixaban led to a significant reduction in all-cause and ischemic strokes in medically ill patients who required hospitalization as compared with conventional prophylaxis for 10 days, based on a post-hoc analysis of data from a randomized trial with more than 7,500 patients.
But the trial’s unusual design left it unclear whether the incremental benefit seen from prolonged prophylaxis with a NOAC resulted primarily from a longer period of treatment, the drug used, or both.
The safety analysis showed that prolonged treatment with betrixaban roughly doubled the rate of major or clinically relevant nonmajor bleeding events during the period of treatment and for the first 7 days after treatment stopped. The incidence of these bleeds was 1.6% among control patients on 10 days of enoxaparin treatment and 3.1% among patients who received extended treatment with betrixaban, a statistically significant difference. The rates of fatal bleeds and intracranial hemorrhages in the two study groups did not significantly differ.
The data Dr. Gibson reported came from the Multicenter, Randomized, Active-Controlled Efficacy And Safety Study Comparing Extended Duration Betrixaban With Standard Of Care Enoxaparin For The Prevention Of Venous Thromboembolism In Acute Medically Ill Patients (APEX). The study’s primary aim was testing in 7,513 hospitalized medically ill patients the safety and efficacy of prolonged prophylaxis with the oral, factor Xa inhibitor betrixaban, compared with 10 days of prophylaxis with the low molecular weight heparin enoxaparin. The primary endpoint was the rate of venous thromboembolic events and deaths from venous thromboembolism (VTE) out to 47 days after the start of treatment.
APEX enrolled patients hospitalized for acute decompensated heart failure, chronic respiratory failure, acute infection without septic shock, acute rheumatic disorders or acute ischemic stroke. All enrolled patients had to be expected to be immobilized for at least 24 hours following randomization and to be hospitalized for at least 3 days. Patients also had to have an additional risk marker for high thrombotic risk: They had to be at least 75 years old, or 60-74 years old with a D-dimer level at least twice the upper limit of normal, or 40-59 years old with a D-dimer level at least twice the upper limit of normal and a history of either VTE or cancer.
Results for the primary endpoint, reported in 2016, showed that prolonged betrixaban prophylaxis linked with an absolute 1.6% reduction in the combined endpoint, which resulted in a 19% relative risk reduction that fell just short of the trial’s prespecified definition of statistical significance. The study’s primary safety endpoint was the occurrence of major bleeding events through 7 days after the stop of treatment, which occurred in 0.7% of the betrixaban patients and in 0.6% of those on enoxaparin (N Engl J Med. 2016 Aug 11;375[6]:534-44).
Even thought the primary results from this pivotal trial failed to meet the prespecified threshold for statistical significance, the company developing betrixaban, Portola, submitted an application to the Food and Drug Administration to approve marketing of extended-duration betrixaban for VTE prophylaxis in acute medically-ill patients with VTE risk factors. In December 2016, Portola announced that the FDA had given the application priority status for a decision.
The post-hoc analysis that Dr. Gibson presented at the meeting looked at the impact of betrixaban compared with enoxaparin on the incidence of all-cause and ischemic stroke during 77 days of follow-up after the start of treatment in the 7,432 patients who received at least one dose of their assigned drug, two endpoints that weren’t even secondary outcomes in APEX’s original design.
Among the 3,716 treated with betrixaban, the all-cause stroke incidence was 0.54%; among the 3,716 patients treated with enoxaparin, the all-cause stroke incidence was 0.97%. The 56% relative risk reduction was statistically significant. The incidence of ischemic strokes was 0.48% with betrixaban and 0.91% with enoxaparin, a 53% relative risk reduction that was also statistically significant.
The post-hoc analysis also looked specifically at the comparison between betrixaban and enoxaparin for stroke prevention in a subgroup of patients who had the highest stroke rate, the patients who were hospitalized because of an index stroke or an index heart failure episode. In this high-risk subgroup, prophylaxis with betrixaban cut the all-cause stroke rate compared with enoxaparin by 49% and the ischemic stroke rate by 45%, both statistically significant effects. When the high-risk subgroup also included patients hospitalized for an index episode of atrial fibrillation, betrixaban cut the rate of all-cause strokes by a relative 48% and ischemic strokes by a relative 44%.
Concurrently with Dr. Gibson’s report at the meeting, the results also appeared online (Circulation. 2016 Nov 14. doi: 10.1161/CIRCULATIONAHA.116.025427).
APEX was sponsored by Portola, the company developing betrixaban. Dr. Gibson has been a consultant to Eli Lilly, Gilead, The Medicines Company, Novo Nordisk, Pfizer, and St. Jude. He has received research support from Portola and several other companies.
mzoler@frontlinemedcom.com
On Twitter @mitchelzoler
AT THE AHA SCIENTIFIC SESSIONS
Key clinical point:
Major finding: Strokes occurred in 0.54% of patients on extended-duration betrixaban prophylaxis and in 0.97% of patients on standard-duration enoxaparin.
Data source: APEX, a multicenter randomized trial with 7,513 patients.
Disclosures: APEX was sponsored by Portola, the company developing betrixaban. Dr. Gibson has been a consultant to Eli Lilly, Gilead, The Medicines Company, Novo Nordisk, Pfizer and St. Jude. He has received research support from Portola and several other companies.
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.
mzoler@frontlinemedcom.com
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.
mzoler@frontlinemedcom.com
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.
mzoler@frontlinemedcom.com
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.
mzoler@frontlinemedcom.com
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.
mzoler@frontlinemedcom.com
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.
mzoler@frontlinemedcom.com
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.
Childhood obesity tied to maternal obesity, cesarean birth
NEW ORLEANS – Maternal obesity and cesarean delivery were each independently associated with increased rates of overweight or obesity during childhood in a prospective study of 1,441 mothers and their children.
In addition, these risks for childhood obesity appeared to interact in an additive way, so that women who were both obese and delivered by C-section had a nearly threefold increased rate of having a child who was overweight or obese at about 5 years of age, compared with children born to normal-weight women who delivered vaginally, Noel T. Mueller, PhD, said at the American Heart Association Scientific Sessions.
This finding of a link between maternal overweight and obesity and childhood obesity in the next generation supports results from previously reported studies. The new results “also add to the growing evidence for an association between C-section and obesity [in offspring], as well as C-section and immune-related disorders such as asthma and allergies” in offspring, Dr. Mueller said in an interview.
He hypothesized that delivery mode may contribute to a child’s obesity risk by producing an abnormal gastrointestinal microbiome. For example, vaginal delivery seems to associate with a higher prevalence of Bacteroides species in a child’s gut, bacteria that aid in the digestion of breast milk, Dr. Mueller said.
His study used data collected in the Boston Birth Cohort from 1,441 mothers and their children from full-term, singleton pregnancies born to women with a body mass index of at least 18.5 kg/m2 during 1998-2014. The child’s weight was measured at a median age of 4.8 years, with an interquartile range of 3-6 years. Children were deemed overweight if they were at or above the 85th percentile for weight, according to standards from the Centers for Disease Control and Prevention.
Just under half the women were normal weight, slightly more than a quarter were overweight, and a quarter were obese. The incidence of 5-year-old children who were overweight or obese was 70% higher in children of overweight mothers and 80% higher in those with obese mothers, compared with children with normal-weight mothers in an analysis that adjusted for maternal age at delivery, race or ethnicity, and education. Both were statistically significant differences, Dr. Mueller reported.
Two-thirds of the women had vaginal deliveries and a third had C-sections. Overweight or obesity occurred in 40% more of the children delivered by C-section, compared with children born vaginally, a statistically significant difference in an analysis that controlled for the same three covariates as well as prepregnancy body mass index, pregnancy weight gain, and other variables.
When Dr. Mueller and his associates ran a combined analysis they found that the highest risk for childhood overweight or obesity was in children born to obese mothers by C-section, and it was a 2.8-fold higher rate than that in the children born to normal-weight mothers by vaginal delivery, a statistically significant difference.
Dr. Mueller had no disclosures.
mzoler@frontlinemedcom.com
On Twitter @mitchelzoler
NEW ORLEANS – Maternal obesity and cesarean delivery were each independently associated with increased rates of overweight or obesity during childhood in a prospective study of 1,441 mothers and their children.
In addition, these risks for childhood obesity appeared to interact in an additive way, so that women who were both obese and delivered by C-section had a nearly threefold increased rate of having a child who was overweight or obese at about 5 years of age, compared with children born to normal-weight women who delivered vaginally, Noel T. Mueller, PhD, said at the American Heart Association Scientific Sessions.
This finding of a link between maternal overweight and obesity and childhood obesity in the next generation supports results from previously reported studies. The new results “also add to the growing evidence for an association between C-section and obesity [in offspring], as well as C-section and immune-related disorders such as asthma and allergies” in offspring, Dr. Mueller said in an interview.
He hypothesized that delivery mode may contribute to a child’s obesity risk by producing an abnormal gastrointestinal microbiome. For example, vaginal delivery seems to associate with a higher prevalence of Bacteroides species in a child’s gut, bacteria that aid in the digestion of breast milk, Dr. Mueller said.
His study used data collected in the Boston Birth Cohort from 1,441 mothers and their children from full-term, singleton pregnancies born to women with a body mass index of at least 18.5 kg/m2 during 1998-2014. The child’s weight was measured at a median age of 4.8 years, with an interquartile range of 3-6 years. Children were deemed overweight if they were at or above the 85th percentile for weight, according to standards from the Centers for Disease Control and Prevention.
Just under half the women were normal weight, slightly more than a quarter were overweight, and a quarter were obese. The incidence of 5-year-old children who were overweight or obese was 70% higher in children of overweight mothers and 80% higher in those with obese mothers, compared with children with normal-weight mothers in an analysis that adjusted for maternal age at delivery, race or ethnicity, and education. Both were statistically significant differences, Dr. Mueller reported.
Two-thirds of the women had vaginal deliveries and a third had C-sections. Overweight or obesity occurred in 40% more of the children delivered by C-section, compared with children born vaginally, a statistically significant difference in an analysis that controlled for the same three covariates as well as prepregnancy body mass index, pregnancy weight gain, and other variables.
When Dr. Mueller and his associates ran a combined analysis they found that the highest risk for childhood overweight or obesity was in children born to obese mothers by C-section, and it was a 2.8-fold higher rate than that in the children born to normal-weight mothers by vaginal delivery, a statistically significant difference.
Dr. Mueller had no disclosures.
mzoler@frontlinemedcom.com
On Twitter @mitchelzoler
NEW ORLEANS – Maternal obesity and cesarean delivery were each independently associated with increased rates of overweight or obesity during childhood in a prospective study of 1,441 mothers and their children.
In addition, these risks for childhood obesity appeared to interact in an additive way, so that women who were both obese and delivered by C-section had a nearly threefold increased rate of having a child who was overweight or obese at about 5 years of age, compared with children born to normal-weight women who delivered vaginally, Noel T. Mueller, PhD, said at the American Heart Association Scientific Sessions.
This finding of a link between maternal overweight and obesity and childhood obesity in the next generation supports results from previously reported studies. The new results “also add to the growing evidence for an association between C-section and obesity [in offspring], as well as C-section and immune-related disorders such as asthma and allergies” in offspring, Dr. Mueller said in an interview.
He hypothesized that delivery mode may contribute to a child’s obesity risk by producing an abnormal gastrointestinal microbiome. For example, vaginal delivery seems to associate with a higher prevalence of Bacteroides species in a child’s gut, bacteria that aid in the digestion of breast milk, Dr. Mueller said.
His study used data collected in the Boston Birth Cohort from 1,441 mothers and their children from full-term, singleton pregnancies born to women with a body mass index of at least 18.5 kg/m2 during 1998-2014. The child’s weight was measured at a median age of 4.8 years, with an interquartile range of 3-6 years. Children were deemed overweight if they were at or above the 85th percentile for weight, according to standards from the Centers for Disease Control and Prevention.
Just under half the women were normal weight, slightly more than a quarter were overweight, and a quarter were obese. The incidence of 5-year-old children who were overweight or obese was 70% higher in children of overweight mothers and 80% higher in those with obese mothers, compared with children with normal-weight mothers in an analysis that adjusted for maternal age at delivery, race or ethnicity, and education. Both were statistically significant differences, Dr. Mueller reported.
Two-thirds of the women had vaginal deliveries and a third had C-sections. Overweight or obesity occurred in 40% more of the children delivered by C-section, compared with children born vaginally, a statistically significant difference in an analysis that controlled for the same three covariates as well as prepregnancy body mass index, pregnancy weight gain, and other variables.
When Dr. Mueller and his associates ran a combined analysis they found that the highest risk for childhood overweight or obesity was in children born to obese mothers by C-section, and it was a 2.8-fold higher rate than that in the children born to normal-weight mothers by vaginal delivery, a statistically significant difference.
Dr. Mueller had no disclosures.
mzoler@frontlinemedcom.com
On Twitter @mitchelzoler
AT THE AHA SCIENTIFIC SESSIONS
Key clinical point:
Major finding: Children from obese mothers who had cesarean sections had a 2.8-fold higher obesity rate, compared with children from normal-weight mothers who had vaginal deliveries.
Data source: The Boston Birth Cohort, with prospective data from 1,441 pregnant women and their children.
Disclosures: Dr. Mueller had no disclosures.
Strokes, migraines linked in women with possible CAD
NEW ORLEANS – Women who underwent a clinically indicated coronary angiogram and also reported having migraine headaches had a twofold increased rate of strokes, compared with similar women without a history of migraine, in a prospective, observational study of 888 women followed for a median of 6.5 years.
This finding “underscores that more attention should be placed on evaluating women with a history of migraine headache for cardiovascular disease,” Cecil A. Rambarat, MD, said at the American Heart Association scientific sessions.
Aspirin aside, what’s important for these women is to “modify their risk factors and look at their family history,” reported Dr Rambarat of the University of Florida in Gainesville.
The study used data collected on women enrolled in the Women’s Ischemic Syndrome Evaluation (WISE) study during 1996-1999. WISE entered women at four U.S. centers scheduled for a clinically indicated coronary angiogram as part of their routine care for chest pain symptoms or suspected myocardial ischemia.
Among the 936 women enrolled in WISE, 917 completed a baseline questionnaire about their migraine history that showed 224 women had a migraine history and 693 women did not report having migraine headaches. The average age of women with a migraine history was 54 years, compared with 59 years in those without migraines.
All 917 women were followed for a median of 6.5 years for the incidence of nonfatal myocardial infarction, stroke, or heart failure. A subgroup of 888 of these women were also followed for a median of 9.5 years for mortality, including the incidence of cardiovascular death.
After the investigators adjusted for age, race, body mass index, history of diabetes or hypertension, dyslipidemia, smoking, and other variables, women with migraine were 83% more likely to have a cardiovascular event (cardiovascular death or nonfatal event) during follow-up, compared with women with no migraine history, a statistically significant difference.
Women with migraine were also 2.33-fold more likely to have a nonfatal stroke during follow-up, also a statistically significant difference. The increased stroke rate seems to have largely driven the significant difference in all cardiovascular events.
The mechanisms that might link migraine headaches with stroke are not clear, but Dr. Rambarat suggested several possibilities. Women with migraine may have dysfunction of their vascular endothelium, increased inflammatory markers, increased release of prothrombotic factors, a patent foramen ovale, or certain genetic risk factors that predispose them to migraine and to stroke or other cardiovascular disease, he said.
A report of these findings was recently published online (Am J Med. 2016 Dec 28. doi: 10.1016/j.amjmed.2016.12.028).
Dr. Rambarat had no relevant financial disclosures.
mzoler@frontlinemedcom.com
On Twitter @mitchelzoler
NEW ORLEANS – Women who underwent a clinically indicated coronary angiogram and also reported having migraine headaches had a twofold increased rate of strokes, compared with similar women without a history of migraine, in a prospective, observational study of 888 women followed for a median of 6.5 years.
This finding “underscores that more attention should be placed on evaluating women with a history of migraine headache for cardiovascular disease,” Cecil A. Rambarat, MD, said at the American Heart Association scientific sessions.
Aspirin aside, what’s important for these women is to “modify their risk factors and look at their family history,” reported Dr Rambarat of the University of Florida in Gainesville.
The study used data collected on women enrolled in the Women’s Ischemic Syndrome Evaluation (WISE) study during 1996-1999. WISE entered women at four U.S. centers scheduled for a clinically indicated coronary angiogram as part of their routine care for chest pain symptoms or suspected myocardial ischemia.
Among the 936 women enrolled in WISE, 917 completed a baseline questionnaire about their migraine history that showed 224 women had a migraine history and 693 women did not report having migraine headaches. The average age of women with a migraine history was 54 years, compared with 59 years in those without migraines.
All 917 women were followed for a median of 6.5 years for the incidence of nonfatal myocardial infarction, stroke, or heart failure. A subgroup of 888 of these women were also followed for a median of 9.5 years for mortality, including the incidence of cardiovascular death.
After the investigators adjusted for age, race, body mass index, history of diabetes or hypertension, dyslipidemia, smoking, and other variables, women with migraine were 83% more likely to have a cardiovascular event (cardiovascular death or nonfatal event) during follow-up, compared with women with no migraine history, a statistically significant difference.
Women with migraine were also 2.33-fold more likely to have a nonfatal stroke during follow-up, also a statistically significant difference. The increased stroke rate seems to have largely driven the significant difference in all cardiovascular events.
The mechanisms that might link migraine headaches with stroke are not clear, but Dr. Rambarat suggested several possibilities. Women with migraine may have dysfunction of their vascular endothelium, increased inflammatory markers, increased release of prothrombotic factors, a patent foramen ovale, or certain genetic risk factors that predispose them to migraine and to stroke or other cardiovascular disease, he said.
A report of these findings was recently published online (Am J Med. 2016 Dec 28. doi: 10.1016/j.amjmed.2016.12.028).
Dr. Rambarat had no relevant financial disclosures.
mzoler@frontlinemedcom.com
On Twitter @mitchelzoler
NEW ORLEANS – Women who underwent a clinically indicated coronary angiogram and also reported having migraine headaches had a twofold increased rate of strokes, compared with similar women without a history of migraine, in a prospective, observational study of 888 women followed for a median of 6.5 years.
This finding “underscores that more attention should be placed on evaluating women with a history of migraine headache for cardiovascular disease,” Cecil A. Rambarat, MD, said at the American Heart Association scientific sessions.
Aspirin aside, what’s important for these women is to “modify their risk factors and look at their family history,” reported Dr Rambarat of the University of Florida in Gainesville.
The study used data collected on women enrolled in the Women’s Ischemic Syndrome Evaluation (WISE) study during 1996-1999. WISE entered women at four U.S. centers scheduled for a clinically indicated coronary angiogram as part of their routine care for chest pain symptoms or suspected myocardial ischemia.
Among the 936 women enrolled in WISE, 917 completed a baseline questionnaire about their migraine history that showed 224 women had a migraine history and 693 women did not report having migraine headaches. The average age of women with a migraine history was 54 years, compared with 59 years in those without migraines.
All 917 women were followed for a median of 6.5 years for the incidence of nonfatal myocardial infarction, stroke, or heart failure. A subgroup of 888 of these women were also followed for a median of 9.5 years for mortality, including the incidence of cardiovascular death.
After the investigators adjusted for age, race, body mass index, history of diabetes or hypertension, dyslipidemia, smoking, and other variables, women with migraine were 83% more likely to have a cardiovascular event (cardiovascular death or nonfatal event) during follow-up, compared with women with no migraine history, a statistically significant difference.
Women with migraine were also 2.33-fold more likely to have a nonfatal stroke during follow-up, also a statistically significant difference. The increased stroke rate seems to have largely driven the significant difference in all cardiovascular events.
The mechanisms that might link migraine headaches with stroke are not clear, but Dr. Rambarat suggested several possibilities. Women with migraine may have dysfunction of their vascular endothelium, increased inflammatory markers, increased release of prothrombotic factors, a patent foramen ovale, or certain genetic risk factors that predispose them to migraine and to stroke or other cardiovascular disease, he said.
A report of these findings was recently published online (Am J Med. 2016 Dec 28. doi: 10.1016/j.amjmed.2016.12.028).
Dr. Rambarat had no relevant financial disclosures.
mzoler@frontlinemedcom.com
On Twitter @mitchelzoler
AT THE AHA SCIENTIFIC SESSIONS
Key clinical point:
Major finding: The stroke rate during 6.5 years of follow-up was more than twofold greater in women with a migraine headache history.
Data source: WISE, a study of 936 U.S. women enrolled during 1996-1999 and followed prospectively.
Disclosures: Dr. Rambarat had no relevant financial disclosures.