Obstetrics

EXPERT ANALYSIS AT THE PREGNANCY MEETING

SAN DIEGO – In inflammatory bowel disease, it’s active disease – not therapy – that poses the greatest risk to pregnancy.

“You want quiescent disease at the time of conception,” Dr. Chad A. Grotegut said at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.

Women in remission from IBD at the time of conception face a 20%-25% increased risk of flare during the course of their pregnancy, said Dr. Grotegut of the division of maternal-fetal medicine in the department of obstetrics and gynecology at Duke University, Durham, N.C. But IBD patients with active disease at the time of conception face a 50%-70% increased risk of flare.

Two confounding factors that influence a woman’s risk for flare during pregnancy are smoking cessation and the cessation of medications to control symptoms.

“Interestingly, there is no correlation of symptoms from one pregnancy to another,” said Dr. Grotegut, who added that IBD patients who become pregnant appear to be at increased risk for poor pregnancy outcomes, compared with women who don’t have the disorder.

“Many of the studies on that topic are problematic, though,” he said. “They’re typically small, there may be conflicting results, but the most consistent findings are increased rates of preterm birth, low birth weight, and cesarean delivery.”

Active disease seems to increase the risk of adverse outcomes, especially in those who have active disease at the time of conception.

“It’s unclear what drives the association with adverse outcomes,” Dr. Grotegut said. “It may be the disease itself, disease activity, the generalized inflammatory state, medications, and other factors. The most consistent outcome associated with IBD disease activity in pregnancy is preterm birth.”

He said that women with IBD who wish to become pregnant often ask him about the safety of medications they’re taking. The main classes used for IBD are corticosteroids, aminosalicylates, antibiotics, immunomodulators, and biologics.

Corticosteroids are safe and used only for flares, while aminosalicylates are often used as frontline agents for inducing remission, primarily in ulcerative colitis.

Common aminosalicylates used in IBD include sulfasalazine, balsalazide, mesalamine, and olsalazine. Sulfasalazine is a pro-drug of 5-ASA linked to sulfapyridine, which allows passage to the colon. It potentially interferes with folic acid metabolism, “so expert opinion is that women who are on sulfasalazine have increased folic supplementation 2 mg daily preconception,” he said.

Antibiotics are primarily used for flares and complications, not for maintenance. Common agents include metronidazole and ciprofloxacin, though ciprofloxacin is not typically used in pregnancy due to potential concerns for fetal arthropathies.

Immunomodulators are primarily used to maintain remission. From this category of agents Dr. Grotegut and his associates at Duke most commonly use azathioprine and 6-mercaptopurine.

“They are closely related medications [that] interfere with DNA synthesis and both are classified as FDA pregnancy category D,” he said. “There was initial concern for anomalies in transplant populations but current data suggest no increased risk. Discontinuation results in a high rate of relapse.”

Cyclosporine is used for severe flares in severe steroid-refractory ulcerative colitis. The experience with this agent is largely among transplant recipients but it does not seem to be associated with congenital anomalies, Dr. Grotegut said.

The use of methotrexate is contraindicated during pregnancy and it is advised to wait 3-6 months for conception following discontinuation. Thalidomide is also contraindicated.

As for the safety of biologic agents, the most data exist for infliximab, which crosses the placenta and is detected in cord blood, Dr. Grotegut said. Infliximab is used for both induction and maintenance of IBD remission. It is not associated with congenital anomalies, “but it theoretically may increase the risk of infection, and it may decrease responsiveness to vaccination,” he said. “Because of this, expert opinion is to avoid live vaccinations in newborns exposed to perinatal infliximab.”

There is also increasing recognition that IBD is an independent predictor of venous thromboembolism (VTE), Dr. Grotegut said.

In the nonpregnant population, all IBD patients have a threefold increased risk of VTE, compared with the general population. The relative risk rises to 15- to 20-fold during flares, he said.

VTE prophylaxis and IBD are not currently addressed in guidelines from the American College of Chest Physicians, but the Canadian Association of Gastroenterology recommends anticoagulation prophylaxis during moderate to severe outpatient flare with history of VTE, hospitalization for flare, and during hospitalization for other indications, including those in remission and those undergoing major pelvic surgery.

The Canadian Association of Gastroenterology goes on to recommend anticoagulant prophylaxis for “women with IBD who have undergone cesarean delivery while hospitalized,” Dr. Grotegut said.

“The ACCP recommends postcesarean anticoagulant prophylaxis for women with one major or at least two minor factors for VTE, but it does not specifically consider IBD a risk factor for VTE,” he said.

At the same time, he continued, the United Kingdom’s Royal College of Obstetricians and Gynaecologists includes IBD as an intermediate risk factor for consideration of anticoagulation prophylaxis.

Dr. Grotegut reported having no relevant financial disclosures.

[email protected]

On Twitter @dougbrunk

EXPERT ANALYSIS AT THE PREGNANCY MEETING

SAN DIEGO – In inflammatory bowel disease, it’s active disease – not therapy – that poses the greatest risk to pregnancy.

“You want quiescent disease at the time of conception,” Dr. Chad A. Grotegut said at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.

Women in remission from IBD at the time of conception face a 20%-25% increased risk of flare during the course of their pregnancy, said Dr. Grotegut of the division of maternal-fetal medicine in the department of obstetrics and gynecology at Duke University, Durham, N.C. But IBD patients with active disease at the time of conception face a 50%-70% increased risk of flare.

Two confounding factors that influence a woman’s risk for flare during pregnancy are smoking cessation and the cessation of medications to control symptoms.

“Interestingly, there is no correlation of symptoms from one pregnancy to another,” said Dr. Grotegut, who added that IBD patients who become pregnant appear to be at increased risk for poor pregnancy outcomes, compared with women who don’t have the disorder.

“Many of the studies on that topic are problematic, though,” he said. “They’re typically small, there may be conflicting results, but the most consistent findings are increased rates of preterm birth, low birth weight, and cesarean delivery.”

Active disease seems to increase the risk of adverse outcomes, especially in those who have active disease at the time of conception.

“It’s unclear what drives the association with adverse outcomes,” Dr. Grotegut said. “It may be the disease itself, disease activity, the generalized inflammatory state, medications, and other factors. The most consistent outcome associated with IBD disease activity in pregnancy is preterm birth.”

He said that women with IBD who wish to become pregnant often ask him about the safety of medications they’re taking. The main classes used for IBD are corticosteroids, aminosalicylates, antibiotics, immunomodulators, and biologics.

Corticosteroids are safe and used only for flares, while aminosalicylates are often used as frontline agents for inducing remission, primarily in ulcerative colitis.

Common aminosalicylates used in IBD include sulfasalazine, balsalazide, mesalamine, and olsalazine. Sulfasalazine is a pro-drug of 5-ASA linked to sulfapyridine, which allows passage to the colon. It potentially interferes with folic acid metabolism, “so expert opinion is that women who are on sulfasalazine have increased folic supplementation 2 mg daily preconception,” he said.

Antibiotics are primarily used for flares and complications, not for maintenance. Common agents include metronidazole and ciprofloxacin, though ciprofloxacin is not typically used in pregnancy due to potential concerns for fetal arthropathies.

Immunomodulators are primarily used to maintain remission. From this category of agents Dr. Grotegut and his associates at Duke most commonly use azathioprine and 6-mercaptopurine.

“They are closely related medications [that] interfere with DNA synthesis and both are classified as FDA pregnancy category D,” he said. “There was initial concern for anomalies in transplant populations but current data suggest no increased risk. Discontinuation results in a high rate of relapse.”

Cyclosporine is used for severe flares in severe steroid-refractory ulcerative colitis. The experience with this agent is largely among transplant recipients but it does not seem to be associated with congenital anomalies, Dr. Grotegut said.

The use of methotrexate is contraindicated during pregnancy and it is advised to wait 3-6 months for conception following discontinuation. Thalidomide is also contraindicated.

As for the safety of biologic agents, the most data exist for infliximab, which crosses the placenta and is detected in cord blood, Dr. Grotegut said. Infliximab is used for both induction and maintenance of IBD remission. It is not associated with congenital anomalies, “but it theoretically may increase the risk of infection, and it may decrease responsiveness to vaccination,” he said. “Because of this, expert opinion is to avoid live vaccinations in newborns exposed to perinatal infliximab.”

There is also increasing recognition that IBD is an independent predictor of venous thromboembolism (VTE), Dr. Grotegut said.

In the nonpregnant population, all IBD patients have a threefold increased risk of VTE, compared with the general population. The relative risk rises to 15- to 20-fold during flares, he said.

VTE prophylaxis and IBD are not currently addressed in guidelines from the American College of Chest Physicians, but the Canadian Association of Gastroenterology recommends anticoagulation prophylaxis during moderate to severe outpatient flare with history of VTE, hospitalization for flare, and during hospitalization for other indications, including those in remission and those undergoing major pelvic surgery.

The Canadian Association of Gastroenterology goes on to recommend anticoagulant prophylaxis for “women with IBD who have undergone cesarean delivery while hospitalized,” Dr. Grotegut said.

“The ACCP recommends postcesarean anticoagulant prophylaxis for women with one major or at least two minor factors for VTE, but it does not specifically consider IBD a risk factor for VTE,” he said.

At the same time, he continued, the United Kingdom’s Royal College of Obstetricians and Gynaecologists includes IBD as an intermediate risk factor for consideration of anticoagulation prophylaxis.

Dr. Grotegut reported having no relevant financial disclosures.

[email protected]

On Twitter @dougbrunk

EXPERT ANALYSIS AT THE PREGNANCY MEETING

SAN DIEGO – In inflammatory bowel disease, it’s active disease – not therapy – that poses the greatest risk to pregnancy.

“You want quiescent disease at the time of conception,” Dr. Chad A. Grotegut said at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.

Women in remission from IBD at the time of conception face a 20%-25% increased risk of flare during the course of their pregnancy, said Dr. Grotegut of the division of maternal-fetal medicine in the department of obstetrics and gynecology at Duke University, Durham, N.C. But IBD patients with active disease at the time of conception face a 50%-70% increased risk of flare.

Two confounding factors that influence a woman’s risk for flare during pregnancy are smoking cessation and the cessation of medications to control symptoms.

“Interestingly, there is no correlation of symptoms from one pregnancy to another,” said Dr. Grotegut, who added that IBD patients who become pregnant appear to be at increased risk for poor pregnancy outcomes, compared with women who don’t have the disorder.

“Many of the studies on that topic are problematic, though,” he said. “They’re typically small, there may be conflicting results, but the most consistent findings are increased rates of preterm birth, low birth weight, and cesarean delivery.”

Active disease seems to increase the risk of adverse outcomes, especially in those who have active disease at the time of conception.

“It’s unclear what drives the association with adverse outcomes,” Dr. Grotegut said. “It may be the disease itself, disease activity, the generalized inflammatory state, medications, and other factors. The most consistent outcome associated with IBD disease activity in pregnancy is preterm birth.”

He said that women with IBD who wish to become pregnant often ask him about the safety of medications they’re taking. The main classes used for IBD are corticosteroids, aminosalicylates, antibiotics, immunomodulators, and biologics.

Corticosteroids are safe and used only for flares, while aminosalicylates are often used as frontline agents for inducing remission, primarily in ulcerative colitis.

Common aminosalicylates used in IBD include sulfasalazine, balsalazide, mesalamine, and olsalazine. Sulfasalazine is a pro-drug of 5-ASA linked to sulfapyridine, which allows passage to the colon. It potentially interferes with folic acid metabolism, “so expert opinion is that women who are on sulfasalazine have increased folic supplementation 2 mg daily preconception,” he said.

Antibiotics are primarily used for flares and complications, not for maintenance. Common agents include metronidazole and ciprofloxacin, though ciprofloxacin is not typically used in pregnancy due to potential concerns for fetal arthropathies.

Immunomodulators are primarily used to maintain remission. From this category of agents Dr. Grotegut and his associates at Duke most commonly use azathioprine and 6-mercaptopurine.

“They are closely related medications [that] interfere with DNA synthesis and both are classified as FDA pregnancy category D,” he said. “There was initial concern for anomalies in transplant populations but current data suggest no increased risk. Discontinuation results in a high rate of relapse.”

Cyclosporine is used for severe flares in severe steroid-refractory ulcerative colitis. The experience with this agent is largely among transplant recipients but it does not seem to be associated with congenital anomalies, Dr. Grotegut said.

The use of methotrexate is contraindicated during pregnancy and it is advised to wait 3-6 months for conception following discontinuation. Thalidomide is also contraindicated.

As for the safety of biologic agents, the most data exist for infliximab, which crosses the placenta and is detected in cord blood, Dr. Grotegut said. Infliximab is used for both induction and maintenance of IBD remission. It is not associated with congenital anomalies, “but it theoretically may increase the risk of infection, and it may decrease responsiveness to vaccination,” he said. “Because of this, expert opinion is to avoid live vaccinations in newborns exposed to perinatal infliximab.”

There is also increasing recognition that IBD is an independent predictor of venous thromboembolism (VTE), Dr. Grotegut said.

In the nonpregnant population, all IBD patients have a threefold increased risk of VTE, compared with the general population. The relative risk rises to 15- to 20-fold during flares, he said.

VTE prophylaxis and IBD are not currently addressed in guidelines from the American College of Chest Physicians, but the Canadian Association of Gastroenterology recommends anticoagulation prophylaxis during moderate to severe outpatient flare with history of VTE, hospitalization for flare, and during hospitalization for other indications, including those in remission and those undergoing major pelvic surgery.

The Canadian Association of Gastroenterology goes on to recommend anticoagulant prophylaxis for “women with IBD who have undergone cesarean delivery while hospitalized,” Dr. Grotegut said.

“The ACCP recommends postcesarean anticoagulant prophylaxis for women with one major or at least two minor factors for VTE, but it does not specifically consider IBD a risk factor for VTE,” he said.

At the same time, he continued, the United Kingdom’s Royal College of Obstetricians and Gynaecologists includes IBD as an intermediate risk factor for consideration of anticoagulation prophylaxis.

Dr. Grotegut reported having no relevant financial disclosures.

[email protected]

On Twitter @dougbrunk

SAN DIEGO – The use of electronic fetal monitoring is ubiquitous in the United States, but a case-control study shows that monitoring patterns do not differ between term infants with evidence of brain injury on magnetic resonance imaging and those without injury.

Of 220 apparently normal term infants who underwent MRI, 25 had injury identified by the MRI, including 23 with mild injury, 1 with moderate injury, and 1 with severe injury. None of several electronic fetal monitoring characteristics – including moderate, minimal, marked, or absent variability, or late, prolonged, or variable repetitive decelerations – predicted injury, Dr. Alison Cahill reported at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.

The researchers also did not find a significant association between the injuries and several clinical factors known to increase the odds of injury, such as cesarean delivery (odds ratio, 1.8), nulliparity (OR, 1.0), acidemia (OR, 2.8), and labor induction (OR, 0.7).

The study results are based on findings at both 30 and 60 minutes prior to delivery.

Although white race and a complete absence of moderate variability on EFM in the 1-2 hours prior to birth were more common in those with injury, the predictive value of these factors alone was poor, said Dr. Cahill of Washington University, St. Louis.

The patients included in this study were from a prospective cohort of 8,340 women with vertex anatomically normal singleton pregnancies, who were in labor after at least 37 weeks’ gestation.

Case infants had an arterial cord gas pH less than 7.10, and control infants were temporally-, age-, and sex-matched infants with a normal arterial cord gas pH of 7.20 or greater. All infants underwent nonsedated MRI between 24 and 72 hours after birth.

The MRI findings were independently interpreted by a pediatric neuroradiologist and intensivist, who were blinded to clinical data and patient outcomes, and EFM patterns were interpreted by obstetric research nurses who were blinded to clinical outcomes, Dr. Cahill said.

Cerebral MRI has become the clinical imaging modality of choice for preterm infants and those with hypoxic-ischemic encephalopathy (HIE), because MRI findings in these populations have been correlated with neonatal outcomes, and enable increased surveillance and early intervention, she said.

However, more than three-quarters of neurologic disability occurs among infants born after 36 weeks without HIE, she said.

The aim of the current study was to characterize neurologic injury in neonates and term infants without HIE, and to identify intrapartum EFM patterns and peripartum risk factors for injury. But no such risk factors emerged, she said.

Though limited by the inherent subjectivity in EFM and MRI interpretation, the study involves the largest cohort to date in which the ability of clinical and EFM characteristics to predict brain injury is examined, Dr. Cahill said.

“We believe it is important to acknowledge the limitations of our clinical ability to use EFM based on our current knowledge and the manner in which we use it at the bedside,” she said. “Clinicians cannot predict brain injury in apparently normal term infants with EFM patterns preceding birth.”

The study was supported by a grant from the National Institute of Child Health and Human Development. Dr. Cahill reported having no relevant financial disclosures.

SAN DIEGO – The use of electronic fetal monitoring is ubiquitous in the United States, but a case-control study shows that monitoring patterns do not differ between term infants with evidence of brain injury on magnetic resonance imaging and those without injury.

Of 220 apparently normal term infants who underwent MRI, 25 had injury identified by the MRI, including 23 with mild injury, 1 with moderate injury, and 1 with severe injury. None of several electronic fetal monitoring characteristics – including moderate, minimal, marked, or absent variability, or late, prolonged, or variable repetitive decelerations – predicted injury, Dr. Alison Cahill reported at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.

The researchers also did not find a significant association between the injuries and several clinical factors known to increase the odds of injury, such as cesarean delivery (odds ratio, 1.8), nulliparity (OR, 1.0), acidemia (OR, 2.8), and labor induction (OR, 0.7).

The study results are based on findings at both 30 and 60 minutes prior to delivery.

Although white race and a complete absence of moderate variability on EFM in the 1-2 hours prior to birth were more common in those with injury, the predictive value of these factors alone was poor, said Dr. Cahill of Washington University, St. Louis.

The patients included in this study were from a prospective cohort of 8,340 women with vertex anatomically normal singleton pregnancies, who were in labor after at least 37 weeks’ gestation.

Case infants had an arterial cord gas pH less than 7.10, and control infants were temporally-, age-, and sex-matched infants with a normal arterial cord gas pH of 7.20 or greater. All infants underwent nonsedated MRI between 24 and 72 hours after birth.

The MRI findings were independently interpreted by a pediatric neuroradiologist and intensivist, who were blinded to clinical data and patient outcomes, and EFM patterns were interpreted by obstetric research nurses who were blinded to clinical outcomes, Dr. Cahill said.

Cerebral MRI has become the clinical imaging modality of choice for preterm infants and those with hypoxic-ischemic encephalopathy (HIE), because MRI findings in these populations have been correlated with neonatal outcomes, and enable increased surveillance and early intervention, she said.

However, more than three-quarters of neurologic disability occurs among infants born after 36 weeks without HIE, she said.

The aim of the current study was to characterize neurologic injury in neonates and term infants without HIE, and to identify intrapartum EFM patterns and peripartum risk factors for injury. But no such risk factors emerged, she said.

Though limited by the inherent subjectivity in EFM and MRI interpretation, the study involves the largest cohort to date in which the ability of clinical and EFM characteristics to predict brain injury is examined, Dr. Cahill said.

“We believe it is important to acknowledge the limitations of our clinical ability to use EFM based on our current knowledge and the manner in which we use it at the bedside,” she said. “Clinicians cannot predict brain injury in apparently normal term infants with EFM patterns preceding birth.”

The study was supported by a grant from the National Institute of Child Health and Human Development. Dr. Cahill reported having no relevant financial disclosures.

SAN DIEGO – The use of electronic fetal monitoring is ubiquitous in the United States, but a case-control study shows that monitoring patterns do not differ between term infants with evidence of brain injury on magnetic resonance imaging and those without injury.

Of 220 apparently normal term infants who underwent MRI, 25 had injury identified by the MRI, including 23 with mild injury, 1 with moderate injury, and 1 with severe injury. None of several electronic fetal monitoring characteristics – including moderate, minimal, marked, or absent variability, or late, prolonged, or variable repetitive decelerations – predicted injury, Dr. Alison Cahill reported at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.

The researchers also did not find a significant association between the injuries and several clinical factors known to increase the odds of injury, such as cesarean delivery (odds ratio, 1.8), nulliparity (OR, 1.0), acidemia (OR, 2.8), and labor induction (OR, 0.7).

The study results are based on findings at both 30 and 60 minutes prior to delivery.

Although white race and a complete absence of moderate variability on EFM in the 1-2 hours prior to birth were more common in those with injury, the predictive value of these factors alone was poor, said Dr. Cahill of Washington University, St. Louis.

The patients included in this study were from a prospective cohort of 8,340 women with vertex anatomically normal singleton pregnancies, who were in labor after at least 37 weeks’ gestation.

Case infants had an arterial cord gas pH less than 7.10, and control infants were temporally-, age-, and sex-matched infants with a normal arterial cord gas pH of 7.20 or greater. All infants underwent nonsedated MRI between 24 and 72 hours after birth.

The MRI findings were independently interpreted by a pediatric neuroradiologist and intensivist, who were blinded to clinical data and patient outcomes, and EFM patterns were interpreted by obstetric research nurses who were blinded to clinical outcomes, Dr. Cahill said.

Cerebral MRI has become the clinical imaging modality of choice for preterm infants and those with hypoxic-ischemic encephalopathy (HIE), because MRI findings in these populations have been correlated with neonatal outcomes, and enable increased surveillance and early intervention, she said.

However, more than three-quarters of neurologic disability occurs among infants born after 36 weeks without HIE, she said.

The aim of the current study was to characterize neurologic injury in neonates and term infants without HIE, and to identify intrapartum EFM patterns and peripartum risk factors for injury. But no such risk factors emerged, she said.

Though limited by the inherent subjectivity in EFM and MRI interpretation, the study involves the largest cohort to date in which the ability of clinical and EFM characteristics to predict brain injury is examined, Dr. Cahill said.

“We believe it is important to acknowledge the limitations of our clinical ability to use EFM based on our current knowledge and the manner in which we use it at the bedside,” she said. “Clinicians cannot predict brain injury in apparently normal term infants with EFM patterns preceding birth.”

The study was supported by a grant from the National Institute of Child Health and Human Development. Dr. Cahill reported having no relevant financial disclosures.

SAN DIEGO – Labor induction and augmentation were not associated with an increased likelihood of autism spectrum disorder during childhood in a large cohort study.

While the findings conflict with those of a recently published, large epidemiologic study, they fit with the preponderance of evidence, which refutes an association between labor induction and/or augmentation and autism spectrum disorder (ASD), Dr. Erin Clark reported at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.

© MattZ90/Thinkstockphotos.com

Of the more than 166,000 children in the current cohort, 2,547 (or about 1 in 65) had a diagnosis of ASD. After adjusting for numerous potential confounders related to socioeconomic status, maternal health, pregnancy-related events and conditions, and birth cohort, there were no significant differences found between those with and without ASD with respect to exposure to labor induction and/or augmentation, said Dr. Clark of the University of Utah, Salt Lake City.

The odds ratios compared with no exposure to induction or augmentation were 0.897 for induction with augmentation, 0.959 for induction only, and 0.978 for augmentation only.

The findings were similar among boys and girls with ASD, although about 1 in 45 boys in the cohort and 1 in 130 girls had ASD, figures which are consistent with the known case prevalence for boys versus girls, she said.

“This work supports current recommendations from [the Society for Maternal-Fetal Medicine] and [the American College of Obstetricians and Gynecologists] that recommend against a change in current guidance regarding counseling and indications for, and methods of labor induction and augmentation,” she said.

Dr. Clark and her colleagues performed the epidemiologic analysis using data from the Utah Registry of Autism and Developmental Disabilities (URADD) for the 1998, 2000, 2002, 2004, and 2006 birth cohorts from a four-county surveillance area, and from the Utah Department of Health Vital Records and Statistics.

The registry data represent about 70% of the state’s population, and the vital records and statistics data include information about exposure to induction and/or augmentation and known ASD risk factors.

ASD increased in prevalence by 120% between 2002 and 2010, and the reasons for this are multifactorial. The increase is at least partially due to changes in case ascertainment, but the extent to which legitimate changes in case prevalence have contributed to the increase is unclear and concerning, Dr. Clark said.

“So the hunt for risk factors is on as we seek etiologic clues and possible prevention and treatment strategies,” she said.

When it comes to perinatal risk factors, the data have been conflicting, but because alterations in oxytocin and oxytocin signaling have been linked to autism, labor induction and augmentation are potential risk factors “of great interest and controversy,” Dr. Clark said.

Of nine studies published before 2012 that evaluated the association between induction/augmentation and ASD, one found an association that persisted after controlling for confounders, but a subsequent meta-analysis was negative (Br. J. Psychiatry 2009;195:7-14).

In 2013, a large epidemiologic study showed an association, particularly in boys (JAMA Pediatr. 2013;167:959-66).

The current study was undertaken with these previous studies in mind, Dr. Clark said, noting that the differences in outcomes might be due to differences in population characteristics or methodologic approach, including management of confounding variables.

In response to an audience member who asked if the researchers had controlled for vaccination status, Dr. Clark said vaccination information was not available, but that it likely would not have been included in the analysis regardless as “that association has been completely debunked.”

Dr. Clark reported having no financial disclosures.

SAN DIEGO – Labor induction and augmentation were not associated with an increased likelihood of autism spectrum disorder during childhood in a large cohort study.

While the findings conflict with those of a recently published, large epidemiologic study, they fit with the preponderance of evidence, which refutes an association between labor induction and/or augmentation and autism spectrum disorder (ASD), Dr. Erin Clark reported at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.

© MattZ90/Thinkstockphotos.com

Of the more than 166,000 children in the current cohort, 2,547 (or about 1 in 65) had a diagnosis of ASD. After adjusting for numerous potential confounders related to socioeconomic status, maternal health, pregnancy-related events and conditions, and birth cohort, there were no significant differences found between those with and without ASD with respect to exposure to labor induction and/or augmentation, said Dr. Clark of the University of Utah, Salt Lake City.

The odds ratios compared with no exposure to induction or augmentation were 0.897 for induction with augmentation, 0.959 for induction only, and 0.978 for augmentation only.

The findings were similar among boys and girls with ASD, although about 1 in 45 boys in the cohort and 1 in 130 girls had ASD, figures which are consistent with the known case prevalence for boys versus girls, she said.

“This work supports current recommendations from [the Society for Maternal-Fetal Medicine] and [the American College of Obstetricians and Gynecologists] that recommend against a change in current guidance regarding counseling and indications for, and methods of labor induction and augmentation,” she said.

Dr. Clark and her colleagues performed the epidemiologic analysis using data from the Utah Registry of Autism and Developmental Disabilities (URADD) for the 1998, 2000, 2002, 2004, and 2006 birth cohorts from a four-county surveillance area, and from the Utah Department of Health Vital Records and Statistics.

The registry data represent about 70% of the state’s population, and the vital records and statistics data include information about exposure to induction and/or augmentation and known ASD risk factors.

ASD increased in prevalence by 120% between 2002 and 2010, and the reasons for this are multifactorial. The increase is at least partially due to changes in case ascertainment, but the extent to which legitimate changes in case prevalence have contributed to the increase is unclear and concerning, Dr. Clark said.

“So the hunt for risk factors is on as we seek etiologic clues and possible prevention and treatment strategies,” she said.

When it comes to perinatal risk factors, the data have been conflicting, but because alterations in oxytocin and oxytocin signaling have been linked to autism, labor induction and augmentation are potential risk factors “of great interest and controversy,” Dr. Clark said.

Of nine studies published before 2012 that evaluated the association between induction/augmentation and ASD, one found an association that persisted after controlling for confounders, but a subsequent meta-analysis was negative (Br. J. Psychiatry 2009;195:7-14).

In 2013, a large epidemiologic study showed an association, particularly in boys (JAMA Pediatr. 2013;167:959-66).

The current study was undertaken with these previous studies in mind, Dr. Clark said, noting that the differences in outcomes might be due to differences in population characteristics or methodologic approach, including management of confounding variables.

In response to an audience member who asked if the researchers had controlled for vaccination status, Dr. Clark said vaccination information was not available, but that it likely would not have been included in the analysis regardless as “that association has been completely debunked.”

Dr. Clark reported having no financial disclosures.

SAN DIEGO – Labor induction and augmentation were not associated with an increased likelihood of autism spectrum disorder during childhood in a large cohort study.

While the findings conflict with those of a recently published, large epidemiologic study, they fit with the preponderance of evidence, which refutes an association between labor induction and/or augmentation and autism spectrum disorder (ASD), Dr. Erin Clark reported at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.

© MattZ90/Thinkstockphotos.com

Of the more than 166,000 children in the current cohort, 2,547 (or about 1 in 65) had a diagnosis of ASD. After adjusting for numerous potential confounders related to socioeconomic status, maternal health, pregnancy-related events and conditions, and birth cohort, there were no significant differences found between those with and without ASD with respect to exposure to labor induction and/or augmentation, said Dr. Clark of the University of Utah, Salt Lake City.

The odds ratios compared with no exposure to induction or augmentation were 0.897 for induction with augmentation, 0.959 for induction only, and 0.978 for augmentation only.

The findings were similar among boys and girls with ASD, although about 1 in 45 boys in the cohort and 1 in 130 girls had ASD, figures which are consistent with the known case prevalence for boys versus girls, she said.

“This work supports current recommendations from [the Society for Maternal-Fetal Medicine] and [the American College of Obstetricians and Gynecologists] that recommend against a change in current guidance regarding counseling and indications for, and methods of labor induction and augmentation,” she said.

Dr. Clark and her colleagues performed the epidemiologic analysis using data from the Utah Registry of Autism and Developmental Disabilities (URADD) for the 1998, 2000, 2002, 2004, and 2006 birth cohorts from a four-county surveillance area, and from the Utah Department of Health Vital Records and Statistics.

The registry data represent about 70% of the state’s population, and the vital records and statistics data include information about exposure to induction and/or augmentation and known ASD risk factors.

ASD increased in prevalence by 120% between 2002 and 2010, and the reasons for this are multifactorial. The increase is at least partially due to changes in case ascertainment, but the extent to which legitimate changes in case prevalence have contributed to the increase is unclear and concerning, Dr. Clark said.

“So the hunt for risk factors is on as we seek etiologic clues and possible prevention and treatment strategies,” she said.

When it comes to perinatal risk factors, the data have been conflicting, but because alterations in oxytocin and oxytocin signaling have been linked to autism, labor induction and augmentation are potential risk factors “of great interest and controversy,” Dr. Clark said.

Of nine studies published before 2012 that evaluated the association between induction/augmentation and ASD, one found an association that persisted after controlling for confounders, but a subsequent meta-analysis was negative (Br. J. Psychiatry 2009;195:7-14).

In 2013, a large epidemiologic study showed an association, particularly in boys (JAMA Pediatr. 2013;167:959-66).

The current study was undertaken with these previous studies in mind, Dr. Clark said, noting that the differences in outcomes might be due to differences in population characteristics or methodologic approach, including management of confounding variables.

In response to an audience member who asked if the researchers had controlled for vaccination status, Dr. Clark said vaccination information was not available, but that it likely would not have been included in the analysis regardless as “that association has been completely debunked.”

Dr. Clark reported having no financial disclosures.

SAN DIEGO – If a pregnant woman presents with a headache accompanied by nausea, think migraine unless proven otherwise.

“One in five women will have migraines, so the first thing you want to do is get a good history,” Dr. Kathleen B. Digre said at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.

Dr. Digre, chief of the division of headache and neuro-ophthalmology at the University of Utah, subscribes to the “five histories” of headache, starting with family history. “You want to know if this person is genetically susceptible to migraine, so you want to ask, ‘Does anybody in your family get migraine?’ If they say ‘no, but my mom had sinus headaches,’ that’s telling because most sinus headaches end up being migraine.”

The second phase involves asking about life history of headache, such as having car sickness or abdominal pains as a child.

The third phase involves asking about the history of headache attacks, such as location, frequency, length, and accompanying features, including photophobia, phonophobia, nausea, vomiting, and autonomic symptoms. “I spend some time trying to determine if they have headache with aura, which is a neurologic event, usually visual like zig-zagging lines. But it can affect speech and [result in] numbness in the hand,” Dr. Digre said. “Usually this happens before the headache starts. Then I ask about key features of migraine [such as] are you light sensitive? Sound sensitive? Do you have any nausea? As soon as a person has nausea with a headache and they don’t have a secondary headache, it’s migraine.”

The fourth phase of history-taking involves questions about medical and psychiatric history, “because there are some medical conditions that increase the incidence of headache, such as thyroid disease, anemia, anxiety, and depression,” she said.

The fifth phase involves an investigation of medication history: prescriptions, over-the-counter herbal supplements, and the use of alcohol, amphetamines, or other drugs.

Key components of the physical exam involve taking blood pressure to make sure patients are not preeclamptic, and inspecting the back of their eyes with an ophthalmoscope to rule out papilledema. The brief neurologic exam should also be normal.

Red flags in the history-taking of headache include comments such as “I’ve never had a headache before; I just had a sudden onset of the worst headache of my life.”

“You’ve got to work that one up,” Dr. Digre advised. “That could be an aneurysm or something else serious like reversible cerebral vasoconstriction syndrome.”

Other worrisome signs include unexplained worsening of the headache; changes in the typical headache; headaches that wake people up in the middle of the night; headaches that get worse with coughing, sneezing, or Valsalva maneuver; and headaches that occur in women with underlying cancer, HIV, or some kind of systemic condition or fever. “If I’m worried about a stroke or a TIA I can order an MR with diffusion, which is very sensitive to acute ischemic events,” Dr. Digre said. “A CT scan with contrast is helpful but involves ionizing radiation; I’d rather go with the MR.”

Pregnancy itself impacts women with a preexisting history of migraine. “Often it will worsen the first trimester and migraines will get better the second and third trimester, but there are people who experience worsening of symptoms throughout pregnancy,” she said. “Sometimes migraines start with the pregnancy.”

Dr. Digre noted that women with migraines tend to have a higher incidence of preterm birth and preeclampsia, increased blood pressure, and increased odds of stroke. “Having migraine, especially migraine with aura, should alert you to follow that person closely,” she said.

Dr. Digre emphasized the importance of behavioral approaches to headache and migraine prevention, such as getting ample sleep, eating regularly, and avoiding fasts. “Those are trigger factors for getting migraine,” she said. “You also need to stay hydrated and you need to exercise. People can also do biofeedback and relaxation training.”

As for medications to consider in pregnant patients with migraines, triptans are effective, but Dr. Digre cautions against the use of narcotics, which “set up more headaches and make them harder to treat.”

Antinauseants can be effective, as can tricyclic antidepressants, “especially if people aren’t sleeping well,” she said. “Small doses work. If auras continue I use baby aspirin as a preventive. It usually works well.”

Dr. Digre reported having no relevant financial conflicts.

[email protected]

On Twitter @dougbrunk

SAN DIEGO – If a pregnant woman presents with a headache accompanied by nausea, think migraine unless proven otherwise.

“One in five women will have migraines, so the first thing you want to do is get a good history,” Dr. Kathleen B. Digre said at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.

Dr. Digre, chief of the division of headache and neuro-ophthalmology at the University of Utah, subscribes to the “five histories” of headache, starting with family history. “You want to know if this person is genetically susceptible to migraine, so you want to ask, ‘Does anybody in your family get migraine?’ If they say ‘no, but my mom had sinus headaches,’ that’s telling because most sinus headaches end up being migraine.”

The second phase involves asking about life history of headache, such as having car sickness or abdominal pains as a child.

The third phase involves asking about the history of headache attacks, such as location, frequency, length, and accompanying features, including photophobia, phonophobia, nausea, vomiting, and autonomic symptoms. “I spend some time trying to determine if they have headache with aura, which is a neurologic event, usually visual like zig-zagging lines. But it can affect speech and [result in] numbness in the hand,” Dr. Digre said. “Usually this happens before the headache starts. Then I ask about key features of migraine [such as] are you light sensitive? Sound sensitive? Do you have any nausea? As soon as a person has nausea with a headache and they don’t have a secondary headache, it’s migraine.”

The fourth phase of history-taking involves questions about medical and psychiatric history, “because there are some medical conditions that increase the incidence of headache, such as thyroid disease, anemia, anxiety, and depression,” she said.

The fifth phase involves an investigation of medication history: prescriptions, over-the-counter herbal supplements, and the use of alcohol, amphetamines, or other drugs.

Key components of the physical exam involve taking blood pressure to make sure patients are not preeclamptic, and inspecting the back of their eyes with an ophthalmoscope to rule out papilledema. The brief neurologic exam should also be normal.

Red flags in the history-taking of headache include comments such as “I’ve never had a headache before; I just had a sudden onset of the worst headache of my life.”

“You’ve got to work that one up,” Dr. Digre advised. “That could be an aneurysm or something else serious like reversible cerebral vasoconstriction syndrome.”

Other worrisome signs include unexplained worsening of the headache; changes in the typical headache; headaches that wake people up in the middle of the night; headaches that get worse with coughing, sneezing, or Valsalva maneuver; and headaches that occur in women with underlying cancer, HIV, or some kind of systemic condition or fever. “If I’m worried about a stroke or a TIA I can order an MR with diffusion, which is very sensitive to acute ischemic events,” Dr. Digre said. “A CT scan with contrast is helpful but involves ionizing radiation; I’d rather go with the MR.”

Pregnancy itself impacts women with a preexisting history of migraine. “Often it will worsen the first trimester and migraines will get better the second and third trimester, but there are people who experience worsening of symptoms throughout pregnancy,” she said. “Sometimes migraines start with the pregnancy.”

Dr. Digre noted that women with migraines tend to have a higher incidence of preterm birth and preeclampsia, increased blood pressure, and increased odds of stroke. “Having migraine, especially migraine with aura, should alert you to follow that person closely,” she said.

Dr. Digre emphasized the importance of behavioral approaches to headache and migraine prevention, such as getting ample sleep, eating regularly, and avoiding fasts. “Those are trigger factors for getting migraine,” she said. “You also need to stay hydrated and you need to exercise. People can also do biofeedback and relaxation training.”

As for medications to consider in pregnant patients with migraines, triptans are effective, but Dr. Digre cautions against the use of narcotics, which “set up more headaches and make them harder to treat.”

Antinauseants can be effective, as can tricyclic antidepressants, “especially if people aren’t sleeping well,” she said. “Small doses work. If auras continue I use baby aspirin as a preventive. It usually works well.”

Dr. Digre reported having no relevant financial conflicts.

[email protected]

On Twitter @dougbrunk

SAN DIEGO – If a pregnant woman presents with a headache accompanied by nausea, think migraine unless proven otherwise.

“One in five women will have migraines, so the first thing you want to do is get a good history,” Dr. Kathleen B. Digre said at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.

Dr. Digre, chief of the division of headache and neuro-ophthalmology at the University of Utah, subscribes to the “five histories” of headache, starting with family history. “You want to know if this person is genetically susceptible to migraine, so you want to ask, ‘Does anybody in your family get migraine?’ If they say ‘no, but my mom had sinus headaches,’ that’s telling because most sinus headaches end up being migraine.”

The second phase involves asking about life history of headache, such as having car sickness or abdominal pains as a child.

The third phase involves asking about the history of headache attacks, such as location, frequency, length, and accompanying features, including photophobia, phonophobia, nausea, vomiting, and autonomic symptoms. “I spend some time trying to determine if they have headache with aura, which is a neurologic event, usually visual like zig-zagging lines. But it can affect speech and [result in] numbness in the hand,” Dr. Digre said. “Usually this happens before the headache starts. Then I ask about key features of migraine [such as] are you light sensitive? Sound sensitive? Do you have any nausea? As soon as a person has nausea with a headache and they don’t have a secondary headache, it’s migraine.”

The fourth phase of history-taking involves questions about medical and psychiatric history, “because there are some medical conditions that increase the incidence of headache, such as thyroid disease, anemia, anxiety, and depression,” she said.

The fifth phase involves an investigation of medication history: prescriptions, over-the-counter herbal supplements, and the use of alcohol, amphetamines, or other drugs.

Key components of the physical exam involve taking blood pressure to make sure patients are not preeclamptic, and inspecting the back of their eyes with an ophthalmoscope to rule out papilledema. The brief neurologic exam should also be normal.

Red flags in the history-taking of headache include comments such as “I’ve never had a headache before; I just had a sudden onset of the worst headache of my life.”

“You’ve got to work that one up,” Dr. Digre advised. “That could be an aneurysm or something else serious like reversible cerebral vasoconstriction syndrome.”

Other worrisome signs include unexplained worsening of the headache; changes in the typical headache; headaches that wake people up in the middle of the night; headaches that get worse with coughing, sneezing, or Valsalva maneuver; and headaches that occur in women with underlying cancer, HIV, or some kind of systemic condition or fever. “If I’m worried about a stroke or a TIA I can order an MR with diffusion, which is very sensitive to acute ischemic events,” Dr. Digre said. “A CT scan with contrast is helpful but involves ionizing radiation; I’d rather go with the MR.”

Pregnancy itself impacts women with a preexisting history of migraine. “Often it will worsen the first trimester and migraines will get better the second and third trimester, but there are people who experience worsening of symptoms throughout pregnancy,” she said. “Sometimes migraines start with the pregnancy.”

Dr. Digre noted that women with migraines tend to have a higher incidence of preterm birth and preeclampsia, increased blood pressure, and increased odds of stroke. “Having migraine, especially migraine with aura, should alert you to follow that person closely,” she said.

Dr. Digre emphasized the importance of behavioral approaches to headache and migraine prevention, such as getting ample sleep, eating regularly, and avoiding fasts. “Those are trigger factors for getting migraine,” she said. “You also need to stay hydrated and you need to exercise. People can also do biofeedback and relaxation training.”

As for medications to consider in pregnant patients with migraines, triptans are effective, but Dr. Digre cautions against the use of narcotics, which “set up more headaches and make them harder to treat.”

Antinauseants can be effective, as can tricyclic antidepressants, “especially if people aren’t sleeping well,” she said. “Small doses work. If auras continue I use baby aspirin as a preventive. It usually works well.”

Dr. Digre reported having no relevant financial conflicts.

[email protected]

On Twitter @dougbrunk

A small group of senators is pushing legislation that would establish a set of maternal care quality measures under the Medicaid and the Children’s Health Insurance programs.

The Quality Care for Moms and Babies Act (S. 466), introduced Feb. 11, instructs the Health & Human Services secretary to develop a set of measures to assess the quality of care provided during pregnancy and the postpartum period. The measures would apply to clinicians and group practices, hospitals, health plans, and accountable care organizations.

The bill was introduced by Sen. Debbie Stabenow (D-Mich.) and Sen. Chuck Grassley (R-Iowa) and cosponsored by a handful of Democrats in the Senate. A companion bill is expected to be introduced in the House.

Sen. Stabenow introduced the same bill in 2013, but it stalled in committee.

The bill would require HHS to seek public comments on a set of proposed measures by Jan. 1, 2018, with the publication of an initial measure set by Jan. 1, 2019. Measures would be evidence based and risk adjusted.

Debra L. Ness, president of the National Partnership for Women & Families, praised the introduction of the bill.

“Our country’s infant and maternal mortality rates are too high, and our performance on prematurity, low-birth-weight babies, cesareans, early elective deliveries, and exclusive breastfeeding lags behind that of many other nations,” she said in a statement. “We simply must improve the quality of care for both mothers and babies – and this legislation can do that.”

[email protected]

On Twitter @maryellenny

A small group of senators is pushing legislation that would establish a set of maternal care quality measures under the Medicaid and the Children’s Health Insurance programs.

The Quality Care for Moms and Babies Act (S. 466), introduced Feb. 11, instructs the Health & Human Services secretary to develop a set of measures to assess the quality of care provided during pregnancy and the postpartum period. The measures would apply to clinicians and group practices, hospitals, health plans, and accountable care organizations.

The bill was introduced by Sen. Debbie Stabenow (D-Mich.) and Sen. Chuck Grassley (R-Iowa) and cosponsored by a handful of Democrats in the Senate. A companion bill is expected to be introduced in the House.

Sen. Stabenow introduced the same bill in 2013, but it stalled in committee.

The bill would require HHS to seek public comments on a set of proposed measures by Jan. 1, 2018, with the publication of an initial measure set by Jan. 1, 2019. Measures would be evidence based and risk adjusted.

Debra L. Ness, president of the National Partnership for Women & Families, praised the introduction of the bill.

“Our country’s infant and maternal mortality rates are too high, and our performance on prematurity, low-birth-weight babies, cesareans, early elective deliveries, and exclusive breastfeeding lags behind that of many other nations,” she said in a statement. “We simply must improve the quality of care for both mothers and babies – and this legislation can do that.”

[email protected]

On Twitter @maryellenny

A small group of senators is pushing legislation that would establish a set of maternal care quality measures under the Medicaid and the Children’s Health Insurance programs.

The Quality Care for Moms and Babies Act (S. 466), introduced Feb. 11, instructs the Health & Human Services secretary to develop a set of measures to assess the quality of care provided during pregnancy and the postpartum period. The measures would apply to clinicians and group practices, hospitals, health plans, and accountable care organizations.

The bill was introduced by Sen. Debbie Stabenow (D-Mich.) and Sen. Chuck Grassley (R-Iowa) and cosponsored by a handful of Democrats in the Senate. A companion bill is expected to be introduced in the House.

Sen. Stabenow introduced the same bill in 2013, but it stalled in committee.

The bill would require HHS to seek public comments on a set of proposed measures by Jan. 1, 2018, with the publication of an initial measure set by Jan. 1, 2019. Measures would be evidence based and risk adjusted.

Debra L. Ness, president of the National Partnership for Women & Families, praised the introduction of the bill.

“Our country’s infant and maternal mortality rates are too high, and our performance on prematurity, low-birth-weight babies, cesareans, early elective deliveries, and exclusive breastfeeding lags behind that of many other nations,” she said in a statement. “We simply must improve the quality of care for both mothers and babies – and this legislation can do that.”

[email protected]

On Twitter @maryellenny

SAN DIEGO – Nifedipine and atosiban for tocolysis in women with threatened preterm delivery had similar rates of adverse perinatal outcomes in a randomized clinical trial, but an increase in perinatal mortality in those treated with nifedipine is raising concerns about its safety.

The rate of the composite primary outcome of perinatal death, bronchopulmonary dysplasia, culture-proven sepsis, intraventricular hemorrhage worse than stage II, periventricular leukomalacia worse than stage I, and necrotizing enterocolitis worse than stage I was 14.2% among the 248 women randomized to receive nifedipine. Similarly, it was 15.1% in the 254 women randomized to receive atosiban in the multicenter Assessment of Perinatal Outcome After Specific Tocolysis in Early Labor (APOSTEL III trial), Dr. Elvira Vliet reported at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.

There also was no difference between the nifedipine and atosiban groups on a number of secondary outcomes, including prolongation of pregnancy (6 days and 4 days, respectively) and the percentage of patients undelivered at 48 hours after randomization (66% and 69%, respectively). No cases of maternal mortality occurred.

But the rate of perinatal mortality was 5.4% in the nifedipine group vs. 2.1% in the atosiban group for a relative risk of 2.567, said Dr. Vliet of University Medical Center Utrecht, the Netherlands. Two of the perinatal deaths in the nifedipine group and one in the atosiban group were associated with congenital abnormalities, she noted.

Study participants were women with either a singleton or twin pregnancy between the 25th and 34th week of gestation who presented to one of 19 perinatal or large teaching hospitals with symptoms of threatened preterm delivery. Treatment with nifedipine or atosiban was given for 48 hours.

The groups did not differ with respect to baseline characteristics such as maternal age, body mass index, previous preterm birth, and gestational age.

The current findings suggest that most perinatal outcomes are similar in patients treated with either nifedipine or atosiban, but the higher perinatal death rate in the nifedipine group requires further in-depth analysis, Dr. Vliet said.

Dr. Vliet reported having no financial disclosures.

SAN DIEGO – Nifedipine and atosiban for tocolysis in women with threatened preterm delivery had similar rates of adverse perinatal outcomes in a randomized clinical trial, but an increase in perinatal mortality in those treated with nifedipine is raising concerns about its safety.

The rate of the composite primary outcome of perinatal death, bronchopulmonary dysplasia, culture-proven sepsis, intraventricular hemorrhage worse than stage II, periventricular leukomalacia worse than stage I, and necrotizing enterocolitis worse than stage I was 14.2% among the 248 women randomized to receive nifedipine. Similarly, it was 15.1% in the 254 women randomized to receive atosiban in the multicenter Assessment of Perinatal Outcome After Specific Tocolysis in Early Labor (APOSTEL III trial), Dr. Elvira Vliet reported at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.

There also was no difference between the nifedipine and atosiban groups on a number of secondary outcomes, including prolongation of pregnancy (6 days and 4 days, respectively) and the percentage of patients undelivered at 48 hours after randomization (66% and 69%, respectively). No cases of maternal mortality occurred.

But the rate of perinatal mortality was 5.4% in the nifedipine group vs. 2.1% in the atosiban group for a relative risk of 2.567, said Dr. Vliet of University Medical Center Utrecht, the Netherlands. Two of the perinatal deaths in the nifedipine group and one in the atosiban group were associated with congenital abnormalities, she noted.

Study participants were women with either a singleton or twin pregnancy between the 25th and 34th week of gestation who presented to one of 19 perinatal or large teaching hospitals with symptoms of threatened preterm delivery. Treatment with nifedipine or atosiban was given for 48 hours.

The groups did not differ with respect to baseline characteristics such as maternal age, body mass index, previous preterm birth, and gestational age.

The current findings suggest that most perinatal outcomes are similar in patients treated with either nifedipine or atosiban, but the higher perinatal death rate in the nifedipine group requires further in-depth analysis, Dr. Vliet said.

Dr. Vliet reported having no financial disclosures.

SAN DIEGO – Nifedipine and atosiban for tocolysis in women with threatened preterm delivery had similar rates of adverse perinatal outcomes in a randomized clinical trial, but an increase in perinatal mortality in those treated with nifedipine is raising concerns about its safety.

The rate of the composite primary outcome of perinatal death, bronchopulmonary dysplasia, culture-proven sepsis, intraventricular hemorrhage worse than stage II, periventricular leukomalacia worse than stage I, and necrotizing enterocolitis worse than stage I was 14.2% among the 248 women randomized to receive nifedipine. Similarly, it was 15.1% in the 254 women randomized to receive atosiban in the multicenter Assessment of Perinatal Outcome After Specific Tocolysis in Early Labor (APOSTEL III trial), Dr. Elvira Vliet reported at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.

There also was no difference between the nifedipine and atosiban groups on a number of secondary outcomes, including prolongation of pregnancy (6 days and 4 days, respectively) and the percentage of patients undelivered at 48 hours after randomization (66% and 69%, respectively). No cases of maternal mortality occurred.

But the rate of perinatal mortality was 5.4% in the nifedipine group vs. 2.1% in the atosiban group for a relative risk of 2.567, said Dr. Vliet of University Medical Center Utrecht, the Netherlands. Two of the perinatal deaths in the nifedipine group and one in the atosiban group were associated with congenital abnormalities, she noted.

Study participants were women with either a singleton or twin pregnancy between the 25th and 34th week of gestation who presented to one of 19 perinatal or large teaching hospitals with symptoms of threatened preterm delivery. Treatment with nifedipine or atosiban was given for 48 hours.

The groups did not differ with respect to baseline characteristics such as maternal age, body mass index, previous preterm birth, and gestational age.

The current findings suggest that most perinatal outcomes are similar in patients treated with either nifedipine or atosiban, but the higher perinatal death rate in the nifedipine group requires further in-depth analysis, Dr. Vliet said.

Dr. Vliet reported having no financial disclosures.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

[email protected]

On Twitter @dougbrunk

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

[email protected]

On Twitter @dougbrunk

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

[email protected]

On Twitter @dougbrunk

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

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

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

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

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

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

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

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

Continue for more on the early treatment group >>

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

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

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

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

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

Next page: Prediabetes in pregnant women >>

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Continue for more on the early treatment group >>

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

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

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

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

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

Next page: Prediabetes in pregnant women >>

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Continue for more on the early treatment group >>

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

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

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

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

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

Next page: Prediabetes in pregnant women >>

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Dr. Page reported having no relevant financial conflicts.

[email protected]

On Twitter @dougbrunk

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

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

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

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

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

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

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

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

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

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

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

Dr. Page reported having no relevant financial conflicts.

[email protected]

On Twitter @dougbrunk

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

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

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

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

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

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

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

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

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

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

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

Dr. Page reported having no relevant financial conflicts.

[email protected]

On Twitter @dougbrunk