Society for Maternal-Fetal Medicine (SMFM): Annual Meeting (The Pregnancy Meeting)

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Extending second stage of labor raised maternal and neonatal morbidity

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Extending second stage of labor raised maternal and neonatal morbidity

SAN DIEGO – The crossing times for the rate of spontaneous vaginal delivery versus a composite maternal or neonatal morbidity/mortality occurred slightly earlier than current recommended guidelines for women with an epidural (2.6 hours versus 3 hours), regardless of parity, results from a large federally funded retrospective study showed.

After this time, the risk of morbidity was higher than the chance of vaginal delivery.

But for women without an epidural, the crossing times for spontaneous vaginal delivery (SVD) and any morbidity occurred slightly later than current guidelines suggest (2.4 hours versus 2 hours in nulliparous women, and 2.3 hours versus 1 hour in multiparous women). Only in multiparous women without an epidural did the lines cross at least 1 hour later, Dr. Katherine Laughon Grantz said at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.

Dr. Katherine Grantz

“We provide data that can be used to balance chances of SVD versus morbidity with increasing duration of second stage,” said Dr. Grantz, an investigator at the National Institute of Child Health and Human Development.

A June 2000 clinical management guideline from the American College of Obstetricians and Gynecologists states that operative vaginal delivery is indicated for nulliparous women who lack progress after 3 hours with an epidural, or 2 hours without an epidural. For multiparous women, the guideline is 2 hours with an epidural and 1 hour without. Dr. Grantz said that historical guidance for the 2-hour rule was first described in the 1850s by expert opinion and case series.

“Recently, however, it’s been recommended that it is safe to extend the current ACOG guidelines by 1 hour,” she said.

In 2014, Dr. Grantz and her colleagues published a study showing that prolonged second stage is associated with increased risk of maternal and neonatal morbidity (Obstet. Gynecol. 2014;124:57-67).

“Therefore, our group wanted to take this a step further, to determine the second-stage duration wherein the chance of vaginal delivery became so low it was outweighed by the increased risk of morbidity,” she said.

The researchers used data from the Consortium on Safe Labor, a study of 19 hospitals within 12 medical institutions in the United States. Medical records from 228,438 deliveries between 2002 and 2008 were evaluated, including patient demographics, prenatal complications, labor and delivery information, and maternal and neonatal outcomes.

They limited the analysis to singleton gestations delivered greater than or equal to 36 weeks’ gestation and excluded nonvertex presentation, antepartum stillbirth prior to onset of labor, women with a prior uterine scar, congenital anomalies, and cervical exams prior to vaginal delivery that were less than 10 cm or missing. This resulted in a total of 103,415 deliveries studied.

The researchers analyzed the groups in four strata: by parity (nulliparous or multiparous), and by epidural status (yes or no). Four outcomes were studied: spontaneous vaginal delivery; a composite of maternal morbidity (which included postpartum hemorrhage, blood transfusion, cesarean hysterectomy, endometritis, or ICU admission); composite neonatal morbidity/mortality (including shoulder dystocia, 5-minute Apgar score of less than 4, need for continuous positive airway pressure resuscitation or higher, NICU admission, sepsis, pneumonia, hypoxic-ischemic encephalopathy/periventricular leukomalacia, seizure, intracranial hemorrhage/periventricular hemorrhage, asphyxia, or neonatal death); and any maternal or neonatal morbidity.

They calculated the hazard rates of each outcome and created joint models for hazard rates that model rate of spontaneous vaginal delivery versus the risk of each of the three morbidity categories.

Dr. Grantz reported that for nulliparous women with an epidural, extending the second stage from 3 to 4 hours resulted in 16% of maternal and 15% of neonatal morbidities, with approximately 5.5% additional SVD during that hour.

“Our data are limited because these are retrospective data,” Dr. Grantz noted. “Women who were allowed to continue with a prolonged second stage might have been different than women who did not continue with a prolonged second stage. We also did not have information on delayed versus active pushing, and we lacked long-term maternal and child outcomes.”

But the major strength of the study is the large number of deliveries, she said, which allowed the researchers to investigate rare neonatal outcomes at term.

The study was supported by the NICHD. Dr. Grantz reported having no relevant financial conflicts.

[email protected]

On Twitter @dougbrunk

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SAN DIEGO – The crossing times for the rate of spontaneous vaginal delivery versus a composite maternal or neonatal morbidity/mortality occurred slightly earlier than current recommended guidelines for women with an epidural (2.6 hours versus 3 hours), regardless of parity, results from a large federally funded retrospective study showed.

After this time, the risk of morbidity was higher than the chance of vaginal delivery.

But for women without an epidural, the crossing times for spontaneous vaginal delivery (SVD) and any morbidity occurred slightly later than current guidelines suggest (2.4 hours versus 2 hours in nulliparous women, and 2.3 hours versus 1 hour in multiparous women). Only in multiparous women without an epidural did the lines cross at least 1 hour later, Dr. Katherine Laughon Grantz said at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.

Dr. Katherine Grantz

“We provide data that can be used to balance chances of SVD versus morbidity with increasing duration of second stage,” said Dr. Grantz, an investigator at the National Institute of Child Health and Human Development.

A June 2000 clinical management guideline from the American College of Obstetricians and Gynecologists states that operative vaginal delivery is indicated for nulliparous women who lack progress after 3 hours with an epidural, or 2 hours without an epidural. For multiparous women, the guideline is 2 hours with an epidural and 1 hour without. Dr. Grantz said that historical guidance for the 2-hour rule was first described in the 1850s by expert opinion and case series.

“Recently, however, it’s been recommended that it is safe to extend the current ACOG guidelines by 1 hour,” she said.

In 2014, Dr. Grantz and her colleagues published a study showing that prolonged second stage is associated with increased risk of maternal and neonatal morbidity (Obstet. Gynecol. 2014;124:57-67).

“Therefore, our group wanted to take this a step further, to determine the second-stage duration wherein the chance of vaginal delivery became so low it was outweighed by the increased risk of morbidity,” she said.

The researchers used data from the Consortium on Safe Labor, a study of 19 hospitals within 12 medical institutions in the United States. Medical records from 228,438 deliveries between 2002 and 2008 were evaluated, including patient demographics, prenatal complications, labor and delivery information, and maternal and neonatal outcomes.

They limited the analysis to singleton gestations delivered greater than or equal to 36 weeks’ gestation and excluded nonvertex presentation, antepartum stillbirth prior to onset of labor, women with a prior uterine scar, congenital anomalies, and cervical exams prior to vaginal delivery that were less than 10 cm or missing. This resulted in a total of 103,415 deliveries studied.

The researchers analyzed the groups in four strata: by parity (nulliparous or multiparous), and by epidural status (yes or no). Four outcomes were studied: spontaneous vaginal delivery; a composite of maternal morbidity (which included postpartum hemorrhage, blood transfusion, cesarean hysterectomy, endometritis, or ICU admission); composite neonatal morbidity/mortality (including shoulder dystocia, 5-minute Apgar score of less than 4, need for continuous positive airway pressure resuscitation or higher, NICU admission, sepsis, pneumonia, hypoxic-ischemic encephalopathy/periventricular leukomalacia, seizure, intracranial hemorrhage/periventricular hemorrhage, asphyxia, or neonatal death); and any maternal or neonatal morbidity.

They calculated the hazard rates of each outcome and created joint models for hazard rates that model rate of spontaneous vaginal delivery versus the risk of each of the three morbidity categories.

Dr. Grantz reported that for nulliparous women with an epidural, extending the second stage from 3 to 4 hours resulted in 16% of maternal and 15% of neonatal morbidities, with approximately 5.5% additional SVD during that hour.

“Our data are limited because these are retrospective data,” Dr. Grantz noted. “Women who were allowed to continue with a prolonged second stage might have been different than women who did not continue with a prolonged second stage. We also did not have information on delayed versus active pushing, and we lacked long-term maternal and child outcomes.”

But the major strength of the study is the large number of deliveries, she said, which allowed the researchers to investigate rare neonatal outcomes at term.

The study was supported by the NICHD. Dr. Grantz reported having no relevant financial conflicts.

[email protected]

On Twitter @dougbrunk

SAN DIEGO – The crossing times for the rate of spontaneous vaginal delivery versus a composite maternal or neonatal morbidity/mortality occurred slightly earlier than current recommended guidelines for women with an epidural (2.6 hours versus 3 hours), regardless of parity, results from a large federally funded retrospective study showed.

After this time, the risk of morbidity was higher than the chance of vaginal delivery.

But for women without an epidural, the crossing times for spontaneous vaginal delivery (SVD) and any morbidity occurred slightly later than current guidelines suggest (2.4 hours versus 2 hours in nulliparous women, and 2.3 hours versus 1 hour in multiparous women). Only in multiparous women without an epidural did the lines cross at least 1 hour later, Dr. Katherine Laughon Grantz said at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.

Dr. Katherine Grantz

“We provide data that can be used to balance chances of SVD versus morbidity with increasing duration of second stage,” said Dr. Grantz, an investigator at the National Institute of Child Health and Human Development.

A June 2000 clinical management guideline from the American College of Obstetricians and Gynecologists states that operative vaginal delivery is indicated for nulliparous women who lack progress after 3 hours with an epidural, or 2 hours without an epidural. For multiparous women, the guideline is 2 hours with an epidural and 1 hour without. Dr. Grantz said that historical guidance for the 2-hour rule was first described in the 1850s by expert opinion and case series.

“Recently, however, it’s been recommended that it is safe to extend the current ACOG guidelines by 1 hour,” she said.

In 2014, Dr. Grantz and her colleagues published a study showing that prolonged second stage is associated with increased risk of maternal and neonatal morbidity (Obstet. Gynecol. 2014;124:57-67).

“Therefore, our group wanted to take this a step further, to determine the second-stage duration wherein the chance of vaginal delivery became so low it was outweighed by the increased risk of morbidity,” she said.

The researchers used data from the Consortium on Safe Labor, a study of 19 hospitals within 12 medical institutions in the United States. Medical records from 228,438 deliveries between 2002 and 2008 were evaluated, including patient demographics, prenatal complications, labor and delivery information, and maternal and neonatal outcomes.

They limited the analysis to singleton gestations delivered greater than or equal to 36 weeks’ gestation and excluded nonvertex presentation, antepartum stillbirth prior to onset of labor, women with a prior uterine scar, congenital anomalies, and cervical exams prior to vaginal delivery that were less than 10 cm or missing. This resulted in a total of 103,415 deliveries studied.

The researchers analyzed the groups in four strata: by parity (nulliparous or multiparous), and by epidural status (yes or no). Four outcomes were studied: spontaneous vaginal delivery; a composite of maternal morbidity (which included postpartum hemorrhage, blood transfusion, cesarean hysterectomy, endometritis, or ICU admission); composite neonatal morbidity/mortality (including shoulder dystocia, 5-minute Apgar score of less than 4, need for continuous positive airway pressure resuscitation or higher, NICU admission, sepsis, pneumonia, hypoxic-ischemic encephalopathy/periventricular leukomalacia, seizure, intracranial hemorrhage/periventricular hemorrhage, asphyxia, or neonatal death); and any maternal or neonatal morbidity.

They calculated the hazard rates of each outcome and created joint models for hazard rates that model rate of spontaneous vaginal delivery versus the risk of each of the three morbidity categories.

Dr. Grantz reported that for nulliparous women with an epidural, extending the second stage from 3 to 4 hours resulted in 16% of maternal and 15% of neonatal morbidities, with approximately 5.5% additional SVD during that hour.

“Our data are limited because these are retrospective data,” Dr. Grantz noted. “Women who were allowed to continue with a prolonged second stage might have been different than women who did not continue with a prolonged second stage. We also did not have information on delayed versus active pushing, and we lacked long-term maternal and child outcomes.”

But the major strength of the study is the large number of deliveries, she said, which allowed the researchers to investigate rare neonatal outcomes at term.

The study was supported by the NICHD. Dr. Grantz reported having no relevant financial conflicts.

[email protected]

On Twitter @dougbrunk

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Extending second stage of labor raised maternal and neonatal morbidity
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Key clinical point: Extending the second stage in nulliparous women from 3 hours to 4 hours was associated with an increased rate of maternal and neonatal morbidity.

Major finding: Among nulliparous women with an epidural, extending the second stage of labor from 3 hours to 4 hours resulted in 16% of maternal and 15% of neonatal morbidities, with approximately 5.5% additional spontaneous vaginal deliveries during that hour.

Data source: A retrospective study of medical records from 103,415 deliveries between 2002 and 2008.

Disclosures: The study was supported by the National Institute of Child Health and Human Development. Dr. Grantz reported having no relevant financial conflicts.

TOLAC: Induction poses no maternal risk vs. expectant management

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TOLAC: Induction poses no maternal risk vs. expectant management

SAN DIEGO – Maternal morbidity was not consistently increased in a study of women with one prior cesarean delivery who were attempting a trial of labor and who were induced between 37 and 40 weeks, according to a secondary analysis of data from the National Institutes of Health Consortium on Safe Labor.

But the risk of admission to the neonatal intensive care unit did increase among women induced at 37 weeks, Dr. Justin Lappen reported at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.

Further, induction at 37, 38, and 39 weeks of gestation increased the risk of a failed trial of labor after cesarean section (TOLAC) in the 1,626 women in the retrospective multicenter study who were induced, compared with 4,407 who were managed expectantly (odds ratios, 1.53, 1.74, and 2.16, respectively).

The induction group was compared at gestational weeks 37-40 with all undelivered women in the expectant management group. After adjustment for prior spontaneous vaginal delivery, body mass index, hypertensive disorders, maternal age, week of gestation, birth weight, and neonatal gender, induction was not associated with any consistent increase in the risk of maternal morbidity (odds ratios at weeks 37-40 were 0.49, 0.64, 1.87, and 1.06, respectively).

The researchers defined maternal morbidity based on a composite of outcomes including hysterectomy, transfusion, intensive care unit transfer, venous thromboembolism, and death.

The increased risk of the composite maternal morbidity at 39 weeks was primarily the result of a significantly increased risk of transfusion among women with failed TOLAC, said Dr. Lappen of Case Western Reserve University, Cleveland.

However, among those who were induced at 37 weeks, the risk of neonatal ICU admission was increased, compared with women being expectantly managed who delivered at or beyond 37 weeks (OR, 2.51).

No increased risk was seen in those induced beyond 37 weeks, and no increased risk in neonatal morbidity – defined as a composite of 5-minute Apgar scores of less than 5, arterial cord pH less than 7.0, asphyxia, hypoxic ischemic encephalopathy, and death – was seen with induction at any week of gestation analyzed, Dr. Lappen said.

“Our findings should not change the current obstetric practice, which supports an individualized approach to the use of induction in appropriate candidates attempting TOLAC, Dr. Lappen said.

The researchers also performed a subset analysis in a low-risk cohort derived by excluding all women with chronic conditions who were ineligible for expectant management and by limiting the induction group to include only nonmedically indicated inductions of labor.

The association between induction and composite maternal morbidity was unchanged in this subset analysis, with greater risk seen at 39 weeks – again in association with increased risk of transfusion among those with a failed TOLAC attempt.

However, the association between induction and NICU admission at 37 weeks was no longer present in the low-risk cohort, and the risk was cut in half at 39 weeks in this cohort (OR, 0.52). As in the entire cohort, no association between induction and neonatal morbidity was present.

“Consistent with the primary cohort, nonmedically indicated induction was associated with an increased risk of failed TOLAC,” Dr. Lappen said. This finding was statistically significant at 38 and 39 weeks (ORs, 2.67 and 2.34, respectively), he said.

No association was seen between induction and uterine rupture in either the entire cohort or the low-risk cohort, he said.

Study subjects were women with a live, singleton gestation of at least 37 weeks identified from the Consortium on Safe Labor, a cohort of more than 228,600 deliveries at 12 centers between 2002 and 2008, which was designed to characterize current obstetric practice and outcomes.

Dr. Lappen reported having no financial disclosures.

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SAN DIEGO – Maternal morbidity was not consistently increased in a study of women with one prior cesarean delivery who were attempting a trial of labor and who were induced between 37 and 40 weeks, according to a secondary analysis of data from the National Institutes of Health Consortium on Safe Labor.

But the risk of admission to the neonatal intensive care unit did increase among women induced at 37 weeks, Dr. Justin Lappen reported at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.

Further, induction at 37, 38, and 39 weeks of gestation increased the risk of a failed trial of labor after cesarean section (TOLAC) in the 1,626 women in the retrospective multicenter study who were induced, compared with 4,407 who were managed expectantly (odds ratios, 1.53, 1.74, and 2.16, respectively).

The induction group was compared at gestational weeks 37-40 with all undelivered women in the expectant management group. After adjustment for prior spontaneous vaginal delivery, body mass index, hypertensive disorders, maternal age, week of gestation, birth weight, and neonatal gender, induction was not associated with any consistent increase in the risk of maternal morbidity (odds ratios at weeks 37-40 were 0.49, 0.64, 1.87, and 1.06, respectively).

The researchers defined maternal morbidity based on a composite of outcomes including hysterectomy, transfusion, intensive care unit transfer, venous thromboembolism, and death.

The increased risk of the composite maternal morbidity at 39 weeks was primarily the result of a significantly increased risk of transfusion among women with failed TOLAC, said Dr. Lappen of Case Western Reserve University, Cleveland.

However, among those who were induced at 37 weeks, the risk of neonatal ICU admission was increased, compared with women being expectantly managed who delivered at or beyond 37 weeks (OR, 2.51).

No increased risk was seen in those induced beyond 37 weeks, and no increased risk in neonatal morbidity – defined as a composite of 5-minute Apgar scores of less than 5, arterial cord pH less than 7.0, asphyxia, hypoxic ischemic encephalopathy, and death – was seen with induction at any week of gestation analyzed, Dr. Lappen said.

“Our findings should not change the current obstetric practice, which supports an individualized approach to the use of induction in appropriate candidates attempting TOLAC, Dr. Lappen said.

The researchers also performed a subset analysis in a low-risk cohort derived by excluding all women with chronic conditions who were ineligible for expectant management and by limiting the induction group to include only nonmedically indicated inductions of labor.

The association between induction and composite maternal morbidity was unchanged in this subset analysis, with greater risk seen at 39 weeks – again in association with increased risk of transfusion among those with a failed TOLAC attempt.

However, the association between induction and NICU admission at 37 weeks was no longer present in the low-risk cohort, and the risk was cut in half at 39 weeks in this cohort (OR, 0.52). As in the entire cohort, no association between induction and neonatal morbidity was present.

“Consistent with the primary cohort, nonmedically indicated induction was associated with an increased risk of failed TOLAC,” Dr. Lappen said. This finding was statistically significant at 38 and 39 weeks (ORs, 2.67 and 2.34, respectively), he said.

No association was seen between induction and uterine rupture in either the entire cohort or the low-risk cohort, he said.

Study subjects were women with a live, singleton gestation of at least 37 weeks identified from the Consortium on Safe Labor, a cohort of more than 228,600 deliveries at 12 centers between 2002 and 2008, which was designed to characterize current obstetric practice and outcomes.

Dr. Lappen reported having no financial disclosures.

SAN DIEGO – Maternal morbidity was not consistently increased in a study of women with one prior cesarean delivery who were attempting a trial of labor and who were induced between 37 and 40 weeks, according to a secondary analysis of data from the National Institutes of Health Consortium on Safe Labor.

But the risk of admission to the neonatal intensive care unit did increase among women induced at 37 weeks, Dr. Justin Lappen reported at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.

Further, induction at 37, 38, and 39 weeks of gestation increased the risk of a failed trial of labor after cesarean section (TOLAC) in the 1,626 women in the retrospective multicenter study who were induced, compared with 4,407 who were managed expectantly (odds ratios, 1.53, 1.74, and 2.16, respectively).

The induction group was compared at gestational weeks 37-40 with all undelivered women in the expectant management group. After adjustment for prior spontaneous vaginal delivery, body mass index, hypertensive disorders, maternal age, week of gestation, birth weight, and neonatal gender, induction was not associated with any consistent increase in the risk of maternal morbidity (odds ratios at weeks 37-40 were 0.49, 0.64, 1.87, and 1.06, respectively).

The researchers defined maternal morbidity based on a composite of outcomes including hysterectomy, transfusion, intensive care unit transfer, venous thromboembolism, and death.

The increased risk of the composite maternal morbidity at 39 weeks was primarily the result of a significantly increased risk of transfusion among women with failed TOLAC, said Dr. Lappen of Case Western Reserve University, Cleveland.

However, among those who were induced at 37 weeks, the risk of neonatal ICU admission was increased, compared with women being expectantly managed who delivered at or beyond 37 weeks (OR, 2.51).

No increased risk was seen in those induced beyond 37 weeks, and no increased risk in neonatal morbidity – defined as a composite of 5-minute Apgar scores of less than 5, arterial cord pH less than 7.0, asphyxia, hypoxic ischemic encephalopathy, and death – was seen with induction at any week of gestation analyzed, Dr. Lappen said.

“Our findings should not change the current obstetric practice, which supports an individualized approach to the use of induction in appropriate candidates attempting TOLAC, Dr. Lappen said.

The researchers also performed a subset analysis in a low-risk cohort derived by excluding all women with chronic conditions who were ineligible for expectant management and by limiting the induction group to include only nonmedically indicated inductions of labor.

The association between induction and composite maternal morbidity was unchanged in this subset analysis, with greater risk seen at 39 weeks – again in association with increased risk of transfusion among those with a failed TOLAC attempt.

However, the association between induction and NICU admission at 37 weeks was no longer present in the low-risk cohort, and the risk was cut in half at 39 weeks in this cohort (OR, 0.52). As in the entire cohort, no association between induction and neonatal morbidity was present.

“Consistent with the primary cohort, nonmedically indicated induction was associated with an increased risk of failed TOLAC,” Dr. Lappen said. This finding was statistically significant at 38 and 39 weeks (ORs, 2.67 and 2.34, respectively), he said.

No association was seen between induction and uterine rupture in either the entire cohort or the low-risk cohort, he said.

Study subjects were women with a live, singleton gestation of at least 37 weeks identified from the Consortium on Safe Labor, a cohort of more than 228,600 deliveries at 12 centers between 2002 and 2008, which was designed to characterize current obstetric practice and outcomes.

Dr. Lappen reported having no financial disclosures.

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TOLAC: Induction poses no maternal risk vs. expectant management
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AT THE PREGNANCY MEETING

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Key clinical point: An individualized approach is warranted for induction in appropriate candidates attempting TOLAC.

Major finding: Induction was not consistently associated with composite maternal morbidity (odds ratios at weeks 37-40 were 0.49, 0.64, 1.87, and 1.06, respectively).

Data source: A secondary analysis of data from a retrospective multicenter study of 6,033 women.

Disclosures: Dr. Lappen reported having no financial disclosures.

Feedback device helped shorten second stage of labor

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Feedback device helped shorten second stage of labor

SAN DIEGO – An investigational system that provides precise measurement and real-time maternal feedback of descent during the second stage of labor shortened the second stage in pregnant women who received epidural anesthesia, a randomized, controlled study demonstrated.

The system also reduced composite adverse maternal outcomes and reduced neonatal ICU admissions, Dr. Merlin B. Fausett reported at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.

Dr. Merlin B. Fausett

“The length of second-stage labor is highly correlated with the incidence of maternal morbidities and the incidence of neonatal ICU admissions,” said Dr. Fausett, a maternal-fetal medicine specialist in Missoula, Montana. “The majority of laboring women in the U.S. have epidurals during labor for labor pain management. In some studies, the length of second-stage labor is increased in women receiving regional anesthesia, compared with women without. This increased length of labor may be due to the lack of maternal sensation, resulting in decreased physiologic feedback that inhibits learning and decreases the efficacy of maternal expulsive efforts.”

Recognizing the difficulties with a long second stage of labor, clinicians have developed several nonoperative methods of attempting to reduce its length, including coached pushing, allowing periods of passive descent, and waiting for the laboring women to develop an urge to push. Some physicians also provide maternal visual feedback with a mirror.

“These methods have proven to be of limited benefit at best,” Dr. Fausett said. “With coached pushing, for example, frequent or continuous vaginal examinations may cause genital trauma, perinatal edema, and increased rates of infection. This method also requires a significant amount of the provider’s time. Finally, the use of mirrors is not well accepted by many patients and is only effective if the baby is already low enough in the pelvis to be visible to the mother with the mirror.”

Dr. Fausett and his colleagues hypothesized that using an experimental metrology device and software to give real-time quantitative maternal feedback of fetal descent during labor could result in more effective expulsion efforts, reduce the length of second stage, and improve perinatal outcomes.

They designed a prospective randomized, nonblinded trial to assess the clinical impact of providing laboring women real-time audiovisual feedback regarding fetal descent during second stage. The primary outcomes were a comparison of the length of time from initiation of pushing until delivery of the baby and a comparison of a composite of clinical outcomes.

“The pushing time comparison was to be made between study and control group subjects who had a spontaneous vaginal delivery, thus excluding those whose second stage was short with an operational or cesarean delivery,” Dr. Fausett said. “This comparison was also to control for fetal station at the initiation of pushing, as well as neonatal birth weight.”

The composite outcome was defined as a comparison of the number of women in the study versus control group who had any one of the following outcomes: cesarean delivery, operative vaginal delivery, third- or fourth-degree lacerations, an intra-amniotic infection, or NICU admission.

Developed by OB Technologies, the metrology device consisted of a support arm attached to the maternal sacral area using tape. This support arm extended through the gluteal cleft and terminated distal to the perineum. An optical sensor was then attached to the distal center of the support arm. A standard needle scalp electrode was modified by placing a semirigid wire at the base of the attachment where the spiral electrode attached to the needle head.

“This wire extended from the scalp across the optical sensor, and thus movement of the fetal head relative to the maternal pelvis was detected,” Dr. Fausett explained. “The instrument allowed detection of movements as small as 50 micrometers. Fetal station relative to the position in the pelvis was recorded. For feedback subjects, the movement was conveyed to them graphically and audibly using piano tones that occurred as often as every 150 milliseconds. The feedback was related to both the velocity and the distance of descent.”

Dr. Fausett reported results from 69 laboring nulliparous women with singleton pregnancies who were at least 36 weeks’ gestational age with epidural anesthesia.

Women in the study group received feedback on descent during the second stage by way of a laptop that displayed graphics and sounded musical notes corresponding to the movement of the fetus relative to the maternal bony pelvis.

Control subjects were not provided the visual and auditory feedback but the descent information was recorded with the same equipment. Normal labor and delivery procedures, including pelvic examination and nurse-provided feedback to the patient, were allowed in both groups. On postpartum day one, study subjects were asked to complete an anonymous survey about the use of the feedback device.

 

 

The study was halted after the planned interim analysis because the researchers identified a difference in the composite outcome between study and controls that was substantially above the threshold prescribed by the study design (more than 30%), Dr. Fausett said.

He presented findings from 46 women in the feedback group and 23 women in the control group. There were no differences between the groups in birth weights, mean station at the initiation of pushing, or in the maternal body mass indexes. However, the incidence of the composite adverse outcome was 9% in the feedback group, compared with 33% in the control group (P = .011). This corresponded to a 73% reduction in the composite outcome in the feedback group.

With regard to pushing time, the median pushing time was 77 minutes versus 58 minutes for control and study groups, respectively (P = .016).

The researchers did not identify any statistical differences in the incidence of cesarean delivery or intra-amniotic infections between the study and control groups. However, in the feedback group there were significant reductions in the incidences of operative vaginal deliveries (6.6% vs. 25%; P = .035), third- and fourth-degree lacerations (0% vs. 17%; P = .005), and neonatal ICU admission (0% vs. 13%; P = .015).

Among the 35 subjects that responded to a survey about the device on postpartum day one, “the majority strongly agreed that the device was comfortable, it helped them to push better, and they felt it gave them an increased sense of control during pushing,” he said.

Dr. Fausett acknowledged certain limitations of the study, including the potential for bias since it was not a blinded trial.

“We also did not address the optimal method or methods of feedback in this study,” he said. “Additional studies should evaluate and validate our findings as well as focus on fine-tuning the methods of graphic, auditory, and haptic feedback. If such feedback continues to prove effective, there are significant potential benefits on perinatal outcomes with important medical and economic consequences.”

Dr. Fausett disclosed that he is a shareholder in OB Technologies.

[email protected]

On Twitter @dougbrunk

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SAN DIEGO – An investigational system that provides precise measurement and real-time maternal feedback of descent during the second stage of labor shortened the second stage in pregnant women who received epidural anesthesia, a randomized, controlled study demonstrated.

The system also reduced composite adverse maternal outcomes and reduced neonatal ICU admissions, Dr. Merlin B. Fausett reported at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.

Dr. Merlin B. Fausett

“The length of second-stage labor is highly correlated with the incidence of maternal morbidities and the incidence of neonatal ICU admissions,” said Dr. Fausett, a maternal-fetal medicine specialist in Missoula, Montana. “The majority of laboring women in the U.S. have epidurals during labor for labor pain management. In some studies, the length of second-stage labor is increased in women receiving regional anesthesia, compared with women without. This increased length of labor may be due to the lack of maternal sensation, resulting in decreased physiologic feedback that inhibits learning and decreases the efficacy of maternal expulsive efforts.”

Recognizing the difficulties with a long second stage of labor, clinicians have developed several nonoperative methods of attempting to reduce its length, including coached pushing, allowing periods of passive descent, and waiting for the laboring women to develop an urge to push. Some physicians also provide maternal visual feedback with a mirror.

“These methods have proven to be of limited benefit at best,” Dr. Fausett said. “With coached pushing, for example, frequent or continuous vaginal examinations may cause genital trauma, perinatal edema, and increased rates of infection. This method also requires a significant amount of the provider’s time. Finally, the use of mirrors is not well accepted by many patients and is only effective if the baby is already low enough in the pelvis to be visible to the mother with the mirror.”

Dr. Fausett and his colleagues hypothesized that using an experimental metrology device and software to give real-time quantitative maternal feedback of fetal descent during labor could result in more effective expulsion efforts, reduce the length of second stage, and improve perinatal outcomes.

They designed a prospective randomized, nonblinded trial to assess the clinical impact of providing laboring women real-time audiovisual feedback regarding fetal descent during second stage. The primary outcomes were a comparison of the length of time from initiation of pushing until delivery of the baby and a comparison of a composite of clinical outcomes.

“The pushing time comparison was to be made between study and control group subjects who had a spontaneous vaginal delivery, thus excluding those whose second stage was short with an operational or cesarean delivery,” Dr. Fausett said. “This comparison was also to control for fetal station at the initiation of pushing, as well as neonatal birth weight.”

The composite outcome was defined as a comparison of the number of women in the study versus control group who had any one of the following outcomes: cesarean delivery, operative vaginal delivery, third- or fourth-degree lacerations, an intra-amniotic infection, or NICU admission.

Developed by OB Technologies, the metrology device consisted of a support arm attached to the maternal sacral area using tape. This support arm extended through the gluteal cleft and terminated distal to the perineum. An optical sensor was then attached to the distal center of the support arm. A standard needle scalp electrode was modified by placing a semirigid wire at the base of the attachment where the spiral electrode attached to the needle head.

“This wire extended from the scalp across the optical sensor, and thus movement of the fetal head relative to the maternal pelvis was detected,” Dr. Fausett explained. “The instrument allowed detection of movements as small as 50 micrometers. Fetal station relative to the position in the pelvis was recorded. For feedback subjects, the movement was conveyed to them graphically and audibly using piano tones that occurred as often as every 150 milliseconds. The feedback was related to both the velocity and the distance of descent.”

Dr. Fausett reported results from 69 laboring nulliparous women with singleton pregnancies who were at least 36 weeks’ gestational age with epidural anesthesia.

Women in the study group received feedback on descent during the second stage by way of a laptop that displayed graphics and sounded musical notes corresponding to the movement of the fetus relative to the maternal bony pelvis.

Control subjects were not provided the visual and auditory feedback but the descent information was recorded with the same equipment. Normal labor and delivery procedures, including pelvic examination and nurse-provided feedback to the patient, were allowed in both groups. On postpartum day one, study subjects were asked to complete an anonymous survey about the use of the feedback device.

 

 

The study was halted after the planned interim analysis because the researchers identified a difference in the composite outcome between study and controls that was substantially above the threshold prescribed by the study design (more than 30%), Dr. Fausett said.

He presented findings from 46 women in the feedback group and 23 women in the control group. There were no differences between the groups in birth weights, mean station at the initiation of pushing, or in the maternal body mass indexes. However, the incidence of the composite adverse outcome was 9% in the feedback group, compared with 33% in the control group (P = .011). This corresponded to a 73% reduction in the composite outcome in the feedback group.

With regard to pushing time, the median pushing time was 77 minutes versus 58 minutes for control and study groups, respectively (P = .016).

The researchers did not identify any statistical differences in the incidence of cesarean delivery or intra-amniotic infections between the study and control groups. However, in the feedback group there were significant reductions in the incidences of operative vaginal deliveries (6.6% vs. 25%; P = .035), third- and fourth-degree lacerations (0% vs. 17%; P = .005), and neonatal ICU admission (0% vs. 13%; P = .015).

Among the 35 subjects that responded to a survey about the device on postpartum day one, “the majority strongly agreed that the device was comfortable, it helped them to push better, and they felt it gave them an increased sense of control during pushing,” he said.

Dr. Fausett acknowledged certain limitations of the study, including the potential for bias since it was not a blinded trial.

“We also did not address the optimal method or methods of feedback in this study,” he said. “Additional studies should evaluate and validate our findings as well as focus on fine-tuning the methods of graphic, auditory, and haptic feedback. If such feedback continues to prove effective, there are significant potential benefits on perinatal outcomes with important medical and economic consequences.”

Dr. Fausett disclosed that he is a shareholder in OB Technologies.

[email protected]

On Twitter @dougbrunk

SAN DIEGO – An investigational system that provides precise measurement and real-time maternal feedback of descent during the second stage of labor shortened the second stage in pregnant women who received epidural anesthesia, a randomized, controlled study demonstrated.

The system also reduced composite adverse maternal outcomes and reduced neonatal ICU admissions, Dr. Merlin B. Fausett reported at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.

Dr. Merlin B. Fausett

“The length of second-stage labor is highly correlated with the incidence of maternal morbidities and the incidence of neonatal ICU admissions,” said Dr. Fausett, a maternal-fetal medicine specialist in Missoula, Montana. “The majority of laboring women in the U.S. have epidurals during labor for labor pain management. In some studies, the length of second-stage labor is increased in women receiving regional anesthesia, compared with women without. This increased length of labor may be due to the lack of maternal sensation, resulting in decreased physiologic feedback that inhibits learning and decreases the efficacy of maternal expulsive efforts.”

Recognizing the difficulties with a long second stage of labor, clinicians have developed several nonoperative methods of attempting to reduce its length, including coached pushing, allowing periods of passive descent, and waiting for the laboring women to develop an urge to push. Some physicians also provide maternal visual feedback with a mirror.

“These methods have proven to be of limited benefit at best,” Dr. Fausett said. “With coached pushing, for example, frequent or continuous vaginal examinations may cause genital trauma, perinatal edema, and increased rates of infection. This method also requires a significant amount of the provider’s time. Finally, the use of mirrors is not well accepted by many patients and is only effective if the baby is already low enough in the pelvis to be visible to the mother with the mirror.”

Dr. Fausett and his colleagues hypothesized that using an experimental metrology device and software to give real-time quantitative maternal feedback of fetal descent during labor could result in more effective expulsion efforts, reduce the length of second stage, and improve perinatal outcomes.

They designed a prospective randomized, nonblinded trial to assess the clinical impact of providing laboring women real-time audiovisual feedback regarding fetal descent during second stage. The primary outcomes were a comparison of the length of time from initiation of pushing until delivery of the baby and a comparison of a composite of clinical outcomes.

“The pushing time comparison was to be made between study and control group subjects who had a spontaneous vaginal delivery, thus excluding those whose second stage was short with an operational or cesarean delivery,” Dr. Fausett said. “This comparison was also to control for fetal station at the initiation of pushing, as well as neonatal birth weight.”

The composite outcome was defined as a comparison of the number of women in the study versus control group who had any one of the following outcomes: cesarean delivery, operative vaginal delivery, third- or fourth-degree lacerations, an intra-amniotic infection, or NICU admission.

Developed by OB Technologies, the metrology device consisted of a support arm attached to the maternal sacral area using tape. This support arm extended through the gluteal cleft and terminated distal to the perineum. An optical sensor was then attached to the distal center of the support arm. A standard needle scalp electrode was modified by placing a semirigid wire at the base of the attachment where the spiral electrode attached to the needle head.

“This wire extended from the scalp across the optical sensor, and thus movement of the fetal head relative to the maternal pelvis was detected,” Dr. Fausett explained. “The instrument allowed detection of movements as small as 50 micrometers. Fetal station relative to the position in the pelvis was recorded. For feedback subjects, the movement was conveyed to them graphically and audibly using piano tones that occurred as often as every 150 milliseconds. The feedback was related to both the velocity and the distance of descent.”

Dr. Fausett reported results from 69 laboring nulliparous women with singleton pregnancies who were at least 36 weeks’ gestational age with epidural anesthesia.

Women in the study group received feedback on descent during the second stage by way of a laptop that displayed graphics and sounded musical notes corresponding to the movement of the fetus relative to the maternal bony pelvis.

Control subjects were not provided the visual and auditory feedback but the descent information was recorded with the same equipment. Normal labor and delivery procedures, including pelvic examination and nurse-provided feedback to the patient, were allowed in both groups. On postpartum day one, study subjects were asked to complete an anonymous survey about the use of the feedback device.

 

 

The study was halted after the planned interim analysis because the researchers identified a difference in the composite outcome between study and controls that was substantially above the threshold prescribed by the study design (more than 30%), Dr. Fausett said.

He presented findings from 46 women in the feedback group and 23 women in the control group. There were no differences between the groups in birth weights, mean station at the initiation of pushing, or in the maternal body mass indexes. However, the incidence of the composite adverse outcome was 9% in the feedback group, compared with 33% in the control group (P = .011). This corresponded to a 73% reduction in the composite outcome in the feedback group.

With regard to pushing time, the median pushing time was 77 minutes versus 58 minutes for control and study groups, respectively (P = .016).

The researchers did not identify any statistical differences in the incidence of cesarean delivery or intra-amniotic infections between the study and control groups. However, in the feedback group there were significant reductions in the incidences of operative vaginal deliveries (6.6% vs. 25%; P = .035), third- and fourth-degree lacerations (0% vs. 17%; P = .005), and neonatal ICU admission (0% vs. 13%; P = .015).

Among the 35 subjects that responded to a survey about the device on postpartum day one, “the majority strongly agreed that the device was comfortable, it helped them to push better, and they felt it gave them an increased sense of control during pushing,” he said.

Dr. Fausett acknowledged certain limitations of the study, including the potential for bias since it was not a blinded trial.

“We also did not address the optimal method or methods of feedback in this study,” he said. “Additional studies should evaluate and validate our findings as well as focus on fine-tuning the methods of graphic, auditory, and haptic feedback. If such feedback continues to prove effective, there are significant potential benefits on perinatal outcomes with important medical and economic consequences.”

Dr. Fausett disclosed that he is a shareholder in OB Technologies.

[email protected]

On Twitter @dougbrunk

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Maternal obesity, not mild GDM, affects childhood BMI

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Maternal obesity, not mild GDM, affects childhood BMI

SAN DIEGO – Maternal glycemia was associated with anthropometric measures of obesity in offspring during childhood, but not with childhood body mass index, fasting glucose, or insulin resistance in a secondary analysis of a long-term follow-up study of women with mild gestational diabetes mellitus.

Baseline maternal body mass index (BMI), maternal weight gain, and Hispanic ethnicity, however, were consistently related to childhood BMI (P < .01) in the study of 236 children born to women who had untreated mild gestational diabetes mellitus (GDM) and 480 children whose mothers had a normal oral glucose tolerance test during pregnancy.

Courtesy Ohio State University
Dr. Mark B. Landon

The findings underscore the importance of reducing obesity prior to pregnancy, and suggest that obesity reduction efforts should be emphasized in clinical practice, Dr. Mark B. Landon said at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.

“The obesity epidemic certainly has not spared the pediatric population,” said Dr. Landon, chair of obstetrics and gynecology at the Ohio State University in Columbus.

And a serious concern is that overweight and obesity are associated with a downstream risk of both metabolic and cardiovascular abnormalities into adulthood, he added.

Hispanic ethnicity and maternal BMI were also associated with childhood homeostatic model assessment-insulin resistance (HOMA-IR), and Hispanic ethnicity was associated with fasting glucose, Dr. Landon reported on behalf of the National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network.

There was a significant correlation between fasting, 1-hour, 2-hour, and 3-hour maternal glucose and subscapular/triceps skin fold ratio (Spearman correlation coefficients, 0.10, 0.08, 0.11, and 0.12, respectively). Similar correlations were seen between maternal glucose and HOMA-IR, and maternal glucose and sum of skin folds.

Fasting maternal glucose and fasting child glucose were also significantly correlated (Spearman correlation coefficients, 0.09).

On multivariable regression analysis – after controlling for maternal and neonatal factors – the only significant correlations between maternal glycemia and childhood outcomes were for 1-hour, 2-hour, and 3-hour maternal glucose measures, sum of skin folds, and subscapular/triceps skin fold ratio, he said.

 

 

Study subjects were the offspring of women who underwent a 3-hour oral glucose tolerance test between 27 and 31 weeks’ gestation, and childhood outcomes were assessed between the ages of 5 and 10 years.

Prior to the widespread recognition of the concept of fetal programming over 3 decades ago, Dr. Norbert Freinkel proposed that mild forms of diabetes, such as GDM, might exaggerate the normal dependency of the fetus on maternal fuels and that the concept of teratogenesis should be expanded to include alterations which could have long-range effects on behavioral, anthropometric, and metabolic functions, Dr. Landon said.

Multiple subsequent studies have demonstrated a link between in utero exposure to maternal hyperglycemia and the development of obesity in childhood – findings that are independent of both birth weight and maternal obesity.

©moodboard/ thinkstockphotos.com

A 2013 study showed that GDM was associated with both overweight status in childhood and childhood obesity (Diabet. Med. 2013;30:1449-56). Also, the landmark Hyperglycemia and Adverse Pregnancy Outcomes study showed that with increasing maternal glucose levels lower than the threshold for GDM diagnosis, the frequency of large-for-gestational-age infants increased proportionately – and this risk also remained after adjustment for maternal BMI and other confounders (N. Engl. J. Med. 2008;358:1991-2002).

“We have similarly reported a monotonic relationship between maternal glucose levels and the frequency of large-for-gestational-age infants in a secondary analysis from the Mild GDM Network randomized controlled trial. Recognizing that maternal glycemia clearly contributes to fetal growth, we sought to determine in this analysis whether the degree of maternal glucose tolerance during pregnancy affects the risk of childhood obesity and metabolic dysfunction,” Dr. Landon said.

Although the findings do not address the potential long-term effects of more significant hyperglycemia during pregnancy, they do confirm that maternal obesity has a greater impact on childhood obesity risk than exposure to mild hyperglycemia during pregnancy, he said in an interview.

Dr. Landon reported having no financial disclosures.

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SAN DIEGO – Maternal glycemia was associated with anthropometric measures of obesity in offspring during childhood, but not with childhood body mass index, fasting glucose, or insulin resistance in a secondary analysis of a long-term follow-up study of women with mild gestational diabetes mellitus.

Baseline maternal body mass index (BMI), maternal weight gain, and Hispanic ethnicity, however, were consistently related to childhood BMI (P < .01) in the study of 236 children born to women who had untreated mild gestational diabetes mellitus (GDM) and 480 children whose mothers had a normal oral glucose tolerance test during pregnancy.

Courtesy Ohio State University
Dr. Mark B. Landon

The findings underscore the importance of reducing obesity prior to pregnancy, and suggest that obesity reduction efforts should be emphasized in clinical practice, Dr. Mark B. Landon said at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.

“The obesity epidemic certainly has not spared the pediatric population,” said Dr. Landon, chair of obstetrics and gynecology at the Ohio State University in Columbus.

And a serious concern is that overweight and obesity are associated with a downstream risk of both metabolic and cardiovascular abnormalities into adulthood, he added.

Hispanic ethnicity and maternal BMI were also associated with childhood homeostatic model assessment-insulin resistance (HOMA-IR), and Hispanic ethnicity was associated with fasting glucose, Dr. Landon reported on behalf of the National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network.

There was a significant correlation between fasting, 1-hour, 2-hour, and 3-hour maternal glucose and subscapular/triceps skin fold ratio (Spearman correlation coefficients, 0.10, 0.08, 0.11, and 0.12, respectively). Similar correlations were seen between maternal glucose and HOMA-IR, and maternal glucose and sum of skin folds.

Fasting maternal glucose and fasting child glucose were also significantly correlated (Spearman correlation coefficients, 0.09).

On multivariable regression analysis – after controlling for maternal and neonatal factors – the only significant correlations between maternal glycemia and childhood outcomes were for 1-hour, 2-hour, and 3-hour maternal glucose measures, sum of skin folds, and subscapular/triceps skin fold ratio, he said.

 

 

Study subjects were the offspring of women who underwent a 3-hour oral glucose tolerance test between 27 and 31 weeks’ gestation, and childhood outcomes were assessed between the ages of 5 and 10 years.

Prior to the widespread recognition of the concept of fetal programming over 3 decades ago, Dr. Norbert Freinkel proposed that mild forms of diabetes, such as GDM, might exaggerate the normal dependency of the fetus on maternal fuels and that the concept of teratogenesis should be expanded to include alterations which could have long-range effects on behavioral, anthropometric, and metabolic functions, Dr. Landon said.

Multiple subsequent studies have demonstrated a link between in utero exposure to maternal hyperglycemia and the development of obesity in childhood – findings that are independent of both birth weight and maternal obesity.

©moodboard/ thinkstockphotos.com

A 2013 study showed that GDM was associated with both overweight status in childhood and childhood obesity (Diabet. Med. 2013;30:1449-56). Also, the landmark Hyperglycemia and Adverse Pregnancy Outcomes study showed that with increasing maternal glucose levels lower than the threshold for GDM diagnosis, the frequency of large-for-gestational-age infants increased proportionately – and this risk also remained after adjustment for maternal BMI and other confounders (N. Engl. J. Med. 2008;358:1991-2002).

“We have similarly reported a monotonic relationship between maternal glucose levels and the frequency of large-for-gestational-age infants in a secondary analysis from the Mild GDM Network randomized controlled trial. Recognizing that maternal glycemia clearly contributes to fetal growth, we sought to determine in this analysis whether the degree of maternal glucose tolerance during pregnancy affects the risk of childhood obesity and metabolic dysfunction,” Dr. Landon said.

Although the findings do not address the potential long-term effects of more significant hyperglycemia during pregnancy, they do confirm that maternal obesity has a greater impact on childhood obesity risk than exposure to mild hyperglycemia during pregnancy, he said in an interview.

Dr. Landon reported having no financial disclosures.

SAN DIEGO – Maternal glycemia was associated with anthropometric measures of obesity in offspring during childhood, but not with childhood body mass index, fasting glucose, or insulin resistance in a secondary analysis of a long-term follow-up study of women with mild gestational diabetes mellitus.

Baseline maternal body mass index (BMI), maternal weight gain, and Hispanic ethnicity, however, were consistently related to childhood BMI (P < .01) in the study of 236 children born to women who had untreated mild gestational diabetes mellitus (GDM) and 480 children whose mothers had a normal oral glucose tolerance test during pregnancy.

Courtesy Ohio State University
Dr. Mark B. Landon

The findings underscore the importance of reducing obesity prior to pregnancy, and suggest that obesity reduction efforts should be emphasized in clinical practice, Dr. Mark B. Landon said at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.

“The obesity epidemic certainly has not spared the pediatric population,” said Dr. Landon, chair of obstetrics and gynecology at the Ohio State University in Columbus.

And a serious concern is that overweight and obesity are associated with a downstream risk of both metabolic and cardiovascular abnormalities into adulthood, he added.

Hispanic ethnicity and maternal BMI were also associated with childhood homeostatic model assessment-insulin resistance (HOMA-IR), and Hispanic ethnicity was associated with fasting glucose, Dr. Landon reported on behalf of the National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network.

There was a significant correlation between fasting, 1-hour, 2-hour, and 3-hour maternal glucose and subscapular/triceps skin fold ratio (Spearman correlation coefficients, 0.10, 0.08, 0.11, and 0.12, respectively). Similar correlations were seen between maternal glucose and HOMA-IR, and maternal glucose and sum of skin folds.

Fasting maternal glucose and fasting child glucose were also significantly correlated (Spearman correlation coefficients, 0.09).

On multivariable regression analysis – after controlling for maternal and neonatal factors – the only significant correlations between maternal glycemia and childhood outcomes were for 1-hour, 2-hour, and 3-hour maternal glucose measures, sum of skin folds, and subscapular/triceps skin fold ratio, he said.

 

 

Study subjects were the offspring of women who underwent a 3-hour oral glucose tolerance test between 27 and 31 weeks’ gestation, and childhood outcomes were assessed between the ages of 5 and 10 years.

Prior to the widespread recognition of the concept of fetal programming over 3 decades ago, Dr. Norbert Freinkel proposed that mild forms of diabetes, such as GDM, might exaggerate the normal dependency of the fetus on maternal fuels and that the concept of teratogenesis should be expanded to include alterations which could have long-range effects on behavioral, anthropometric, and metabolic functions, Dr. Landon said.

Multiple subsequent studies have demonstrated a link between in utero exposure to maternal hyperglycemia and the development of obesity in childhood – findings that are independent of both birth weight and maternal obesity.

©moodboard/ thinkstockphotos.com

A 2013 study showed that GDM was associated with both overweight status in childhood and childhood obesity (Diabet. Med. 2013;30:1449-56). Also, the landmark Hyperglycemia and Adverse Pregnancy Outcomes study showed that with increasing maternal glucose levels lower than the threshold for GDM diagnosis, the frequency of large-for-gestational-age infants increased proportionately – and this risk also remained after adjustment for maternal BMI and other confounders (N. Engl. J. Med. 2008;358:1991-2002).

“We have similarly reported a monotonic relationship between maternal glucose levels and the frequency of large-for-gestational-age infants in a secondary analysis from the Mild GDM Network randomized controlled trial. Recognizing that maternal glycemia clearly contributes to fetal growth, we sought to determine in this analysis whether the degree of maternal glucose tolerance during pregnancy affects the risk of childhood obesity and metabolic dysfunction,” Dr. Landon said.

Although the findings do not address the potential long-term effects of more significant hyperglycemia during pregnancy, they do confirm that maternal obesity has a greater impact on childhood obesity risk than exposure to mild hyperglycemia during pregnancy, he said in an interview.

Dr. Landon reported having no financial disclosures.

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Key clinical point: Maternal obesity is associated with childhood body mass index and should be addressed in clinical practice.

Major finding: Baseline maternal BMI, weight gain, and Hispanic ethnicity – but not maternal glycemia – were consistently related to childhood BMI (P < 0.01).

Data source: A secondary analysis of a long-term follow-up study of women with mild gestational diabetes mellitus and 716 of their offspring.

Disclosures: Dr. Landon reported having no financial disclosures.

Is midwifery the key to laborist model success?

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

But in a larger cross-sectional population-based study involving multiple community hospitals, no difference was seen in the primary cesarean rate, the successful vaginal birth after cesarean (VBAC) rate, or maternal morbidity for laboring women who gave birth in hospitals with an obstetrician available around the clock versus hospitals not using a laborist model.

Researchers who worked on the two studies said the differences might be explained by multiple factors, including the midwifery component in the single-center study, and a lack of information about exactly how laborists functioned at the various centers included in the larger, multicenter study.

In the single-center prospective cohort study, conducted at Marin General Hospital in Greenbrae, Calif., the nulliparous term single vertex cesarean delivery (NTSV CD) rate among privately insured women fell from 32.2% prior to the model change, to 25% after the switch. There was an immediate 5% decrease, followed by a nearly 2% decrease each year thereafter.

Prior to the switch to a laborist model, the NTSV CD rate had been increasing by 0.6% annually, similar to national trends, Dr. Melissa Rosenstein of the University of California, San Francisco, reported at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.

Further, the VBAC rate, which had been decreasing slightly each year before the change, increased from 13% to 22% after the change, and increased by about 8% per year thereafter, she said.

Previously, privately insured women were managed by their individual obstetricians; only publicly insured women utilized the laborist model at the hospital.

The rates of NTSV CD and VBAC among publicly insured women did not change significantly during the study period – the NTSV CD rates were 15.7% and 15.8% before and after the change, and VBAC rates were 33.9% and 27.9% before and after the change, she said.

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

“The changes were seen to a statistically significant degree only in the group of women exposed to the practice change, suggesting causation rather than secular trends for other hospitalwide interventions,” Dr. Rosenstein said.

But a larger, multicenter study found no difference between 43 hospitals with laborists and 139 without laborists on a range of outcomes, including the primary cesarean delivery rate (13.9% vs. 14.1%), the rate of maternal composite morbidity (10.3% vs. 10.8%), the rate of severe maternal complications (1.25% vs. 1.07%), and the successful VBAC rate (55.8% vs. 59.8%).

The researchers relied on structured 1-hour interviews conducted with labor and delivery nurse managers from 182 community hospitals with 221,247 deliveries in California between November 2012 and January 2014. They also considered discharge data and information regarding hospital policies and practices.

So why were the findings so different? Dr. Rosenstein, who worked on the single-center study, stressed the importance of the midwives in the laborist model used at Marin General Hospital.

“The other study didn’t include the midwifery component, which I think is a very important part of the Marin General Hospital experience,” Dr. Rosenstein said. “Not only does our hospital have midwives, but they work closely and collaboratively with physicians and participate in twice-daily rounds to discuss patient management.”

The principal investigator in the multicenter study, Dr. Kimberly Gregory, director of the division of maternal-fetal medicine at Cedars-Sinai Medical Center in Los Angeles, agreed, noting that midwifery is already known to make a difference.

“What we don’t know is what model of laborists, if any, makes a difference,” she said.

Other models that employ both midwives and dedicated obstetricians in labor and delivery, while having separate physicians for gynecologic and emergency care, are showing promise, Dr. Gregory said.

Another major difference between the two studies was the lack of categorization of hospitals by “how laborists actually functioned on the unit” in her study, Dr. Gregory said.

Since the multicenter study didn’t look at the specific roles of laborists on the hospital unit, it’s unclear whether they took care of just a few patients, or whether they managed all of the obstetrics patients, Dr. Rosenstein said.

 

 

Additionally, the multicenter study defined a laborist hospital as one where there was an obstetrician present 24/7. By that definition, the Marin General Hospital, where the single-center study was conducted, would have been considered a laborist hospital both before and after the intervention, she said.

Dr. Gregory also pointed out that all of the patients in the single-hospital study were exposed to the same “culture,” whereas patients in the multicenter study were subject to varying approaches and cultures.

The findings of both studies are of value for identifying the best approach to improving outcomes, Dr. Rosenstein said.

“Studies at the hospital level and at the population level are both important to determine the most optimal labor and delivery staffing pattern,” she said.

The single-center study was funded by the National Institutes of Health and the Prima Medical Foundation. The multicenter study was funded by the Agency for Healthcare Research and Quality, the American College of Obstetricians and Gynecologists, and the March of Dimes. The researchers reported having no relevant financial disclosures.

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

But in a larger cross-sectional population-based study involving multiple community hospitals, no difference was seen in the primary cesarean rate, the successful vaginal birth after cesarean (VBAC) rate, or maternal morbidity for laboring women who gave birth in hospitals with an obstetrician available around the clock versus hospitals not using a laborist model.

Researchers who worked on the two studies said the differences might be explained by multiple factors, including the midwifery component in the single-center study, and a lack of information about exactly how laborists functioned at the various centers included in the larger, multicenter study.

In the single-center prospective cohort study, conducted at Marin General Hospital in Greenbrae, Calif., the nulliparous term single vertex cesarean delivery (NTSV CD) rate among privately insured women fell from 32.2% prior to the model change, to 25% after the switch. There was an immediate 5% decrease, followed by a nearly 2% decrease each year thereafter.

Prior to the switch to a laborist model, the NTSV CD rate had been increasing by 0.6% annually, similar to national trends, Dr. Melissa Rosenstein of the University of California, San Francisco, reported at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.

Further, the VBAC rate, which had been decreasing slightly each year before the change, increased from 13% to 22% after the change, and increased by about 8% per year thereafter, she said.

Previously, privately insured women were managed by their individual obstetricians; only publicly insured women utilized the laborist model at the hospital.

The rates of NTSV CD and VBAC among publicly insured women did not change significantly during the study period – the NTSV CD rates were 15.7% and 15.8% before and after the change, and VBAC rates were 33.9% and 27.9% before and after the change, she said.

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

“The changes were seen to a statistically significant degree only in the group of women exposed to the practice change, suggesting causation rather than secular trends for other hospitalwide interventions,” Dr. Rosenstein said.

But a larger, multicenter study found no difference between 43 hospitals with laborists and 139 without laborists on a range of outcomes, including the primary cesarean delivery rate (13.9% vs. 14.1%), the rate of maternal composite morbidity (10.3% vs. 10.8%), the rate of severe maternal complications (1.25% vs. 1.07%), and the successful VBAC rate (55.8% vs. 59.8%).

The researchers relied on structured 1-hour interviews conducted with labor and delivery nurse managers from 182 community hospitals with 221,247 deliveries in California between November 2012 and January 2014. They also considered discharge data and information regarding hospital policies and practices.

So why were the findings so different? Dr. Rosenstein, who worked on the single-center study, stressed the importance of the midwives in the laborist model used at Marin General Hospital.

“The other study didn’t include the midwifery component, which I think is a very important part of the Marin General Hospital experience,” Dr. Rosenstein said. “Not only does our hospital have midwives, but they work closely and collaboratively with physicians and participate in twice-daily rounds to discuss patient management.”

The principal investigator in the multicenter study, Dr. Kimberly Gregory, director of the division of maternal-fetal medicine at Cedars-Sinai Medical Center in Los Angeles, agreed, noting that midwifery is already known to make a difference.

“What we don’t know is what model of laborists, if any, makes a difference,” she said.

Other models that employ both midwives and dedicated obstetricians in labor and delivery, while having separate physicians for gynecologic and emergency care, are showing promise, Dr. Gregory said.

Another major difference between the two studies was the lack of categorization of hospitals by “how laborists actually functioned on the unit” in her study, Dr. Gregory said.

Since the multicenter study didn’t look at the specific roles of laborists on the hospital unit, it’s unclear whether they took care of just a few patients, or whether they managed all of the obstetrics patients, Dr. Rosenstein said.

 

 

Additionally, the multicenter study defined a laborist hospital as one where there was an obstetrician present 24/7. By that definition, the Marin General Hospital, where the single-center study was conducted, would have been considered a laborist hospital both before and after the intervention, she said.

Dr. Gregory also pointed out that all of the patients in the single-hospital study were exposed to the same “culture,” whereas patients in the multicenter study were subject to varying approaches and cultures.

The findings of both studies are of value for identifying the best approach to improving outcomes, Dr. Rosenstein said.

“Studies at the hospital level and at the population level are both important to determine the most optimal labor and delivery staffing pattern,” she said.

The single-center study was funded by the National Institutes of Health and the Prima Medical Foundation. The multicenter study was funded by the Agency for Healthcare Research and Quality, the American College of Obstetricians and Gynecologists, and the March of Dimes. The researchers reported having no relevant financial disclosures.

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

But in a larger cross-sectional population-based study involving multiple community hospitals, no difference was seen in the primary cesarean rate, the successful vaginal birth after cesarean (VBAC) rate, or maternal morbidity for laboring women who gave birth in hospitals with an obstetrician available around the clock versus hospitals not using a laborist model.

Researchers who worked on the two studies said the differences might be explained by multiple factors, including the midwifery component in the single-center study, and a lack of information about exactly how laborists functioned at the various centers included in the larger, multicenter study.

In the single-center prospective cohort study, conducted at Marin General Hospital in Greenbrae, Calif., the nulliparous term single vertex cesarean delivery (NTSV CD) rate among privately insured women fell from 32.2% prior to the model change, to 25% after the switch. There was an immediate 5% decrease, followed by a nearly 2% decrease each year thereafter.

Prior to the switch to a laborist model, the NTSV CD rate had been increasing by 0.6% annually, similar to national trends, Dr. Melissa Rosenstein of the University of California, San Francisco, reported at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.

Further, the VBAC rate, which had been decreasing slightly each year before the change, increased from 13% to 22% after the change, and increased by about 8% per year thereafter, she said.

Previously, privately insured women were managed by their individual obstetricians; only publicly insured women utilized the laborist model at the hospital.

The rates of NTSV CD and VBAC among publicly insured women did not change significantly during the study period – the NTSV CD rates were 15.7% and 15.8% before and after the change, and VBAC rates were 33.9% and 27.9% before and after the change, she said.

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

“The changes were seen to a statistically significant degree only in the group of women exposed to the practice change, suggesting causation rather than secular trends for other hospitalwide interventions,” Dr. Rosenstein said.

But a larger, multicenter study found no difference between 43 hospitals with laborists and 139 without laborists on a range of outcomes, including the primary cesarean delivery rate (13.9% vs. 14.1%), the rate of maternal composite morbidity (10.3% vs. 10.8%), the rate of severe maternal complications (1.25% vs. 1.07%), and the successful VBAC rate (55.8% vs. 59.8%).

The researchers relied on structured 1-hour interviews conducted with labor and delivery nurse managers from 182 community hospitals with 221,247 deliveries in California between November 2012 and January 2014. They also considered discharge data and information regarding hospital policies and practices.

So why were the findings so different? Dr. Rosenstein, who worked on the single-center study, stressed the importance of the midwives in the laborist model used at Marin General Hospital.

“The other study didn’t include the midwifery component, which I think is a very important part of the Marin General Hospital experience,” Dr. Rosenstein said. “Not only does our hospital have midwives, but they work closely and collaboratively with physicians and participate in twice-daily rounds to discuss patient management.”

The principal investigator in the multicenter study, Dr. Kimberly Gregory, director of the division of maternal-fetal medicine at Cedars-Sinai Medical Center in Los Angeles, agreed, noting that midwifery is already known to make a difference.

“What we don’t know is what model of laborists, if any, makes a difference,” she said.

Other models that employ both midwives and dedicated obstetricians in labor and delivery, while having separate physicians for gynecologic and emergency care, are showing promise, Dr. Gregory said.

Another major difference between the two studies was the lack of categorization of hospitals by “how laborists actually functioned on the unit” in her study, Dr. Gregory said.

Since the multicenter study didn’t look at the specific roles of laborists on the hospital unit, it’s unclear whether they took care of just a few patients, or whether they managed all of the obstetrics patients, Dr. Rosenstein said.

 

 

Additionally, the multicenter study defined a laborist hospital as one where there was an obstetrician present 24/7. By that definition, the Marin General Hospital, where the single-center study was conducted, would have been considered a laborist hospital both before and after the intervention, she said.

Dr. Gregory also pointed out that all of the patients in the single-hospital study were exposed to the same “culture,” whereas patients in the multicenter study were subject to varying approaches and cultures.

The findings of both studies are of value for identifying the best approach to improving outcomes, Dr. Rosenstein said.

“Studies at the hospital level and at the population level are both important to determine the most optimal labor and delivery staffing pattern,” she said.

The single-center study was funded by the National Institutes of Health and the Prima Medical Foundation. The multicenter study was funded by the Agency for Healthcare Research and Quality, the American College of Obstetricians and Gynecologists, and the March of Dimes. The researchers reported having no relevant financial disclosures.

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AT THE PREGNANCY MEETING

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Remission before conception: goal for IBD patients desiring pregnancy

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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.

Dr. Chad A. Grotegut

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

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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.

Dr. Chad A. Grotegut

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.

Dr. Chad A. Grotegut

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

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Electronic fetal monitoring fails to predict brain injury

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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.

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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.

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Key clinical point: Clinical factors and electronic fetal monitoring patterns do not appear useful for predicting brain injury in term infants.

Major finding: No EFM characteristics or clinical factors, including cesarean delivery (odds ratio, 1.8), nulliparity (OR, 1.0), acidemia (OR, 2.8), and labor induction (OR, 0.7), were associated with injury.

Data source: A nested case-control study of 220 infants.

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

Study finds no link between labor induction/augmentation and autism

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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.

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The authors of the study found no association between autism and labor induction and/or augmentation.

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.

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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
The authors of the study found no association between autism and labor induction and/or augmentation.

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
The authors of the study found no association between autism and labor induction and/or augmentation.

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.

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Key clinical point: Labor induction and/or augmentation were not associated with autism spectrum disorder in a large Utah cohort study.

Major finding: No association was found between induction/augmentation and ASD (odds ratios vs. no exposure to induction or augmentation: 0.897 for induction with augmentation, 0.959 for induction only, and 0.978 for augmentation only)

Data source: An epidemiologic cohort study involving more than 166,000 children.

Disclosures: Dr. Clark reported having no financial disclosures.

Tips for managing pregnant patients with migraine

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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.”

Dr. Kathleen Digre

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

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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.”

Dr. Kathleen Digre

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.”

Dr. Kathleen Digre

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

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Nifedipine for tocolysis upped perinatal mortality vs. atosiban

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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.

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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.

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Nifedipine for tocolysis upped perinatal mortality vs. atosiban
Display Headline
Nifedipine for tocolysis upped perinatal mortality vs. atosiban
Legacy Keywords
nifedipine, tocolysis, atosiban, perinatal mortality, pregnancy
Legacy Keywords
nifedipine, tocolysis, atosiban, perinatal mortality, pregnancy
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AT THE PREGNANCY MEETING

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Key clinical point: A higher rate of perinatal mortality with nifedipine vs. atosiban for tocolysis requires further study.

Major finding: The rate of perinatal mortality was 5.4% in the nifedipine group vs. 2.1% in the atosiban group (RR, 2.567).

Data source: A multicenter randomized clinical trial (APOSTEL III) involving 502 women.

Disclosures: Dr. Vliet reported having no disclosures.