Obstetrics

Major Finding: Death or neurologic impairment at 18-24 months was just under 14% among the offspring of women at high risk for preterm birth, irrespective of whether they were given a single course or multiple courses of antenatal corticosteroids.

Data Source: The MACS trial of 1,858 women at high risk for preterm birth.

Disclosures: MACS was funded by the Canadian Institutes of Health Research. The authors disclosed no conflicts of interest.

CHICAGO — The risk of death or neurologic impairment was similar at 2 years after exposure to either single or multiple courses of antenatal corticosteroids, according to a follow-up analysis of data from the multicenter MACS trial.

“Continued follow-up of these children is important and necessary to determine if there are subtle effects of steroid exposure that only become evident in later years,” Dr. Elizabeth Asztalos said at the annual meeting of the Society of Maternal-Fetal Medicine.

The findings are encouraging as the same group previously reported that multiple courses of antenatal corticosteroids (ACS) given at 14-day intervals do not improve preterm birth outcomes and are associated with a significant decrease in weight, length, and head circumference at birth (Lancet 2008;372:2143-51). “Therefore, this treatment schedule is not recommended,” the authors wrote.

MACS, the Multiple Courses of Antenatal Corticosteroids for Preterm Birth Study, included women who were at high risk of preterm birth at 25-32 weeks' gestation. All of the women received an initial course of ACS. There were 1,858 women who were undelivered and remained at high risk at 14-21 days after the initial course of ACS. These women were randomized to either ACS or placebo given every 14 days until week 33 or delivery, whichever came first.

The secondary composite outcome of death or neurologic impairment was evaluated at 18-24 months. Neurologic impairment was defined as cerebral palsy or abnormal cognitive development defined by a Mental Development Index (MDI) score of less than 70 on the Bayley Scales of Infant Development–Second Edition.

Evaluations were conducted in 1,069 infants exposed to multiple courses of ACS and 1,035 infants exposed to placebo at a median of 22 months old.

The occurrence rate of the composite outcome was nearly identical—13.8% (148) of the ACS group and in 13.7% (142) of the placebo group, said Dr. Asztalos of the department of Newborn & Developmental Paediatrics, Sunnybrook Health Sciences Centre in Toronto. Also, the components of the composite outcome were nearly identical—mortality (49 vs. 47), cerebral palsy (24 vs. 25), and cognitive impairment (86 vs. 84).

Major Finding: Death or neurologic impairment at 18-24 months was just under 14% among the offspring of women at high risk for preterm birth, irrespective of whether they were given a single course or multiple courses of antenatal corticosteroids.

Data Source: The MACS trial of 1,858 women at high risk for preterm birth.

Disclosures: MACS was funded by the Canadian Institutes of Health Research. The authors disclosed no conflicts of interest.

CHICAGO — The risk of death or neurologic impairment was similar at 2 years after exposure to either single or multiple courses of antenatal corticosteroids, according to a follow-up analysis of data from the multicenter MACS trial.

“Continued follow-up of these children is important and necessary to determine if there are subtle effects of steroid exposure that only become evident in later years,” Dr. Elizabeth Asztalos said at the annual meeting of the Society of Maternal-Fetal Medicine.

The findings are encouraging as the same group previously reported that multiple courses of antenatal corticosteroids (ACS) given at 14-day intervals do not improve preterm birth outcomes and are associated with a significant decrease in weight, length, and head circumference at birth (Lancet 2008;372:2143-51). “Therefore, this treatment schedule is not recommended,” the authors wrote.

MACS, the Multiple Courses of Antenatal Corticosteroids for Preterm Birth Study, included women who were at high risk of preterm birth at 25-32 weeks' gestation. All of the women received an initial course of ACS. There were 1,858 women who were undelivered and remained at high risk at 14-21 days after the initial course of ACS. These women were randomized to either ACS or placebo given every 14 days until week 33 or delivery, whichever came first.

The secondary composite outcome of death or neurologic impairment was evaluated at 18-24 months. Neurologic impairment was defined as cerebral palsy or abnormal cognitive development defined by a Mental Development Index (MDI) score of less than 70 on the Bayley Scales of Infant Development–Second Edition.

Evaluations were conducted in 1,069 infants exposed to multiple courses of ACS and 1,035 infants exposed to placebo at a median of 22 months old.

The occurrence rate of the composite outcome was nearly identical—13.8% (148) of the ACS group and in 13.7% (142) of the placebo group, said Dr. Asztalos of the department of Newborn & Developmental Paediatrics, Sunnybrook Health Sciences Centre in Toronto. Also, the components of the composite outcome were nearly identical—mortality (49 vs. 47), cerebral palsy (24 vs. 25), and cognitive impairment (86 vs. 84).

Major Finding: Death or neurologic impairment at 18-24 months was just under 14% among the offspring of women at high risk for preterm birth, irrespective of whether they were given a single course or multiple courses of antenatal corticosteroids.

Data Source: The MACS trial of 1,858 women at high risk for preterm birth.

Disclosures: MACS was funded by the Canadian Institutes of Health Research. The authors disclosed no conflicts of interest.

CHICAGO — The risk of death or neurologic impairment was similar at 2 years after exposure to either single or multiple courses of antenatal corticosteroids, according to a follow-up analysis of data from the multicenter MACS trial.

“Continued follow-up of these children is important and necessary to determine if there are subtle effects of steroid exposure that only become evident in later years,” Dr. Elizabeth Asztalos said at the annual meeting of the Society of Maternal-Fetal Medicine.

The findings are encouraging as the same group previously reported that multiple courses of antenatal corticosteroids (ACS) given at 14-day intervals do not improve preterm birth outcomes and are associated with a significant decrease in weight, length, and head circumference at birth (Lancet 2008;372:2143-51). “Therefore, this treatment schedule is not recommended,” the authors wrote.

MACS, the Multiple Courses of Antenatal Corticosteroids for Preterm Birth Study, included women who were at high risk of preterm birth at 25-32 weeks' gestation. All of the women received an initial course of ACS. There were 1,858 women who were undelivered and remained at high risk at 14-21 days after the initial course of ACS. These women were randomized to either ACS or placebo given every 14 days until week 33 or delivery, whichever came first.

The secondary composite outcome of death or neurologic impairment was evaluated at 18-24 months. Neurologic impairment was defined as cerebral palsy or abnormal cognitive development defined by a Mental Development Index (MDI) score of less than 70 on the Bayley Scales of Infant Development–Second Edition.

Evaluations were conducted in 1,069 infants exposed to multiple courses of ACS and 1,035 infants exposed to placebo at a median of 22 months old.

The occurrence rate of the composite outcome was nearly identical—13.8% (148) of the ACS group and in 13.7% (142) of the placebo group, said Dr. Asztalos of the department of Newborn & Developmental Paediatrics, Sunnybrook Health Sciences Centre in Toronto. Also, the components of the composite outcome were nearly identical—mortality (49 vs. 47), cerebral palsy (24 vs. 25), and cognitive impairment (86 vs. 84).

MONTREAL — Community-acquired strains are the most common source of methicillin-resistant Staphylococcus aureus colonization and infection in babies in the neonatal intensive care unit, even though they have never left the hospital, researchers have found.

Findings in a 5-year retrospective study of 50 MRSA-colonized neonates in the NICU were presented at the annual meeting of the Infectious Diseases Society for Obstetrics and Gynecology.

“There are higher rates of community-acquired MRSA infection in our neonates than in our general adult and pediatric patient population,” lead investigator Dr. Gweneth Lazenby of the Medical University of South Carolina in Charleston said in an interview. “This is a call for people to help us really detail the sources of such early colonization, how we can prevent it, and how we can prevent subsequent infection.”

Theories on how neonates are exposed to MRSA in the NICU include maternal transmission, transmission from other family members or hospital workers, contaminated equipment, and a recently reported possible transmission through breast milk, she said.

“We have some concern about family members and maternal transmission to neonates, and so we would like to consider interrupting transmission by possibly culturing the individuals the babies are exposed to—including health care workers.”

In the current study, there was a mean of 21 days between birth and colonization of the 50 infants. However, 30% tested positive within 7 days of birth, she said.

“The 30% of infants who acquired early MRSA colonization, within the first week, were 2.5 times more likely to go on to develop infection,” she explained. No other risk factors for infection—including ethnicity, sex, method of delivery, gestational age, or length of stay—could be identified, although there was a nonsignificant trend toward a higher risk with lower birth weight.

In total, 16 of the 50 colonized infants (32%) eventually developed MRSA infections, which included eight blood stream infections, six skin and soft tissue infections, and two ventilator-associated pneumonia cases.

One of the bloodstream infections was fatal and was identified as a community-acquired MRSA strain (USA 300).

Pulse field gel electrophoresis identified USA 300 in 36% of 14 colonizing strains and 56% of 9 infection strains, she said. “This is considerably higher than what is seen in the rest of our hospital's pediatric and adult patient population, where we see a 4%-6% colonization rate and a 19% infection rate, with one-quarter of those infections being community acquired.”

Dr. Lazenby said decolonization is not currently attempted in neonates. “No one has looked at the effect of topical decolonization, and we do try to be as minimally invasive as possible with neonates in the NICU.”

The current management of colonized infants is isolation and contact precautions to prevent spreading the infection to other babies, she said.

Disclosures: None was reported.

MONTREAL — Community-acquired strains are the most common source of methicillin-resistant Staphylococcus aureus colonization and infection in babies in the neonatal intensive care unit, even though they have never left the hospital, researchers have found.

Findings in a 5-year retrospective study of 50 MRSA-colonized neonates in the NICU were presented at the annual meeting of the Infectious Diseases Society for Obstetrics and Gynecology.

“There are higher rates of community-acquired MRSA infection in our neonates than in our general adult and pediatric patient population,” lead investigator Dr. Gweneth Lazenby of the Medical University of South Carolina in Charleston said in an interview. “This is a call for people to help us really detail the sources of such early colonization, how we can prevent it, and how we can prevent subsequent infection.”

Theories on how neonates are exposed to MRSA in the NICU include maternal transmission, transmission from other family members or hospital workers, contaminated equipment, and a recently reported possible transmission through breast milk, she said.

“We have some concern about family members and maternal transmission to neonates, and so we would like to consider interrupting transmission by possibly culturing the individuals the babies are exposed to—including health care workers.”

In the current study, there was a mean of 21 days between birth and colonization of the 50 infants. However, 30% tested positive within 7 days of birth, she said.

“The 30% of infants who acquired early MRSA colonization, within the first week, were 2.5 times more likely to go on to develop infection,” she explained. No other risk factors for infection—including ethnicity, sex, method of delivery, gestational age, or length of stay—could be identified, although there was a nonsignificant trend toward a higher risk with lower birth weight.

In total, 16 of the 50 colonized infants (32%) eventually developed MRSA infections, which included eight blood stream infections, six skin and soft tissue infections, and two ventilator-associated pneumonia cases.

One of the bloodstream infections was fatal and was identified as a community-acquired MRSA strain (USA 300).

Pulse field gel electrophoresis identified USA 300 in 36% of 14 colonizing strains and 56% of 9 infection strains, she said. “This is considerably higher than what is seen in the rest of our hospital's pediatric and adult patient population, where we see a 4%-6% colonization rate and a 19% infection rate, with one-quarter of those infections being community acquired.”

Dr. Lazenby said decolonization is not currently attempted in neonates. “No one has looked at the effect of topical decolonization, and we do try to be as minimally invasive as possible with neonates in the NICU.”

The current management of colonized infants is isolation and contact precautions to prevent spreading the infection to other babies, she said.

Disclosures: None was reported.

MONTREAL — Community-acquired strains are the most common source of methicillin-resistant Staphylococcus aureus colonization and infection in babies in the neonatal intensive care unit, even though they have never left the hospital, researchers have found.

Findings in a 5-year retrospective study of 50 MRSA-colonized neonates in the NICU were presented at the annual meeting of the Infectious Diseases Society for Obstetrics and Gynecology.

“There are higher rates of community-acquired MRSA infection in our neonates than in our general adult and pediatric patient population,” lead investigator Dr. Gweneth Lazenby of the Medical University of South Carolina in Charleston said in an interview. “This is a call for people to help us really detail the sources of such early colonization, how we can prevent it, and how we can prevent subsequent infection.”

Theories on how neonates are exposed to MRSA in the NICU include maternal transmission, transmission from other family members or hospital workers, contaminated equipment, and a recently reported possible transmission through breast milk, she said.

“We have some concern about family members and maternal transmission to neonates, and so we would like to consider interrupting transmission by possibly culturing the individuals the babies are exposed to—including health care workers.”

In the current study, there was a mean of 21 days between birth and colonization of the 50 infants. However, 30% tested positive within 7 days of birth, she said.

“The 30% of infants who acquired early MRSA colonization, within the first week, were 2.5 times more likely to go on to develop infection,” she explained. No other risk factors for infection—including ethnicity, sex, method of delivery, gestational age, or length of stay—could be identified, although there was a nonsignificant trend toward a higher risk with lower birth weight.

In total, 16 of the 50 colonized infants (32%) eventually developed MRSA infections, which included eight blood stream infections, six skin and soft tissue infections, and two ventilator-associated pneumonia cases.

One of the bloodstream infections was fatal and was identified as a community-acquired MRSA strain (USA 300).

Pulse field gel electrophoresis identified USA 300 in 36% of 14 colonizing strains and 56% of 9 infection strains, she said. “This is considerably higher than what is seen in the rest of our hospital's pediatric and adult patient population, where we see a 4%-6% colonization rate and a 19% infection rate, with one-quarter of those infections being community acquired.”

Dr. Lazenby said decolonization is not currently attempted in neonates. “No one has looked at the effect of topical decolonization, and we do try to be as minimally invasive as possible with neonates in the NICU.”

The current management of colonized infants is isolation and contact precautions to prevent spreading the infection to other babies, she said.

Disclosures: None was reported.

Major Finding: The mean interval from catheter withdrawal to delivery time was 9 hours for the CRDB catheter vs. 14 hours for the Foley catheter in multiparous women in the first study, a nonsignificant difference. Time from insertion to delivery was significantly less at a mean of 19 hours with the Foley vs. a mean of 23 hours with the CRDB in the second study.

Data Source: Two prospective, randomized studies comparing the CRDB catheter with the Foley catheter, the first in 200 women and the second in 188 women.

Disclosures: None was reported.

CHICAGO — The cervical-ripening double-balloon catheter has a more favorable effect on cervical ripening than a Foley catheter in nulliparous, but not multiparous, women, according to a prospective randomized trial in 200 women.

Israeli investigators compared the two devices after noting that labor induction rates had risen to 27% of pregnancies in their hospital and that the cervical ripening double-balloon catheter (Cook Medical) costs about 10 times more than a Foley catheter. It has a uterine balloon located at the distal end of the device and a second cervicovaginal balloon located 1.5 cm proximal to the first one.

A total of 100 nulliparous and 100 multiparous women, aged 18-45 years, with singleton pregnancies at at least 37 weeks' gestation and intact membranes were randomized to labor induction by Foley catheter or the cervical ripening double-balloon (CRDB) catheter. Data were evaluable in 180 women.

In nulliparous women, the increment in the Bishop score from catheter insertion until withdrawal or expulsion was significantly higher at a mean of 4.4 in the CRDB group, compared with a mean of 3.4 in the Foley group, Dr. Ido Solt and associates reported in a poster at the annual meeting of the Society for Maternal-Fetal Medicine.

The mean interval from catheter withdrawal to delivery time was significantly shorter at 15 hours in the CRDB group vs. 23 hours in the Foley group.

Nine of 45 (20%) nulliparous women in the CRDB group had a cesarean section, compared with 20 of 50 (40%) nulliparous women in the Foley group, which was statistically significant.

No significant differences were observed in multiparous women between the two catheters, reported Dr. Solt of the department of obstetrics and gynecology at Western Galilee Hospital in Nahariya, Israel.

The mean interval from catheter withdrawal to delivery time was 9 hours for the CRDB catheter vs. 14 hours for the Foley catheter.

Cesarean sections occurred in 17% of the 41 multiparous women who received a CRDB, vs. 16% of 44 multiparous women receiving a Foley.

A second poster presented at the same meeting reported that the Foley catheter with extra-amniotic saline infusion was a faster cervical-ripening device than the CRDB in a randomized trial involving 93 nulliparous and 95 multiparous women.

The primary outcome of time from insertion to delivery was significantly less at a mean of 19 hours with the Foley catheter vs. a mean of 23 hours with the CRDB, reported Dr. Elad Mei-Dan of Hillel Yaffe Medical Center in Hadera, Israel, and associates. Mean insertion to expulsion time was also significantly shorter at 7 hours with the Foley vs. 10 hours with the CRDB.

Ripening success was similar at 97% with the Foley and 99% with the CRDB. Cesarean section rates were also similar at 21% and 20%.

Patient satisfaction on a 10-point scale was 7 with the Foley catheter and 6.6 with the CRDB catheter, which was not statistically different.

In light of the findings and the significant cost difference between the two devices, a Foley catheter should be preferred initially, Dr. Mei-Dan said in an interview. He put the price at $3.50 for a Foley set and at $41 for the CRDB.

He noted that he and his associates still use the CRDB when a Foley catheter fails to achieve cervical ripening or when the preinduction cervical dilation is too big to hold the Foley balloon, but can still hold the Cook balloons.

Major Finding: The mean interval from catheter withdrawal to delivery time was 9 hours for the CRDB catheter vs. 14 hours for the Foley catheter in multiparous women in the first study, a nonsignificant difference. Time from insertion to delivery was significantly less at a mean of 19 hours with the Foley vs. a mean of 23 hours with the CRDB in the second study.

Data Source: Two prospective, randomized studies comparing the CRDB catheter with the Foley catheter, the first in 200 women and the second in 188 women.

Disclosures: None was reported.

CHICAGO — The cervical-ripening double-balloon catheter has a more favorable effect on cervical ripening than a Foley catheter in nulliparous, but not multiparous, women, according to a prospective randomized trial in 200 women.

Israeli investigators compared the two devices after noting that labor induction rates had risen to 27% of pregnancies in their hospital and that the cervical ripening double-balloon catheter (Cook Medical) costs about 10 times more than a Foley catheter. It has a uterine balloon located at the distal end of the device and a second cervicovaginal balloon located 1.5 cm proximal to the first one.

A total of 100 nulliparous and 100 multiparous women, aged 18-45 years, with singleton pregnancies at at least 37 weeks' gestation and intact membranes were randomized to labor induction by Foley catheter or the cervical ripening double-balloon (CRDB) catheter. Data were evaluable in 180 women.

In nulliparous women, the increment in the Bishop score from catheter insertion until withdrawal or expulsion was significantly higher at a mean of 4.4 in the CRDB group, compared with a mean of 3.4 in the Foley group, Dr. Ido Solt and associates reported in a poster at the annual meeting of the Society for Maternal-Fetal Medicine.

The mean interval from catheter withdrawal to delivery time was significantly shorter at 15 hours in the CRDB group vs. 23 hours in the Foley group.

Nine of 45 (20%) nulliparous women in the CRDB group had a cesarean section, compared with 20 of 50 (40%) nulliparous women in the Foley group, which was statistically significant.

No significant differences were observed in multiparous women between the two catheters, reported Dr. Solt of the department of obstetrics and gynecology at Western Galilee Hospital in Nahariya, Israel.

The mean interval from catheter withdrawal to delivery time was 9 hours for the CRDB catheter vs. 14 hours for the Foley catheter.

Cesarean sections occurred in 17% of the 41 multiparous women who received a CRDB, vs. 16% of 44 multiparous women receiving a Foley.

A second poster presented at the same meeting reported that the Foley catheter with extra-amniotic saline infusion was a faster cervical-ripening device than the CRDB in a randomized trial involving 93 nulliparous and 95 multiparous women.

The primary outcome of time from insertion to delivery was significantly less at a mean of 19 hours with the Foley catheter vs. a mean of 23 hours with the CRDB, reported Dr. Elad Mei-Dan of Hillel Yaffe Medical Center in Hadera, Israel, and associates. Mean insertion to expulsion time was also significantly shorter at 7 hours with the Foley vs. 10 hours with the CRDB.

Ripening success was similar at 97% with the Foley and 99% with the CRDB. Cesarean section rates were also similar at 21% and 20%.

Patient satisfaction on a 10-point scale was 7 with the Foley catheter and 6.6 with the CRDB catheter, which was not statistically different.

In light of the findings and the significant cost difference between the two devices, a Foley catheter should be preferred initially, Dr. Mei-Dan said in an interview. He put the price at $3.50 for a Foley set and at $41 for the CRDB.

He noted that he and his associates still use the CRDB when a Foley catheter fails to achieve cervical ripening or when the preinduction cervical dilation is too big to hold the Foley balloon, but can still hold the Cook balloons.

Major Finding: The mean interval from catheter withdrawal to delivery time was 9 hours for the CRDB catheter vs. 14 hours for the Foley catheter in multiparous women in the first study, a nonsignificant difference. Time from insertion to delivery was significantly less at a mean of 19 hours with the Foley vs. a mean of 23 hours with the CRDB in the second study.

Data Source: Two prospective, randomized studies comparing the CRDB catheter with the Foley catheter, the first in 200 women and the second in 188 women.

Disclosures: None was reported.

CHICAGO — The cervical-ripening double-balloon catheter has a more favorable effect on cervical ripening than a Foley catheter in nulliparous, but not multiparous, women, according to a prospective randomized trial in 200 women.

Israeli investigators compared the two devices after noting that labor induction rates had risen to 27% of pregnancies in their hospital and that the cervical ripening double-balloon catheter (Cook Medical) costs about 10 times more than a Foley catheter. It has a uterine balloon located at the distal end of the device and a second cervicovaginal balloon located 1.5 cm proximal to the first one.

A total of 100 nulliparous and 100 multiparous women, aged 18-45 years, with singleton pregnancies at at least 37 weeks' gestation and intact membranes were randomized to labor induction by Foley catheter or the cervical ripening double-balloon (CRDB) catheter. Data were evaluable in 180 women.

In nulliparous women, the increment in the Bishop score from catheter insertion until withdrawal or expulsion was significantly higher at a mean of 4.4 in the CRDB group, compared with a mean of 3.4 in the Foley group, Dr. Ido Solt and associates reported in a poster at the annual meeting of the Society for Maternal-Fetal Medicine.

The mean interval from catheter withdrawal to delivery time was significantly shorter at 15 hours in the CRDB group vs. 23 hours in the Foley group.

Nine of 45 (20%) nulliparous women in the CRDB group had a cesarean section, compared with 20 of 50 (40%) nulliparous women in the Foley group, which was statistically significant.

No significant differences were observed in multiparous women between the two catheters, reported Dr. Solt of the department of obstetrics and gynecology at Western Galilee Hospital in Nahariya, Israel.

The mean interval from catheter withdrawal to delivery time was 9 hours for the CRDB catheter vs. 14 hours for the Foley catheter.

Cesarean sections occurred in 17% of the 41 multiparous women who received a CRDB, vs. 16% of 44 multiparous women receiving a Foley.

A second poster presented at the same meeting reported that the Foley catheter with extra-amniotic saline infusion was a faster cervical-ripening device than the CRDB in a randomized trial involving 93 nulliparous and 95 multiparous women.

The primary outcome of time from insertion to delivery was significantly less at a mean of 19 hours with the Foley catheter vs. a mean of 23 hours with the CRDB, reported Dr. Elad Mei-Dan of Hillel Yaffe Medical Center in Hadera, Israel, and associates. Mean insertion to expulsion time was also significantly shorter at 7 hours with the Foley vs. 10 hours with the CRDB.

Ripening success was similar at 97% with the Foley and 99% with the CRDB. Cesarean section rates were also similar at 21% and 20%.

Patient satisfaction on a 10-point scale was 7 with the Foley catheter and 6.6 with the CRDB catheter, which was not statistically different.

In light of the findings and the significant cost difference between the two devices, a Foley catheter should be preferred initially, Dr. Mei-Dan said in an interview. He put the price at $3.50 for a Foley set and at $41 for the CRDB.

He noted that he and his associates still use the CRDB when a Foley catheter fails to achieve cervical ripening or when the preinduction cervical dilation is too big to hold the Foley balloon, but can still hold the Cook balloons.

Major Finding: Shorter fetal crown-to-rump length in the first trimester is associated with several maternal factors, including higher than average diastolic blood pressure.

Data Source: A population-based prospective study involving 1,631 pregnant women.

Disclosures: Funding sources included Erasmus Medical Center and the Netherlands Organization for Health Research. Dr. Mook-Kanamori reported no relevant conflicts of interest. Dr. Smith reported being a member of GlaxoSmithKline's preterm labor advisory boards.

Pregnant women who smoke, don't take folic acid supplements, or have higher than average blood pressure or hematocrit levels are at greater risk than others for fetal growth restriction during the first trimester, according to a report.

In turn, such growth restriction is associated with a greater risk of poor outcomes such as preterm birth, small size for gestational age (SGA) at birth, and a compensatory accelerated rate of postnatal growth that persists until age 2 years, said Dr. Dennis O. Mook-Kanamori and his associates at Erasmus Medical Center, Rotterdam, the Netherlands.

These findings from a population-based prospective study involving 1,631 pregnant women suggest that growth patterns as early as the first trimester have a far-reaching influence, perhaps affecting disease risk in adulthood as well as in childhood, the investigators said.

They assessed fetal crown-to-rump length via ultrasound during the first trimester among women participating in a larger study in the Netherlands concerning fetal life.

Higher than average diastolic blood pressure and hematocrit levels, smoking, and nonuse of folic acid supplements significantly correlated with shorter crown-to-rump length.

There was even a dose-response relation between the number of cigarettes smoked and the degree of growth restriction.

Maternal weight and height showed no relation to the development of fetal growth restriction, which indicates that the researchers were indeed measuring true in utero growth restriction rather than small stature.

Fetuses in the lowest 20% of crown-to-rump length had a 7% risk of preterm birth, an 11% risk of SGA, and an 8% risk of low birth weight (LBW). In contrast, these rates were 4%, 4%, and 3.5%, respectively, among fetuses that did not show growth restriction.

This indicates a two- to threefold increase in risk for these complications, Dr. Mook-Kanamori and his colleagues said (JAMA 2010;303:527-34).

First-trimester fetal crown-to-rump length also correlated with head circumference, femur length, and weight not only throughout pregnancy and at birth, but also at 1-year and 14-month assessments.

This correlation had disappeared by the time the study subjects were evaluated at age 2 years.

“Increased postnatal growth rate is a well-established risk factor for metabolic and cardiovascular disease in later life,” the researchers noted.

In an editorial comment accompanying this report, Dr. Gordon C.S. Smith of the University of Cambridge (England) said these findings suggest that “complications of late pregnancy may, at least for some women, already be determined in the first 3 months post conception, even before a woman has sought prenatal care.”

It is possible that combined ultrasound and laboratory screening in the first trimester may help identify fetuses with growth restriction who are thus at risk of later complications.

“The challenges for future research are to produce robust screening tests with acceptable levels of detection and prediction, and to identify interventions that are effective in improving outcome when a pregnancy has been identified as high risk,” Dr. Smith wrote (JAMA 2010;303:561-2).

Major Finding: Shorter fetal crown-to-rump length in the first trimester is associated with several maternal factors, including higher than average diastolic blood pressure.

Data Source: A population-based prospective study involving 1,631 pregnant women.

Disclosures: Funding sources included Erasmus Medical Center and the Netherlands Organization for Health Research. Dr. Mook-Kanamori reported no relevant conflicts of interest. Dr. Smith reported being a member of GlaxoSmithKline's preterm labor advisory boards.

Pregnant women who smoke, don't take folic acid supplements, or have higher than average blood pressure or hematocrit levels are at greater risk than others for fetal growth restriction during the first trimester, according to a report.

In turn, such growth restriction is associated with a greater risk of poor outcomes such as preterm birth, small size for gestational age (SGA) at birth, and a compensatory accelerated rate of postnatal growth that persists until age 2 years, said Dr. Dennis O. Mook-Kanamori and his associates at Erasmus Medical Center, Rotterdam, the Netherlands.

These findings from a population-based prospective study involving 1,631 pregnant women suggest that growth patterns as early as the first trimester have a far-reaching influence, perhaps affecting disease risk in adulthood as well as in childhood, the investigators said.

They assessed fetal crown-to-rump length via ultrasound during the first trimester among women participating in a larger study in the Netherlands concerning fetal life.

Higher than average diastolic blood pressure and hematocrit levels, smoking, and nonuse of folic acid supplements significantly correlated with shorter crown-to-rump length.

There was even a dose-response relation between the number of cigarettes smoked and the degree of growth restriction.

Maternal weight and height showed no relation to the development of fetal growth restriction, which indicates that the researchers were indeed measuring true in utero growth restriction rather than small stature.

Fetuses in the lowest 20% of crown-to-rump length had a 7% risk of preterm birth, an 11% risk of SGA, and an 8% risk of low birth weight (LBW). In contrast, these rates were 4%, 4%, and 3.5%, respectively, among fetuses that did not show growth restriction.

This indicates a two- to threefold increase in risk for these complications, Dr. Mook-Kanamori and his colleagues said (JAMA 2010;303:527-34).

First-trimester fetal crown-to-rump length also correlated with head circumference, femur length, and weight not only throughout pregnancy and at birth, but also at 1-year and 14-month assessments.

This correlation had disappeared by the time the study subjects were evaluated at age 2 years.

“Increased postnatal growth rate is a well-established risk factor for metabolic and cardiovascular disease in later life,” the researchers noted.

In an editorial comment accompanying this report, Dr. Gordon C.S. Smith of the University of Cambridge (England) said these findings suggest that “complications of late pregnancy may, at least for some women, already be determined in the first 3 months post conception, even before a woman has sought prenatal care.”

It is possible that combined ultrasound and laboratory screening in the first trimester may help identify fetuses with growth restriction who are thus at risk of later complications.

“The challenges for future research are to produce robust screening tests with acceptable levels of detection and prediction, and to identify interventions that are effective in improving outcome when a pregnancy has been identified as high risk,” Dr. Smith wrote (JAMA 2010;303:561-2).

Major Finding: Shorter fetal crown-to-rump length in the first trimester is associated with several maternal factors, including higher than average diastolic blood pressure.

Data Source: A population-based prospective study involving 1,631 pregnant women.

Disclosures: Funding sources included Erasmus Medical Center and the Netherlands Organization for Health Research. Dr. Mook-Kanamori reported no relevant conflicts of interest. Dr. Smith reported being a member of GlaxoSmithKline's preterm labor advisory boards.

Pregnant women who smoke, don't take folic acid supplements, or have higher than average blood pressure or hematocrit levels are at greater risk than others for fetal growth restriction during the first trimester, according to a report.

In turn, such growth restriction is associated with a greater risk of poor outcomes such as preterm birth, small size for gestational age (SGA) at birth, and a compensatory accelerated rate of postnatal growth that persists until age 2 years, said Dr. Dennis O. Mook-Kanamori and his associates at Erasmus Medical Center, Rotterdam, the Netherlands.

These findings from a population-based prospective study involving 1,631 pregnant women suggest that growth patterns as early as the first trimester have a far-reaching influence, perhaps affecting disease risk in adulthood as well as in childhood, the investigators said.

They assessed fetal crown-to-rump length via ultrasound during the first trimester among women participating in a larger study in the Netherlands concerning fetal life.

Higher than average diastolic blood pressure and hematocrit levels, smoking, and nonuse of folic acid supplements significantly correlated with shorter crown-to-rump length.

There was even a dose-response relation between the number of cigarettes smoked and the degree of growth restriction.

Maternal weight and height showed no relation to the development of fetal growth restriction, which indicates that the researchers were indeed measuring true in utero growth restriction rather than small stature.

Fetuses in the lowest 20% of crown-to-rump length had a 7% risk of preterm birth, an 11% risk of SGA, and an 8% risk of low birth weight (LBW). In contrast, these rates were 4%, 4%, and 3.5%, respectively, among fetuses that did not show growth restriction.

This indicates a two- to threefold increase in risk for these complications, Dr. Mook-Kanamori and his colleagues said (JAMA 2010;303:527-34).

First-trimester fetal crown-to-rump length also correlated with head circumference, femur length, and weight not only throughout pregnancy and at birth, but also at 1-year and 14-month assessments.

This correlation had disappeared by the time the study subjects were evaluated at age 2 years.

“Increased postnatal growth rate is a well-established risk factor for metabolic and cardiovascular disease in later life,” the researchers noted.

In an editorial comment accompanying this report, Dr. Gordon C.S. Smith of the University of Cambridge (England) said these findings suggest that “complications of late pregnancy may, at least for some women, already be determined in the first 3 months post conception, even before a woman has sought prenatal care.”

It is possible that combined ultrasound and laboratory screening in the first trimester may help identify fetuses with growth restriction who are thus at risk of later complications.

“The challenges for future research are to produce robust screening tests with acceptable levels of detection and prediction, and to identify interventions that are effective in improving outcome when a pregnancy has been identified as high risk,” Dr. Smith wrote (JAMA 2010;303:561-2).

Major Finding: Doppler ultrasound imaging in high-risk pregnancies was associated with a 29% reduction in perinatal mortality, and a 10% reduction in cesareans that was confined to emergency procedures.

Data Source: A Cochrane review of 18 studies comprising more than 10,000 patients.

Disclosures: The study was funded by the University of Liverpool and the National Institute for Health Research. None of the authors reported any conflict of interest.

The use of Doppler ultrasound imaging in high-risk pregnancies is associated with a significant 29% reduction in perinatal deaths, significantly fewer labor inductions, and a 10% decrease in the rate of cesarean sections, a Cochrane database review has concluded.

The mortality benefit is probably directly tied to the reduction in cesareans associated with Doppler imaging. “The evidence from this review suggests that better timing of cesarean sections may be the 'cause' of reduced perinatal mortality,” wrote Dr. Zarko Alfirevic of the University of Liverpool (England) and colleagues.

“The overall decrease in cesarean sections appears to be confined to emergency procedures, which leads us to believe that clinicians with no access to Doppler studies are more often faced with a seriously compromised baby in labor,” they said.

This review is the first Cochrane update on the topic since 1996. Unfortunately, many of the 18 studies included in the database review had serious methodological flaws, making it difficult to base any strong clinical recommendations on them. “The quality of the current evidence was not [high]; therefore the results should be interpreted with some caution,” they said (Cochrane Database Syst. Rev. 2010;CD007529 [doi:10.1002/14651858.CD007529.pub2]).

The studies, comprising more than 10,000 women, were conducted from 1987 to 2003, many of them before the 2001 Consolidated Standards of Reporting Trials (CONSORT) agreement.

At that time, “most studies simply did not report information on random sequence generation and allocation blinding that is nowadays considered essential for quality assessment,” the authors wrote. They felt that only three studies had both adequate sequence generation and concealment allocation, and that blinding was adequate in only two. Nine were considered to be free of selection bias.

In considering all 18 studies, the investigators found Doppler imaging was associated with a significant 29% reduction in perinatal mortality, with a number needed to treat of 203.

When the authors examined the association in the subgroups of singleton and multiple pregnancies, they saw lower, but still significant, positive associations with Doppler imaging.

Doppler was also associated with a significant 10% reduction in the rate of cesarean sections. When cesareans were broken down into elective and emergency, the benefit appeared to be confined to emergency procedures, with a 19% risk reduction.

Doppler also significantly influenced the rate of labor induction, with an 11% decrease compared with no Doppler. There was no benefit in vaginal vs. operative births, intubation, or ventilation.

Four trials compared Doppler imaging to electronic fetal monitoring. Two of the four studies were of good quality, but the analysis in these four studies was not well powered, the authors said.

Overall, the two methods were not significantly different in terms of perinatal mortality, stillbirths, or potentially preventable deaths.

The rate of cesarean sections was slightly, but not significantly, lower with Doppler.

The authors concluded that Doppler should be added to fetal monitoring protocols in high-risk pregnancies, but refrained from making other recommendations.

Major Finding: Doppler ultrasound imaging in high-risk pregnancies was associated with a 29% reduction in perinatal mortality, and a 10% reduction in cesareans that was confined to emergency procedures.

Data Source: A Cochrane review of 18 studies comprising more than 10,000 patients.

Disclosures: The study was funded by the University of Liverpool and the National Institute for Health Research. None of the authors reported any conflict of interest.

The use of Doppler ultrasound imaging in high-risk pregnancies is associated with a significant 29% reduction in perinatal deaths, significantly fewer labor inductions, and a 10% decrease in the rate of cesarean sections, a Cochrane database review has concluded.

The mortality benefit is probably directly tied to the reduction in cesareans associated with Doppler imaging. “The evidence from this review suggests that better timing of cesarean sections may be the 'cause' of reduced perinatal mortality,” wrote Dr. Zarko Alfirevic of the University of Liverpool (England) and colleagues.

“The overall decrease in cesarean sections appears to be confined to emergency procedures, which leads us to believe that clinicians with no access to Doppler studies are more often faced with a seriously compromised baby in labor,” they said.

This review is the first Cochrane update on the topic since 1996. Unfortunately, many of the 18 studies included in the database review had serious methodological flaws, making it difficult to base any strong clinical recommendations on them. “The quality of the current evidence was not [high]; therefore the results should be interpreted with some caution,” they said (Cochrane Database Syst. Rev. 2010;CD007529 [doi:10.1002/14651858.CD007529.pub2]).

The studies, comprising more than 10,000 women, were conducted from 1987 to 2003, many of them before the 2001 Consolidated Standards of Reporting Trials (CONSORT) agreement.

At that time, “most studies simply did not report information on random sequence generation and allocation blinding that is nowadays considered essential for quality assessment,” the authors wrote. They felt that only three studies had both adequate sequence generation and concealment allocation, and that blinding was adequate in only two. Nine were considered to be free of selection bias.

In considering all 18 studies, the investigators found Doppler imaging was associated with a significant 29% reduction in perinatal mortality, with a number needed to treat of 203.

When the authors examined the association in the subgroups of singleton and multiple pregnancies, they saw lower, but still significant, positive associations with Doppler imaging.

Doppler was also associated with a significant 10% reduction in the rate of cesarean sections. When cesareans were broken down into elective and emergency, the benefit appeared to be confined to emergency procedures, with a 19% risk reduction.

Doppler also significantly influenced the rate of labor induction, with an 11% decrease compared with no Doppler. There was no benefit in vaginal vs. operative births, intubation, or ventilation.

Four trials compared Doppler imaging to electronic fetal monitoring. Two of the four studies were of good quality, but the analysis in these four studies was not well powered, the authors said.

Overall, the two methods were not significantly different in terms of perinatal mortality, stillbirths, or potentially preventable deaths.

The rate of cesarean sections was slightly, but not significantly, lower with Doppler.

The authors concluded that Doppler should be added to fetal monitoring protocols in high-risk pregnancies, but refrained from making other recommendations.

Major Finding: Doppler ultrasound imaging in high-risk pregnancies was associated with a 29% reduction in perinatal mortality, and a 10% reduction in cesareans that was confined to emergency procedures.

Data Source: A Cochrane review of 18 studies comprising more than 10,000 patients.

Disclosures: The study was funded by the University of Liverpool and the National Institute for Health Research. None of the authors reported any conflict of interest.

The use of Doppler ultrasound imaging in high-risk pregnancies is associated with a significant 29% reduction in perinatal deaths, significantly fewer labor inductions, and a 10% decrease in the rate of cesarean sections, a Cochrane database review has concluded.

The mortality benefit is probably directly tied to the reduction in cesareans associated with Doppler imaging. “The evidence from this review suggests that better timing of cesarean sections may be the 'cause' of reduced perinatal mortality,” wrote Dr. Zarko Alfirevic of the University of Liverpool (England) and colleagues.

“The overall decrease in cesarean sections appears to be confined to emergency procedures, which leads us to believe that clinicians with no access to Doppler studies are more often faced with a seriously compromised baby in labor,” they said.

This review is the first Cochrane update on the topic since 1996. Unfortunately, many of the 18 studies included in the database review had serious methodological flaws, making it difficult to base any strong clinical recommendations on them. “The quality of the current evidence was not [high]; therefore the results should be interpreted with some caution,” they said (Cochrane Database Syst. Rev. 2010;CD007529 [doi:10.1002/14651858.CD007529.pub2]).

The studies, comprising more than 10,000 women, were conducted from 1987 to 2003, many of them before the 2001 Consolidated Standards of Reporting Trials (CONSORT) agreement.

At that time, “most studies simply did not report information on random sequence generation and allocation blinding that is nowadays considered essential for quality assessment,” the authors wrote. They felt that only three studies had both adequate sequence generation and concealment allocation, and that blinding was adequate in only two. Nine were considered to be free of selection bias.

In considering all 18 studies, the investigators found Doppler imaging was associated with a significant 29% reduction in perinatal mortality, with a number needed to treat of 203.

When the authors examined the association in the subgroups of singleton and multiple pregnancies, they saw lower, but still significant, positive associations with Doppler imaging.

Doppler was also associated with a significant 10% reduction in the rate of cesarean sections. When cesareans were broken down into elective and emergency, the benefit appeared to be confined to emergency procedures, with a 19% risk reduction.

Doppler also significantly influenced the rate of labor induction, with an 11% decrease compared with no Doppler. There was no benefit in vaginal vs. operative births, intubation, or ventilation.

Four trials compared Doppler imaging to electronic fetal monitoring. Two of the four studies were of good quality, but the analysis in these four studies was not well powered, the authors said.

Overall, the two methods were not significantly different in terms of perinatal mortality, stillbirths, or potentially preventable deaths.

The rate of cesarean sections was slightly, but not significantly, lower with Doppler.

The authors concluded that Doppler should be added to fetal monitoring protocols in high-risk pregnancies, but refrained from making other recommendations.

The high risk of neural tube defects and other major malformations in babies exposed to valproate sodium and the related products, valproic acid and divalproex sodium, during the first trimester is the focus of a Food and Drug Administration notice to health care professionals.

The FDA statement also emphasizes the need for health practitioners to counsel women of childbearing potential about these teratogenic risks, and to “consider alternative therapies, especially if using valproate to treat migraines or other conditions not usually considered life-threatening.”

The statement was posted on the FDA's MedWatch site in December.

The risk of a neural tube defect in a baby born to a mother who took valproate or one of the two related products during the first 12 weeks of pregnancy is 1 in 20, compared with the background rate of 1 in 1,500 in the United States, according to the FDA.

The notice cites data from the North American Antiepileptic Drug (NAAED) Pregnancy Registry, which indicate that the major malformation rate in babies born to women who have epilepsy and take valproate alone is nearly fourfold greater than among the babies born to women with epilepsy who take a different antiepileptic: 10.7%, compared with 2.9%.

The 16 major malformations among the babies in the registry who were exposed to valproate during the first trimester of pregnancy included neural tube defects, craniofacial defects, cardiovascular malformations, and malformations involving other body systems.

Included in the FDA statement were comments on the importance of taking folic acid supplements before and during the first trimester of pregnancy in order to reduce the risk of neural tube defects, and a recommendation that women who are treated with one of these drugs and who are not planning a pregnancy use an effective method of contraception.

Valproic acid, which is marketed as Depakene and as Stavzor, was approved in 1978 for the treatment of epilepsy. Valproate, marketed as Depacon, was approved more recently for the treatment of bipolar disorder and migraine headaches.

“As valproate's indications for use expand, it is critical that health care professionals caring for women of childbearing potential and taking valproate for any indication be informed that valproate causes an increased risk of major birth defects,” the FDA statement said.

“Awareness of the therapeutic benefits and risks of valproate and alternative therapies, as well as the risks of untreated disease is critical for informed prescribing and counseling of all women taking valproate.”

Divalproex sodium is marketed as Depakote, Depakote CP, and Depakote ER, and is approved for migraine prophylaxis, manic episodes associated with bipolar disorder, as well as epilepsy.

The FDA notice also includes an information section specific to patients.

The agency is working with the manufacturers of these products to make labeling changes that reflect the information regarding teratogenic risk.

The notice can be found at: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm192788.htmwww.aedpregnancyregistry.orgwww.fda.gov/medwatch/

The high risk of neural tube defects and other major malformations in babies exposed to valproate sodium and the related products, valproic acid and divalproex sodium, during the first trimester is the focus of a Food and Drug Administration notice to health care professionals.

The FDA statement also emphasizes the need for health practitioners to counsel women of childbearing potential about these teratogenic risks, and to “consider alternative therapies, especially if using valproate to treat migraines or other conditions not usually considered life-threatening.”

The statement was posted on the FDA's MedWatch site in December.

The risk of a neural tube defect in a baby born to a mother who took valproate or one of the two related products during the first 12 weeks of pregnancy is 1 in 20, compared with the background rate of 1 in 1,500 in the United States, according to the FDA.

The notice cites data from the North American Antiepileptic Drug (NAAED) Pregnancy Registry, which indicate that the major malformation rate in babies born to women who have epilepsy and take valproate alone is nearly fourfold greater than among the babies born to women with epilepsy who take a different antiepileptic: 10.7%, compared with 2.9%.

The 16 major malformations among the babies in the registry who were exposed to valproate during the first trimester of pregnancy included neural tube defects, craniofacial defects, cardiovascular malformations, and malformations involving other body systems.

Included in the FDA statement were comments on the importance of taking folic acid supplements before and during the first trimester of pregnancy in order to reduce the risk of neural tube defects, and a recommendation that women who are treated with one of these drugs and who are not planning a pregnancy use an effective method of contraception.

Valproic acid, which is marketed as Depakene and as Stavzor, was approved in 1978 for the treatment of epilepsy. Valproate, marketed as Depacon, was approved more recently for the treatment of bipolar disorder and migraine headaches.

“As valproate's indications for use expand, it is critical that health care professionals caring for women of childbearing potential and taking valproate for any indication be informed that valproate causes an increased risk of major birth defects,” the FDA statement said.

“Awareness of the therapeutic benefits and risks of valproate and alternative therapies, as well as the risks of untreated disease is critical for informed prescribing and counseling of all women taking valproate.”

Divalproex sodium is marketed as Depakote, Depakote CP, and Depakote ER, and is approved for migraine prophylaxis, manic episodes associated with bipolar disorder, as well as epilepsy.

The FDA notice also includes an information section specific to patients.

The agency is working with the manufacturers of these products to make labeling changes that reflect the information regarding teratogenic risk.

The notice can be found at: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm192788.htmwww.aedpregnancyregistry.orgwww.fda.gov/medwatch/

The high risk of neural tube defects and other major malformations in babies exposed to valproate sodium and the related products, valproic acid and divalproex sodium, during the first trimester is the focus of a Food and Drug Administration notice to health care professionals.

The FDA statement also emphasizes the need for health practitioners to counsel women of childbearing potential about these teratogenic risks, and to “consider alternative therapies, especially if using valproate to treat migraines or other conditions not usually considered life-threatening.”

The statement was posted on the FDA's MedWatch site in December.

The risk of a neural tube defect in a baby born to a mother who took valproate or one of the two related products during the first 12 weeks of pregnancy is 1 in 20, compared with the background rate of 1 in 1,500 in the United States, according to the FDA.

The notice cites data from the North American Antiepileptic Drug (NAAED) Pregnancy Registry, which indicate that the major malformation rate in babies born to women who have epilepsy and take valproate alone is nearly fourfold greater than among the babies born to women with epilepsy who take a different antiepileptic: 10.7%, compared with 2.9%.

The 16 major malformations among the babies in the registry who were exposed to valproate during the first trimester of pregnancy included neural tube defects, craniofacial defects, cardiovascular malformations, and malformations involving other body systems.

Included in the FDA statement were comments on the importance of taking folic acid supplements before and during the first trimester of pregnancy in order to reduce the risk of neural tube defects, and a recommendation that women who are treated with one of these drugs and who are not planning a pregnancy use an effective method of contraception.

Valproic acid, which is marketed as Depakene and as Stavzor, was approved in 1978 for the treatment of epilepsy. Valproate, marketed as Depacon, was approved more recently for the treatment of bipolar disorder and migraine headaches.

“As valproate's indications for use expand, it is critical that health care professionals caring for women of childbearing potential and taking valproate for any indication be informed that valproate causes an increased risk of major birth defects,” the FDA statement said.

“Awareness of the therapeutic benefits and risks of valproate and alternative therapies, as well as the risks of untreated disease is critical for informed prescribing and counseling of all women taking valproate.”

Divalproex sodium is marketed as Depakote, Depakote CP, and Depakote ER, and is approved for migraine prophylaxis, manic episodes associated with bipolar disorder, as well as epilepsy.

The FDA notice also includes an information section specific to patients.

The agency is working with the manufacturers of these products to make labeling changes that reflect the information regarding teratogenic risk.

The notice can be found at: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm192788.htmwww.aedpregnancyregistry.orgwww.fda.gov/medwatch/

Major Finding: Thirty-one percent of women in the internal-tocodynamometry group and thirty percent in the external-monitoring group required operative delivery, a nonsignificant difference.

Data Source: A multicenter trial of 1,456 women.

Disclosures: None reported.

Internal tocodynamometry during induced or augmented labor failed to reduce the rate of operative deliveries compared with external monitoring of uterine contractions, according to a report.

Nor did internal tocodynamometry improve the rate of adverse neonatal outcomes, the use of analgesia, the use of antibiotics, or duration of labor in a multicenter trial comparing the two approaches, according to Jannet J.H. Bakker of the Academic Medical Center, Amsterdam, and her associates.

Internal tocodynamometry is advocated by professional obstetric societies because it “is thought to quantify the frequency, duration, and magnitude of uterine activity more accurately” than external monitoring. This in turn is assumed to allow better adjustment of oxytocin infusion and improved interpretation of fetal heart-rate patterns.

“However, clinical data to support such hypotheses are limited, and recommendations are based on expert opinion” in the absence of definitive data, the investigators noted.

Only three small clinical trials have compared the two techniques, and “the small samples in these trials resulted in limited power to detect differences and in wide confidence intervals around estimated risk reductions,” they said.

Ms. Bakker and her colleagues assessed 1,456 women who delivered at six hospitals in the Netherlands over a 4-year period. All the women had singleton, term pregnancies and received oxytocin for induction or augmentation of labor. They were randomized to internal tocodynamometry (734 patients) or external monitoring (722 patients).

The primary outcome was the rate of operative delivery. In all, 230 women (31%) in the internal-tocodynamometry group and 214 (30%) in the external-monitoring group required operative delivery, a nonsignificant difference, the researchers said (N. Engl. J. Med. 2010;362:306-13).

The rates of secondary outcomes also were similar between the two groups. These included adverse neonatal outcomes, use of antibiotics during labor, use of analgesia, and total amount of oxytocin used.

Internal tocodynamometry carries serious risks, “including placental or fetal-vessel damage, infection, and anaphylactic reaction. We did not observe any complications of internal monitoring in our study, but it was not powered to detect these events,” which are estimated to occur in up to 1 in 300 deliveries.

Major Finding: Thirty-one percent of women in the internal-tocodynamometry group and thirty percent in the external-monitoring group required operative delivery, a nonsignificant difference.

Data Source: A multicenter trial of 1,456 women.

Disclosures: None reported.

Internal tocodynamometry during induced or augmented labor failed to reduce the rate of operative deliveries compared with external monitoring of uterine contractions, according to a report.

Nor did internal tocodynamometry improve the rate of adverse neonatal outcomes, the use of analgesia, the use of antibiotics, or duration of labor in a multicenter trial comparing the two approaches, according to Jannet J.H. Bakker of the Academic Medical Center, Amsterdam, and her associates.

Internal tocodynamometry is advocated by professional obstetric societies because it “is thought to quantify the frequency, duration, and magnitude of uterine activity more accurately” than external monitoring. This in turn is assumed to allow better adjustment of oxytocin infusion and improved interpretation of fetal heart-rate patterns.

“However, clinical data to support such hypotheses are limited, and recommendations are based on expert opinion” in the absence of definitive data, the investigators noted.

Only three small clinical trials have compared the two techniques, and “the small samples in these trials resulted in limited power to detect differences and in wide confidence intervals around estimated risk reductions,” they said.

Ms. Bakker and her colleagues assessed 1,456 women who delivered at six hospitals in the Netherlands over a 4-year period. All the women had singleton, term pregnancies and received oxytocin for induction or augmentation of labor. They were randomized to internal tocodynamometry (734 patients) or external monitoring (722 patients).

The primary outcome was the rate of operative delivery. In all, 230 women (31%) in the internal-tocodynamometry group and 214 (30%) in the external-monitoring group required operative delivery, a nonsignificant difference, the researchers said (N. Engl. J. Med. 2010;362:306-13).

The rates of secondary outcomes also were similar between the two groups. These included adverse neonatal outcomes, use of antibiotics during labor, use of analgesia, and total amount of oxytocin used.

Internal tocodynamometry carries serious risks, “including placental or fetal-vessel damage, infection, and anaphylactic reaction. We did not observe any complications of internal monitoring in our study, but it was not powered to detect these events,” which are estimated to occur in up to 1 in 300 deliveries.

Major Finding: Thirty-one percent of women in the internal-tocodynamometry group and thirty percent in the external-monitoring group required operative delivery, a nonsignificant difference.

Data Source: A multicenter trial of 1,456 women.

Disclosures: None reported.

Internal tocodynamometry during induced or augmented labor failed to reduce the rate of operative deliveries compared with external monitoring of uterine contractions, according to a report.

Nor did internal tocodynamometry improve the rate of adverse neonatal outcomes, the use of analgesia, the use of antibiotics, or duration of labor in a multicenter trial comparing the two approaches, according to Jannet J.H. Bakker of the Academic Medical Center, Amsterdam, and her associates.

Internal tocodynamometry is advocated by professional obstetric societies because it “is thought to quantify the frequency, duration, and magnitude of uterine activity more accurately” than external monitoring. This in turn is assumed to allow better adjustment of oxytocin infusion and improved interpretation of fetal heart-rate patterns.

“However, clinical data to support such hypotheses are limited, and recommendations are based on expert opinion” in the absence of definitive data, the investigators noted.

Only three small clinical trials have compared the two techniques, and “the small samples in these trials resulted in limited power to detect differences and in wide confidence intervals around estimated risk reductions,” they said.

Ms. Bakker and her colleagues assessed 1,456 women who delivered at six hospitals in the Netherlands over a 4-year period. All the women had singleton, term pregnancies and received oxytocin for induction or augmentation of labor. They were randomized to internal tocodynamometry (734 patients) or external monitoring (722 patients).

The primary outcome was the rate of operative delivery. In all, 230 women (31%) in the internal-tocodynamometry group and 214 (30%) in the external-monitoring group required operative delivery, a nonsignificant difference, the researchers said (N. Engl. J. Med. 2010;362:306-13).

The rates of secondary outcomes also were similar between the two groups. These included adverse neonatal outcomes, use of antibiotics during labor, use of analgesia, and total amount of oxytocin used.

Internal tocodynamometry carries serious risks, “including placental or fetal-vessel damage, infection, and anaphylactic reaction. We did not observe any complications of internal monitoring in our study, but it was not powered to detect these events,” which are estimated to occur in up to 1 in 300 deliveries.

Major Finding: There was no significant difference between pregnant women who received treatment for periodontal disease and those who did not in terms of spontaneous preterm birth, gestational age at birth, or major neonatal adverse outcomes.

Data Source: Randomized, controlled trial of 756 pregnant women with periodontal disease.

Disclosures: The study was supported by the Pennsylvania Department of Health, the National Center for Research Resources, and the National Center on Minority and Health Disparities. No conflicts of interest were reported.

Treating periodontal disease in pregnant women does not decrease their chances of preterm birth, according to a study of 756 women.

Several previous studies have found that pregnant women with periodontal disease have an increased likelihood of giving birth prematurely.

But this was the first study to use a randomized controlled trial to test the idea that treating periodontal disease may improve a woman's chances of carrying her pregnancy to term.

Periodontal disease is very common, affecting more than 30% of individuals in some populations. The investigators, led by Dr. George A. Macones of Washington University in St. Louis found that 50% of the 3,563 pregnant women they screened had either gingivitis or periodontitis (Am. J. Obstet. Gynecol. 2010;202:147.e1-8).

Women were included in the study if they had periodontal disease and were 6–20 weeks pregnant. They were excluded if they had already received periodontal treatment during their pregnancy, if they had used antibiotics or antibiotic mouthwash within 2 weeks, if they had a multiple pregnancy, or if they had known mitral valve prolapse.

The 376 women in the active treatment group received thorough periodontal treatment, in which trained dental hygienists removed stains, plaque, and calculus above and below the gum line, leaving the root surfaces smooth and clean. The 380 women in the control group received only a superficial cleaning and stain removal above the gum line.

The primary outcome was spontaneous preterm birth, which the investigators defined as births occurring before 35 weeks' gestation.

Secondary outcomes included the type of preterm birth (either spontaneous or indicated), delivery before 37 weeks' gestation, gestational age at delivery, birth weight, and major neonatal adverse outcomes, such as death, sepsis, and chronic lung disease.

There were no significant differences between active treatment and control groups on any of these measures. Investigators did, however, find one significant difference within the planned subgroup analyses: Among women with a history of previous preterm birth, those in the active treatment arm had a greater risk of preterm birth than those in the control treatment arm.

The investigators suggested that this one statistically significant result among many results that were not significant may have arisen by chance.

In an accompanying editorial, Dr. Kim A. Boggess of the University of North Carolina at Chapel Hill offered another possibility. Dr. Boggess suggested that scaling and root planing may have disseminated oral pathogens or their toxins to the rest of the body, accounting for the apparently increased risk of active treatment in this one subgroup of women (Am. J. Obstet. Gynecol. 2010;202:101-2).

Regarding the idea of treating pregnant women for periodontal disease, Dr. Boggess wrote: “Although promising, the current data do not support periodontal treatment during pregnancy to reduce the preterm birth risk.”

However, she also said that the trial “confirmed that periodontal treatment improves the oral health of pregnant women, and oral health for the sake of oral health cannot be disputed.”

Major Finding: There was no significant difference between pregnant women who received treatment for periodontal disease and those who did not in terms of spontaneous preterm birth, gestational age at birth, or major neonatal adverse outcomes.

Data Source: Randomized, controlled trial of 756 pregnant women with periodontal disease.

Disclosures: The study was supported by the Pennsylvania Department of Health, the National Center for Research Resources, and the National Center on Minority and Health Disparities. No conflicts of interest were reported.

Treating periodontal disease in pregnant women does not decrease their chances of preterm birth, according to a study of 756 women.

Several previous studies have found that pregnant women with periodontal disease have an increased likelihood of giving birth prematurely.

But this was the first study to use a randomized controlled trial to test the idea that treating periodontal disease may improve a woman's chances of carrying her pregnancy to term.

Periodontal disease is very common, affecting more than 30% of individuals in some populations. The investigators, led by Dr. George A. Macones of Washington University in St. Louis found that 50% of the 3,563 pregnant women they screened had either gingivitis or periodontitis (Am. J. Obstet. Gynecol. 2010;202:147.e1-8).

Women were included in the study if they had periodontal disease and were 6–20 weeks pregnant. They were excluded if they had already received periodontal treatment during their pregnancy, if they had used antibiotics or antibiotic mouthwash within 2 weeks, if they had a multiple pregnancy, or if they had known mitral valve prolapse.

The 376 women in the active treatment group received thorough periodontal treatment, in which trained dental hygienists removed stains, plaque, and calculus above and below the gum line, leaving the root surfaces smooth and clean. The 380 women in the control group received only a superficial cleaning and stain removal above the gum line.

The primary outcome was spontaneous preterm birth, which the investigators defined as births occurring before 35 weeks' gestation.

Secondary outcomes included the type of preterm birth (either spontaneous or indicated), delivery before 37 weeks' gestation, gestational age at delivery, birth weight, and major neonatal adverse outcomes, such as death, sepsis, and chronic lung disease.

There were no significant differences between active treatment and control groups on any of these measures. Investigators did, however, find one significant difference within the planned subgroup analyses: Among women with a history of previous preterm birth, those in the active treatment arm had a greater risk of preterm birth than those in the control treatment arm.

The investigators suggested that this one statistically significant result among many results that were not significant may have arisen by chance.

In an accompanying editorial, Dr. Kim A. Boggess of the University of North Carolina at Chapel Hill offered another possibility. Dr. Boggess suggested that scaling and root planing may have disseminated oral pathogens or their toxins to the rest of the body, accounting for the apparently increased risk of active treatment in this one subgroup of women (Am. J. Obstet. Gynecol. 2010;202:101-2).

Regarding the idea of treating pregnant women for periodontal disease, Dr. Boggess wrote: “Although promising, the current data do not support periodontal treatment during pregnancy to reduce the preterm birth risk.”

However, she also said that the trial “confirmed that periodontal treatment improves the oral health of pregnant women, and oral health for the sake of oral health cannot be disputed.”

Major Finding: There was no significant difference between pregnant women who received treatment for periodontal disease and those who did not in terms of spontaneous preterm birth, gestational age at birth, or major neonatal adverse outcomes.

Data Source: Randomized, controlled trial of 756 pregnant women with periodontal disease.

Disclosures: The study was supported by the Pennsylvania Department of Health, the National Center for Research Resources, and the National Center on Minority and Health Disparities. No conflicts of interest were reported.

Treating periodontal disease in pregnant women does not decrease their chances of preterm birth, according to a study of 756 women.

Several previous studies have found that pregnant women with periodontal disease have an increased likelihood of giving birth prematurely.

But this was the first study to use a randomized controlled trial to test the idea that treating periodontal disease may improve a woman's chances of carrying her pregnancy to term.

Periodontal disease is very common, affecting more than 30% of individuals in some populations. The investigators, led by Dr. George A. Macones of Washington University in St. Louis found that 50% of the 3,563 pregnant women they screened had either gingivitis or periodontitis (Am. J. Obstet. Gynecol. 2010;202:147.e1-8).

Women were included in the study if they had periodontal disease and were 6–20 weeks pregnant. They were excluded if they had already received periodontal treatment during their pregnancy, if they had used antibiotics or antibiotic mouthwash within 2 weeks, if they had a multiple pregnancy, or if they had known mitral valve prolapse.

The 376 women in the active treatment group received thorough periodontal treatment, in which trained dental hygienists removed stains, plaque, and calculus above and below the gum line, leaving the root surfaces smooth and clean. The 380 women in the control group received only a superficial cleaning and stain removal above the gum line.

The primary outcome was spontaneous preterm birth, which the investigators defined as births occurring before 35 weeks' gestation.

Secondary outcomes included the type of preterm birth (either spontaneous or indicated), delivery before 37 weeks' gestation, gestational age at delivery, birth weight, and major neonatal adverse outcomes, such as death, sepsis, and chronic lung disease.

There were no significant differences between active treatment and control groups on any of these measures. Investigators did, however, find one significant difference within the planned subgroup analyses: Among women with a history of previous preterm birth, those in the active treatment arm had a greater risk of preterm birth than those in the control treatment arm.

The investigators suggested that this one statistically significant result among many results that were not significant may have arisen by chance.

In an accompanying editorial, Dr. Kim A. Boggess of the University of North Carolina at Chapel Hill offered another possibility. Dr. Boggess suggested that scaling and root planing may have disseminated oral pathogens or their toxins to the rest of the body, accounting for the apparently increased risk of active treatment in this one subgroup of women (Am. J. Obstet. Gynecol. 2010;202:101-2).

Regarding the idea of treating pregnant women for periodontal disease, Dr. Boggess wrote: “Although promising, the current data do not support periodontal treatment during pregnancy to reduce the preterm birth risk.”

However, she also said that the trial “confirmed that periodontal treatment improves the oral health of pregnant women, and oral health for the sake of oral health cannot be disputed.”

Major Finding: Apgar scores and NICU admissions were not significantly different in IUGR pregnancies when women were induced vs. expectantly monitored.

Data Source: The multicenter randomized DIGITAT study of 650 women.

Disclosures: The study was sponsored by the Netherlands Organization for Health Research and Development. Dr. Boers disclosed no relevant conflicts of interest.

CHICAGO — Monitoring and labor induction produce comparable neonatal outcome and operative delivery rates in women with suspected intrauterine growth restriction at term, based on the multicenter randomized DIGITAT study.

“It seems that both policies can be safely offered,” principal investigator Dr. Kim Boers said at the annual meeting of the Society of Maternal-Fetal Medicine.

The Disproportionate Intrauterine Growth Intervention Trial at Term (DIGITAT) was conducted at 52 hospitals from a nationwide obstetric consortium in the Netherlands and involved 650 women with a singleton pregnancy with clinical suspicion of failure to thrive in utero after 36 weeks' gestation.

A total of 321 women were randomized to induction of labor within 48 hours and 329 to expectant monitoring according to a local protocol in an inpatient or outpatient setting. Cervical ripening with prostaglandins, osmotic cervical dilation, or digital sweeping of the membranes was optional.

The primary outcome was a composite adverse neonatal outcome of umbilical cord pH less than 7.1, a base excess less than −10, a 5-minute Apgar score of less than 7, and neonatal ICU (NICU) admission.

The composite outcome occurred in 17 cases in the induction group and in 20 cases in the expectant group, which was not statistically different, said Dr. Boers of Leiden (the Netherlands) University Medical Center.

NICU admissions were also similar at nine cases in the induction group vs. two in the expectant group. However, significantly more neonates in the induction group were admitted to high or medium care (155 cases vs. 118 cases), she said.

Infants born to the expectant group were significantly older and heavier at birth, with a mean gestational age of 277 days and a birth weight of 2,550 g vs. 266 days and 2,420 g in the induction group. There were no stillbirths or neonatal deaths in the trial, Dr. Boers reported. The use of induction did not significantly change the secondary outcome of operative delivery, which was reported in 45 cases in both groups.

During a discussion of the study, one attendee asked why obstetricians should wait to deliver a baby if IUGR was suspected. Dr. Boers responded, “If you are very keen on preventing every stillbirth, then you can induce and not raise cesarean rates, but I think there is a problem at 37 weeks because we saw more children admitted to high and medium care. So we are going deeper in debt to see which children benefit most from induction.”

'It seems that both policies can be safely offered' to women with suspected IUGR at term.

Source DR. BOERS

Major Finding: Apgar scores and NICU admissions were not significantly different in IUGR pregnancies when women were induced vs. expectantly monitored.

Data Source: The multicenter randomized DIGITAT study of 650 women.

Disclosures: The study was sponsored by the Netherlands Organization for Health Research and Development. Dr. Boers disclosed no relevant conflicts of interest.

CHICAGO — Monitoring and labor induction produce comparable neonatal outcome and operative delivery rates in women with suspected intrauterine growth restriction at term, based on the multicenter randomized DIGITAT study.

“It seems that both policies can be safely offered,” principal investigator Dr. Kim Boers said at the annual meeting of the Society of Maternal-Fetal Medicine.

The Disproportionate Intrauterine Growth Intervention Trial at Term (DIGITAT) was conducted at 52 hospitals from a nationwide obstetric consortium in the Netherlands and involved 650 women with a singleton pregnancy with clinical suspicion of failure to thrive in utero after 36 weeks' gestation.

A total of 321 women were randomized to induction of labor within 48 hours and 329 to expectant monitoring according to a local protocol in an inpatient or outpatient setting. Cervical ripening with prostaglandins, osmotic cervical dilation, or digital sweeping of the membranes was optional.

The primary outcome was a composite adverse neonatal outcome of umbilical cord pH less than 7.1, a base excess less than −10, a 5-minute Apgar score of less than 7, and neonatal ICU (NICU) admission.

The composite outcome occurred in 17 cases in the induction group and in 20 cases in the expectant group, which was not statistically different, said Dr. Boers of Leiden (the Netherlands) University Medical Center.

NICU admissions were also similar at nine cases in the induction group vs. two in the expectant group. However, significantly more neonates in the induction group were admitted to high or medium care (155 cases vs. 118 cases), she said.

Infants born to the expectant group were significantly older and heavier at birth, with a mean gestational age of 277 days and a birth weight of 2,550 g vs. 266 days and 2,420 g in the induction group. There were no stillbirths or neonatal deaths in the trial, Dr. Boers reported. The use of induction did not significantly change the secondary outcome of operative delivery, which was reported in 45 cases in both groups.

During a discussion of the study, one attendee asked why obstetricians should wait to deliver a baby if IUGR was suspected. Dr. Boers responded, “If you are very keen on preventing every stillbirth, then you can induce and not raise cesarean rates, but I think there is a problem at 37 weeks because we saw more children admitted to high and medium care. So we are going deeper in debt to see which children benefit most from induction.”

'It seems that both policies can be safely offered' to women with suspected IUGR at term.

Source DR. BOERS

Major Finding: Apgar scores and NICU admissions were not significantly different in IUGR pregnancies when women were induced vs. expectantly monitored.

Data Source: The multicenter randomized DIGITAT study of 650 women.

Disclosures: The study was sponsored by the Netherlands Organization for Health Research and Development. Dr. Boers disclosed no relevant conflicts of interest.

CHICAGO — Monitoring and labor induction produce comparable neonatal outcome and operative delivery rates in women with suspected intrauterine growth restriction at term, based on the multicenter randomized DIGITAT study.

“It seems that both policies can be safely offered,” principal investigator Dr. Kim Boers said at the annual meeting of the Society of Maternal-Fetal Medicine.

The Disproportionate Intrauterine Growth Intervention Trial at Term (DIGITAT) was conducted at 52 hospitals from a nationwide obstetric consortium in the Netherlands and involved 650 women with a singleton pregnancy with clinical suspicion of failure to thrive in utero after 36 weeks' gestation.

A total of 321 women were randomized to induction of labor within 48 hours and 329 to expectant monitoring according to a local protocol in an inpatient or outpatient setting. Cervical ripening with prostaglandins, osmotic cervical dilation, or digital sweeping of the membranes was optional.

The primary outcome was a composite adverse neonatal outcome of umbilical cord pH less than 7.1, a base excess less than −10, a 5-minute Apgar score of less than 7, and neonatal ICU (NICU) admission.

The composite outcome occurred in 17 cases in the induction group and in 20 cases in the expectant group, which was not statistically different, said Dr. Boers of Leiden (the Netherlands) University Medical Center.

NICU admissions were also similar at nine cases in the induction group vs. two in the expectant group. However, significantly more neonates in the induction group were admitted to high or medium care (155 cases vs. 118 cases), she said.

Infants born to the expectant group were significantly older and heavier at birth, with a mean gestational age of 277 days and a birth weight of 2,550 g vs. 266 days and 2,420 g in the induction group. There were no stillbirths or neonatal deaths in the trial, Dr. Boers reported. The use of induction did not significantly change the secondary outcome of operative delivery, which was reported in 45 cases in both groups.

During a discussion of the study, one attendee asked why obstetricians should wait to deliver a baby if IUGR was suspected. Dr. Boers responded, “If you are very keen on preventing every stillbirth, then you can induce and not raise cesarean rates, but I think there is a problem at 37 weeks because we saw more children admitted to high and medium care. So we are going deeper in debt to see which children benefit most from induction.”

'It seems that both policies can be safely offered' to women with suspected IUGR at term.

Source DR. BOERS

Major Finding: The likelihood of delivery within 12 hours was significantly increased from 14% with 30-mL Foley catheter inflation to 26% with 60-mL inflation.

Data Source: The prospective LIFT study of 192 women.

Disclosures: Dr. Delaney reported no study sponsorship or conflicts of interest. Coauthor Dr. Aaron Caughey was funded as a Robert Wood Johnson Physician Faculty Scholar.

CHICAGO — Inflating a transcervical Foley balloon catheter to 60 mL is more effective at inducing labor than standard inflation to 30 mL, based on data from the prospective LIFT study.

The likelihood of delivery within 12 hours was significantly increased from 14% with 30-mL inflation to 26% with 60-mL inflation. The number needed to treat for this outcome is nine, Dr. Shani Delaney and associates reported at the annual meeting of the Society for Maternal-Fetal Medicine.

“The number needed to treat of nine women provides an achievable intervention without increasing cesarean delivery rates and [while still] maintaining both maternal and neonatal safety,” she said.

The Labor Induction With a Foley Balloon Trial (LIFT) failed to meet its primary end point of delivery within 24 hours, with 64% of controls and 66% of the 60-mL group achieving this outcome. The percentage of women giving birth within 24 hours was higher than anticipated in both the control and study groups; thus there was not enough statistical power to detect such a small difference between the groups, Dr. Delaney explained in an interview.

As expected, larger balloon inflation to 60 mL produced significantly increased cervical dilation after expulsion compared with 30-mL inflation (4 cm vs. 3 cm).

An 18 French Foley catheter with a 30-mL balloon tip was inflated to 30 mL in 94 evaluable patients and to 60 mL in 98 patients. Intravenous oxytocin was started within 30 minutes of balloon placement.

Only age was significantly higher at 31.4 years in the control group vs. 29.4 years in the 60-mL group.

The study design was influenced by previous trials, which have reported inflation rates of 30–80 mL, Dr. Delaney said.

The American College of Obstetricians and Gynecologists issued a new practice bulletin for labor induction in August 2009 stating that the “Foley catheter is a reasonable and effective alternative for cervical ripening and inducing labor,” but ACOG did not specify inflation sizes.

During the discussion of the study, a member of the audience sounded a word of caution regarding the findings, noting that most manufacturers recommend inflation to only 50 mL.

There was no difference in maternal or neonatal morbidities between treatment groups, said Dr. Delaney of the department of obstetrics and gynecology at the University of Washington in Seattle.

“If only a 30-mL balloon tip is available, inflation to a volume of 60 mL appears to be safe,” she said.

Maternal outcomes that were similar in the control and 60-mL groups included maximum oxytocin dose (19.1 vs. 19.2 mU/min), median delivery time (20 hours vs. 18.8 hours), spontaneous vaginal delivery (66% vs. 63%), cesarean delivery (21% vs. 23%), chorioamnionitis (15% vs. 19%), meconium (21% vs. 20%), cervical laceration (2% vs. 1%), and placental abruption (1% vs. 2%).

Among infants, 5-minute Apgar scores less than 7 were reported in 5% of the 30-mL group and 4% of the 60-mL group. Umbilical artery blood pH was identical in both groups at 7.27, while umbilical artery base excess was −3.38 in the 30-mL group and −2.95 in the 60-mL group.

In a multivariate analysis, delivery within 12 hours was significantly increased with 60-mL balloon inflation among all patients (relative risk, 1.84), and particularly among nulliparous women (RR, 2.88), Dr. Delaney reported.

Major Finding: The likelihood of delivery within 12 hours was significantly increased from 14% with 30-mL Foley catheter inflation to 26% with 60-mL inflation.

Data Source: The prospective LIFT study of 192 women.

Disclosures: Dr. Delaney reported no study sponsorship or conflicts of interest. Coauthor Dr. Aaron Caughey was funded as a Robert Wood Johnson Physician Faculty Scholar.

CHICAGO — Inflating a transcervical Foley balloon catheter to 60 mL is more effective at inducing labor than standard inflation to 30 mL, based on data from the prospective LIFT study.

The likelihood of delivery within 12 hours was significantly increased from 14% with 30-mL inflation to 26% with 60-mL inflation. The number needed to treat for this outcome is nine, Dr. Shani Delaney and associates reported at the annual meeting of the Society for Maternal-Fetal Medicine.

“The number needed to treat of nine women provides an achievable intervention without increasing cesarean delivery rates and [while still] maintaining both maternal and neonatal safety,” she said.

The Labor Induction With a Foley Balloon Trial (LIFT) failed to meet its primary end point of delivery within 24 hours, with 64% of controls and 66% of the 60-mL group achieving this outcome. The percentage of women giving birth within 24 hours was higher than anticipated in both the control and study groups; thus there was not enough statistical power to detect such a small difference between the groups, Dr. Delaney explained in an interview.

As expected, larger balloon inflation to 60 mL produced significantly increased cervical dilation after expulsion compared with 30-mL inflation (4 cm vs. 3 cm).

An 18 French Foley catheter with a 30-mL balloon tip was inflated to 30 mL in 94 evaluable patients and to 60 mL in 98 patients. Intravenous oxytocin was started within 30 minutes of balloon placement.

Only age was significantly higher at 31.4 years in the control group vs. 29.4 years in the 60-mL group.

The study design was influenced by previous trials, which have reported inflation rates of 30–80 mL, Dr. Delaney said.

The American College of Obstetricians and Gynecologists issued a new practice bulletin for labor induction in August 2009 stating that the “Foley catheter is a reasonable and effective alternative for cervical ripening and inducing labor,” but ACOG did not specify inflation sizes.

During the discussion of the study, a member of the audience sounded a word of caution regarding the findings, noting that most manufacturers recommend inflation to only 50 mL.

There was no difference in maternal or neonatal morbidities between treatment groups, said Dr. Delaney of the department of obstetrics and gynecology at the University of Washington in Seattle.

“If only a 30-mL balloon tip is available, inflation to a volume of 60 mL appears to be safe,” she said.

Maternal outcomes that were similar in the control and 60-mL groups included maximum oxytocin dose (19.1 vs. 19.2 mU/min), median delivery time (20 hours vs. 18.8 hours), spontaneous vaginal delivery (66% vs. 63%), cesarean delivery (21% vs. 23%), chorioamnionitis (15% vs. 19%), meconium (21% vs. 20%), cervical laceration (2% vs. 1%), and placental abruption (1% vs. 2%).

Among infants, 5-minute Apgar scores less than 7 were reported in 5% of the 30-mL group and 4% of the 60-mL group. Umbilical artery blood pH was identical in both groups at 7.27, while umbilical artery base excess was −3.38 in the 30-mL group and −2.95 in the 60-mL group.

In a multivariate analysis, delivery within 12 hours was significantly increased with 60-mL balloon inflation among all patients (relative risk, 1.84), and particularly among nulliparous women (RR, 2.88), Dr. Delaney reported.

Major Finding: The likelihood of delivery within 12 hours was significantly increased from 14% with 30-mL Foley catheter inflation to 26% with 60-mL inflation.

Data Source: The prospective LIFT study of 192 women.

Disclosures: Dr. Delaney reported no study sponsorship or conflicts of interest. Coauthor Dr. Aaron Caughey was funded as a Robert Wood Johnson Physician Faculty Scholar.

CHICAGO — Inflating a transcervical Foley balloon catheter to 60 mL is more effective at inducing labor than standard inflation to 30 mL, based on data from the prospective LIFT study.

The likelihood of delivery within 12 hours was significantly increased from 14% with 30-mL inflation to 26% with 60-mL inflation. The number needed to treat for this outcome is nine, Dr. Shani Delaney and associates reported at the annual meeting of the Society for Maternal-Fetal Medicine.

“The number needed to treat of nine women provides an achievable intervention without increasing cesarean delivery rates and [while still] maintaining both maternal and neonatal safety,” she said.

The Labor Induction With a Foley Balloon Trial (LIFT) failed to meet its primary end point of delivery within 24 hours, with 64% of controls and 66% of the 60-mL group achieving this outcome. The percentage of women giving birth within 24 hours was higher than anticipated in both the control and study groups; thus there was not enough statistical power to detect such a small difference between the groups, Dr. Delaney explained in an interview.

As expected, larger balloon inflation to 60 mL produced significantly increased cervical dilation after expulsion compared with 30-mL inflation (4 cm vs. 3 cm).

An 18 French Foley catheter with a 30-mL balloon tip was inflated to 30 mL in 94 evaluable patients and to 60 mL in 98 patients. Intravenous oxytocin was started within 30 minutes of balloon placement.

Only age was significantly higher at 31.4 years in the control group vs. 29.4 years in the 60-mL group.

The study design was influenced by previous trials, which have reported inflation rates of 30–80 mL, Dr. Delaney said.

The American College of Obstetricians and Gynecologists issued a new practice bulletin for labor induction in August 2009 stating that the “Foley catheter is a reasonable and effective alternative for cervical ripening and inducing labor,” but ACOG did not specify inflation sizes.

During the discussion of the study, a member of the audience sounded a word of caution regarding the findings, noting that most manufacturers recommend inflation to only 50 mL.

There was no difference in maternal or neonatal morbidities between treatment groups, said Dr. Delaney of the department of obstetrics and gynecology at the University of Washington in Seattle.

“If only a 30-mL balloon tip is available, inflation to a volume of 60 mL appears to be safe,” she said.

Maternal outcomes that were similar in the control and 60-mL groups included maximum oxytocin dose (19.1 vs. 19.2 mU/min), median delivery time (20 hours vs. 18.8 hours), spontaneous vaginal delivery (66% vs. 63%), cesarean delivery (21% vs. 23%), chorioamnionitis (15% vs. 19%), meconium (21% vs. 20%), cervical laceration (2% vs. 1%), and placental abruption (1% vs. 2%).

Among infants, 5-minute Apgar scores less than 7 were reported in 5% of the 30-mL group and 4% of the 60-mL group. Umbilical artery blood pH was identical in both groups at 7.27, while umbilical artery base excess was −3.38 in the 30-mL group and −2.95 in the 60-mL group.

In a multivariate analysis, delivery within 12 hours was significantly increased with 60-mL balloon inflation among all patients (relative risk, 1.84), and particularly among nulliparous women (RR, 2.88), Dr. Delaney reported.