AT THE PREGNANCY MEETING
SAN DIEGO (FRONTLINE MEDICAL NEWS) – In women with an unfavorable cervix at term, induction of labor with oral misoprostol was comparable to the Foley catheter in terms of effectiveness and safety, results from a multicenter Dutch study demonstrated.
Between 20% and 30% of pregnant women are induced in Western countries, and around 10% in the developing world, Dr. Mieke L.G. ten Eikelder said at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine. “When cervical ripening is necessary, the safest method is still unclear. Current guidelines suggest prostaglandin E analogues and [note that] the Foley catheter is a reasonable and effective alternative.”
In 2011, researchers published results from the PROBAAT trial, which found that induction with a Foley catheter was just as effective as prostaglandins, with less neonatal and maternal morbidity ( Lancet 2011;378:2095-2103 ). For the current noninferiority trial, known as PROBAAT-II , the researchers set out to study the safety and effectiveness of labor induction using oral misoprostol, compared with transcervical catheter in term pregnant women with an unfavorable cervix.
Between July 2012 and October 2013, Dr. ten Eikelder of the department of obstetrics and gynecology at Leiden University Medical Center, the Netherlands, and her associates in 28 other Dutch hospitals, enrolled 1,845 women with a term singleton pregnancy in cephalic presentation, intact membranes, an unfavorable cervix, without prior cesarean section.
The researchers randomly assigned 924 women to 50 mcg oral misoprostol administered every 4 hours (for a maximum of three times in a 24-hour period) and 921 women to 30 mL Foley catheter. The primary outcome was a composite of asphyxia (an arterial umbilical cord pH of 7.05 or lower, and/or a 5-minute Apgar score of less than 7) and/or postpartum hemorrhage (greater than or equal to 1,000 mL). Secondary outcomes were maternal and neonatal morbidity and time from intervention to birth. Analyses were done by intention to treat.
The primary composite outcome occurred in 12% of patients in both the oral misoprostol and Foley catheter groups, for a risk ratio of 1.1, Dr. ten Eikelder reported. Spontaneous vaginal delivery did not differ between the two groups (70% vs. 70%; relative risk 0.99), nor did the rates of delivery by cesarean section (17% vs. 20%; RR 0.84) or by vaginal instrument (14% vs. 10%; RR 1.4).
However, cesarean section for failure to progress occurred less frequently in the oral misoprostol group, compared with the Foley catheter group (6% vs. 11%, RR 0.58). The time from the start of induction to delivery was comparable between the two groups and there were no cases of serious maternal or neonatal morbidity.
“In women with an unfavorable cervix at term, induction of labor with oral misoprostol and Foley catheter are comparable in terms of safety and effectiveness,” Dr. ten Eikelder said.
The study was funded by Fonds NutsOhra, a Dutch health research and development organization. Dr. ten Eikelder reported that she and the other researchers had no relevant financial disclosures.
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