|November 2011 · Vol. 23, No. 11
New data: Foley catheter is as effective as prostaglandin gel for induction of labor—with fewer side effects
Findings from a randomized, controlled trial suggest that the Foley catheter “should at least be considered” for induction of labor in women who have an unfavorable cervix at term
The Foley catheter is one of the oldest mechanical methods used for inducing labor. New data show that it produces a vaginal delivery rate similar to that of prostaglandin E2 gel, the current treatment of choice in the United States and United Kingdom—but carries fewer side effects.1
The newly published PROBAAT trial suggests that a mechanical approach to induction of labor could reduce complications; it also challenges the belief that mechanical methods increase the risk of infection for mothers and newborns.1
In the open-label trial of 824 women in 12 hospitals in the Netherlands, women who had a singleton gestation in cephalic presentation, with intact membranes and an unfavorable cervix, were randomized to induction of labor with a 30-mL Foley catheter (n=412) or vaginal prostaglandin E2 gel (n=412). The rate of cesarean delivery was similar between groups (23% for the Foley catheter vs 20% for prostaglandin gel; risk ratio, 1.13; 95% confidence interval [CI], 0.87–1.47). Two serious maternal adverse events were recorded in the prostaglandin group—one uterine perforation after insertion of a uterine pressure catheter and one uterine rupture during augmentation with oxytocin—versus none in the Foley-catheter group, though this difference was not statistically significant.1
In addition, the women randomized to the Foley catheter had a lower rate of operative delivery for suspected fetal distress, fewer mothers required intrapartum antibiotics, and fewer newborns were admitted to the NICU. However, the time from the start of induction of labor to birth was longer with the Foley catheter (median of 29 versus 18 hours; relative risk, 1.66; 95% CI, 1.34-1.61; P < .0001).
A meta-analysis that included these new data was then conducted by the researchers; it confirmed that induction of labor with the Foley catheter produces a vaginal delivery rate similar to that of prostaglandin E2 gel and significantly reduces the rates of uterine hyperstimulation and postpartum hemorrhage. This finding is in line with another recent meta-analysis.2
In a commentary accompanying the study, Jane Norman and Sarah Stock of the University of Edinburgh in Edinburgh, Scotland, conclude: “These data should prompt a revision of the recommendation that ‘mechanical procedures (balloon catheters and laminaria tents) should not be used routinely for induction of [labor].’”3
The authors of the study itself conclude: “We think that a Foley catheter should at least be considered for induction of labor in women with an unfavorable cervix at term.”
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1. Jozwiak M, Rengerink KO, Benthem M, et al, for the PROBAAT Study Group. Foley catheter versus vaginal prostaglandin E2 gel for induction of labour at term (PROBAAT trial): an open-label, randomised controlled trial [published online ahead of print October 25, 2011]. Lancet. doi: 10.1016/S0140-6736(11)61484-0.
2. Vaknin Z, Kurzweil Y, Sherman D, et al. Foley catheter balloon vs locally applied prostaglandins for cervical ripening and labor induction: a systematic review and meta-analysis. Am J Obstet Gynecol. 2010;203(5):418–429.
3. Norman JE, Stock S. Intracervical Foley catheter for induction of labour [published online ahead of print October 25, 2011]. Lancet. doi: 10.1016/S0140-6736(11)61581-X.
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