Misoprostol in Addition to a Double-Balloon Catheter for Induction: A Double-Blind Randomized Controlled Trial

Abstract

Objective This article aims to evaluate whether the use of a double-balloon catheter with oral misoprostol results in a lower rate of cesarean and shorter times to delivery than the use of the double-balloon catheter with oral placebo.

Study Design In a double-blind randomized controlled trial, a double-balloon catheter was used for induction of labor with two doses of either 50 µg of misoprostol or placebo. Outcomes included cesarean rate, time to vaginal delivery, change in Bishop's score, and oxytocin usage.

Results A total of 343 women were screened and 199 randomized: 99 to the misoprostol arm and 100 to the placebo arm. Cesarean delivery rate was not different between the groups (misoprostol: 13.1% vs. placebo: 17.0%, p = 0.45). Time to vaginal delivery was significantly shorter (mean: 14.6 ± 6.9 vs. 20.8 ± 13.8 hours, p < 0.0001), change in Bishop's score was significantly greater (median: 5 vs. 4 points, p = 0.005), and use of oxytocin was significantly less frequent (86.9 vs. 98.0% patients, p = 0.01) in the misoprostol group.

Conclusion The use of a double-balloon catheter with oral misoprostol for induction did not reduce the cesarean delivery rate, but did result in shorter labors, a greater increase in Bishop's score, and a lower need for oxytocin use.

Keywords

induction of labor - misoprostol - double-balloon catheter - cesarean delivery rate - Bishop's score

Note

This is a double-blind randomized controlled trial performed at a single institution. Lili Zhou, MS, with the Department of Pharmacology, University of Arizona, Tucson, Arizona provided assistance with statistical analysis for this study. Cook Medical provided 200 Cook Cervical Ripening Balloons for use in this study.

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