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

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 mu g 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: 14.66.9 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.