Induction of labor with oral misoprostol for premature rupture of membranes at term in women with unfavorable cervix: a randomized, double-blind, placebo-controlled trial

Aim: To evaluate the efficacy and safety of oral misoprostol for labor induction in women with term premature rupture of membranes (PROM) and an unfavorable cervix. Methods: We randomized 130 women with PROM of <= 4 h to either oral misoprostol, 50 mu g, or a placebo given every 4 h for up to three doses. Intravenous oxytocin was initiated if active labor did not begin within 12 h. Results: Sixty-four women received oral misoprostol and 66 received placebo. The PROM-to-delivery interval was shorter with misoprostol than with placebo (13.7 +/- 5.8 vs. 20.3 +/- 6.8 h, respectively, P < 0.05). Misoprostol significantly reduced the need for oxytocin (28.1 vs. 72.7%, P < 0.001) and antibiotics (25 vs. 69.7%, P < 0.001). No significant differences in cesarean section or hyper-stimulation rate were noted. Conclusion: Oral misoprostol given to women with unfavorable cervix soon after term PROM significantly reduces the induction-to-delivery time and the need for oxytocin and antibiotics.