The MisoPROM study: a multicenter randomized comparison of oral misoprostol and oxytocin for premature rupture of membranes at term.

OBJECTIVE: This study was undertaken to determine whether induction of labor with oral misoprostol will result in fewer cesarean deliveries than intravenous oxytocin in nulliparous women with premature rupture of membranes at term. STUDY DESIGN: Three hundred five women at 10 centers were randomly assigned to receive oral misoprostol, 100 microg every 6 hours to a maximum of two doses or intravenous oxytocin. The primary outcome measure was cesarean deliveries. Secondary outcomes were time from induction to vaginal delivery and measures of maternal and neonatal safety. RESULTS: The study was stopped prematurely because of recruitment difficulties. We present the results for the 305 enrolled women. There was no difference in the proportion of women who underwent cesarean delivery (20.1% in the misoprostol group, 19.9% in the oxytocin group). The time interval from induction to vaginal delivery was also similar (11.9 hours for the misoprostol group, and 11.8 hours for the oxytocin group). Maternal and neonatal safety outcomes were similar for the two treatments. More infants born to women in the misoprostol group received intravenous antibiotics in the neonatal period (16.4% vs 6.9%, P=.01), although there were no differences in chorioamnionitis or in proven neonatal infections. Women receiving misoprostol were less likely to have postpartum hemorrhage than those receiving oxytocin (1.9% vs 6.2%, P=.05). CONCLUSION: Oral misoprostol does not offer any advantage in time from induction to vaginal delivery or risk of cesarean section.

Randomized trial of concurrent oxytocin with a sustained-release dinoprostone vaginal insert for labor induction at term.

OBJECTIVE: The purpose of this study was to determine whether the concurrent administration of oxytocin with sustained-release dinoprostone results in shorter induction times when compared with oxytocin after the removal of the dinoprostone insert. STUDY DESIGN: Women with singleton pregnancies at > or = 36 weeks, vertex presentations, reactive nonstress tests, no prior uterine scar, intact membranes, and Bishop scores of < or = 6 were randomly assigned to receive oxytocin either immediately after placement of a sustained-release dinoprostone insert (immediate) or 30 minutes after its removal (delayed). The primary outcome was the time interval from induction to delivery. RESULTS: Seventy-one patients were enrolled (immediate, 34 patients; delayed, 37 patients). There were no differences between treatment groups in non-reassuring fetal heart tracings, excess uterine activity, and epidural use. The mean time from dinoprostone placement until delivery was 544 minutes, shorter in the immediate group (972 vs 1516 minutes; P =.001). The proportion of deliveries within 24 hours was higher (90% vs 53%; P =.002) in the immediate group. Cesarean delivery rates were similar between the immediate and delayed groups (16% vs 13%; P =.73). No adverse maternal or neonatal outcomes were observed with concurrent therapy. CONCLUSION: Oxytocin that is administered concurrently with sustained-release dinoprostone significantly shortens induction-to-delivery times and results in a higher proportion of vaginal deliveries of < or = 24 hours with no apparent adverse effects.