RESUMO
OBJECTIVE: To test the hypothesis that use of the Foley bulb plus vaginal misoprostol will result in shorter induction-to-delivery time compared with vaginal misoprostol alone. METHODS: We randomized 123 women undergoing induction of labor with singleton pregnancies at 24 weeks of gestation or greater with an unfavorable cervix (Bishop score 6 or lower) to Foley bulb plus vaginal misoprostol (n=56) or vaginal misoprostol alone (n=61). Women with fetal malpresentation, multifetal gestation, spontaneous labor, contraindication to prostaglandins, nonreassuring fetal heart rate tracing, intrauterine growth restriction, anomalous fetus, fetal demise, or previous cesarean delivery or other significant uterine surgery were excluded. The primary outcome measure was induction-to-delivery time. Secondary outcomes were mode of delivery, tachysystole with fetal decelerations, terbutaline use, postpartum hemorrhage, chorioamnionitis, neonatal Apgar scores, and neonatal intensive care unit admission. Analysis followed the intention-to-treat principle. RESULTS: The mean induction-to-delivery time was shorter with the combination of the Foley bulb and vaginal misoprostol when compared with vaginal misoprostol alone (15.3±6.5 compared with 18.3±8.7 hours, difference -3.1 hours, 95% confidence interval [CI] -5.9 to -0.30). The combination also resulted in shorter induction to complete cervical dilation time (13.7±5.9 compared with 17.1±8.7 hours, difference -3.5 hours, 95% CI -6.7 to -0.4). There were no differences in labor complications or adverse neonatal and maternal outcomes. CONCLUSION: A combination of the Foley bulb and vaginal misoprostol resulted in a shorter induction-to-delivery time when compared with vaginal misoprostol alone without increasing labor complications. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT01279343. LEVEL OF EVIDENCE: I.