OBJECTIVE: We sought to compare the efficacy and safety of oral misoprostol administered to patients with the efficacy and safety in a control group treated with a Foley catheter and oxytocin for induction of labor. STUDY DESIGN: Two hundred patients requiring induction of labor at term with a Bishop score of less than or equal to 5 were randomized to receive oral misoprostol or a cervical Foley catheter plus oxytocin. Patients in the misoprostol group received 50 mu g at 4-hour intervals for a maximum of 6 doses or until an adequate contraction pattern developed. Those in the control group had a Foley catheter inserted in the cervix, whereas oxytocin was administered intravenously by a standard incremental infusion protocol to a maximum close of 36 mU/min. RESULTS: In multiparous patients the percentage delivered of their neonates within 24 hours and the median induction-to-delivery times were similar in the 2 groups. In nulliparous patients, however, delivery within 24 hours was significantly less likely in the misoprostol group (53.4% vs 82.5%; P < .001), and the median induction-to-delivery time was longer (23.3 hours vs 17.2 hours; P < .01). There were no differences in the Incidence of meconium, chorioamnionitis, low Apgar scores, or cesarean delivery. The incidence of hyperstimulation was higher in the oxytocin-foley group (4.1% vs 13.1%: P = .02). CONCLUSION: Oral misoprostol is as effective as oxytocin-foley catheter for inducing labor in multiparous women. Misoprostol appears less efficacious in nulliparous patients.