A RANDOMIZED CLINICAL-TRIAL COMPARING MISOPROSTOL WITH PROSTAGLANDIN E-2 GEL FOR PREINDUCTION CERVICAL RIPENING

OBJECTIVE: Our purpose was to perform a randomized trial comparing int ravaginal misoprostol to intravaginal prostaglandin E-2 gel for preind uction cervical ripening evaluating efficacy and side effects. STUDY D ESIGN: Seventy-five women seen for induction of labor were randomized to receive 100 mu g of intravaginal misoprostol or 5 mg of pharmacy-pr epared intravaginal prostaglandin E-2 gel for cervical ripening before oxytocin induction. Six hours after placement of the study agent, pat ients were given oxytocin if they were not in labor. The primary outco me measure was induction-to-delivery time; secondary measures were cha nge in Bishop score, delivery mode, and side effects. Results were ana lyzed by the Student t test and Fisher's exact test, with p < 0.05 con sidered significant. RESULTS: There was no difference in the incidence of primiparity or the median initial Bishop score between the two stu dy groups. The mean time to delivery and the need for oxytocin was sig nificantly less for subjects receiving misoprostol. There was no diffe rence in the incidence of uterine hyperstimulation syndrome or cesarea n delivery between the groups. CONCLUSIONS: This randomized clinical t rial indicates that misoprostol is efficacious for preinduction cervic al ripening. Misoprostol use resulted in a significantly shorter induc tion-to-delivery time compared with prostaglandin E-2 gel use. The sid e effects associated with misoprostol may be dose related, and further studies to identify the optimum dosage and interval are needed.