Comparison of the efficacy and safety of titrated oral misoprostol and a conventional oral regimen for cervical ripening and labor induction

Objective: To compare the efficacy and safety of titrated oral misoprostol and a conventional oral regimen for cervical ripening and labor induction. Methods: A randomized double-blind trial of women with term singleton pregnancies with indications for labor induction. Participants were allocated to receive 20 mL of misoprostol solution (1 mu g/mL) orally every 1 hour for 4 doses then titrated to 40 mu g every 1 hour (titrated group) or 50 mu g of misoprostol orally every 4 hours up to 12 hours (conventional group). Primary outcomes were success rate of cervical ripening within 12 hours, interval from first dose until more favorable cervix or active labor occurred, and total dose of misoprostol. Results: Sixty-four participants were included. Mean total dose of misoprostol and incidence of tachysystole were significantly higher in the titrated compared with the conventional group (236.2 +/- 110.1 mu g vs 103.1 +/- 35.7 mu g; P = 0.001 and 25.0% vs 6.3%; P = 0.03), whereas success rate, interval from drug administration to more favorable cervix and delivery, proportion of patients delivered vaginally within 12 hours and 24 hours, need for oxytocin augmentation, cesarean delivery rate, maternal adverse effects and complications, and neonatal outcome were not significantly different (P>0.05). Conclusion: Conventional oral misoprostol is as effective as titrated misoprostol for cervical ripening and labor induction, but has a lower incidence of tachysystole and a lower total dose of misoprostol is required. ClinicalTrial.gov: NCT00886860. (C) 2011 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.