Titrated oral misoprostol solution versus vaginal misoprostol for labor induction

Abstract

Objective: To determine the efficacy and safety of a titrated oral misoprostol solution compared with vaginal misoprostol tablets for labor induction.

Methods: A randomized, triple-blind, multicenter clinical trial was conducted between March 2010 and June 2011. Women with a single gestation (n=200) were randomized to receive a titrated oral misoprostol solution (initial misoprostol dose 20 μg/hour; dose increased by 20 μg/hour every 6 hours up to 80 μg/hour for a maximum of 48 doses) or vaginal misoprostol tablets (25 μg of misoprostol every 6 hours for a maximum of 8 doses). Risk ratios (RR) and 95% confidence intervals (CIs) were calculated for maternal and perinatal outcomes.

Results: The frequencies of vaginal delivery not achieved within 12 hours (RR 0.87; 95% CI, 0.62-1.22) and within 24 hours (RR 1.11; 95% CI, 0.83-1.49) were similar in the 2 groups. No differences were found in terms of uterine hyperstimulation, unfavorable cervix at 12 and 24 hours, oxytocin augmentation, tachysystole, epidural analgesia, adverse effects, and perinatal outcome. Approximately 70% of the women preferred the oral solution.

Conclusion: A titrated oral misoprostol solution was as effective and safe for labor induction as vaginal misoprostol tablets. ClinicalTrial.gov: NCT00 992524.

Trial registration: ClinicalTrials.gov NCT00992524.

Keywords: Clinical trial; Induced labor; Misoprostol.