Objective: To compare sublingual with vaginal misoprostol for the induction of labor.
Methods: This double-blind clinical trial randomized 150 women to receive every 6 h 25 mug of sublingual misoprostol and vaginal placebo or 25 mug of vaginal misoprostol and sublingual placebo. Maternal and neonatal outcomes were analyzed and risk ratios (RRs) with 95% confidence intervals (CIs) calculated. The significance level was 5%.
Results: Vaginal delivery rates were 57% in the sublingual group and 69% in the vaginal group (RR, 0.8; 95% CI, 0.6-1.1). There were 11 cases of fetal distress in the sublingual group and 4 cases in the vaginal group (RR, 2.7; 95% CI, 0.9-8.2). There were no significant differences in the number of doses needed, interval between first dose and delivery, incidence of contractility disturbances, or neonatal results.
Conclusion: The administration of misoprostol 25 mug by the sublingual route was neither more effective nor safer than the same dose administered vaginally.