Effectiveness and safety of vaginal versus sublingual misoprostol for cervical ripening and induction of labor: A randomized controlled trial

Background: Vaginal misoprostol is a highly effective method of cervical ripening and induction of labor; however, it is associated with some complications. Therefore, there is need to explore other routes of administration that may be safer, acceptable, and also effective. Objective: The aim of this study was to compare the effectiveness and safety of vaginal versus sublingual misoprostol for cervical ripening and induction of labor. Materials and Methods: This was a randomized controlled trial conducted among booked antenatal women in Owerri, South-East Nigeria. The eligible participants were randomized to receive either 25 μg of misoprostol vaginally (n = 90) or 25 μg sublingually (n = 90). Outcome measures included delivery within 24 h, induction to delivery interval, cesarean section rate, side effects of misoprostol, Apgar Score at birth, and admission into the Neonatal Intensive Care Unit. Results: There was no significant difference in the effectiveness and side effects of both routes of administration (p > 0.05). The results were comparable in both groups, except for the time to reach the active phase of labor (vaginal route 16.64 ± 9.12 vs. sublingual route 13.78 ± 7.47, P = 0.023) and the number of doses of misoprostol used (vaginal route 2.81 ± 1.53 vs. sublingual route 2.34 ± 1.49, P = 0.040). Conclusion: The effectiveness of cervical ripening and induction of labor is comparable in both groups and the side effect profile is also similar. Hence, the sublingual route is as effective and as safe as the vaginal route but with added advantage of shortening the duration of active phase of labor and requiring less doses for induction of labor.