Efficacy and Safety of Sublingual Versus Vaginal Misoprostol for Labor Induction in Pregnancies with a Live Fetus: A Randomized Controlled Trial at Mulago Hospital, Uganda

Abstract Background: Labor induction involves stimulating uterine contractions to achieve delivery before spontaneous labor onset. Misoprostol, a synthetic prostaglandin E1 analogue, is effective for this purpose, commonly administered orally or vaginally. However, studies comparing the efficacy and safety of sublingual versus vaginal misoprostol are lacking. This study aims to compare these two routes for labor induction in pregnant women with a live fetus at Mulago Hospital, Uganda. Methods: A randomized clinical trial was conducted at the Mulago National Referral Hospital Labor Suite in Kampala, Uganda. Pregnant women at a gestational age of ≥ 34 completed weeks, with a live fetus, scheduled for labor induction, were included after informed consent. Exclusions were made for patients with known gross fetal anomalies, multiple pregnancies, and misoprostol allergy. A total of 156 women were randomly assigned to two groups: vaginal (80) and sublingual (76) misoprostol administration. Participants were followed through labor and delivery. Data was entered and analyzed using Epidata version 2.1b and STATA version 11. Results: The study showed comparable demographic and clinical characteristics between the sublingual and vaginal misoprostol groups. The mean time from induction to vaginal delivery was 12.79 ± 9.72 hours for the sublingual group and 13.30 ± 8.31 hours for the vaginal group (P = .37). A higher percentage of participants in the vaginal group delivered within 24 hours compared to the sublingual group (49.5% vs. 40.9%, P = .98). Vaginal delivery rates were 86.8% in the sublingual group and 88.8% in the vaginal group (P = .71). The rate of failed induction was 25% in the sublingual group and 22.5% in the vaginal group (P = .71). There were no cases of uterine hyperstimulation in either group. Intrapartum complications (fever, nausea/vomiting, fetal distress/meconium-stained liquor) and birth outcomes did not differ significantly between the groups. However, there was a significant difference in 1-minute APGAR scores < 7 between the sublingual and vaginal groups (P = .006). Conclusion: This study supports the use of sublingual misoprostol as a viable alternative to vaginal administration for labor induction in resource-limited settings like Mulago Hospital, Uganda. Future research could explore larger, multi-center trials to further validate these findings and investigate long-term maternal and neonatal outcomes associated with sublingual misoprostol use.