A randomized controlled trial comparing oral and vaginal misoprostol for induction of labour at term

Background: Induction of labour is a common obstetric intervention, and misoprostol is widely used due to its efficacy, stability, and low cost. However, the optimal route of administration remains controversial, particularly in terms of safety and efficacy. Objectives: To compare the efficacy and safety of oral versus vaginal misoprostol for induction of labour at term. Methods: This prospective randomized controlled trial was conducted in the Department of Obstetrics and Gynaecology, Narayan Medical College and Hospital, Jamuhar, from November 2018 to November 2020. A total of 100 term pregnant women with singleton cephalic presentation, Bishop score ≤6, and intact membranes were randomized into two groups. Group A (n=50) received oral misoprostol 50 µg every 4 hours (maximum 5 doses), while Group B (n=50) received vaginal misoprostol 50 µg every 6 hours (maximum 4 doses). Primary outcomes included induction–delivery interval, number of doses required, failed induction, and need for oxytocin augmentation. Secondary outcomes included mode of delivery, maternal complications, and neonatal outcomes. Statistical analysis was performed using Epi Info™, with p <0.05 considered significant. Results: Baseline characteristics were comparable between the groups. The mean number of doses required was significantly higher in the oral group compared to the vaginal group (3.8 vs 2.7; p<0.05). Failed induction was significantly more common in the oral group (14% vs 4%; p<0.05). Oxytocin augmentation was required more frequently in the oral group (42% vs 32%). Vaginal delivery rates were comparable between groups. Neonatal intensive care unit admission was significantly higher in the vaginal group (14% vs 10%; p<0.05). Maternal complications were minimal and comparable. Conclusion: Both oral and vaginal misoprostol are effective for induction of labour at term. Vaginal misoprostol requires fewer doses and has a lower failed induction rate, while oral misoprostol is associated with fewer neonatal intensive care admissions. Route selection should be individualized based on clinical context and fetal monitoring facilities.