Comparative Study of 25 Microgram Vaginal Misoprost vs Cerviprime Gel for Induction of Labour at Term

Abstract Prostaglandin E1 analogue misoprostol (25-μg vaginal) and prostaglandin E2 (dinoprostone) gel (Cerviprime® 0.5 mg intracervical) are commonly used for cervical ripening and induction of labour (IOL) at term, but comparative effectiveness and safety remain context-dependent. Objectives: To compare efficacy and safety of 25-μg vaginal misoprostol with Cerviprime® gel for IOL at term singleton pregnancies with an unfavorable cervix Design-Prospective, randomized, parallel-group controlled trial. Place: Department of Obstetrics & Gynaecology, Government Medical College, Pali and Bangur Hospital. Participants: Term (≥37+0 weeks) singleton, cephalic, Bishop score ≤5, intact autmembranes, reassuring fetal status. Interventions: Group A: 25-μg misoprostol vaginally every 4–6 h (max 6 doses). Group B: Cerviprime® (dinoprostone 0.5 mg) intracervical, repeatable after 6 h (max 2 doses), with amniotomy/oxytocin as indicated. Primary outcome: Induction-to-delivery interval. Secondary outcomes: Vaginal delivery within 24 h, need for oxytocin, mode of delivery, Bishop score change, tachysystole/hyperstimulatin, non-reassuring fetal heart rate (FHR), meconium, postpartum hemorrhage (PPH), NICU admission, Apgar scores, composite neonatal morbidity. Results: In the sample analysis below (n=220; 110 per arm), median induction-to-delivery time was shorter with misoprostol (11.2 h) vs dinoprostone (14.6 h), p=0.004; vaginal delivery within 24 h was higher with misoprostol (86% vs 68%, RR 1.26, 95% CI 1.04–1.53). Tachysystole was more frequent with misoprostol (11% vs 5%), p=0.11 (NS). Caesarean rates and neonatal outcomes were comparable. Conclusions: Low-dose (25-μg) vaginal misoprostol may achieve a shorter induction-to delivery interval and higher likelihood of delivery within 24 h compared with dinoprostone gel, with similar overall safety when used with continuous surveillance.