1Obstetrics and Gynaecology Resident, Rajshree Medical Research Institute, Bareilly
2HOD, Department of Obstetrics and Gynaecology, Rajshree Medical Research Institute, Bareilly
3Professor, Department of Obstetrics and Gynaecology, Rajshree Medical Research Institute, Bareilly
4Senior Resident, Department of General Medicine, PGIMS, Rohtak
Introduction: Pre-induction cervical ripening is a crucial determinant of successful induction of labour (IOL), particularly in women with an unfavourable cervix. Pharmacological agents such as vaginal misoprostol and mechanical methods like the single balloon (Foley) catheter are commonly used for cervical ripening. However, controversy persists regarding their relative efficacy and safety profiles.
Aim: To compare the efficacy and safety of vaginal misoprostol versus single balloon catheter for pre-induction cervical ripening in term primigravida women.
Materials and Methods: This randomised controlled trial was conducted in the Department of Obstetrics and Gynaecology at Rajshree Medical Research Institute, Bareilly, from April 2024 to November 2025. A total of 126 primigravida women with singleton live cephalic pregnancies between 37–42 weeks of gestation and Bishop score <4 were randomly allocated into two groups. Group A (n=63) received 25 μg vaginal misoprostol every 6 hours (maximum four doses). Group B (n=63) underwent intracervical single balloon catheter insertion (30 mL balloon) for up to 24 hours. Primary outcomes included time to achieve Bishop score >8 and induction-to-delivery interval. Secondary outcomes included duration of labour stages, mode of delivery, maternal complications, Apgar score, and NICU admission. Statistical analysis was performed using Student's t-test and Chi-square test, with p ≤0.05 considered statistically significant.
Results: Baseline demographic and obstetric characteristics were comparable between the two groups (p>0.05). The misoprostol group demonstrated a significantly shorter time to achieve Bishop score >8 and shorter induction-to-delivery interval compared to the balloon catheter group (p<0.0001). Duration of first stage of labour was significantly reduced in Group A. However, there was no statistically significant difference between the groups regarding mode of delivery, cesarean section rate, maternal complications including postpartum haemorrhage, Apgar scores at 1 and 5 minutes, or NICU admissions (p>0.05).
Conclusion: Both vaginal misoprostol and single balloon catheter are effective and safe methods for pre-induction cervical ripening. Vaginal misoprostol is associated with faster cervical ripening and shorter induction-to-delivery interval, whereas the single balloon catheter remains a reliable alternative with comparable maternal and neonatal outcomes.
Keywords: Cervical ripening, Induction of labour, Misoprostol, Foley catheter, Bishop score, Randomised controlled trial
How to cite this article: Shikha, Agarwal R, Sharma M, Kashish. Comparative Study of Vaginal Misoprostol versus Single Balloon Catheter for Pre-Induction Cervical Ripening: A Randomised Controlled Trial. Int J Drug Deliv Technol. 2026;16(6s): 318-323; DOI: 10.25258/ijddt.16.6s.35
Source of support: Nil
Conflict of interest: None