Trial to Evaluate Combined Misoprostol and Cervical Balloon for Faster Labor Induction in Primiparas

Labor induction is a common obstetric procedure, particularly for primiparas (first-time mothers) with an unfavorable cervix. Current methods, such as misoprostol (a prostaglandin E1 analog) and mechanical cervical balloons, are effective but can result in prolonged induction times. While both are low-cost and widely available, the optimal strategy for accelerating cervical ripening and reducing overall labor duration remains an area of active research. Existing meta-analyses suggest that combining these methods may offer benefits like shorter labor and reduced tachysystole, but robust data, especially from diverse populations like Asian women, are lacking. This trial aims to fill this evidence gap.

This randomized controlled trial will compare misoprostol alone versus misoprostol combined with a cervical balloon for labor induction in first-time mothers. Participants will be randomly assigned to one of two groups on the first day of induction. The control group will receive misoprostol (vaginal administration) as standard care. The intervention group will receive misoprostol plus a cervical balloon (placed in the cervix). The primary endpoint is the time from the start of induction to delivery. Secondary outcomes include rates of cesarean section, maternal complications, and newborn outcomes, ensuring a comprehensive safety assessment.