Comparing Propess and Prostaglandin E2 Vaginal Gel with Balloon Catheter for Labor Induction in Women at Term with Unfavorable Cervix

What this Trial Is About

Researchers are comparing two methods of labor induction in women with a single baby at term who have an unfavorable cervix, meaning the cervix is not ready for labor Bishop score below 5. The study aims to find out which method leads to a shorter time from the start of labor induction until delivery. This is a Phase 4 randomized clinical trial sponsored by HaEmek Medical Center in Israel, focusing on the safety and effectiveness of these induction methods. One group will receive a slow-release 10 mg dinoprostone vaginal insert Propess placed in the posterior fornix for up to 24 hours until labor begins or the cervix becomes favorable. Labor is then induced with amniotomy and oxytocin. If this does not work, induction with PGE2 gel andor a Foley catheter balloon will be used. The other group will start with 1 mg dinoprostone vaginal gel, with reassessment up to 6 hours later. Additional gel or a 60 ml Foley catheter balloon may be used based on contractions and cervical readiness. Labor is then induced with amniotomy and oxytocin, and if this fails, induction with Propess will be done. Participants will be monitored from enrollment until delivery, with researchers measuring the time from induction to vaginal delivery as the primary outcome. Additional outcomes include the rate of vaginal delivery within 24 and 48 hours, success rates of induction and cervical ripening, and treatment-related side effects. The study includes follow-up for about a month after enrollment to assess these outcomes and ensure safety throughout the process.

Induction of Labor - Comparison Propess With Prostaglandin E2 Vaginal Gel and Balloon Catheter