Dilapan-S Versus Double Balloon Catheter (CRB) for Preinduction of Labor at Term

Launched by UNIVERSITY OF ROMA LA SAPIENZA · May 29, 2025

Keywords

ClinConnect Summary

This clinical trial is comparing two methods for preparing the cervix for labor in women who are about to give birth. The two methods being studied are Dilapan-S, a gentle device that expands as it absorbs fluid, and the double balloon catheter (CRB), which uses pressure to help open the cervix. The goal is to see which method is more effective and leads to better experiences for mothers during labor.

To participate in the trial, women must be at least 18 years old and have a single baby in a head-down position, with a pregnancy of at least 37 weeks. They should be planning to induce labor for reasons like being overdue or having high blood pressure. Participants will be monitored during the process, and their experiences will be compared to see how each method affects labor time, comfort, and overall satisfaction. It's important to note that women with certain conditions, like infections or previous major surgeries, may not be eligible to join the study.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • • Singleton pregnancy
• • Cephalic fetal presentation
• • Gestational age ≥ 37+0 weeks
• • Indication for labor induction (e.g., postdates, maternal hypertension)
• • Bishop score ≤ 6
• • Maternal age ≥18 years
• • Ability to provide informed consent
• Exclusion Criteria:
• • • Premature rupture of membranes (PROM)
• • Placenta previa, vasa previa, or abnormal placentation
• • Active genital tract infection
• • Prior classical cesarean section or extensive uterine surgery
• • Known fetal anomaly contraindicating vaginal delivery
• • Allergy or sensitivity to device materials
• • Any contraindication to labor induction or vaginal birth