Comparing Balloon Catheter and Hygroscopic Cervical Dilator for Labor Induction After Previous Cesarean Section A Randomized Trial to Assess Safety and Effectiveness

What this Trial Is About

Researchers are comparing two mechanical methods for inducing labor in women who have had a previous cesarean section. The study focuses on evaluating the Dilapan-S hygroscopic cervical dilator and the Cook double balloon catheter to better understand their effectiveness and patient satisfaction. This research aims to fill the current gap in data regarding the best approach for mechanical labor induction in this group, where such methods are considered off-label. The main goal is to measure the time from device placement to delivery, with other outcomes including cesarean delivery rates and patient satisfaction. The study involves two groups one where labor is induced using the Cook double balloon device, which is inserted into the cervix and inflated with saline, remaining in place until labor begins or up to 12-24 hours before removal and possible further induction steps. The other group uses up to five Dilapan-S rods inserted after humidification, fixed with a vaginal compress, and left until labor starts or up to 12-24 hours before removal, followed by oxytocin and amniotomy if needed. If labor does not progress after additional oxytocin infusions, cesarean delivery is planned. Participants will be monitored closely during and after induction, with assessments including delivery timing, cesarean rates, neonatal outcomes within 2 hours, maternal infection rates within 96 hours, and patient satisfaction. The study includes women aged 18 to 60 with a previous cesarean and an indication for labor induction. Safety and effectiveness will be tracked throughout, with the total follow-up covering at least 72 to 96 hours after induction.

Comparison Between Two Medical Devices for Labor Induction After Previous C-section