Evaluating the Safety and Ease of Use of the INGA Balloon Catheter for Cervical Ripening in Labor Induction of Pregnant Women at Term

What this Trial Is About

This clinical study investigates the safety, usability, and performance of a new mechanical balloon catheter called the INGA catheter, which is used to prepare the cervix for labor induction in pregnant women at term. The study enrolls pregnant women at or beyond 37 weeks of gestation with a single baby in a head-down position and an unfavorable cervix. The goal is to understand how well the device works for cervical ripening and to collect feedback from both participants and healthcare providers. Participants will have the INGA balloon catheter inserted as part of their labor induction process. The catheter is placed between the fetal membranes and the internal cervical opening during a vaginal exam, then filled with sterile saline and maintained under gentle traction for up to 24 hours or until it detaches spontaneously. Cervical status is assessed before and after catheter use using the Bishop score. Participants receive standard obstetric care throughout labor induction and delivery, with no comparison group in this study. During the study, researchers collect clinical data on catheter usability, insertion experience, pain levels, retention time, and delivery outcomes. Both participants and healthcare professionals provide feedback through questionnaires and structured evaluations. Safety is monitored throughout the cervical ripening and delivery period by tracking any adverse events or device-related incidents. The study is designed to provide preliminary data to support further development and future studies of the INGA catheter.

Safety and Usability of the Inga Catheter for Labor Induction (INGA-MDP)