Early Safety and Performance Study of the INGA Catheter Compared to Standard Balloon Catheter for Labor Induction in Pregnant Women

What this Trial Is About

This research aims to evaluate the safety and usability of the new INGA catheter for labor induction, a process commonly used in about one in three births. The study compares the INGA catheter, a single-balloon device made from different materials, to a currently used balloon catheter method. Feedback will be gathered from both healthcare professionals and participating women to assess the devices performance. Participants will be randomly assigned to receive either the INGA catheter or the standard balloon catheter. The catheter is inserted through the cervical canal and inflated with sterile saline, remaining in place for up to 24 hours or until it detaches spontaneously. During the procedure, fetal heart rate and contractions are monitored, and cervical ripeness is assessed before and after catheter use. Labor induction continues following hospital protocols after catheter removal. Participants will undergo screening to confirm eligibility, including medical history, physical and fetal assessments, and informed consent. Throughout the study, data on labor induction, delivery outcomes, maternal safety, and newborn health will be collected. Participants and physicians will complete questionnaires evaluating comfort and device usability. No additional study visits are needed after delivery, and routine post-delivery care will follow standard practices.

Open, Randomized Feasibility Trial on the Safety and Performance of the INGA Catheter for Labor Induction