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

"Insertion of the INGA balloon catheter (medical device) through the cervical canal into the uterus is performed for labor induction. During a vaginal examination, the Investigator inserts the catheter so that the balloon tip lies between the amniotic membranes and the internal cervical os. The balloon is filled with 50-75 ml of sterile saline (NaCl) and secured to the upper thigh to maintain gentle traction. The catheter remains in place for up to 24 hours or until spontaneous expulsion. If not expelled, it is removed after 24 hours.~After expulsion or removal, cervical status and Bishop score are assessed. If Bishop ≥ 6, amniotomy and/or oxytocin induction are initiated within one hour. If Bishop \< 6, further management follows"

Insertion of a balloon catheter through the cervical canal into the uterus for induction of labor.