This clinical trial is focused on helping pregnant women who experience a condition known as premature rupture of membranes (PROM) at full term. PROM occurs when the water breaks before labor begins, which can lead to complications if not managed properly. The study is comparing two different methods to induce labor in women who have not given birth before and have an unfavorable cervix, which means the cervix is not yet ready for labor. The first method involves using a balloon catheter along with the hormone oxytocin, which is given intravenously to help start contractions. The second method uses a medication called misoprostol, taken orally, which is a synthetic form of a natural substance in the body that helps induce labor.
The purpose of the study is to determine which method is more effective in achieving a vaginal birth within 24 hours and to assess the satisfaction of the women with the induction process. Participants will be randomly assigned to one of the two methods. For those in the balloon and oxytocin group, a balloon catheter will be inserted, and oxytocin will be administered after six hours if needed. For those in the misoprostol group, a low dose of the medication will be given every two hours. The study will also collect feedback from participants about their experience using a survey before they leave the hospital.
The trial will monitor various outcomes, such as the time it takes to give birth, the level of discomfort during labor induction, and the overall experience of contractions. Other factors being studied include the duration from the rupture of membranes to the start of induction, the total dose of misoprostol received, and the rate of different types of delivery, including cesarean sections. The study aims to provide valuable information on the best approach to manage labor induction in cases of PROM, ensuring both the safety and satisfaction of the mother and baby.



France