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Study Comparing Balloon with Oxytocin and Oral Misoprostol for Inducing Labor in First-Time Mothers with Premature Rupture of Membranes at Term

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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria such as age, pregnancy status, and gestational age. Consent is required to participate.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to evaluate the condition of the cervix using the Bishop score, which helps determine the readiness for labor induction.

  3. Step 3

    Treatment allocation

    Participants are assigned to one of two treatment groups. One group receives a balloon catheter insertion followed by oxytocin administered intravenously after 6 hours. The other group receives oral misoprostol at a low dose of 25 micrograms every 2 hours.

  4. Step 4

    Monitoring and evaluation

    Throughout the trial, regular monitoring is conducted to assess the progress of labor and the response to the treatment. This includes checking the cervix, monitoring contractions, and evaluating the overall health of both the mother and the baby.

  5. Step 5

    Delivery

    The goal is to achieve a vaginal birth within 24 hours. The method of delivery, whether vaginal or cesarean, is recorded along with any complications that may arise during labor.

  6. Step 6

    Post-delivery assessment

    After delivery, an assessment is conducted to evaluate the mother's satisfaction with the induction method using the EXperience of Induction Tool (EXIT). This includes feedback on the time taken to give birth, discomfort experienced, and the overall experience of contractions.

  7. Step 7

    Hospital discharge

    Before discharge from the hospital, a final evaluation is performed to ensure the well-being of both the mother and the baby. This includes checking for any signs of infection or complications.

Who can join the trial?

9 criteria

  • Must be over 18 years old.
  • Must be pregnant with a pregnancy that is at least 37 weeks along.
  • Must have a single baby in the head-down position.
  • Must be pregnant for the first time (nulliparous).
  • Must have experienced premature rupture of membranes (PROM) at or after 37 weeks, without going into labor for more than 12 hours. PROM means that the water has broken before labor starts.
  • Must have an unfavorable cervix, which means a Bishop score of less than 6. The Bishop score is a system to assess the readiness of the cervix for labor.
  • Must be able to give informed consent, meaning you understand the study and agree to participate.
  • Must be able to follow the study requirements.
  • Must be covered by the French Social Security welfare system.

Who cannot join the trial?

4 criteria

  • Women who are currently pregnant with a condition called premature rupture of membranes (PROM), which means the water breaks before labor starts.
  • Women who have already given birth before (the study is for nulliparous women, meaning those who have not given birth).
  • Men cannot participate in this study.
  • Individuals who are considered part of a vulnerable population, which means they might need special protection or care.
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Investigated drugs

  • Oxytocin

    is a medication used to help start or improve labor in pregnant women. In this trial, it is used in combination with a balloon catheter. Oxytocin works by stimulating the muscles of the uterus to contract, which can help in progressing labor and achieving a vaginal birth.

  • Oral Misoprostol

    is a medication used to induce labor. It is taken by mouth and helps to soften and open the cervix, making it easier for labor to start. In this trial, it is used as an alternative to the combination of a balloon catheter and oxytocin, to see which method is more effective in helping women give birth within 24 hours after their water breaks.

What is already known about the treatment

  • Oxytocin

    Oxytocin is administered intravenously, meaning it is given through a vein, often using a drip. It is currently well-established in medical practice and literature as a medication used to induce labor. The main therapeutic indication for oxytocin is to stimulate contractions in pregnant women, especially in cases like premature rupture of membranes (PROM) at term. At the molecular level, oxytocin works by binding to receptors in the uterus, causing the muscles to contract. It is classified pharmacologically as a hormone and uterotonic agent.

  • Misoprostol

    Misoprostol is taken orally, meaning it is swallowed in pill form. It is widely recognized in medical literature as a medication used to induce labor and manage other gynecological conditions. The primary therapeutic use of misoprostol in this context is to help induce labor in pregnant women with premature rupture of membranes (PROM) at term. On a molecular level, misoprostol acts by binding to prostaglandin receptors in the uterus, leading to muscle contractions. It is classified as a prostaglandin analog.

Investigated diseases

Premature Rupture of Membranes – Premature Rupture of Membranes (PROM) occurs when the amniotic sac breaks before labor begins. This condition can happen at any point during pregnancy but is most concerning when it occurs before 37 weeks of gestation, known as preterm PROM. The rupture leads to the leakage of amniotic fluid, which can increase the risk of infection for both the mother and the baby. PROM can result in complications such as umbilical cord prolapse or placental abruption. The progression of PROM involves monitoring for signs of labor or infection, as well as assessing the health and development of the fetus. Management strategies depend on the gestational age and the presence of any complications.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-501142-30-00Protocol codePHRC N 2020 GALLOTEstimated enrolment520 patientsSponsorCHU Gabriel-Montpied

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