Ongoing Clinical Trials for Premature Rupture of Membranes
There are currently 2 active clinical trials investigating treatments for premature rupture of membranes, a condition where the amniotic sac breaks before labor begins. Both trials are being conducted in France and focus on improving outcomes for mothers and babies through different approaches to managing early membrane rupture and labor induction.
Clinical trial locations
- France
Study on Nifedipine for Managing Preterm Premature Rupture of Membranes (PPROM) in Pregnant Women Before 34 Weeks
This trial is testing whether a medication called nifedipine can help reduce risks when the water breaks too early in pregnancy, specifically between 22 and 33 weeks of gestation. The medication is given as a prolonged-release tablet for a short period of 48 hours.
Who can participate:
- Women who have experienced preterm premature rupture of membranes between 22 weeks and 33 weeks and 6 days of pregnancy
- Must be carrying a single baby (not twins or more)
- The baby must be alive at the time of joining the study
- Must be 18 years of age or older
- Must speak French and be affiliated with social security or an equivalent system
- Must provide informed consent
Who cannot participate:
- Those who are not experiencing pregnancy complications related to pathological delivery
- Those outside the specified age range
- Men (this study is only for pregnant women)
- People who are part of vulnerable populations requiring special protection
Focus of the trial: The study aims to determine if using nifedipine can help safely prolong pregnancy and improve health outcomes for both mother and baby when PPROM occurs early. Participants will be randomly assigned to receive either the medication or a placebo (inactive substance), and neither participants nor researchers will know which is being given. The trial will monitor several outcomes including the baby’s health at birth and up to hospital discharge, the mother’s health, and the baby’s development at two years of age. The study is expected to conclude by April 2027.
Investigational drug: Nifedipine is being studied for its potential to manage preterm premature rupture of membranes. It works by relaxing the muscles of the uterus and preventing contractions, which may help delay premature labor and reduce complications.
Study Comparing Balloon with Oxytocin and Oral Misoprostol for Inducing Labor in First-Time Mothers with Premature Rupture of Membranes at Term
This trial compares two different methods of inducing labor in first-time mothers whose water has broken at full term (37 weeks or later) but labor has not started. The study focuses on women with an unfavorable cervix, meaning the cervix is not yet ready for labor.
Who can participate:
- Women over 18 years old
- Pregnant with at least 37 weeks of gestation
- Carrying a single baby in the head-down position
- Pregnant for the first time (first pregnancy)
- Experienced premature rupture of membranes at or after 37 weeks, without going into labor for more than 12 hours
- Have an unfavorable cervix with a Bishop score of less than 6 (a system to assess cervix readiness)
- Able to give informed consent and follow study requirements
- Covered by the French Social Security welfare system
Who cannot participate:
- Women who have already given birth before
- Men
- Individuals considered part of vulnerable populations
Focus of the trial: The study compares two labor induction methods to determine which is more effective in achieving vaginal birth within 24 hours and which provides greater satisfaction for mothers. One method uses a balloon catheter inserted into the cervix combined with the hormone oxytocin given intravenously after six hours. The other method uses misoprostol, a medication taken orally every two hours at a low dose. The trial will monitor various outcomes including time to delivery, discomfort during labor induction, overall experience of contractions, and rates of different types of delivery including cesarean sections. Participants will complete a satisfaction survey before leaving the hospital.
Investigational drugs: Oxytocin is a hormone given through an intravenous drip that stimulates uterine contractions to help progress labor. Misoprostol is a medication taken orally that helps soften and open the cervix, making it easier for labor to start. Both medications work by causing the uterine muscles to contract, but through different mechanisms.
Summary
Both clinical trials for premature rupture of membranes are being conducted exclusively in France. The trials represent two distinct clinical scenarios: one addresses very early rupture of membranes before 34 weeks (preterm), while the other focuses on rupture at full term (37 weeks or later).
The first trial investigates whether nifedipine can reduce complications when membranes rupture very early in pregnancy, potentially helping to safely prolong pregnancy and improve outcomes. The second trial examines the best method for inducing labor when membranes rupture at full term, comparing a combination approach using a balloon catheter with oxytocin against oral misoprostol alone.
Both studies emphasize patient safety and involve careful monitoring of both maternal and infant health outcomes. Women interested in participating should discuss eligibility with their healthcare providers and ensure they meet the specific criteria for each trial.
