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Study on Nifedipine for Managing Preterm Premature Rupture of Membranes (PPROM) in Pregnant Women Before 34 Weeks

Fast replyRegistered drugNo placebo
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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 studying the effects of a treatment for a condition known as preterm premature rupture of membranes (PPROM), which occurs when the water breaks too early in pregnancy, specifically before 34 weeks of gestation. The treatment being tested is a medication called nifedipine, which is taken as a prolonged-release tablet. The study also involves a comparison with a placebo, which is a substance with no active medication.

The purpose of the study is to determine if using nifedipine for a short period of 48 hours can help reduce the risks to the baby and mother when PPROM occurs between 22 and 33 weeks of pregnancy. Participants in the study will be randomly assigned to receive either the medication or the placebo, and neither the participants nor the researchers will know which one is being given, to ensure unbiased results.

The study will monitor several outcomes, including the health of the baby at birth and up to discharge from the hospital, as well as the health of the mother. It will also look at how long the pregnancy can be safely prolonged and the health of the baby at two years of age. The study aims to provide valuable information on managing PPROM to improve outcomes for both mothers and their babies.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Participation begins after meeting specific criteria, including a diagnosis of preterm premature rupture of membranes (PPROM) between 22 and 33 weeks of pregnancy, a single pregnancy, and the fetus being alive at the time of joining the study.

    Participants must be 18 years or older, speak French, and be affiliated with social security or an equivalent system. Informed consent is required.

  2. Step 2

    Randomization

    Participants are randomly assigned to receive either nifedipine or a placebo. This process is double-blinded, meaning neither the participant nor the medical team knows which treatment is being administered.

  3. Step 3

    Medication administration

    The medication, nifedipine, is taken orally. The specific dosage and frequency are determined by the medical team and are administered for a short-term period of 48 hours.

  4. Step 4

    Monitoring and follow-up

    Participants are monitored for any changes in their condition, including fetal and maternal health. The primary focus is on reducing risks associated with PPROM, such as fetal or neonatal death and severe health issues in the newborn.

    Secondary outcomes include the length of pregnancy, maternal health, minor health issues in the newborn, and developmental outcomes at two years of corrected age.

  5. Step 5

    Completion of the study

    The study is expected to conclude by April 2027. Participants will be informed of the results and any relevant findings related to their health and the health of their child.

Who can join the trial?

7 criteria

  • Have a condition called preterm premature rupture of membranes (PPROM) between 22 weeks and 33 weeks and 6 days of pregnancy. This means the water breaks early, before labor starts.
  • Have a single baby in the womb, not twins or more.
  • The baby must be alive at the time of joining the study.
  • Be 18 years of age or older.
  • Speak French.
  • Be affiliated with social security or an equivalent system.
  • Provide informed consent, which means understanding the study and agreeing to participate by signing a form.

Who cannot join the trial?

4 criteria

  • Individuals who are not experiencing a pathological delivery related to pregnancy complications.
  • Individuals who are not within the age range specified for the study.
  • Individuals who are not female, as the study is only for female participants.
  • Individuals who are part of a vulnerable population, which means people who might need special protection or care.
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Investigated drugs

TOCOPROM: This is a medication being studied for its potential to help manage preterm premature rupture of membranes (PPROM) in pregnant women. The trial is investigating whether using this medication for a short period (48 hours) can reduce complications and improve outcomes for both the mother and baby when PPROM occurs between 22 and 33 weeks of pregnancy.

What is already known about the treatment

Tocolytic Medication – This medication is administered orally or intravenously to delay premature labor. It is currently being studied in clinical trials to determine its effectiveness in reducing complications associated with preterm premature rupture of membranes (PPROM) before 34 weeks of gestation. The main therapeutic indication is to manage and delay preterm labor, thereby reducing risks to the baby. At the molecular level, it works by relaxing the muscles of the uterus, preventing contractions. It is classified pharmacologically as a tocolytic agent, which is used to suppress premature labor.

Investigated diseases

Pathological Delivery – Pathological delivery refers to complications that arise during childbirth, which deviate from the normal process. These complications can include prolonged labor, abnormal fetal positions, or issues with the placenta. Such conditions may require medical interventions to ensure the safety of both the mother and the baby. The progression of a pathological delivery can vary widely depending on the specific complication. It may involve increased monitoring and potential surgical procedures, such as a cesarean section. The focus is on managing the situation to minimize risks and ensure a healthy outcome for both mother and child.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-512872-36-00Protocol codeP160917Estimated enrolment850 patientsSponsorAssistance Publique Hopitaux De Paris

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

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