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Study of oxytocin, dinoprostone, and misoprostol combination for active management in pregnant women with premature rupture of membranes

Verified siteFast 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 study focuses on pregnant women with premature rupture of membranes (PROM), a condition where the water breaks before labor begins. The study aims to determine if early induction of labor can reduce the need for breathing support in newborns compared to waiting for labor to start naturally.

The study will use several medications to help start labor: oxytocin, a hormone given through a vein that helps the uterus contract; dinoprostone, a medication used vaginally to prepare the cervix and induce labor; and misoprostol, a medication taken by mouth that also helps induce labor. Mifepristone may also be used to help prepare the body for labor.

During the study, women will be randomly assigned to either receive these medications to start labor right away or wait for labor to begin on its own. The study will track how many newborns need breathing support after birth, as well as monitor for other health outcomes in both mothers and babies. This includes checking for signs of infection, monitoring the pattern of uterine contractions, and keeping track of how long mothers and babies need to stay in the hospital.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial evaluation

    After being diagnosed with premature rupture of membranes (PROM), your eligibility for the study will be confirmed

    The medical team will verify that you are at least 37 weeks pregnant, have a negative GBS test, and have minimal contractions (0-2 contractions per 10 minutes)

    Your baby must be in head-down position (cephalic presentation)

  2. Step 2

    Group assignment

    You will be randomly assigned to either active management or expectant management group

    The study is open-label, which means you and your healthcare providers will know which group you are in

  3. Step 3

    Treatment administration

    Depending on your assigned group, you may receive one or more of the following medications:

    Oxytocin through an intravenous line

    Dinoprostone administered vaginally

    Misoprostol taken by mouth

  4. Step 4

    Monitoring during labor

    Your contractions will be monitored to ensure they do not exceed 5 contractions in 10 minutes

    Your temperature will be checked regularly

    The medical team will monitor for signs of infection

  5. Step 5

    Delivery and newborn assessment

    After delivery, your baby will be evaluated for any breathing support needs

    The medical team will check if your baby requires oxygen support or breathing assistance

  6. Step 6

    Post-delivery follow-up

    You will be monitored for signs of infection for up to 42 days after delivery

    The length of hospital stay will be recorded

    Your baby will be monitored for any signs of infection or breathing problems

Who can join the trial?

9 criteria

  • Must be pregnant with pregnancy lasting at least 37 weeks (full-term pregnancy)
  • Must have tested negative for GBS (Group B Streptococcus, a type of bacteria) in a rectovaginal swab test
  • Must have little to no uterine contractions (0-2 contractions every 10 minutes) 6 hours after water breaking
  • Baby must be in head-down position (cephalic presentation)
  • Must be at least 18 years old when joining the study
  • Must be able to understand and agree to participate in the study
  • Must sign the informed consent form
  • Must be female
  • Must have experienced premature rupture of membranes (water breaking)

Who cannot join the trial?

15 criteria

  • History of allergic reactions to any medications used in the study
  • Multiple pregnancy (carrying more than one baby)
  • Active vaginal bleeding
  • Chorioamnionitis (infection of the membranes surrounding the baby)
  • Known fetal abnormalities that could affect breathing
  • Previous uterine surgery including cesarean section
  • Placental complications (such as placenta previa - when placenta covers the cervix)
  • Active genital herpes infection
  • Severe medical conditions that could affect pregnancy outcome
  • Participation in other clinical trials within the past 30 days
  • Unable to provide informed consent (written permission to participate)
  • Age below 18 years
  • Preeclampsia (high blood pressure during pregnancy)
  • Known fetal distress (signs that baby is not well)
  • Planned relocation during the study period
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Investigated drugs

Based on the provided trial data, there are no specific medications listed in the source information. The trial appears to be comparing two management approaches (active vs. expectant) for women with pre-labor rupture of membranes (PROM), rather than testing specific medications. The trial focuses on comparing two treatment strategies: Active management involves early induction of labor in women whose membranes have ruptured before labor begins. Expectant management involves waiting and monitoring the situation without immediate intervention when membranes rupture before labor begins. This is a management strategy comparison trial rather than a medication trial, so there are no specific drugs to list and describe.

What is already known about the treatment

  • Dinoprostone

    Dinoprostone is given as a vaginal tablet or gel that is placed inside the vagina, where it slowly releases the drug to the cervix; it is an approved medication that is widely used in obstetrics. It is mainly used to soften the cervix and start labor in pregnant women, especially when the water has broken early. The drug works by acting like a natural hormone called prostaglandin E2, binding to receptors in the uterus and cervix to cause the muscles to contract and the cervix to ripen. It belongs to the prostaglandin E2 analog class of medicines.

  • Misoprostol

    Misoprostol comes as an oral tablet that is swallowed, and it is a well‑established drug that is approved for several pregnancy‑related uses. It is mainly used to help the cervix open and to start labor, and it is also used for medical termination of early pregnancy. Misoprostol mimics prostaglandin E1, binding to uterine receptors to trigger muscle contractions and cervical softening. It is classified as a prostaglandin E1 analog.

  • Oxytocin

    Oxytocin is administered through an intravenous (IV) line, allowing a controlled dose to be given directly into the bloodstream; it is a standard, approved drug used in labor and delivery. It is primarily used to start or strengthen uterine contractions during labor and to help stop bleeding after birth. The drug works by attaching to oxytocin receptors on the uterine muscle, which causes the muscle fibers to contract. Oxytocin belongs to the peptide hormone (oxytocic) class.

Investigated diseases

  • Premature Rupture of Membranes (PROM)

    A condition that occurs during pregnancy when the amniotic sac breaks before labor begins. The amniotic sac is filled with fluid that surrounds and protects the baby during pregnancy. When the membranes rupture early, it can lead to complications if labor doesn't start naturally within a specific time frame. This condition can occur at any time during pregnancy but is most concerning when it happens before the pregnancy reaches full term. The main symptom is a sudden gush or steady leaking of clear or pale yellow fluid from the vagina.

  • Intraamniotic Infection

    An infection that occurs inside the amniotic cavity, affecting the amniotic fluid, placenta, fetus, or membranes. It typically develops when bacteria enter the amniotic sac and multiply. The condition is characterized by maternal fever, increased heart rate in both mother and fetus, and elevated white blood cell count. The amniotic fluid may become cloudy or have an unusual odor.

  • Neonatal Pneumonia

    A lung infection that affects newborns, characterized by inflammation of the lung tissue. The condition causes breathing difficulties and affects the baby's oxygen levels. It can be identified through chest X-rays showing areas of inflammation in the lungs. The baby may show signs of respiratory distress, including rapid breathing and difficulty feeding.

Trial detailsLast updated 21 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-517504-11-00Estimated enrolment1 400 patientsSponsorAzienda Ospedaliero Universitaria Di Modena

sourced from the EU Clinical Trials Register and site verification

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