Recruiting

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

Verified siteRegistered 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.

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)
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
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
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
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
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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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

ASST Fatebenefratelli Sacco
Verified
Milan, Italy
Azienda Ospedaliera di Padova
Verified
Padua, Italy
Azienda Ospedaliero Universitaria Parma
Responsive
Parma, Italy

Trial locations

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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

Since no specific medications are mentioned in the provided trial data, I cannot create medication descriptions in the requested format. The trial appears to be comparing active management (early induction) versus expectant management in cases of premature rupture of membranes (PROM), but doesn't specify particular medications. To create accurate medication descriptions, I would need information about specific drugs used in the trial. If you'd like me to describe medications commonly used in PROM management, please provide those specific medications, and I will format them according to your requirements.

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.