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

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What is this study about?

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.

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 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 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 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 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 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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
ASST Fatebenefratelli Sacco Milan Italy
IRCCS Istituto Giannina Gaslini Genoa Italy
Azienda Ospedaliero Universitaria Di Modena Modena Italy
Azienda Unita Sanitaria Locale Di Modena Carpi Italy
Ospedale Di Sassuolo S.p.A. Sassuolo Italy
Azienda Ospedaliera di Padova Padua Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milan Italy
Alessandro Manzoni Hospital Lecco Italy
Azienda Unita Sanitaria Locale Della Romagna Faenza Italy
Universita Degli Studi Di Brescia Brescia Italy
Azienda Ospedaliera Universitaria Città della Salute e della Scienza di Torino Turin Italy
Aopirzq Oaynmsjvgme Uklknhmjqzroa Palrv Parma Italy
Aocdvfa Sencv Savuwrtay Tuzyiwzvbqbf Dyhen Blphjwk Vimercate Italy
Afwfxdz Uml Icwsf Dx Rkvann Ejxiow Reggio Emilia Italy

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Italy Italy
Recruiting
27.03.2024

Trial locations

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.

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 ID:
2024-517504-11-00
Trial Phase:
Therapeutic confirmatory (Phase III)

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