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Search / Trial NCT04307069

Management of Prelabor Rupture of the Membranes at Term

Launched by RAMBAM HEALTH CARE CAMPUS · Mar 11, 2020

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying how to manage a situation called prelabor rupture of membranes (when the water breaks before labor starts) in pregnant women. The researchers want to find out if starting labor early with a medication called oxytocin is better than simply waiting for labor to begin naturally within 24 hours. They are focusing on the risks of infections that can happen when the membranes have been ruptured for a long time.

To participate in this trial, women must be first-time mothers (primiparous) who are at least 37 weeks pregnant with a single baby in the head-down position. Unfortunately, women under 19, those with multiple pregnancies, or those experiencing other complications (like active labor or infections) cannot take part. If eligible, participants can expect to receive either the early intervention with oxytocin or the usual care while being closely monitored for their health and the health of their baby. This trial is currently recruiting participants, and it aims to improve the care provided to mothers and their babies during this critical time.

Gender

FEMALE

Eligibility criteria

  • Inclusion Criteria:
  • 1. Primiparous women with a singleton pregnancy that are admitted with prelabor rupture of membranes.
  • 2. Women at gestational age 370/7 or more.
  • 3. Vertex presentation.
  • Exclusion Criteria:
  • 1. Age 18 and under.
  • 2. High order gestation.
  • 3. Women with contraindication for a vaginal delivery.
  • 4. Active labor.
  • 5. Documented fetal anomalies.
  • 6. Known or suspected intrauterine infection (temperature \> 38 degrees, leucocytosis).
  • 7. Non reassuring fetal heart rate tracing.
  • 8. Positive group B streptococcus status.

About Rambam Health Care Campus

Rambam Health Care Campus is a leading medical institution located in Haifa, Israel, renowned for its comprehensive patient care, advanced research initiatives, and commitment to medical education. As a prominent clinical trial sponsor, Rambam is dedicated to advancing healthcare through innovative research and development, facilitating a wide range of clinical studies across various therapeutic areas. The campus boasts state-of-the-art facilities, a multidisciplinary team of expert researchers and clinicians, and a robust infrastructure that supports rigorous scientific inquiry and ethical standards in clinical trials. By fostering collaboration and leveraging cutting-edge technology, Rambam Health Care Campus aims to enhance treatment options and improve patient outcomes globally.

Locations

Ramat Yishai, , Israel

Patients applied

0 patients applied

Trial Officials

Gal Bachar, MD

Principal Investigator

Rambam Medical Health Center

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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