RecruitingNot ApplicableNCT04307069

Management of Prelabor Rupture of the Membranes at Term

Comparison Between Two Protocols for Management of Prelabor Rupture of the Membranes at Term


Sponsor

Rambam Health Care Campus

Enrollment

524 participants

Start Date

May 1, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

Prolonged rupture of membranes has been associated with increased risk of chorioamnionitis and endometritis. In this study the investigators will investigate whether an early intervention to augment labor with oxytocin is superior to expected management for spontaneous delivery (up to 24 hours).


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two management strategies for women who arrive at the hospital with their membranes ruptured (water breaking) at full term — before labor has started on its own. This condition is called prelabor rupture of membranes (PROM). Once the membranes rupture, there is an increased risk of infection, so doctors must decide: induce labor right away, or wait to see if labor starts naturally? Both approaches are used in practice, and this trial aims to determine which leads to better outcomes for mother and baby. Participants will be randomly assigned to either immediate induction of labor or a period of expectant management (waiting for natural labor onset). Researchers will track rates of infection, cesarean delivery, labor duration, and neonatal outcomes. You may be eligible if you: - Are a first-time mother (primiparous) - Are at least 37 weeks pregnant (full term) - Are carrying a single baby in the head-down position - Were admitted with confirmed prelabor rupture of membranes You may NOT be eligible if you: - Are under 18 years of age (or over 45) - Are carrying multiple babies - Have contraindications to vaginal delivery - Are already in active labor - Have documented fetal anomalies - Have signs of uterine infection (fever, high white blood cell count) - Have a non-reassuring fetal heart rate tracing - Are positive for Group B Streptococcus (GBS) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGOxytocin

The drug wil be adminisrate for augmentation of labor at admission.


Locations(1)

Rambam

Ramat Yishai, Israel

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NCT04307069


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