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Premature Rupture of Membranes With a Bishop Score<6: Comparison of Medical Induction/Expectant Management

NCT02825641 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 458

Last updated 2022-10-26

No results posted yet for this study

Summary

The study is intended to compare expectant management and on presentation labor induction in women with premature rupture of membranes.

The means of labor induction and cervical ripening are either oxytocin or dinoprostone.

Expectant management in this obstetrical state means waiting 24 hours from the onset of rupture of membranes and then commencing labor induction with either oxytocin or dinoprostone depending on the patient's obstetrical history and cervical condition.

The investigators' hypothesis is that active management will lead to a higher rate of vaginal deliveries, a shorter interval between the time of rupture of membranes and the time of delivery, a lower rate of cesarean sections and a better obstetric result for the mother and the fetus/newborn.

Conditions

  • Medical Induction of Labor Affecting Newborn

Interventions

DRUG

Oxytocin

Labor induction and cervical ripening by oxytocin in women with premature rupture of membranes in 2 types of women: 1. Induction of labor on presentation at the delivery room. 2. Induction of labor after 24 hours of rupture of membranes.

DRUG

Dinoprostone

Labor induction and cervical ripening by dinoprostone in women with premature rupture of membranes in 2 types of women: 1. Induction of labor on presentation at the delivery room. 2. Induction of labor after 24 hours of rupture of membranes.

Sponsors & Collaborators

  • Rambam Health Care Campus

    lead OTHER

Principal Investigators

  • Amir Weissman, MD · Rambam Health Care Campus

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-01
Primary Completion
2021-11-01
Completion
2022-09-30

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02825641 on ClinicalTrials.gov