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

October 24, 2022 updated by: ROY LAUTERBACH MD, Rambam Health Care Campus

Premature Rupture of Membranes at Term With an Unfavorable Cervix (Bishop Score<6): Comparison of Oxytocin, Dinoprostone Induction and Expectant Management

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In the setting of premature rupture of membranes in term pregnancies, it is customary in women who are not in active labor to wait for 24 hours before attempting to induce labor. The means of labor induction used at our medical center are either intravenous oxytocin or per-vaginal dinoprostone, depending on patient's obstetric history and cervical conditions.

The investigators hypothesize that commencing induction of labor at presentation in these women by either means of induction will lead to higher rates of vaginal delivery, shorter intervals between the time of onset of rupture of membranes and the time of delivery and lower rates of cesarean sections.

The participants in the study, upon signing informed consents, will be randomized to 4 groups-2 groups of expectant management in which labor induction will be commenced after 24 hours with either oxytocin or dinoprostone and 2 groups of active management in which labor induction will be commenced at presentation with either oxytocin or dinoprostone.

The participants will be followed from the time of presentation with rupture of membranes at the delivery room and until the time of delivery.

Further obstetric, clinical and demographic information will be acquired from the patient's electronic medical file for analysis accuracy and sub-analysis.

Study Type

Interventional

Enrollment (Actual)

458

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Haifa, Israel
        • Rambam Health Care Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Term pregnancies >37 weeks of gestation.
  • Certain rupture of membranes.
  • Bishop score < 6.
  • Singleton pregnancies.
  • Vertex presentation.
  • No obstetric or clinical contraindications for labor induction.
  • Reactive non stress test on presentation.

Exclusion Criteria:

  • Previous cesarean section.
  • Previous uterine surgeries (Myomectomy etc.).
  • Placenta Previa.
  • Multiple gestation pregnancies.
  • Pregnancies with history of fetal reduction or Intrapartum uterine fetal demise.
  • Known fetal defects/Chromosomal abnormalities.
  • Active genital Herpes.
  • HIV carrier.
  • Contractions that are less than 10 minutes apart.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Expectant Management-Dinoprostone

Women with premature rupture of membranes who are not in active labor and have an unfavorable cervix (Bishop score<6).

Labor induction will be initiated with Dinoprostone after 24 hours of waiting depending on obstetric history and cervical conditions.
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.
Other Names:
  • Cervidil
Active Comparator: Expectant Management-Oxytocin

Women with premature rupture of membranes who are not in active labor and have an unfavorable cervix (Bishop score<6).

Labor induction will be initiated with oxytocin after 24 hours of waiting depending on obstetric history and cervical conditions.
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.
Other Names:
  • Pitocin
Experimental: Active Management-Dinoprostone

Women with premature rupture of membranes who are not in active labor and have an unfavorable cervix (Bishop score<6).

Labor induction will be initiated with Dinoprostone on presentation depending on obstetric history and cervical conditions.
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.
Other Names:
  • Cervidil
Experimental: Active Management-Oxytocin

Women with premature rupture of membranes who are not in active labor and have an unfavorable cervix (Bishop score<6).

Labor induction will be initiated with oxytocin on presentation depending on obstetric history and cervical conditions.
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.
Other Names:
  • Pitocin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vaginal delivery rate
Time Frame: Up to 7 days from the time of presentation with rupture of membranes
The percentage of participants that achieved vaginal delivery
Up to 7 days from the time of presentation with rupture of membranes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Interval to delivery
Time Frame: Up to 7 days from the time of presentation with rupture of membranes
Interval from the time of onset of premature rupture of membranes and the time of delivery (In minutes)
Up to 7 days from the time of presentation with rupture of membranes
Caesarian delivery rate
Time Frame: Up to 7 days from the time of presentation with rupture of membranes
The percentage of participants that required caesarian delivery
Up to 7 days from the time of presentation with rupture of membranes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rambam Health Care Campus

Investigators

  • Principal Investigator: Amir Weissman, MD, Rambam Health Care Campus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2016

Primary Completion (Actual)

November 1, 2021

Study Completion (Actual)

September 30, 2022

Study Registration Dates

First Submitted

June 6, 2016

First Submitted That Met QC Criteria

July 6, 2016

First Posted (Estimate)

July 7, 2016

Study Record Updates

Last Update Posted (Actual)

October 26, 2022

Last Update Submitted That Met QC Criteria

October 24, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0213-15-RMB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Medical Induction of Labor Affecting Newborn

Clinical Trials on Dinoprostone

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Canada

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe