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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
458

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Rambam Health Care Campus

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 6, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 6, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 7, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 26, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 24, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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