Labor Induction After Failed Induction With Dinoprostone.

April 19, 2022 updated by: ROY LAUTERBACH MD, Rambam Health Care Campus

Comparison of Cervical Ripening Balloon Versus 2nd Dinoprostone Insert for Labor Induction in Women With a Failed 1st Attempt of Induction With Dinoprostone.

Women after induction of labor with a dinoprostone insert will be evaluated after 24 hours from the beginning of labor induction. Women with a BISHOP score of less than 5 will be randomized to 1 of 2 groups. Induction with a cervical ripening balloon versus induction with a 2nd dinoprostone insert.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Nulliparous women with obstetric indications for induction of labor who were induced with a dinoprostone insert and failed to go into labor after 24 hours from the beginning of labor induction and a BISHOP score of less than 5 will receive a thorough explanation regarding the study and sign informed consent. The eligible women will be randomized to 1 of 2 groups. Induction with a cervical ripening balloon versus induction with a 2nd dinoprostone insert. Relevant demographic and medical information will be gathered from the patients' electronic files.

Study Type

Interventional

Enrollment (Actual)

144

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

16 years to 43 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women after induction of labor with Dinoprostone.
  • BISHOP score of under 5 after 1st induction attempt.
  • Nulliparous women.

Exclusion Criteria:

  • Women after induction of labor with a cervical ripening balloon.
  • BISHOP score of over 5 after 1st induction attempt.
  • Multiparous women.

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: 2nd Dinoprostone.
Women induced with a second dinoprostone insert.
Drug: Dinoprostone
Dinoprostone vaginal insert.
Active Comparator: Cervical ripening balloon.
Women induced with a cervical ripening balloon.
Device: Cervical ripening balloon.
Double lumen cervical ripening balloon.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Delivery within 24 hours.
Time Frame: From the time of induction up to 24 hours from induction.
Rate of delivery in 24 hours.
From the time of induction up to 24 hours from induction.
Time to delivery.
Time Frame: From the time of induction up to 120 hours from induction.
The number of hours it takes to deliver.
From the time of induction up to 120 hours from induction.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mode of delivery.
Time Frame: From the time of induction up to 120 hours from induction.
Vaginal and cesarean delivery rates.
From the time of induction up to 120 hours from induction.
Uterine revision.
Time Frame: From the time of induction up to 120 hours from induction.
The rate of uterine revision postpartum.
From the time of induction up to 120 hours from induction.
Postpartum hemorrhage.
Time Frame: From the time of induction up to 120 hours from induction.
The rate of postpartum hemorrhage.
From the time of induction up to 120 hours from induction.
Chorioamnionitis.
Time Frame: From the time of induction up to 120 hours from induction.
The rate of chorioamnionitis.
From the time of induction up to 120 hours from induction.

Collaborators and Investigators

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

Sponsor

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)

October 15, 2020

Primary Completion (Actual)

November 30, 2021

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

October 15, 2020

First Submitted That Met QC Criteria

October 15, 2020

First Posted (Actual)

October 22, 2020

Study Record Updates

Last Update Posted (Actual)

April 20, 2022

Last Update Submitted That Met QC Criteria

April 19, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0009-20-RMB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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