Labor Induction With Dinoprostone in Oppose to Cervical Ripening Balloon as a Factor of BMI.

October 15, 2020 updated by: ROY LAUTERBACH MD, Rambam Health Care Campus

A Comparison Between Labor Induction With Dinoprostone and a Cervical Ripening Balloon in Women With a BMI>30 as Oppose With a BMI<30.

Women with a BMI>30 and women with a BMI<30 will be divided in a randomized controlled manor to 4 groups depending on the mode of labor induction and BMI value:

  1. Dinoprostone in women with a BMI>30.
  2. Dinoprostone in women with a BMI<30.
  3. Cervical ripening balloon in women with a BMI>30.
  4. Cervical ripening balloon in women with a BMI<30. The subjects will be followed until labor, and information regarding the success of induction, mode of delivery and time of delivery will be collected from patients' electronic files.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study is a randomized controlled test in which women with a BMI>30 and women with a BMI<30 will sign an informed consent and then divided to 4 groups depending on the mode of labor induction and BMI value:

  1. Dinoprostone in women with a BMI>30.
  2. Dinoprostone in women with a BMI<30.
  3. Cervical ripening balloon in women with a BMI>30.
  4. Cervical ripening balloon in women with a BMI<30. All subjects participating in the study will be induced for obstetrical indications alone.

The subjects will be followed until labor, and information regarding the success of induction, mode of delivery and time of delivery will be collected from patients' electronic files.

The participants will finish participation in the study after delivery.

Study Type

Interventional

Enrollment (Actual)

164

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 44 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Any pregnant woman at term with an obstetric indication for labor induction.

Exclusion Criteria:

  • Previous cesarean section.
  • Positive Oxytocin challenge test.
  • Positive contraction stress test.

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
Experimental: BMI>30+Dinoprostone
Women with a BMI>30 at term that will be induced for obstetrical indications with 10 mg of a Dinoprostone vaginal insert.
Drug: Dinoprostone
10 mg of a Dinoprostone vaginal insert.
Other Names:
  • Prostaglandin E2
Experimental: BMI<30+Dinoprostone
Women with a BMI<30 at term that will be induced for obstetrical indications with 10 mg of a Dinoprostone vaginal insert.
Drug: Dinoprostone
10 mg of a Dinoprostone vaginal insert.
Other Names:
  • Prostaglandin E2
Experimental: BMI>30+Cervical ripening balloon
Women with a BMI>30 at term that will be induced for obstetrical indications with a double lumen cervical ripening balloon.
Device: Double lumen cervical ripening balloon.
Double lumen cervical ripening balloon.
Experimental: BMI<30+Cervical ripening balloon
Women with a BMI<30 at term that will be induced for obstetrical indications with a double lumen cervical ripening balloon.
Device: Double lumen cervical ripening balloon.
Double lumen cervical ripening balloon.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mode of delivery
Time Frame: Up to 5 days.
Vaginal delivery in oppose to cesarean section.
Up to 5 days.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to delivery
Time Frame: Up to 5 days.
Time from insertion of induction device\drug until delivery.
Up to 5 days.
Induction success.
Time Frame: Up to 5 days.
Cervical dilatation and effacement after cessation of induction.
Up to 5 days.
Neonatal complications and outcome.
Time Frame: Up to 5 days.
Any neonatal complications as mentioned In the neonate's electronic file.
Up to 5 days.

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)

January 1, 2017

Primary Completion (Actual)

July 31, 2020

Study Completion (Actual)

October 1, 2020

Study Registration Dates

First Submitted

December 24, 2016

First Submitted That Met QC Criteria

January 24, 2017

First Posted (Estimate)

January 26, 2017

Study Record Updates

Last Update Posted (Actual)

October 19, 2020

Last Update Submitted That Met QC Criteria

October 15, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0192-19-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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