A Trial of Prostaglandin E2 Tablets Versus Foley Catheter for Labor Induction

April 28, 2016 updated by: Hadas Ganer Herman, Wolfson Medical Center

Cervical Ripening at Term With Prostaglandin E2 Tablets Versus Foley Catheter: a Randomized Controlled Trial

A randomized controlled trial comparing labor induction with vaginal PGE2 tablets and foley catheter for cervical ripening.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Phase 4

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
      • Holon, Israel
        • Recruiting
        • Edith Wolfson Medical Center
        • Contact:

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Singleton term pregnancies (>37 weeks), vertex presentation
  • Intact membranes
  • Low Bishop score (<7)
  • First, second or third delivery
  • Medical indication for induction
  • Viable fetus

Exclusion Criteria:

  • Contraindication for vaginal delivery, for PGE2 or foley catheter
  • Gestational age<37 weeks, premature rupture of membranes, fetal or uterine malformations, previous cesarean section, uncertain dating, unwilling to participate in trial

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: PGE2
Patients allocated to vaginal PGE2 (Prostin) for cervical ripening
Drug: Prostin (PGE2) tablets
Active Comparator: Foley catheter
Patients allocated to foley catheter placement for cervical ripening
Device: Foley catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to active labor
Time Frame: Post labor- up to 24 hours
Hours from foley cather placement or first PGE2 tablet placment to active labor, defined as cervical dilitation >4 cm and/or cervical effacement>80%
Post labor- up to 24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Delivery within 24 hours
Time Frame: post-labor - up to 24 hours
Delivery within 24 hours from foley catheter /first PGE2 tablet palcement
post-labor - up to 24 hours
Cesarean section rate
Time Frame: post labor - up to 24 hours
Delivery via cesarean section
post labor - up to 24 hours
Maternal complications
Time Frame: participants will be followed for labor course and the duration of hospital stay, an expected average of 5 days
Documented complications during labor, including: excessive hemmorhage, infection (chorioamnionitis)
participants will be followed for labor course and the duration of hospital stay, an expected average of 5 days
Neonatal complications
Time Frame: Neonates of participants will be followed for labor course and the duration of hospital stay, up to 1 month
Documented complications such as non-reassuring fetal heart rate, fetal pH, NICU admission, early neonatal sepsis
Neonates of participants will be followed for labor course and the duration of hospital stay, up to 1 month

Collaborators and Investigators

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

Sponsor

Wolfson Medical Center

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

July 1, 2015

Primary Completion (Anticipated)

July 1, 2017

Study Completion (Anticipated)

July 1, 2017

Study Registration Dates

First Submitted

June 22, 2015

First Submitted That Met QC Criteria

June 28, 2015

First Posted (Estimate)

July 1, 2015

Study Record Updates

Last Update Posted (Estimate)

April 29, 2016

Last Update Submitted That Met QC Criteria

April 28, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • 0095-15-WOMC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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