A Comparison of Transcervical Foley Catheter and Prostaglandins for Induction of Labor at Term

December 8, 2013 updated by: Seoul National University Hospital
The purpose of this study is to assess the effectiveness and safety of transcervical foley catheter as compared to prostaglandins for preinduction cervical ripening and labor induction in term nulliparous women with unfavorable cervix.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

154

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

  • Korea, Republic of
    • Gyeonggi-do
      • Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
        • Department of Obstetrics and Gynecology Seoul National University Bundang Hospital

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • singleton pregnancy
  • nulliparous women
  • gestational age >= 37.0 weeks
  • Bishop score <= 5
  • intact amniotic membrane
  • abscence of labor
  • live fetus with vertex presentation
  • no previous uterine surgical procedure

Exclusion Criteria:

  • major congenital anomaly

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: Transcervical foley catheter
Device: Transcervical foley catheter, Prostaglandins
16 French foley catheter 10mg dinoprostone vaginal insert
Active Comparator: Prostaglandins
Device: Transcervical foley catheter, Prostaglandins
16 French foley catheter 10mg dinoprostone vaginal insert

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Successful labor induction
Time Frame: Twelve hours of initiating oxytocin on the fist day of induction
Successful labor induction is defined as an ability to achieve the active phase of labor corresponding to a cervical dilatation of >=4cm.
Twelve hours of initiating oxytocin on the fist day of induction

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cervical change in the bishop scores and cervical lengths induced by transcervical foley catheter and prostaglandins
Time Frame: When transcervical foley catheter or prostagladins was removed befor adminitoring oxytocin
  1. Cervical change based on the bishop score and cervical length induced by cervical ripening method(foley catheter balloon vs prostaglandin)
  2. Incidence of cesarean delivery
  3. Vaginal delivery with 24 hours of starting of induction
  4. The interval from start of oxytocin to delivery
  5. Incidence of admission to neonatal intensive care unit and uterine tachysystole
  6. Pain score by the type of ripening method
When transcervical foley catheter or prostagladins was removed befor adminitoring oxytocin

Collaborators and Investigators

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

Sponsor

Seoul National University Hospital

Investigators

  • Principal Investigator: Kyo Hoon Park, MD, PhD, Seoul National University Bundang Hospital

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

January 1, 2011

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

March 15, 2011

First Submitted That Met QC Criteria

March 16, 2011

First Posted (Estimate)

March 17, 2011

Study Record Updates

Last Update Posted (Estimate)

December 10, 2013

Last Update Submitted That Met QC Criteria

December 8, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • FCB_PG_01

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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