Cervical Foley Plus Vaginal Misoprostol for Labor Induction

May 2, 2019 updated by: Washington University School of Medicine

Cervical Foley Plus Vaginal Misoprostol Versus Vaginal Misoprostol for Cervical Ripening and Labor Induction: A Randomized Trial

The purpose of this study is to compare the efficacy of the combination of the supracervical foley bulb and vaginal misoprostol to vaginal misoprostol alone for labor induction. We hypothesize that use of the foley bulb plus vaginal misoprostol will result in shorter induction to delivery time.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

More than 22% of all gravid women undergo induction of labor in the United States for various indications. Although there are several techniques and methods for induction of labor, the best agent and method still remains uncertain. To date, there has been no randomized trial comparing foley bulb plus vaginal misoprostol versus vaginal misoprostol alone. The combination of a mechanical device (foley bulb) and synthetic prostaglandin may have an additive or synergistic effect, resulting in greater degree of cervical ripening and shorter induction to delivery time (IDT). The addition of a synthetic prostaglandin to the foley bulb may also overcome the frequent observation of cervical dilation to 4cm by the foley bulb without effacement.

Study Type

Interventional

Enrollment (Actual)

123

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

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Barnes Jewish 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

16 years to 45 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • singleton pregnancy
  • vertex presentation
  • unfavorable cervix(Bishop's score less than or equal to 6)
  • greater than 24 weeks gestation

Exclusion Criteria:

  • fetal malpresentation
  • multifetal gestation
  • spontaneous labor
  • more than 5 uterine contractions in 10 minutes
  • contraindication to prostaglandins
  • non-reassuring fetal heart rate tracing
  • intrauterine growth restriction
  • anomalous fetus
  • fetal demise
  • previous cesarean delivery or other significant uterine surgery

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Foley Bulb plus Misoprostol
Device: Foley bulb
This is a randomized trial comparing foley bulb with the use of misoprostol versus use of misoprostol alone for cervical ripening and labor induction.
Other Names:
  • cytotec
NO_INTERVENTION: Misoprostol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time From Start of Labor Induction to Vaginal Delivery
Time Frame: 72 hours
72 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Successful Number of Vaginal and Cesarean Deliveries
Time Frame: 72 hours
To compare the number of vaginal deliveries to failed inductions requiring cesarean deliveries.
72 hours
Number of Participants Experiencing Tachysystole With Deceleration
Time Frame: 72 hours
72 hours
Number of Participants With Post-partum Hemorrhage
Time Frame: 96 hours
96 hours
Chorioamnionitis
Time Frame: 96 hours
96 hours
Neonatal APGAR Scores
Time Frame: 5 minutes

APGAR scores will be recorded at 1 and 5 minutes after birth. In the test, five things are used to check a baby's health. Each is scored on a scale of 0 to 2, with 2 being the best score:

Appearance (skin color) Pulse (heart rate) Grimace response (reflexes) Activity (muscle tone) Respiration (breathing rate and effort)
5 minutes
NICU Admission
Time Frame: 96 hours
96 hours
Time to Complete Cervical Dilation
Time Frame: 72 hours
We will record the start time of induction until the patient's cervix is 10cm dilated
72 hours
Delivery Within 24 Hours
Time Frame: Delivery within 24 hours of induction
Delivery within 24 hours of induction
Admission to NICU or Special Care Nursery
Time Frame: birth to 96 hours of age
birth to 96 hours of age

Collaborators and Investigators

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

Sponsor

Washington University School of Medicine

Investigators

  • Principal Investigator: Jeanine F Carbone, MD, Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

March 1, 2014

Study Completion (ACTUAL)

March 1, 2014

Study Registration Dates

First Submitted

January 6, 2011

First Submitted That Met QC Criteria

January 14, 2011

First Posted (ESTIMATE)

January 19, 2011

Study Record Updates

Last Update Posted (ACTUAL)

May 3, 2019

Last Update Submitted That Met QC Criteria

May 2, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10-1135-201107249

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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