Cervical Ripening for Induction of Labor: Misoprostol Versus Oxytocin in Conjunction With Foley Balloon

August 22, 2018 updated by: Aultman Health Foundation
The purpose of this study is to specifically investigate the efficacy of an alternative pharmacologic cervical ripening agent, misoprostol, versus the standard oxytocin, as an adjunct to Foley balloon for induction of the unfavorable cervix.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The design of this study is a randomized, controlled study with two arms. Both groups will undergo placement of a Foley catheter, through the external and internal os of the cervix, according to standard practice. In group A, receiving intravenous infusion of oxytocin, will serve as the control group as it is standard protocol at Aultman Hospital. Group B, intravaginal placement of misoprostol, will serve as the experimental group. The expected duration of participation begins at induction of labor and concludes at time of delivery.

Study Type

Interventional

Enrollment (Actual)

50

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
    • Ohio
      • Canton, Ohio, United States, 44710
        • Aultman Health Foundation

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Participant or surrogate is capable of giving informed consent
  • Anticipated number - 50 patients with 25 in each study arm Female with singleton gestation, live intrauterine pregnancy
  • Participant is undergoing an indicated induction of labor
  • Participant is found to have cervical Bishop score ≤5 on initial cervical exam
  • Participant has no medical or obstetrical contraindications to induction of labor

Exclusion Criteria:

  • Participant has ≥2 painful contractions in 10 min in 2 subsequent 10 min periods
  • Manufacturer's contraindications to misoprostol or oxytocin

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: Oxytocin
Foley balloon placement with intravenous low dose oxytocin administration starting 2 milliunits per minute.
Drug: Oxytocin
Foley balloon placement with intravenous low dose oxytocin administration starting 2 milliunits per minute.
Other Names:
  • pitocin
Experimental: Misoprostol
Misoprostol, 25 mcg, is placed intravaginally into the posterior fornix of the vagina in conjunction with Foley balloon placement
Drug: Misoprostol
Misoprostol, 25 mcg, is placed intravaginally into the posterior fornix of the vagina in conjunction with Foley balloon placement
Other Names:
  • cytotec

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Induction To Delivery
Time Frame: 24 hrs
To assess effectiveness of misoprostol used in conjunction with Foley balloon versus the standard oxytocin regimen in regards to induction times
24 hrs

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Delivery Route
Time Frame: 24 hrs
To assess for differences in delivery routes
24 hrs

Collaborators and Investigators

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

Sponsor

Aultman Health Foundation

Investigators

  • Principal Investigator: Erica Downey, MD, Aultman Health Foundation

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

September 1, 2009

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

June 7, 2010

First Submitted That Met QC Criteria

June 7, 2010

First Posted (Estimate)

June 9, 2010

Study Record Updates

Last Update Posted (Actual)

August 24, 2018

Last Update Submitted That Met QC Criteria

August 22, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009 ED

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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