Efficacy and Safety Study of Titrated Oral Misoprostol Solution for Labor Augmentation

July 8, 2008 updated by: China Medical University Hospital

A Comparison of Titrated Oral Misoprostol Solution to Intravenous Oxytocin for Labor Augmentation: A Randomized Controlled Trial

The purpose of this study is to compare the efficacy and safety of titrated oral misoprostol solution with intravenous oxytocin for labor augmentation in women without adequate uterine contractions.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Numerous labor course necessitate augmentation when uterine contractions are inadequate. When the cervix is favorable, labor augmentation attempts are more likely to be successful. Augmentation is these women is traditionally undertaken with intravenous oxytocin and amniotomy, either alone or in combination.

In our previous trial, it has been proven that the method of titrated oral misoprostol is associated with a lower incidence of uterine hyperstimulation and a lower cesarean delivery rate than vaginal misoprostol for labor induction in patients with unfavorable cervix. Because administering Misoprostol solution is easy and cost saving, it is worth to develop this novel method in labor augmentation.

Study Type

Interventional

Enrollment (Anticipated)

143

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

  • Taiwan
      • Taichung, Taiwan, 404
        • Recruiting
        • Labor Unit, Department of Obstetric and Gynecology, China Medical Univertiy Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ming Ho, MD

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 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Pregnancy between 36 and 42 weeks of gestation
  • Live singleton
  • Cephalic presentation
  • A reassuring fetal heart rate pattern
  • Bishop score greater than 6
  • Inadequate uterine contraction (less than or equal to 2 per 10 minutes)

Exclusion Criteria:

  • Nonreassuring fetal heart rate pattern
  • Parity more than five
  • Uterine scar
  • Suspected placental abruption with abnormal fetal heart rate
  • Vaginal bleeding other than "bloody show"
  • Significant maternal cardiac, renal, or hepatic disease
  • hypersensitivity to oxytocin, misoprostol or prostaglandin analogues

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
Experimental: 1
Titrated Oral Misoprostol Solution
Drug: Misoprostol
Titrated Misoprostol Solution
Other Names:
  • Cytotec
Active Comparator: 2
Intravenous Oxytocin
Drug: Oxytocin
Titrated Intravenous Oxytocin
Other Names:
  • Piton-S

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
the percentage of women delivering infants vaginally within 12 hours of augmentation
Time Frame: post vaginal delivery
post vaginal delivery

Secondary Outcome Measures

Outcome Measure
Time Frame
uterine hyperstimulation rate
Time Frame: post vaginal delivery
post vaginal delivery

Collaborators and Investigators

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

Sponsor

China Medical University Hospital

Investigators

  • Study Chair: Shi-Yann Cheng, MD, China Medical University Beigang Hospital

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

Helpful Links

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

February 1, 2008

Primary Completion (Anticipated)

December 1, 2008

Study Completion (Anticipated)

January 1, 2009

Study Registration Dates

First Submitted

June 8, 2008

First Submitted That Met QC Criteria

June 8, 2008

First Posted (Estimate)

June 11, 2008

Study Record Updates

Last Update Posted (Estimate)

July 10, 2008

Last Update Submitted That Met QC Criteria

July 8, 2008

Last Verified

July 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMUBH R96007
  • DMR96-IRB-176

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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