The Comparison of Efficacy for Cervical Ripening in Labor Induction Between Titrated and Conventional Oral Misoprostol

July 12, 2010 updated by: Mahidol University
The purpose of this study is to compare the efficacy for cervical ripening in labor induction between titrated and conventional oral misoprostol

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

64

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

  • Thailand
      • Bangkok, Thailand, 10700
        • Siriraj Hospital, Mahidol University

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

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • age 18 years old or more
  • singleton pregnancy at 37 weeks gestation or more
  • cephalic presentation
  • reassuring fetal heart rate pattern
  • admission for labor induction due to medical or obstetrical conditions
  • bishop score less than 6
  • giving consent and having signed the consent form for this study

Exclusion Criteria:

  • parity more than 3
  • estimated fetal weight more than 3,500 grams
  • non-reassuring fetal heart rate pattern
  • having contraindication for vaginal delivery
  • previous uterine scar
  • suspected abruptio placenta with non-reassuring fetal heart rate pattern
  • abnormal bleeding per vagina, except bloody show
  • PROM
  • having underlying cardiac, hepatic, or renal diseases
  • having history of allergy to misoprostol or prostaglandin analogues
  • cervical dilatation 3 centimeters or more
  • uterine contraction 3 times or more in 10 minute

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: conventional oral misoprostol
misoprostol 50 micrograms oral every 4 hours until cervical dilatation 3 centimeters
Drug: misoprostol
misoprostol 50 micrograms oral every 4 hours until cervical dilatation 3 cm
Other Names:
  • cytotec
Drug: misoprostol
misoprostol 20 micrograms oral every hours until cervical dilatation 3 cm
Other Names:
  • cytotec
Experimental: titrated oral misoprostol
misoprostol 20 micrograms oral every hour until cervical dilatation 3 centimeters
Drug: misoprostol
misoprostol 50 micrograms oral every 4 hours until cervical dilatation 3 cm
Other Names:
  • cytotec
Drug: misoprostol
misoprostol 20 micrograms oral every hours until cervical dilatation 3 cm
Other Names:
  • cytotec

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
success rate of cervical ripening in labor induction
Time Frame: 12 hours after intervention
12 hours after intervention

Secondary Outcome Measures

Outcome Measure
Time Frame
number of vaginal delivery
Time Frame: 24 hours
24 hours

Collaborators and Investigators

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

Sponsor

Mahidol University

Investigators

  • Study Director: Kusol Russameecharoen, MD, Siriraj Hospital, Mahidol University Bangkok, Bangkok, Thailand

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

May 1, 2009

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

April 22, 2009

First Submitted That Met QC Criteria

April 22, 2009

First Posted (Estimate)

April 23, 2009

Study Record Updates

Last Update Posted (Estimate)

July 14, 2010

Last Update Submitted That Met QC Criteria

July 12, 2010

Last Verified

July 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 091/2552(EC2)

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.

Clinical Trials on Cervical Ripening

Clinical Trials on misoprostol

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malawi

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe