Titrated Oral Compared With Vaginal Misoprostol for Labor Induction at Term

September 13, 2007 updated by: China Medical University Hospital
The purpose of this study was to estimate the safety and efficacy of titrated oral misoprostol compared with vaginal route for labor induction at term.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Oral misoprostol absorption is more rapid and possible more predictable, with a peak serum concentration following oral administration of 34 minutes and a half-life of 20-40 minutes. Peak serum concentration for vaginal administration is 60-80 minutes, this level being sustained for up to four hours. Although the direct local effect of vaginal administration on cervical ripening may be advantageous, the shorter half-life of oral delivery may be beneficial in the event of uterine hyperstimulation.In order to avoid uterine hyperstimulation, it appears reasonable to suggest that oral misoprostol should be administered in small, frequent doses, titrated against the uterine response.

Study Type

Interventional

Enrollment (Actual)

220

Phase

  • Phase 3

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
      • Yun Lin, Taiwan, 651
        • China Medical University Beigang 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

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 34 to 42 weeks of gestation
  • live singleton
  • Bishop score < or = 6
  • reassuring fetal heart beat pattern

Exclusion Criteria:

  • nonreassuring fetal heart beat pattern
  • parity ovr five
  • any contraindication to labor and/or vaginal delivery
  • uterine scar
  • suspected placental abruption with abnormal FHR pattern
  • vaginal bleeding other than "bloody show"
  • cervical dilatation of > or = 4 cm
  • uterine contractions > or = 3 in 10 minutes
  • significant maternal cardiac, renal or hepatic disease
  • hypersensitivity to misoprostol or prostaglandin analogs

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: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Titrated oral misoprostol
Drug: misoprostol
Titrated oral misoprostol: one tablet of 200 microgram was dissolved in water 200 ml, and 20 ml P.O. per one hour for 4 doses, then titrated against uterine response; Vaginal misoprostol: 25 microgram per vagina
Active Comparator: 2
Vaginal misoprostol
Drug: misoprostol
Titrated oral misoprostol: one tablet of 200 microgram was dissolved in water 200 ml, and 20 ml P.O. per one hour for 4 doses, then titrated against uterine response; Vaginal misoprostol: 25 microgram per vagina

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The interval from the first misoprostol dose to vaginal delivery and the percentage of women who delivered infants vaginally within 12 and 24 hours of induction. The incidence of tachysystole, hypertonus, uterine hyperstimulation and neonatal outcomes.
Time Frame: within the first week after delivery
within the first week after delivery

Secondary Outcome Measures

Outcome Measure
Time Frame
Total dosage of misoprostol and the rate of women given oxytocin, cesarean section and induction failure.
Time Frame: The days during induction
The days during induction

Collaborators and Investigators

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

Sponsor

China Medical University Hospital

Investigators

  • Principal Investigator: Shi-Yann Cheng, M.D., Chinal 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

June 1, 2005

Study Completion (Actual)

March 1, 2007

Study Registration Dates

First Submitted

September 13, 2007

First Submitted That Met QC Criteria

September 13, 2007

First Posted (Estimate)

September 14, 2007

Study Record Updates

Last Update Posted (Estimate)

September 14, 2007

Last Update Submitted That Met QC Criteria

September 13, 2007

Last Verified

September 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DMR95-IRB-116

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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