Low-dose Vaginal Misoprostol Versus Vaginal Dinoprostone Insert for Induction of Labor (MADUTER)

November 15, 2018 updated by: Jose Manuel Campillos Maza, Hospital Miguel Servet

Low-dose Vaginal Misoprostol Versus Vaginal Dinoprostone Insert for Induction of Labor Beyond 41st Week: a Randomized Trial

Purpose:

To compare the efficacy and safety of low-dose protocol of vaginal misoprostol and vaginal dinoprostone insert for induction of labor in women with post-term pregnancies.

Methods:

The investigators designed a prospective, randomized, open-labeled, blinded for the end-point evaluators trial including women of at least 41 weeks of gestational age with uncomplicated singleton pregnancies and Bishop score lower than 6. Participants were randomized into dinoprostone or misoprostol groups in a 1:1 ratio. Baseline maternal data and perinatal outcomes were recorded for statistical analysis. Successful vaginal delivery within 24 hours was the primary outcome variable.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

198

Phase

  • Phase 4

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 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Singleton uncomplicated pregnancy
  • Nulliparity
  • Live fetus
  • 286 days of gestational age or above
  • Abscence of contraindication for vaginal delivery
  • Bishop score lower than 6

Exclusion Criteria:

  • Multiple pregnancy
  • Multiparity
  • Stillbirth
  • Oligohydramnios
  • Suspected fetal distress
  • Severe asthma
  • Intolerance/allergy to prostaglandins
  • Contraindication for vaginal birth

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
Active Comparator: Misoprostol
Group of women allocated to misoprostol induction.
Drug: Misoprostol 25 mcg
To determine efficacy and safety of vaginal 'Misoprostol 25 mcg' every 4 hours with a maximum of 6 doses for induction of labor.
Other Names:
  • Misoprostol induction
Active Comparator: Dinoprostone
Group of women allocated to dinoprostone induction.
Drug: Dinoprostone 10mg
To determine efficacy and safety of 'Dinoprostone 10mg' vaginal insert for induction of labor.
Other Names:
  • Dinoprostone induction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Successful vaginal delivery within 24 hours
Time Frame: 24 hours since induction was started
Percentage of women that achieve a vaginal delivery within 24 hours since induction process started
24 hours since induction was started

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Successful cervical ripening within 24 hours
Time Frame: 24 hours since induction was started
Percentage of women that achieve Bishop score > 6 within 24 hours since induction process started
24 hours since induction was started
Interval time from induction to delivery
Time Frame: Hours passed between induction of labor until delivery within 72 hours
Time passed since induction of labor started until delivery
Hours passed between induction of labor until delivery within 72 hours
Need for a second induction
Time Frame: Assessed 24 hours since induction of labor was started
Percentage of women that require to use a second method for induction of labor after 24 hours of having started induction of labor
Assessed 24 hours since induction of labor was started
Vaginal delivery rate
Time Frame: Since labor induction had started until delivery had ocurred within 72 hours
Percentage of women that achieve vaginal delivery
Since labor induction had started until delivery had ocurred within 72 hours

Collaborators and Investigators

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

Sponsor

Hospital Miguel Servet

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 (Actual)

June 1, 2014

Primary Completion (Actual)

October 20, 2017

Study Completion (Actual)

November 1, 2017

Study Registration Dates

First Submitted

November 9, 2018

First Submitted That Met QC Criteria

November 15, 2018

First Posted (Actual)

November 16, 2018

Study Record Updates

Last Update Posted (Actual)

November 16, 2018

Last Update Submitted That Met QC Criteria

November 15, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JMC-PGE-2014-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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 Pregnancy

Clinical Trials on Misoprostol 25 mcg

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Pakistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe