Oral Misoprostol Versus Vaginal Dinoprostone For Induction Of Labour: A Randomized Controlled Clinical Trial

June 19, 2014 updated by: Marwan Elkady, Ain Shams University
This study is to compare between oral misoprostol in solution and vaginal dinoprostone in induction of labour in primiparous women with singleton pregnancy as regards efficiency and safety to both mother and fetus.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

342

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

  • Egypt
      • Cairo, Egypt
        • Recruiting
        • Ain Shams Maternity Hospital
        • Contact:
          • Ain Shams, 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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Primigravida
  • >37 wks

Exclusion Criteria:

  • Scarred uterus
  • Macrosomia

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

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: misoprostol
oral misoprostol in solution 25 microgram every 2 hours
Drug: Misoprostol
Active Comparator: dinoprostone
3 mgs dinoprostone vaginally every six hours
Drug: Dinoprostone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
induction delivery time
Time Frame: 2 hourly
2 hourly

Collaborators and Investigators

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

Sponsor

Ain Shams University

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, 2014

Primary Completion (Anticipated)

January 1, 2016

Study Registration Dates

First Submitted

June 19, 2014

First Submitted That Met QC Criteria

June 19, 2014

First Posted (Estimate)

June 20, 2014

Study Record Updates

Last Update Posted (Estimate)

June 20, 2014

Last Update Submitted That Met QC Criteria

June 19, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Misoprostol-2014

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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