Comparison of Misoprostol and PGE2 Gel for Induction of Labour in Women With Premature Rupture of Membranes at Term

March 24, 2010 updated by: Nilratan Sircar Medical College

Comparison of Misorostol & PGE2 Gel for Immediate Induction of Labour for Premature Ropture of Membranes at Term

Induction of labour with vaginal misoprostol, in women with premature rupture of membranes at term, results in significant shortening of induction to delivery time in comparison to vaginal PGE2 gel induction.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

212

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

  • India
    • West Bengal
      • Kolkata, West Bengal, India, 700014
        • NRS Medicl College,138 AJC Bose Road

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:

  • Premature rupture of membranes at 37 or more weeks
  • Single live fetus in cephalic presentation

Exclusion Criteria:

  • Women in labour
  • Women with contraindication of induction of labour
  • Women with previous caesarean section or uterine surgery

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A
In group A, immediate induction of labour will be done by intravaginal misoprostol 25 microgram 4 hourly , a maximum of 5 doses .
Drug: Misoprostol
In one group of women immediate induction of labour will be done by intravaginal misoprostol 25 microgram 4 hourly , a maximum of 5 doses .
Active Comparator: B
In Group B immediate induction of labour will be done by application of vaginal PGE2 gel 0.5 gm at an interval of 6 hours , a maximum of 2 doses.
Drug: PGE2 gel
In other group immediate induction of labour will be done by intravaginal application of PGE2 gel 0.5 mg at an interval of 6 hours , a maximum of 2 doses.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Admission to delivery time
Time Frame: 48 hours
48 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Caesarean Section rate
Time Frame: 48 hours
48 hours
Neonatal morbidity
Time Frame: Till discharge
Till discharge
Maternal morbidity
Time Frame: Till discharge
Till discharge

Collaborators and Investigators

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

Sponsor

Nilratan Sircar Medical College

Investigators

  • Principal Investigator: Snehamay Chaudhuri, MBBS,MD,DNB, NRS Medical College , Kolkata, India

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.

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

August 1, 2006

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

July 18, 2006

First Submitted That Met QC Criteria

July 24, 2006

First Posted (Estimate)

July 25, 2006

Study Record Updates

Last Update Posted (Estimate)

March 25, 2010

Last Update Submitted That Met QC Criteria

March 24, 2010

Last Verified

November 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1-Chaudhuri

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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