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Comparison of Misoprostol and Prostaglandin E2 (PGE2) Gel for Induction of Labour in Premature Rupture of Membranes at Term

Primary Purpose

Premature Rupture of Membranes at Term

Status
Completed
Phase
Phase 4
Locations
India
Study Type
Interventional
Intervention
Misoprostol
PGE2 gel
Sponsored by
Nilratan Sircar Medical College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Premature Rupture of Membranes at Term focused on measuring Premature rupture of membranes at term, Induction of labour, Misoprostol, PGE2 gel, Immediate induction with PGE2 gel, Immediate induction with Misoprostol

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Nilratan Sircar Medical College, 138,AJC Bose Road,

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

Misoprostol tablet, PGE2 gel

Arm Description

participants are assigned to one of two arms for the duration of the study In one group induction of labour is done by intravaginal misoprostol tablets at 4 hrly interval with maximum of five doses.In other group PGE2 gel is applied in poaterior fornix at six hourly interval.

Outcomes

Primary Outcome Measures

Caesarean Section rate

Secondary Outcome Measures

Induction delivery time
Neonatal & maternal infectious morbidity

Full Information

First Posted
July 19, 2006
Last Updated
July 21, 2015
Sponsor
Nilratan Sircar Medical College
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1. Study Identification

Unique Protocol Identification Number
NCT00355303
Brief Title
Comparison of Misoprostol and Prostaglandin E2 (PGE2) Gel for Induction of Labour in Premature Rupture of Membranes at Term
Official Title
Comparison of Misoprostol and PGE2 Gel for Induction of Labour in in Premature Rupture of Membranes at Term- A Randomized Comparative Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nilratan Sircar Medical College

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to determine whether induction of labor with vaginal misoprostol application will result in fewer cesarean deliveries than vaginal PGE2 gel application in women with premature rupture of membranes at term.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Rupture of Membranes at Term
Keywords
Premature rupture of membranes at term, Induction of labour, Misoprostol, PGE2 gel, Immediate induction with PGE2 gel, Immediate induction with Misoprostol

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
932 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Misoprostol tablet, PGE2 gel
Arm Type
Active Comparator
Arm Description
participants are assigned to one of two arms for the duration of the study In one group induction of labour is done by intravaginal misoprostol tablets at 4 hrly interval with maximum of five doses.In other group PGE2 gel is applied in poaterior fornix at six hourly interval.
Intervention Type
Drug
Intervention Name(s)
Misoprostol
Other Intervention Name(s)
Misoprost
Intervention Description
Vaginal application of Misoprostol tablets at 4 hrly interval with maximumof five doses
Intervention Type
Drug
Intervention Name(s)
PGE2 gel
Other Intervention Name(s)
Dinoprostone gel
Intervention Description
PGE2 gel will be applied in poaterior fornix at six hrly interval with maximum of 2 doses
Primary Outcome Measure Information:
Title
Caesarean Section rate
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Induction delivery time
Time Frame
48 hours
Title
Neonatal & maternal infectious morbidity
Time Frame
14 days following date of delivery

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Snehamay Chaudhuri, MBBS,MD.DNB
Organizational Affiliation
Nilratan Sircar Medical College , Kolkata, West bengal , India
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nilratan Sircar Medical College, 138,AJC Bose Road,
City
Kolkata
State/Province
West Bengal
ZIP/Postal Code
700014
Country
India

12. IPD Sharing Statement

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Comparison of Misoprostol and Prostaglandin E2 (PGE2) Gel for Induction of Labour in Premature Rupture of Membranes at Term

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