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Comparison of Misoprostol and PGE2 Gel for Induction of Labour in Women With 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, Induction of labour with Misoprostol, Induction of labour with PGE2 gel

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

  • NRS Medicl College,138 AJC Bose Road

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

A

B

Arm Description

In group A, immediate induction of labour will be done by intravaginal misoprostol 25 microgram 4 hourly , a maximum of 5 doses .

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.

Outcomes

Primary Outcome Measures

Admission to delivery time

Secondary Outcome Measures

Caesarean Section rate
Neonatal morbidity
Maternal morbidity

Full Information

First Posted
July 18, 2006
Last Updated
March 24, 2010
Sponsor
Nilratan Sircar Medical College
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1. Study Identification

Unique Protocol Identification Number
NCT00355966
Brief Title
Comparison of Misoprostol and PGE2 Gel for Induction of Labour in Women With Premature Rupture of Membranes at Term
Official Title
Comparison of Misorostol & PGE2 Gel for Immediate Induction of Labour for Premature Ropture of Membranes at Term
Study Type
Interventional

2. Study Status

Record Verification Date
November 2008
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Nilratan Sircar Medical College

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

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, Induction of labour with Misoprostol, Induction of labour with PGE2 gel

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Active Comparator
Arm Description
In group A, immediate induction of labour will be done by intravaginal misoprostol 25 microgram 4 hourly , a maximum of 5 doses .
Arm Title
B
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Misoprostol
Intervention Description
In one group of women immediate induction of labour will be done by intravaginal misoprostol 25 microgram 4 hourly , a maximum of 5 doses .
Intervention Type
Drug
Intervention Name(s)
PGE2 gel
Intervention Description
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.
Primary Outcome Measure Information:
Title
Admission to delivery time
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Caesarean Section rate
Time Frame
48 hours
Title
Neonatal morbidity
Time Frame
Till discharge
Title
Maternal morbidity
Time Frame
Till discharge

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
NRS Medical College , Kolkata, India
Official's Role
Principal Investigator
Facility Information:
Facility Name
NRS Medicl College,138 AJC Bose Road
City
Kolkata
State/Province
West Bengal
ZIP/Postal Code
700014
Country
India

12. IPD Sharing Statement

Links:
URL
http://medind.nic.in/jaq/t06/i3/jaqt06i3p224.pdf
Description
Chaudhuri S, Mitra SN, Biswas PK, Bhattcharyya S.Pramature rupture of membranes at term: Immediate induction with PGE2 gel compared with delayed induction with oxytocin,Ind J Obstet Gynecol Vol56,no 3; 2006,224-229

Learn more about this trial

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

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