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

NCT ID: NCT00355966

Last Updated: 2010-03-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

212 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2008-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Premature Rupture of Membranes at Term

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

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

Group Type ACTIVE_COMPARATOR

Misoprostol

Intervention Type DRUG

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

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.

Group Type ACTIVE_COMPARATOR

PGE2 gel

Intervention Type DRUG

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.

Interventions

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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 .

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Nilratan Sircar Medical College

OTHER_GOV

Sponsor Role lead

Responsible Party

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Nilratan Sircar Medical College , Kolkata

Principal Investigators

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Snehamay Chaudhuri, MBBS,MD,DNB

Role: PRINCIPAL_INVESTIGATOR

NRS Medical College , Kolkata, India

Locations

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NRS Medicl College,138 AJC Bose Road

Kolkata, West Bengal, India

Site Status

Countries

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India

Related Links

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http://medind.nic.in/jaq/t06/i3/jaqt06i3p224.pdf

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

Other Identifiers

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1-Chaudhuri

Identifier Type: -

Identifier Source: org_study_id

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