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

Phase 4

Completed

• Conditions: Premature Rupture of Membranes at Term
• Interventions: Drug: Misoprostol; Drug: PGE2 gel

• Registration Number: NCT00355303
• Lead Sponsor: Nilratan Sircar Medical College

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-07-19
• Study First Submitted QC: 2006-07-20
• Study First Posted: 2006-07-21
• Study Start: 2006-08
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-21
• Last Update Posted: 2015-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 932

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Misoprostol tablet, PGE2 gel	PGE2 gel	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.
Misoprostol tablet, PGE2 gel	Misoprostol	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.

Primary Outcome Measures

Name	Time	Method
Caesarean Section rate	48 hours

Secondary Outcome Measures

Name	Time	Method
Induction delivery time	48 hours
Neonatal & maternal infectious morbidity	14 days following date of delivery

Trial Locations

Locations (1)

Nilratan Sircar Medical College, 138,AJC Bose Road,; 🇮🇳 Kolkata, West Bengal, India