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

Phase 4

Completed

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

• Registration Number: NCT00355966
• Lead Sponsor: Nilratan Sircar Medical College

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-07-18
• Study First Submitted QC: 2006-07-24
• Study First Posted: 2006-07-25
• Study Start: 2006-08
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Status Verified: 2008-11
• Last Update Submitted: 2010-03-24
• Last Update Posted: 2010-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 212

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: PARALLEL

Arm && Interventions

Group	Intervention	Description
B	PGE2 gel	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.
A	Misoprostol	In group A, immediate induction of labour will be done by intravaginal misoprostol 25 microgram 4 hourly , a maximum of 5 doses .

Primary Outcome Measures

Name	Time	Method
Admission to delivery time	48 hours

Secondary Outcome Measures

Name	Time	Method
Caesarean Section rate	48 hours
Neonatal morbidity	Till discharge
Maternal morbidity	Till discharge

Trial Locations

Locations (1)

NRS Medicl College,138 AJC Bose Road; 🇮🇳 Kolkata, West Bengal, India