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

NCT00355303 | Completed Phase 4 DMC

• 1 other identifier: 2-Chaudhuri
• Study Type: interventional
• Target: 932
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Caesarean Section rate

  48 hours

Secondary Outcomes (2)

• Induction delivery time

  48 hours

• Neonatal & maternal infectious morbidity

  14 days following date of delivery

Study Arms (1)

Misoprostol tablet, PGE2 gel

ACTIVE COMPARATOR

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.

Drug: Misoprostol; Drug: PGE2 gel

Interventions

Misoprostol DRUG

Vaginal application of Misoprostol tablets at 4 hrly interval with maximumof five doses

Also known as: Misoprost

Misoprostol tablet, PGE2 gel

PGE2 gel DRUG

PGE2 gel will be applied in poaterior fornix at six hrly interval with maximum of 2 doses

Also known as: Dinoprostone gel

Misoprostol tablet, PGE2 gel

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Premature rupture of membranes at 37 or more weeks
• Single live fetus in cephalic presentation

You may not qualify if:

• Women in labour
• Women with contraindication of induction of labour
• Women with previous caesarean section or uterine surgery

Sponsors & Collaborators

• Nilratan Sircar Medical College: lead

Study Sites (1)

Nilratan Sircar Medical College, 138,AJC Bose Road,

Kolkata, West Bengal, 700014, India

Location

Related Links

• Chaudhuri, S et al. (2011), Comparison of vaginal misoprostol tablets and prostaglandin E2 gel for the induction of labor in premature rupture of membranes at term: A randomized comparative trial.

MeSH Terms

Interventions

Misoprostol; Dinoprostone

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors; Prostaglandins E

Study Officials

• Snehamay Chaudhuri, MBBS,MD.DNB

  Nilratan Sircar Medical College , Kolkata, West bengal , India

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor , Obstetrics and Gynecology, NRS Medical College

Study Record Dates

• First Submitted: July 19, 2006
• First Posted: July 21, 2006
• Study Start: August 1, 2006
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: July 22, 2015

Record last verified: 2015-07

Locations

IN (1)