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

This study is currently recruiting participants.

Verified by Nilratan Sircar Medical College, June 2009

First Received: July 19, 2006 Last Updated: June 29, 2009 History of Changes

Sponsored by:	Nilratan Sircar Medical College
Information provided by:	Nilratan Sircar Medical College
ClinicalTrials.gov Identifier:	NCT00355303

Purpose

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.

Condition	Intervention	Phase
Premature Rupture of Membranes at Term	Drug: Misoprostol in arm A & PGE2 Gel in arm B	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Crossover Assignment, Safety/Efficacy Study
Official Title:	Comparison of Misoprostol and PGE2 Gel for Induction of Labour in Premature - A Randomized Comparative Trial

Resource links provided by NLM:

MedlinePlus related topics: Cesarean Section

Drug Information available for: Misoprostol Dinoprostone

U.S. FDA Resources

Further study details as provided by Nilratan Sircar Medical College:

Primary Outcome Measures:

Caesarean Section rate [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Induction delivery time [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
Neonatal & maternal infectious morbidity [ Time Frame: till discharge from hospital or death ] [ Designated as safety issue: No ]

Estimated Enrollment:	1300
Study Start Date:	August 2006
Estimated Primary Completion Date:	August 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
misoprostol -A & PGE2 gel-B: Active Comparator participants are assigned to one of two arms for the duration of the study In arm A of study induction of labour is done by intravaginal misoprostol & in arm B, induction of labour is done by PGE2 gel application in posterior fornix and the outcomes will be compared	Drug: Misoprostol in arm A & PGE2 Gel in arm B In arm A Intravaginal Misoprostol is applied 25 microgram 4 hourly a maximum of five doses. In arm B PGE2 gel is applied at 6 hour interval with a maximum of 2 doses.

Eligibility

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00355303

Contacts

Contact: Snehamay Chaudhuri, MBBS,MD,DNB

91-33-23537900

snehamay_chaudhuri_dr@yahoo.com

Locations

India, West Bengal
Nilratan Sircar Medical College, 138,AJC Bose Road,	Recruiting
Kolkata, West Bengal, India, 700014
Contact: Snehamay Chaudhuri, MBBS,MD,DNB 91-33-23537900 snehamay_chaudhuri_dr@yahoo.com

Sponsors and Collaborators

Nilratan Sircar Medical College

Investigators

Principal Investigator:

Snehamay Chaudhuri, MBBS,MD.DNB

Nilratan Sircar Medical College , Kolkata, West bengal , India

More Information

Additional Information:

Chaudhuri S, Mitra S N, Biswas PK et al,Premature Rupture Of Membranes At Term : Immediate Induction With PGE2 gel Compared with Delayed Induction with Oxytocin , J Obstet and Gynaecol India , Vol 56, No 3: 2006, 224-229 This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Nilratan Sircar Medical College , West Bengal , Kolkata ( Dr Snehamay Chaudhuri, Assistant Professor , Department of Gyne & Obstetrics )
Study ID Numbers:	2-Chaudhuri
Study First Received:	July 19, 2006
Last Updated:	June 29, 2009
ClinicalTrials.gov Identifier:	NCT00355303 History of Changes
Health Authority:	India: Ministry of Health

Keywords provided by Nilratan Sircar Medical College:

Premature rupture of membranes at term
Induction of labour
Misoprostol

PGE2 gel
Immediate induction with PGE2 gel
Immediate induction with Misoprostol

Study placed in the following topic categories:

Dinoprostone
Pregnancy Complications
Misoprostol
Wounds and Injuries

Obstetric Labor Complications
Disorders of Environmental Origin
Rupture
Fetal Membranes, Premature Rupture

Additional relevant MeSH terms:

Pregnancy Complications
Oxytocics
Misoprostol
Physiological Effects of Drugs
Gastrointestinal Agents
Obstetric Labor Complications
Wounds and Injuries
Rupture
Disorders of Environmental Origin

Reproductive Control Agents
Abortifacient Agents, Nonsteroidal
Fetal Membranes, Premature Rupture
Pharmacologic Actions
Dinoprostone
Therapeutic Uses
Anti-Ulcer Agents
Abortifacient Agents

ClinicalTrials.gov processed this record on September 11, 2009