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 June 2011 by Nilratan Sircar Medical College

First Received on July 19, 2006. Last Updated on June 23, 2011 History of Changes

Sponsor:	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 Drug: PGE2 gel	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Comparison of Misoprostol and PGE2 Gel for Induction of Labour in in Premature Rupture of Membranes at Term- 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: 14 days following date of delivery ] [ Designated as safety issue: No ]

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

Arms	Assigned Interventions
Active Comparator: Misoprostol tablet, 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.	Drug: Misoprostol Vaginal application of Misoprostol tablets at 4 hrly interval with maximumof five doses Other Name: Misoprost Drug: PGE2 gel PGE2 gel will be applied in poaterior fornix at six hrly interval with maximum of 2 doses Other Name: Dinoprostone gel

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
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

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. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Dr Snehamay Chaudhuri, Associate Professor , Department of Gynecology & Obstetrics, Nilratan Sircar Medical College , West Bengal , Kolkata
ClinicalTrials.gov Identifier:	NCT00355303 History of Changes
Other Study ID Numbers:	2-Chaudhuri
Study First Received:	July 19, 2006
Last Updated:	June 23, 2011
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

Additional relevant MeSH terms:

Fetal Membranes, Premature Rupture
Rupture
Obstetric Labor Complications
Pregnancy Complications
Wounds and Injuries
Dinoprostone
Misoprostol
Oxytocics

Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Anti-Ulcer Agents
Gastrointestinal Agents
Abortifacient Agents, Nonsteroidal
Abortifacient Agents

ClinicalTrials.gov processed this record on February 09, 2012