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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 2012 by Nilratan Sircar Medical College
Sponsor:
Information provided by (Responsible Party):
Dr Snehamay Chaudhuri, Nilratan Sircar Medical College
ClinicalTrials.gov Identifier:
NCT00355303
First received: July 19, 2006
Last updated: June 21, 2012
Last verified: June 2012
History of Changes
  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 4

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
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
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 , Obstetrics and Gynecology, NRS Medical College, Nilratan Sircar Medical College
ClinicalTrials.gov Identifier: NCT00355303     History of Changes
Other Study ID Numbers: 2-Chaudhuri
Study First Received: July 19, 2006
Last Updated: June 21, 2012
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 June 17, 2013