Text Size

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

This study has been completed.
Sponsor:
Information provided by:
Nilratan Sircar Medical College
ClinicalTrials.gov Identifier:
NCT00355966
First received: July 18, 2006
Last updated: March 24, 2010
Last verified: November 2008
History of Changes
  Purpose

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.


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: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of Misorostol & PGE2 Gel for Immediate Induction of Labour for Premature Ropture of Membranes at Term

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Nilratan Sircar Medical College:

Primary Outcome Measures:
  • Admission to delivery time [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Caesarean Section rate [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • Neonatal morbidity [ Time Frame: Till discharge ] [ Designated as safety issue: Yes ]
  • Maternal morbidity [ Time Frame: Till discharge ] [ Designated as safety issue: Yes ]

Enrollment: 212
Study Start Date: August 2006
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
In group A, immediate induction of labour will be done by intravaginal misoprostol 25 microgram 4 hourly , a maximum of 5 doses .
 Drug: Misoprostol
In one group of women immediate induction of labour will be done by intravaginal misoprostol 25 microgram 4 hourly , a maximum of 5 doses .
Active Comparator: B
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.
 Drug: PGE2 gel
In other group immediate induction of labour will be done by intravaginal application of PGE2 gel 0.5 mg at an interval of 6 hours , 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: NCT00355966

Locations
India
NRS Medicl College,138 AJC Bose Road
Kolkata, West Bengal, India, 700014
Sponsors and Collaborators
Nilratan Sircar Medical College
Investigators
Principal Investigator: Snehamay Chaudhuri, MBBS,MD,DNB NRS Medical College , Kolkata, India
  More Information

Additional Information:
Chaudhuri S, Mitra SN, Biswas PK, Bhattcharyya S.Pramature rupture of membranes at term: Immediate induction with PGE2 gel compared with delayed induction with oxytocin,Ind J Obstet Gynecol Vol56,no 3; 2006,224-229  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Chairperson of Ethical Committee & Principal, Nilratan Sircar Medical College , Kolkata
ClinicalTrials.gov Identifier: NCT00355966     History of Changes
Other Study ID Numbers: 1-Chaudhuri
Study First Received: July 18, 2006
Last Updated: March 24, 2010
Health Authority: India: Ministry of Health

Keywords provided by Nilratan Sircar Medical College:
Premature rupture of membranes
Induction of labour with Misoprostol
Induction of labour with PGE2 gel

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 May 19, 2013