Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Information provided by:
Nilratan Sircar Medical College Identifier:
First received: July 18, 2006
Last updated: March 24, 2010
Last verified: November 2008

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:

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.


Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00355966

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

Additional Information:
No publications provided

Responsible Party: Chairperson of Ethical Committee & Principal, Nilratan Sircar Medical College , Kolkata 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
Obstetric Labor Complications
Pregnancy Complications
Wounds and Injuries
Abortifacient Agents
Abortifacient Agents, Nonsteroidal
Anti-Ulcer Agents
Gastrointestinal Agents
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses processed this record on February 26, 2015