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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:
ClinicalTrials.gov Identifier:
NCT00355966
First Posted: July 25, 2006
Last Update Posted: March 25, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Nilratan Sircar Medical College
  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
Intervention Model: Parallel Assignment
Masking: None (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 ]

Secondary Outcome Measures:
  • Caesarean Section rate [ Time Frame: 48 hours ]
  • Neonatal morbidity [ Time Frame: Till discharge ]
  • Maternal morbidity [ Time Frame: Till discharge ]

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

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Ages Eligible for Study:   Child, Adult, Senior
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
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
First Submitted: July 18, 2006
First Posted: July 25, 2006
Last Update Posted: March 25, 2010
Last Verified: November 2008

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:
Premature Birth
Rupture
Fetal Membranes, Premature Rupture
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Wounds and Injuries
Misoprostol
Dinoprostone
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics