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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:
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

July 18, 2006
March 24, 2010
August 2006
September 2008   (final data collection date for primary outcome measure)
Admission to delivery time [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]
Induction to delivery time
Complete list of historical versions of study NCT00355966 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Caesarean Section rate
  • Neonatal morbidity
  • Maternal morbidity
Not Provided
Not Provided
 
Comparison of Misoprostol and PGE2 Gel for Induction of Labour in Women With Premature Rupture of Membranes at Term
Comparison of Misorostol & PGE2 Gel for Immediate Induction of Labour for Premature Ropture of Membranes at Term

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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Premature Rupture of Membranes at Term
  • 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 .
  • 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.
  • 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 .
    Intervention: Drug: Misoprostol
  • 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.
    Intervention: Drug: PGE2 gel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
212
September 2008
September 2008   (final data collection date for primary outcome measure)

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
Female
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
India
 
NCT00355966
1-Chaudhuri
Yes
Chairperson of Ethical Committee & Principal, Nilratan Sircar Medical College , Kolkata
Nilratan Sircar Medical College
Not Provided
Principal Investigator: Snehamay Chaudhuri, MBBS,MD,DNB NRS Medical College , Kolkata, India
Nilratan Sircar Medical College
November 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP