Comparison of Misoprostol and Prostaglandin E2 (PGE2) Gel for Induction of Labour in Premature Rupture of Membranes at Term
Information source: Nilratan Sircar Medical College
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Premature Rupture of Membranes at Term
Intervention: Misoprostol (Drug); PGE2 gel (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Nilratan Sircar Medical College Official(s) and/or principal investigator(s):
Snehamay Chaudhuri, MBBS,MD.DNB, Principal Investigator, Affiliation: Nilratan Sircar Medical College , Kolkata, West bengal , India
Overall contact:
Snehamay Chaudhuri, MBBS,MD,DNB, Phone: 91-33-23537900, Email: snehamay_chaudhuri_dr@yahoo.com
Summary
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.
Clinical Details
Official title: Comparison of Misoprostol and PGE2 Gel for Induction of Labour in in Premature Rupture of Membranes at Term- A Randomized Comparative Trial
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Caesarean Section rate
Secondary outcome: Induction delivery timeNeonatal & maternal infectious morbidity
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Female.
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
Locations and Contacts
Snehamay Chaudhuri, MBBS,MD,DNB, Phone: 91-33-23537900, Email: snehamay_chaudhuri_dr@yahoo.com
Nilratan Sircar Medical College, 138,AJC Bose Road,, Kolkata, West Bengal 700014, India; Recruiting
Snehamay Chaudhuri, MBBS,MD,DNB, Phone: 91-33-23537900, Email: snehamay_chaudhuri_dr@yahoo.com
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 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.
Starting date: August 2006
Last updated: June 21, 2012
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