The purpose of this study is to determine whether induction of labour with vaginal misoprostol application will result in fewer caesarean deliveries than vaginal PGE2 gel application in women with premature rupture of membranes at Term.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: August 2012

Intervention(s) in this Clinical Trial

• Drug: Misoprostol in arm A & PGE2 Gel in arm B
  • In arm A Intravaginal Misoprostol is applied 25 microgram 4 hourly a maximum of five doses. In arm B PGE2 gel is applied at 6 hour interval with a maximum of 2 doses.

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: misoprostol -A & PGE2 gel-B
  • participants are assigned to one of two arms for the duration of the study In arm A of study induction of labour is done by intravaginal misoprostol & in arm B, induction of labour is done by PGE2 gel application in posterior fornix and the outcomes will be compared

Primary Measures

• Caesarean Section rate
  • Time Frame: 48 hours
    Safety Issue?: No

Secondary Measures

• Induction delivery time,
  • Time Frame: 48 hours
    Safety Issue?: No
• Neonatal & maternal infectious morbidity
  • Time Frame: till discharge from hospital or death
    Safety Issue?: 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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Nilratan Sircar Medical College

Overall Clinical Trial Officials and Contacts

Snehamay Chaudhuri, MBBS,MD.DNB Principal Investigator Nilratan Sircar Medical College , Kolkata, West bengal , India  

Overall Contact: Snehamay Chaudhuri, MBBS,MD,DNB 91-33-23537900 snehamay_chaudhuri_dr@yahoo.com

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00355303

Study ID Number: 2-Chaudhuri

ClinicalTrials.gov Identifier: NCT00355303

Health Authority: India: Ministry of Health

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