Comparison of Misoprostol and Prostaglandin E2 (PGE2) Gel for Induction of Labour in Premature Rupture of Membranes at Term

Official Title: “Comparison of Misoprostol and PGE2 Gel for Induction of Labour in in Premature Rupture of Membranes at Term- A Randomized Comparative Trial”

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.

Intervention(s) in this Clinical Trial

• Drug: Misoprostol
  • Vaginal application of Misoprostol tablets at 4 hrly interval with maximumof five doses
• Drug: PGE2 gel
  • PGE2 gel will be applied in poaterior fornix at six hrly interval with maximum of 2 doses

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: Misoprostol tablet, PGE2 gel
  • participants are assigned to one of two arms for the duration of the study In one group induction of labour is done by intravaginal misoprostol tablets at 4 hrly interval with maximum of five doses.In other group PGE2 gel is applied in poaterior fornix at six hourly interval.

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: 14 days following date of delivery
    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 Investigator: Nilratan Sircar Medical College Other

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 February 09, 2012

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

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.