Official Title: “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.

Study Type: Interventional

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

Study Primary Completion Date: August 2008

Intervention(s) in this Clinical Trial

• 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.

Arms, Groups and Cohorts in this Clinical Trial

• 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 .
• 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.

Primary Measures

• Induction to delivery time
  • Time Frame: 48 hours
    Safety Issue?: Yes

Secondary Measures

• Caesarean Section rate
  • Time Frame: 48 hours
    Safety Issue?: No
• Neonatal morbidity
  • Time Frame: Till discharge
    Safety Issue?: Yes
• Maternal morbidity
  • Time Frame: Till discharge
    Safety Issue?: Yes

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 NRS Medical College , Kolkata, India  

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

Information obtained from ClinicalTrials.gov on October 07, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00355966

Study ID Number: 1-Chaudhuri

ClinicalTrials.gov Identifier: NCT00355966

Health Authority: India: Ministry of Health

Chaudhuri S, Mitra SN, Biswas PK, Bhattcharyya S.Pramature rupture of membranes at term: Immediate induction with PGE2 gel compared with delayed induction with oxytocin,Ind J Obstet Gynecol Vol56,no 3; 2006,224-229