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

Premature Rupture of Membranes at Term Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00355303
• Other study ID #: 2-Chaudhuri
• Status: Completed
• Phase: Phase 4
• First received: July 19, 2006
• Last updated: July 21, 2015
• Start date: August 2006
• Est. completion date: May 2013

Study information

• Verified date: July 2015
• Source: Nilratan Sircar Medical College
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 932
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fetal Membranes, Premature Rupture
• Premature Birth
• Premature Rupture of Membranes at Term
• Rupture

Intervention

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

Locations

Country	Name	City	State
India	Nilratan Sircar Medical College, 138,AJC Bose Road,	Kolkata	West Bengal

Sponsors (1)

Lead Sponsor	Collaborator
Nilratan Sircar Medical College

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Caesarean Section rate		48 hours	No
Secondary	Induction delivery time		48 hours	No
Secondary	Neonatal & maternal infectious morbidity		14 days following date of delivery	No

External Links

•   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.