Comparison of Misoprostol and PGE2 Gel for Induction of Labour in Women With Premature Rupture of Membranes at Term

Premature Rupture of Membranes at Term Clinical Trial

Official title:

Comparison of Misorostol & PGE2 Gel for Immediate Induction of Labour for Premature Ropture of Membranes at Term

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00355966
• Other study ID #: 1-Chaudhuri
• Status: Completed
• Phase: Phase 4
• First received: July 18, 2006
• Last updated: March 24, 2010
• Start date: August 2006
• Est. completion date: September 2008

Study information

• Verified date: November 2008
• Source: Nilratan Sircar Medical College
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 212
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• 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: Efficacy Study, Intervention Model: Parallel 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
In one group of women immediate induction of labour will be done by intravaginal misoprostol 25 microgram 4 hourly , a maximum of 5 doses .
• 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.

Locations

Country	Name	City	State
India	NRS Medicl 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	Admission to delivery time		48 hours	Yes
Secondary	Caesarean Section rate		48 hours	No
Secondary	Neonatal morbidity		Till discharge	Yes
Secondary	Maternal morbidity		Till discharge	Yes

External Links

•   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