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

Nilratan Sircar Medical College

Status and phase: Completed; Phase 4

Conditions: Premature Rupture of Membranes at Term

Treatments: Drug: Misoprostol; Drug: PGE2 gel

Study type: Interventional

Funder types: Other

Identifiers

NCT00355303

2-Chaudhuri

Details and patient eligibility

About

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.

Enrollment: 932 patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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932 participants in 1 patient group

Misoprostol tablet, PGE2 gel

Active Comparator group

Description:

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.

Treatment:

Drug: PGE2 gel

Drug: Misoprostol