Comparison of Misoprostol and PGE2 Gel for Induction of Labour in Women With 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

NCT00355966

1-Chaudhuri

Details and patient eligibility

About

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.

Enrollment: 212 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: Parallel Assignment

Masking: None (Open label)

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212 participants in 2 patient groups

A

Active Comparator group

Description:

In group A, immediate induction of labour will be done by intravaginal misoprostol 25 microgram 4 hourly , a maximum of 5 doses .

Treatment:

Drug: Misoprostol

B

Active Comparator group

Description:

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.

Treatment:

Drug: PGE2 gel