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Completed

NCT Number: NCT00355303

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

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.

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Key information

Conditions

Premature Rupture of Membranes at Term

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Nilratan Sircar Medical College, 138,AJC Bose Road,

Kolkata, West Bengal, 700014, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Misoprostol

Drug

Vaginal application of Misoprostol tablets at 4 hrly interval with maximumof five doses

Other names: Misoprost

PGE2 gel

Drug

PGE2 gel will be applied in poaterior fornix at six hrly interval with maximum of 2 doses

Other names: Dinoprostone gel

Primary outcomes

  1. Caesarean Section rate

    Time frame: 48 hours

Secondary outcomes

  1. Induction delivery time

    Time frame: 48 hours

  2. Neonatal & maternal infectious morbidity

    Time frame: 14 days following date of delivery

Sponsors and collaborators

Lead sponsor

Nilratan Sircar Medical College

Other Gov

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2013
Study completion
2013
First posted
Jul 21, 2006
Registry last updated
Jul 22, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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