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OpenTrials
Completed

NCT Number: NCT00355966

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

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.

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Key information

Conditions

Premature Rupture of Membranes at Term Female Urogenital Diseases and Pregnancy Complications Fetal Membranes, Premature Rupture Obstetric Labor Complications Pregnancy Complications Urogenital Diseases

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

NRS Medicl 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

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

Drug

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.

Primary outcomes

  1. Admission to delivery time

    Time frame: 48 hours

Secondary outcomes

  1. Caesarean Section rate

    Time frame: 48 hours

  2. Neonatal morbidity

    Time frame: Till discharge

  3. Maternal morbidity

    Time frame: Till discharge

Sponsors and collaborators

Lead sponsor

Nilratan Sircar Medical College

Other Gov

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Jul 25, 2006
Registry last updated
Mar 25, 2010

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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