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Completed

NCT Number: NCT01070472

Efficacy and Safety of Titrated Oral Misoprostol Solution for Labor Induction at Term

The purpose of this study is to determine whether a titrated solution of oral Misoprostol is safe and effective at inducing labor at term, regardless of Bishop Score.

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Key information

Conditions

Labor Induction at Term

Age range

18 year–44 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

St. Boniface General Hospital

Winnipeg, Manitoba, Canada

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • term,
  • singleton
  • no contraindication to prostaglandins
  • vertex
  • no exposure to vaginal prostaglandins in the index pregnancy

Exclusion criteria

  • parity > 3
  • severe PIH: BP> 160/100, abnormal LFT's, proteinuria >1g/day
  • previous uterine surgery
  • regular uterine contractions
  • maternal age > 45
  • twins

Treatment and study plan

Misoprostol

Drug

titrated oral misoprostol solution

Primary outcomes

  1. Rate of vaginal delivery within 24 hours

    Time frame: 24 hours

Secondary outcomes

  1. Uterine hyperstimulation rate

    Time frame: 24 hours

Sponsors and collaborators

Lead sponsor

University of Manitoba

Other

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Feb 18, 2010
Registry last updated
Dec 10, 2013

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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