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

Not Applicable

Completed

• Conditions: Labor Induction at Term

• Registration Number: NCT01070472
• Lead Sponsor: University of Manitoba

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-02-16
• Study First Submitted QC: 2010-02-17
• Study First Posted: 2010-02-18
• Study Start: 2010-03
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-09
• Last Update Posted: 2013-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 250

Inclusion Criteria

1. term,
2. singleton
3. no contraindication to prostaglandins
4. vertex
5. no exposure to vaginal prostaglandins in the index pregnancy

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Rate of vaginal delivery within 24 hours	24 hours

Secondary Outcome Measures

Name	Time	Method
Uterine hyperstimulation rate	24 hours

Trial Locations

Locations (1)

St. Boniface General Hospital; 🇨🇦 Winnipeg, Manitoba, Canada