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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2011-06-30

Brief Summary

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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

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Conditions

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Labor Induction at Term

Keywords

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labor induction at term using a titrated oral misoprostol solution

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Misoprostol

titrated oral misoprostol solution

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

44 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Dr. debbie Robinson

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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debbie J Robinson, MD FRCSC

Role: PRINCIPAL_INVESTIGATOR

University of Manitoba

Locations

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St. Boniface General Hospital

Winnipeg, Manitoba, Canada

Site Status

Countries

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Canada

Other Identifiers

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B2009:149

Identifier Type: -

Identifier Source: org_study_id