NCT01070472

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 16, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 18, 2010

Completed
11 days until next milestone

Study Start

First participant enrolled

March 1, 2010

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

December 10, 2013

Status Verified

December 1, 2013

Enrollment Period

1.3 years

First QC Date

February 16, 2010

Last Update Submit

December 9, 2013

Conditions

Labor Induction at Term

Keywords

labor induction at term using a titrated oral misoprostol solution

Outcome Measures

Primary Outcomes (1)

  • Rate of vaginal delivery within 24 hours

    24 hours

Secondary Outcomes (1)

  • Uterine hyperstimulation rate

    24 hours

Interventions

MisoprostolDRUG

titrated oral misoprostol solution

Eligibility Criteria

Age18 Years - 44 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Boniface General Hospital

Winnipeg, Manitoba, Canada

Location

MeSH Terms

Interventions

Misoprostol

Intervention Hierarchy (Ancestors)

Prostaglandins E, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Officials

  • debbie J Robinson, MD FRCSC

    University of Manitoba

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

February 16, 2010

First Posted

February 18, 2010

Study Start

March 1, 2010

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

December 10, 2013

Record last verified: 2013-12

Locations

CA(1)