- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01939457
400mcg Sublingual Misoprostol as First Line Treatment
September 6, 2013 updated by: Gynuity Health Projects
Introduction of 400mcg Sublingual Misoprostol as First Line Treatment in 11 Health Posts in Three Districts in Senegal
Women presenting with incomplete abortion and eligible for treatment with misoprostol were offered 400mcg sublingual misoprostol for treatment.
Based on existing literature, the study hypothesises that women can successfully be treated with misoprostol alone as first line treatment.
Study Overview
Study Type
Interventional
Enrollment (Actual)
641
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Guediawaye, Senegal
- Guediawaye Health Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- uterine size less than 12 weeks lmp
- open cervical os
- current or past vaginal bleeding
- willing to provide contact information for follow-up
- over 18 or with guardian consent
Exclusion Criteria:
- suspicion of ectopic pregnancy
- intrauterine device in place
- bad general health (infection, anemia, shoc)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: misoprostol
400 mcg misoprostol sublingually
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
complete abortion
Time Frame: 1 year
|
number of complete abortion with misoprostol treatment alone
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Beverly Winikoff, MD MPH, Gynuity Health Projects
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2011
Primary Completion (Actual)
August 1, 2012
Study Completion (Actual)
August 1, 2012
Study Registration Dates
First Submitted
August 7, 2013
First Submitted That Met QC Criteria
September 6, 2013
First Posted (Estimate)
September 11, 2013
Study Record Updates
Last Update Posted (Estimate)
September 11, 2013
Last Update Submitted That Met QC Criteria
September 6, 2013
Last Verified
September 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2.2.4
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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