- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02524990
Simplified Medical Abortion Follow-Up
March 3, 2016 updated by: Gynuity Health Projects
Simplified Medical Abortion Follow-Up Study
The purpose of this operations research study is to evaluate women's interest in and compliance with using a semiquantitative multi-level dipstick pregnancy test at home for medical abortion follow-up.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
53
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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Maryland
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Chevy Chase, Maryland, United States, 20815
- Carafem Health Center
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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
11 years to 56 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- She has been determined by the site investigator or designee to be fully eligible for medical abortion with mifepristone followed by misoprostol according to the site's standard criteria;
- She is willing to use the semiquantitative pregnancy test at home;
- She is wiling and able to comply with the study procedures;
- She speaks and reads English;
- She has signed the study informed consent form.
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: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Home-based follow-up with SQPT
For the intervention, a semiquantitative pregnancy test (SQPT) will be performed at the health center before the participants take mifepristone, and again two weeks later by the participants, at home.
Study staff will call the participants at two weeks to follow-up with the participants.
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Participants will be followed-up at home.
They will receive an SQPT to perform at home two weeks after enrollment, and a scheduled follow-up phone call by study providers to determine the outcome of the procedure.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patients' compliance in performing the semiquantitative pregnancy test and reporting results
Time Frame: Within 2 weeks after medical abortion
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This will be assessed with a survey administered at the scheduled follow-up phone call.
The survey will determine if the patient performed the SQPT as requested, and whether they can interpret and report the results correctly.
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Within 2 weeks after medical abortion
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Elizabeth Raymond, MD,MPH, Gynuity Health Projects
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
April 1, 2015
Primary Completion (Actual)
November 1, 2015
Study Completion (Actual)
November 1, 2015
Study Registration Dates
First Submitted
August 11, 2015
First Submitted That Met QC Criteria
August 13, 2015
First Posted (Estimate)
August 17, 2015
Study Record Updates
Last Update Posted (Estimate)
March 4, 2016
Last Update Submitted That Met QC Criteria
March 3, 2016
Last Verified
March 1, 2016
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 1024
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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