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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02524990
Other study ID # 1024
Secondary ID
Status Terminated
Phase N/A
First received August 11, 2015
Last updated March 3, 2016
Start date April 2015
Est. completion date November 2015

Study information

Verified date March 2016
Source Gynuity Health Projects
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Terminated
Enrollment 53
Est. completion date November 2015
Est. primary completion date November 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 11 Years to 56 Years
Eligibility 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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research


Related Conditions & MeSH terms


Intervention

Behavioral:
Home-based follow-up with SQPT
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.

Locations

Country Name City State
United States Carafem Health Center Chevy Chase Maryland

Sponsors (1)

Lead Sponsor Collaborator
Gynuity Health Projects

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Patients' compliance in performing the semiquantitative pregnancy test and reporting results 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. Within 2 weeks after medical abortion No
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