Simplified Medical Abortion Follow-Up

Abortion Clinical Trial

Official title:

Simplified Medical Abortion Follow-Up Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02524990
• Other study ID #: 1024
• 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

• Abortion
• Pregnancy Tests

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