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

  • United States
    • Maryland
      • Chevy Chase, Maryland, United States, 20815
        • Carafem 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

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.
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.
Other Names:
  • Simplified Medical Abortion Follow-Up Study

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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gynuity Health Projects

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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