Simplified Medical Abortion Follow-Up

NCT ID: NCT02524990

Last Updated: 2016-03-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2015-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Abortion Pregnancy Tests

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Home-based follow-up with SQPT

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Simplified Medical Abortion Follow-Up Study

Eligibility Criteria

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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.
Minimum Eligible Age

11 Years

Maximum Eligible Age

56 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Gynuity Health Projects

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Elizabeth Raymond, MD,MPH

Role: STUDY_DIRECTOR

Gynuity Health Projects

Locations

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Carafem Health Center

Chevy Chase, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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1024

Identifier Type: -

Identifier Source: org_study_id

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