Self-Assessment of Medical Abortion Outcome Using Serial Multi-level Pregnancy Tests

April 28, 2017 updated by: Gynuity Health Projects
This study aims to investigate the effectiveness and acceptability of the multi-level pregnancy test for self-assessment of abortion outcomes, without a routine provider contact.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

343

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
    • Florida
      • West Palm Beach, Florida, United States, 33407
        • Presidential Women's Center
    • Maryland
      • Chevy Chase, Maryland, United States, 20815
        • Carafem
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19106
        • Philadelphia Women's 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

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Gestational age of less than or equal to 63 days
  • 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
  • Willing to use the MLPT at home
  • 11-56 years old
  • Willing and able to comply with study procedures
  • In the judgement of the site investigator, she is capable of giving informed consent and she has signed the study informed consent or assent form

Exclusion Criteria:

-

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: Self-assessment of abortion outcome
Patients enrolled in the study will self-assess the outcomes of their medical abortion with the aid of a multi-level pregnancy test (MLPT) which they will perform at home.
Behavioral: Self-assessment
Patients enrolled into the study will do a multi-level pregnancy test (MLPT) at enrollment, and will receive one MLPT to do at home one week after taking mifepristone and misoprostol. They will be instructed to call the study site if the at-home MLPT result do not decline, or if they experience any abortion complications.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of subjects who fail to contact the clinic when indicated within two weeks after taking the mifepristone
Time Frame: One month
One month

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

September 1, 2015

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

October 5, 2015

First Submitted That Met QC Criteria

October 5, 2015

First Posted (Estimate)

October 7, 2015

Study Record Updates

Last Update Posted (Actual)

May 1, 2017

Last Update Submitted That Met QC Criteria

April 28, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • 1033

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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