Exploring a Patient-centered Approach to Mifepristone Administration in Medical Abortion

August 11, 2015 updated by: Gynuity Health Projects
This study will test ways to give women more options and flexibility when they are ending their unwanted pregnancies. The investigators will look at uptake and acceptability of using mifepristone outside of the clinic for pregnancy termination.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study will investigate the uptake of mifepristone administration outside of the health center for pregnancy termination and its acceptability to women and to their providers. In addition, we plan to evaluate rates of follow-up, adherence, efficacy, complications, days of missed work and/or school, and lost income. This will be a prospective, comparative, non-randomized, open-label study. All women who are seeking medical abortion will be offered participation in the study. Women who enroll in the study will be given a choice between taking the mifepristone outside the center or in the center setting.

Study Type

Interventional

Enrollment (Actual)

401

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
    • New York
      • New York, New York, United States
        • Planned Parenthood of New York City
    • Vermont
      • Barre, Burlington, Rutland, Vermont, United States
        • Planned Parenthood of Northern New England
    • Washington
      • Seattle, Washington, United States
        • Planned Parenthood of the Great Northwest

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women 18 years and older
  • seeking medical abortion services
  • in general good health
  • assessed by a clinician to have an intrauterine pregnancy less than 64 days L.M.P on the day mifepristone will be taken
  • eligible for medical abortion according to clinician and center standards.

Exclusion Criteria:

  • will be followed up by beta HCG and not ultrasound

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: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: In-Center Use of Mifepristone
Participants who choose to take mifepristone in the center
EXPERIMENTAL: Out-of-Center Use of Mifepristone
Participants who choose to take the mifepristone outside of the center
Drug: Mifepristone
Mifepristone use outside of the center
Other Names:
  • mifeprex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of participants who would choose outside of center administration of mifepristone again
Time Frame: 1-2 weeks
1-2 weeks
Proportion of participants who would recommend outside-of-center administration to a friend
Time Frame: 1-2 weeks
1-2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of women who select outside-of-clinic use of mifepristone
Time Frame: 1-2 weeks
1-2 weeks
Success Rates/Method Failure
Time Frame: 1-2 weeks
Ongoing pregnancy at study end Incomplete abortion at study end Medically indicated surgical intervention during study
1-2 weeks
Adherence
Time Frame: 1-2 weeks
Did not take complete therapy Mifepristone not taken at scheduled time Mifepristone not taken within 63 days L.M.P. Misoprostol not taken within 48 hours of mifepristone administration Did not return for confirmation of outcome
1-2 weeks
Provider-related outcomes
Time Frame: 1-2 weeks
Unscheduled visits to center Unscheduled calls to center/clinician on-call Provider satisfaction- better than center mifepristone, equivalent, or worse; impact on workload; impact on quality of care
1-2 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Productivity
Time Frame: 1-2 weeks
Missed days of school and/or work Additional costs for childcare or eldercare
1-2 weeks
Reasons for selection of mifepristone administration site and experiences with home administration Reason
Time Frame: 1-2 weeks
Reasons for selection of mifepristone administration site and experiences with home administration
1-2 weeks

Collaborators and Investigators

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

Sponsor

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

Helpful Links

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, 2013

Primary Completion (ACTUAL)

July 1, 2014

Study Completion (ACTUAL)

July 1, 2014

Study Registration Dates

First Submitted

March 11, 2013

First Submitted That Met QC Criteria

March 13, 2013

First Posted (ESTIMATE)

March 14, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

August 13, 2015

Last Update Submitted That Met QC Criteria

August 11, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1006 (Other Identifier: Hungarian National Center for Public Health and Pharmacy (NCPHP))

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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