NCT01811056

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
401

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2013

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 11, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 14, 2013

Completed
18 days until next milestone

Study Start

First participant enrolled

April 1, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

August 13, 2015

Status Verified

August 1, 2015

Enrollment Period

1.2 years

First QC Date

March 11, 2013

Last Update Submit

August 11, 2015

Conditions

Termination of Pregnancy

Keywords

medical abortionmifepristone

Outcome Measures

Primary Outcomes (2)

  • Proportion of participants who would choose outside of center administration of mifepristone again

    1-2 weeks

  • Proportion of participants who would recommend outside-of-center administration to a friend

    1-2 weeks

Secondary Outcomes (4)

  • Proportion of women who select outside-of-clinic use of mifepristone

    1-2 weeks

  • Success Rates/Method Failure

    1-2 weeks

  • Adherence

    1-2 weeks

  • Provider-related outcomes

    1-2 weeks

Other Outcomes (2)

  • Productivity

    1-2 weeks

  • Reasons for selection of mifepristone administration site and experiences with home administration Reason

    1-2 weeks

Study Arms (2)

In-Center Use of Mifepristone

NO INTERVENTION

Participants who choose to take mifepristone in the center

Out-of-Center Use of Mifepristone

EXPERIMENTAL

Participants who choose to take the mifepristone outside of the center

Drug: Mifepristone

Interventions

MifepristoneDRUG

Mifepristone use outside of the center

Also known as: mifeprex
Out-of-Center Use of Mifepristone

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • will be followed up by beta HCG and not ultrasound

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Planned Parenthood of New York City

New York, New York, United States

Location

Planned Parenthood of Northern New England

Barre, Burlington, Rutland, Vermont, United States

Location

Planned Parenthood of the Great Northwest

Seattle, Washington, United States

Location

Related Publications (2)

  • Swica Y, Chong E, Middleton T, Prine L, Gold M, Schreiber CA, Winikoff B. Acceptability of home use of mifepristone for medical abortion. Contraception. 2013 Jul;88(1):122-7. doi: 10.1016/j.contraception.2012.10.021. Epub 2012 Nov 21.

    PMID: 23177917BACKGROUND

  • Chong E, Frye LJ, Castle J, Dean G, Kuehl L, Winikoff B. A prospective, non-randomized study of home use of mifepristone for medical abortion in the U.S. Contraception. 2015 Sep;92(3):215-9. doi: 10.1016/j.contraception.2015.06.026. Epub 2015 Jul 2.

    PMID: 26142620RESULT

Related Links

MeSH Terms

Interventions

Mifepristone

Intervention Hierarchy (Ancestors)

EstrenesEstranesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Beverly Winikoff, MD, MPH

    Gynuity Health Projects

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2013

First Posted

March 14, 2013

Study Start

April 1, 2013

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

August 13, 2015

Record last verified: 2015-08

Locations

US(3)