Clinical trial NCT01811056: Exploring a Patient-centered Approach to Mifepristone Administration in Medical Abortion
Official title: Exploring a Patient-centered Approach to Mifepristone Administration in Medical Abortion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Termination of Pregnancy
Keywords: medical abortion
mifepristone
Lead sponsor: Gynuity Health Projects
Sponsor class: OTHER
First posted: 2013-03-14
Enrollment: 401
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of participants who would choose outside of center administration of mifepristone again
timeFrame: 1-2 weeks
measure: Proportion of participants who would recommend outside-of-center administration to a friend
timeFrame: 1-2 weeks
Secondary outcomes:
measure: Proportion of women who select outside-of-clinic use of mifepristone
timeFrame: 1-2 weeks
measure: Success Rates/Method Failure
timeFrame: 1-2 weeks
measure: Adherence
timeFrame: 1-2 weeks
measure: Provider-related outcomes
timeFrame: 1-2 weeks
Other outcomes:
measure: Productivity
timeFrame: 1-2 weeks
measure: Reasons for selection of mifepristone administration site and experiences with home administration Reason
timeFrame: 1-2 weeks
Locations:
city: New York
country: United States
facility: Planned Parenthood of New York City
state: New York
city: Barre, Burlington, Rutland
country: United States
facility: Planned Parenthood of Northern New England
state: Vermont
city: Seattle
country: United States
facility: Planned Parenthood of the Great Northwest
state: Washington
Study officials:
affiliation: Gynuity Health Projects
name: Beverly Winikoff, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.