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

Termination of Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01811056
• Other study ID #: 1006
• Status: Completed
• Phase: N/A
• First received: March 11, 2013
• Last updated: August 11, 2015
• Start date: April 2013
• Est. completion date: July 2014

Study information

• Verified date: August 2015
• Source: Gynuity Health Projects
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 401
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Termination of Pregnancy

Intervention

Drug:
• Mifepristone
Mifepristone use outside of the center

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Gynuity Health Projects

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Productivity	Missed days of school and/or work Additional costs for childcare or eldercare	1-2 weeks	No
Other	Reasons for selection of mifepristone administration site and experiences with home administration Reason	Reasons for selection of mifepristone administration site and experiences with home administration	1-2 weeks	No
Primary	Proportion of participants who would choose outside of center administration of mifepristone again		1-2 weeks	No
Primary	Proportion of participants who would recommend outside-of-center administration to a friend		1-2 weeks	No
Secondary	Proportion of women who select outside-of-clinic use of mifepristone		1-2 weeks	No
Secondary	Success Rates/Method Failure	Ongoing pregnancy at study end Incomplete abortion at study end Medically indicated surgical intervention during study	1-2 weeks	No
Secondary	Adherence	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	No
Secondary	Provider-related outcomes	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	No

External Links

•   Gynuity Health Projects Website