Termination of Pregnancy Clinical Trial
Official title:
Exploring a Patient-centered Approach to Mifepristone Administration in Medical Abortion
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 |
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.
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 |
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
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 |
Lead Sponsor | Collaborator |
---|---|
Gynuity Health Projects |
United States,
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
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 |
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