Termination of Pregnancy
Conditions
Keywords
medical abortion, mifepristone
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.
Interventions
DRUGMifepristone
Mifepristone use outside of the center
Sponsors
Gynuity Health Projects
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Provider-related outcomes | 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 |
| Success Rates/Method Failure | 1-2 weeks | Ongoing pregnancy at study end Incomplete abortion at study end Medically indicated surgical intervention during study |
| Adherence | 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 |
| Proportion of women who select outside-of-clinic use of mifepristone | 1-2 weeks | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Reasons for selection of mifepristone administration site and experiences with home administration Reason | 1-2 weeks | Reasons for selection of mifepristone administration site and experiences with home administration |
| Productivity | 1-2 weeks | Missed days of school and/or work Additional costs for childcare or eldercare |
Countries
United States
Outcome results
None listed