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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Termination of Pregnancy

Intervention / Treatment
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* Drug: Mifepristone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: In-Center Use of Mifepristone<br>Participants who choose to take mifepristone in the center | |
| Experimental: Out-of-Center Use of Mifepristone<br>Participants who choose to take the mifepristone outside of the center | Drug: Mifepristone<br>* Mifepristone use outside of the center<br>* Other names: mifeprex;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of women who select outside-of-clinic use of mifepristone |  | 1-2 weeks | 
| Success Rates/Method Failure | Ongoing pregnancy at study end Incomplete abortion at study end Medically indicated surgical intervention during study | 1-2 weeks | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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medical abortion, mifepristone