Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
326 participants
INTERVENTIONAL
2018-06-01
2020-07-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Medication abortion patients
Oral mifepristone 200 mg, followed by misoprostol 800 mcg administered buccally (at 24-48 hours following mifepristone) or vaginally (as soon as 6 hours following mifepristone)
Mifepristone
Patients will receive Mifeprex® (mifepristone) by pharmacy rather than standard care at clinic visit
Pharmacists
Pharmacists providing services at one of the study pharmacies during the study
Training on mifepristone dispensing
Pharmacists were offered a training on medication abortion and mifepristone dispensing
Interventions
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Mifepristone
Patients will receive Mifeprex® (mifepristone) by pharmacy rather than standard care at clinic visit
Training on mifepristone dispensing
Pharmacists were offered a training on medication abortion and mifepristone dispensing
Eligibility Criteria
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Inclusion Criteria
* Eligible for Mifeprex® at a study clinical site
* English or Spanish speaking
* Willing and able to participate in the study, including willing to go to the study pharmacy to obtain mifepristone
Exclusion Criteria
* Not seeking medication abortion
* Under the age of 15
* Contraindications for medication abortion
* All pharmacists providing services at one of the study pharmacies during the study are eligible for the pharmacist survey and interview.
15 Years
FEMALE
Yes
Sponsors
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University of California, San Diego
OTHER
University of California, Davis
OTHER
University of Washington
OTHER
Kaiser Permanente
OTHER
Planned Parenthood of the Great Northwest and Hawaiian Islands
OTHER
Daniel Grossman
OTHER
Responsible Party
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Daniel Grossman
Professor in Dept ObGyn and Director of Advancing New Standards in Reproductive Health
Principal Investigators
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Daniel Grossman, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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Obstetrics and Gynecology Family Planning Clinic at University of California Davis
Sacramento, California, United States
Women's Health Services at University of California San Diego
San Diego, California, United States
Kaiser Permanente Northern California
San Francisco, California, United States
Mt. Zion Women's Options Clinic, University
San Francisco, California, United States
University of Washington
Seattle, Washington, United States
Planned Parenthood Great Northwest, Hawai'i, Alaska, Indiana, Kentucky
Tacoma, Washington, United States
Countries
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References
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Kaller S, Morris N, Biggs MA, Baba CF, Rafie S, Raine-Bennett TR, Creinin MD, Berry E, Micks EA, Meckstroth KR, Averbach S, Grossman D. Pharmacists' knowledge, perspectives, and experiences with mifepristone dispensing for medication abortion. J Am Pharm Assoc (2003). 2021 Nov-Dec;61(6):785-794.e1. doi: 10.1016/j.japh.2021.06.017. Epub 2021 Jun 18.
Grossman D, Baba CF, Kaller S, Biggs MA, Raifman S, Gurazada T, Rafie S, Averbach S, Meckstroth KR, Micks EA, Berry E, Raine-Bennett TR, Creinin MD. Medication Abortion With Pharmacist Dispensing of Mifepristone. Obstet Gynecol. 2021 Apr 1;137(4):613-622. doi: 10.1097/AOG.0000000000004312.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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A128753
Identifier Type: -
Identifier Source: org_study_id
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