Pregnancy Related Clinical Trial
Official title:
Alternative Provision of Medication Abortion Via Pharmacy Dispensing
NCT number | NCT03320057 |
Other study ID # | A128753 |
Secondary ID | |
Status | Completed |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | June 1, 2018 |
Est. completion date | July 4, 2020 |
Verified date | June 2021 |
Source | University of California, San Francisco |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This mixed-methods study follows a prospective cohort of patients receiving Mifeprex ® (mifepristone) for medication abortion dispensed by pharmacists after undergoing standard clinical evaluation. Women participating in this study will obtain mifepristone and misoprostol from the pharmacy instead of in the clinic. To assess feasibility, acceptability, and effectiveness of pharmacy dispensing of mifepristone, the study will survey patients, evaluate their clinical outcomes from electronic health records, and survey and interview pharmacists at study sites.
Status | Completed |
Enrollment | 326 |
Est. completion date | July 4, 2020 |
Est. primary completion date | July 4, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 15 Years and older |
Eligibility | Patient Inclusion Criteria: - Women seeking medication abortion through 70 days gestation - 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 Patient Exclusion Criteria: - Not pregnant - 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. |
Country | Name | City | State |
---|---|---|---|
United States | 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 |
Lead Sponsor | Collaborator |
---|---|
Daniel Grossman | Kaiser Permanente, Planned Parenthood of the Great Northwest and the Hawaiian Islands, University of California, Davis, University of California, San Diego, University of Washington |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Pharmacists Who Objected to Participate in Dispensing Mifeprex | Number of pharmacists who objected to participate in dispensing Mifeprex at least once during the study period. This includes pharmacists who declined participation in the study training on medication abortion due to discomfort as well as pharmacists who participated in the training but declined to dispense Mifeprex. | End of the study, month 24 | |
Primary | Number of Pharmacists Who Report Being Satisfied With Pharmacy Dispensing of Mifeprex | Number of pharmacists who report being "somewhat satisfied" or "very satisfied" when asked "Overall, how satisfied are you with mifepristone dispensing at your pharmacy?" in endline survey | End of the study, month 24 | |
Secondary | Number of Participants Who Report Being Satisfied With Obtaining Mifeprex in the Pharmacy | Number of participants who report being "somewhat satisfied" or "very satisfied" when asked "Overall, how satisfied were you with your experience at the pharmacy when you got the abortion pill?" | Day 2 following initial medication abortion visit | |
Secondary | Number of Participants With a Complete Abortion With Medication Alone and Who do Not Require a Surgical Procedure to Complete the Abortion | Number of participants who report that their "abortion is now complete and they are no longer pregnant" and who did not "end up having a suction procedure (or vacuum aspiration or dilation and curettage procedure) to complete the abortion" | Up to 6 weeks after initial visit | |
Secondary | Number of Participants With an Adverse Event | Number of participants who had a medical problem that required them to go to the hospital, emergency department or a doctor's office (other than regularly scheduled follow-up visit) since receiving the abortion pill | Up to 6 weeks after initial visit | |
Secondary | Difference in Pharmacists' Mean Knowledge Score Related to Medication Abortion | Difference in pharmacists' mean knowledge score related to medication abortion. Knowledge scores were based on a set of 15 statements or questions related to medication abortion for which respondents selected answer(s) from multiple choice response options. Topics included medication abortion dosing regimen, biological processes during medication abortion, clinical outcomes, and federal and state policies relating to medication abortion. For pharmacists who had completed at least 50% of the items, we calculated their average number of correct responses among completed items, as a proportion of correct answers, ranging from 0-1, with 1 meaning 100% correct. All questions or statements included an "I don't know" response option, which we coded as incorrect. Higher scores mean a higher level of knowledge. | Before and after the intervention, approximately month 1 and month 18 of the study to assess differences in knowledge |
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