Phase 4
N=326
Medication Abortion Via Pharmacy Dispensing
Pregnancy Related · Abortion Early
Bottom Line
View on ClinicalTrials.gov: NCT03320057 ↗Enrolled (actual)
326
Serious AEs
0.0%
Results posted
Jul 2021
Primary outcome: Primary: Number of Pharmacists Who Objected to Participate in Dispensing Mifeprex — 4 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Mifepristone (Drug); Training on mifepristone dispensing (Other)
- Age
- Pediatric, Adult, Older Adult · 15+ yrs
- Sex
- Female
- Sponsor
- Daniel Grossman
- Primary completion
- Jul 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Pharmacists Who Objected to Participate in Dispensing Mifeprex |
4 | — |
| PRIMARY Number of Pharmacists Who Report Being Satisfied With Pharmacy Dispensing of Mifeprex |
36 | — |
| SECONDARY Number of Participants Who Report Being Satisfied With Obtaining Mifeprex in the Pharmacy |
230 | — |
| SECONDARY Number of Participants With a Complete Abortion With Medication Alone and Who do Not Require a Surgical Procedure to Complete the Abortion |
243 | — |
| SECONDARY Number of Participants With an Adverse Event |
4 | — |
| SECONDARY Difference in Pharmacists' Mean Knowledge Score Related to Medication Abortion |
0.51; 0.64 | <0.05 sig |
Summary
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03320057). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.