Skip to main content

Summary

for females ages 15 years and up (full criteria)
healthy people welcome
at San Francisco, California and other locations
study started
estimated completion:

Description

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.

Official Title

Alternative Provision of Medication Abortion Via Pharmacy Dispensing

Details

Improving access to and efficiency of abortion provision is important for patients and providers. The Risk Evaluation and Mitigation Strategy (REMS) requires that Mifeprex ® ( mifepristone) be dispensed only from a doctor's office, clinic or hospital (not from a pharmacy by prescription) by a certified health care provider and the health care provider must obtained a signed Patient Agreement Form before dispensing mifepristone. Data are needed to investigate the feasibility, acceptability, and effectiveness of pharmacy dispensing of mifepristone. In order to address the study question, a mixed methods study design is appropriate. To assess feasibility, the study will collect data on pharmacists' satisfaction with dispensing mifepristone. To assess acceptability, qualitative data will be collected from pharmacists about their perspectives on dispensing Mifeprex before and after the study, as well as measure patient satisfaction through open-ended and close-ended survey questions. To assess effectiveness of the pharmacy dispensing model, the study will evaluate clinical outcomes from electronic health records. The proposed feasibility study would take place at sites in California and Washington states.

Keywords

Pregnancy Related Abortion Early medication abortion mifepristone

Eligibility

For females ages 15 years and up

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.

Locations

  • Mt. Zion Women's Options Clinic, University not yet accepting patients
    San Francisco, California, 94115, United States
  • Obstetrics and Gynecology Family Planning Clinic at University of California Davis not yet accepting patients
    Sacramento, California, 95817, United States

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT03320057
Phase
Phase 4
Lead Scientist
Daniel Grossman
Study Type
Interventional
Last Updated
October 30, 2017
I’m interested in this study!