Skip to main content
OpenTrials
Completed

NCT Number: NCT03320057

Medication Abortion Via Pharmacy Dispensing

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pregnancy Related Abortion Early

Age range

15 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Obstetrics and Gynecology Family Planning Clinic at University of California Davis, Sacramento, California, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mifepristone

Drug

Patients will receive Mifeprex® (mifepristone) by pharmacy rather than standard care at clinic visit

Training on mifepristone dispensing

Other

Pharmacists were offered a training on medication abortion and mifepristone dispensing

Primary outcomes

  1. Number of Pharmacists Who Objected to Participate in Dispensing Mifeprex

    Time frame: End of the study, month 24

    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.

  2. Number of Pharmacists Who Report Being Satisfied With Pharmacy Dispensing of Mifeprex

    Time frame: End of the study, month 24

    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

Secondary outcomes

  1. Number of Participants Who Report Being Satisfied With Obtaining Mifeprex in the Pharmacy

    Time frame: Day 2 following initial medication abortion visit

    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?"

  2. Number of Participants With a Complete Abortion With Medication Alone and Who do Not Require a Surgical Procedure to Complete the Abortion

    Time frame: Up to 6 weeks after initial visit

    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"

  3. Number of Participants With an Adverse Event

    Time frame: Up to 6 weeks after initial visit

    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

  4. Difference in Pharmacists' Mean Knowledge Score Related to Medication Abortion

    Time frame: Before and after the intervention, approximately month 1 and month 18 of the study to assess differences in knowledge

    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.

Sponsors and collaborators

Lead sponsor

Daniel Grossman

Other

Collaborators

  • Kaiser Permanente
  • Planned Parenthood of the Great Northwest and Hawaiian Islands
  • University of California, Davis
  • University of California, San Diego
  • University of Washington

Registry information

Official study title

Alternative Provision of Medication Abortion Via Pharmacy Dispensing

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Oct 25, 2017
Registry last updated
Jul 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.