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Medication Abortion Via Pharmacy Dispensing

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ClinicalTrials.gov Identifier: NCT03320057
Recruitment Status : Completed
First Posted : October 25, 2017
Results First Posted : July 12, 2021
Last Update Posted : July 12, 2021
Sponsor:
Collaborators:
University of California, San Diego
University of California, Davis
University of Washington
Kaiser Permanente
Planned Parenthood of the Great Northwest and the Hawaiian Islands
Information provided by (Responsible Party):
Daniel Grossman, University of California, San Francisco

Brief 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.

Condition or disease Intervention/treatment Phase
Pregnancy Related Abortion Early Drug: Mifepristone Other: Training on mifepristone dispensing Phase 4

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 326 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective cohort
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Alternative Provision of Medication Abortion Via Pharmacy Dispensing
Actual Study Start Date : June 1, 2018
Actual Primary Completion Date : July 4, 2020
Actual Study Completion Date : July 4, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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)
Drug: 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
Other: Training on mifepristone dispensing
Pharmacists were offered a training on medication abortion and mifepristone dispensing




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Females seeking medication abortion
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03320057


Locations
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United States, California
Obstetrics and Gynecology Family Planning Clinic at University of California Davis
Sacramento, California, United States, 95817
Women's Health Services at University of California San Diego
San Diego, California, United States, 92103
Kaiser Permanente Northern California
San Francisco, California, United States, 94115
Mt. Zion Women's Options Clinic, University
San Francisco, California, United States, 94115
United States, Washington
University of Washington
Seattle, Washington, United States, 98105
Planned Parenthood Great Northwest, Hawai'i, Alaska, Indiana, Kentucky
Tacoma, Washington, United States, 98405
Sponsors and Collaborators
Daniel Grossman
University of California, San Diego
University of California, Davis
University of Washington
Kaiser Permanente
Planned Parenthood of the Great Northwest and the Hawaiian Islands
Investigators
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Principal Investigator: Daniel Grossman, MD University of California, San Francisco
  Study Documents (Full-Text)

Documents provided by Daniel Grossman, University of California, San Francisco:
Study Protocol  [PDF] January 9, 2020
Statistical Analysis Plan  [PDF] May 1, 2021

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Daniel Grossman, Professor in Dept ObGyn and Director of Advancing New Standards in Reproductive Health, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03320057    
Other Study ID Numbers: A128753
First Posted: October 25, 2017    Key Record Dates
Results First Posted: July 12, 2021
Last Update Posted: July 12, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Daniel Grossman, University of California, San Francisco:
medication abortion
mifepristone
Additional relevant MeSH terms:
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Mifepristone
Abortifacient Agents, Steroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Contraceptives, Postcoital, Synthetic
Contraceptives, Postcoital
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Luteolytic Agents
Menstruation-Inducing Agents