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Pregnancy RelatedPhase 4NCT03320057

Medication Abortion Via Pharmacy Dispensing

A Phase 4 study testing Mifepristone and Training on mifepristone dispensing in people with Pregnancy Related and Abortion Early, run by Daniel Grossman at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 15 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Pregnancy Related, Abortion Early
What is being tested?
Mifepristone and Training on mifepristone dispensing
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
326 participants
Where
6 sitesUnited States
Study dates
1 Jun 2018to 4 Jul 2020
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 years and older
  • Women only
  • Healthy volunteers accepted
  • Child, Adult, Older adult

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.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • Obstetrics and Gynecology Family Planning Clinic at University of California Davis

    Sacramento, California, 95817

  • Women's Health Services at University of California San Diego

    San Diego, California, 92103

  • Kaiser Permanente Northern California

    San Francisco, California, 94115

  • Mt. Zion Women's Options Clinic, University

    San Francisco, California, 94115

  • University of Washington

    Seattle, Washington, 98105

  • Planned Parenthood Great Northwest, Hawai'i, Alaska, Indiana, Kentucky

    Tacoma, Washington, 98405

Other trials in United States

About this study

Official title: Alternative Provision of 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.

Read the 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.

Being tested
Mifepristone, Training on mifepristone dispensing
Keywords
medication abortion, mifepristone

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MifepristoneDrug

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

  • Training on mifepristone dispensingOther

    Pharmacists were offered a training on medication abortion and mifepristone dispensing

Study groups in NCT03320057
Study groupRoleWhat they receive
Medication abortion patientsExperimentalOral 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)
Receives: Drug: Mifepristone
PharmacistsOtherPharmacists providing services at one of the study pharmacies during the study
Receives: Other: Training on mifepristone dispensing

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: End of the study, month 24

  2. 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

    Measured: End of the study, month 24

Secondary outcomes (4)

  1. 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?"

    Measured: Day 2 following initial medication abortion visit

  2. 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"

    Measured: Up to 6 weeks after initial visit

  3. 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

    Measured: Up to 6 weeks after initial visit

  4. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Oct 2017
  2. Study start1 Jun 2018
  3. Primary completion4 Jul 2020
  4. Study completion4 Jul 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Health services research
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Prospective cohort
Masking
None (open label)
Enrolment
326 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03320057
Sponsor's protocol ID
A128753
Status last verified
Jun 2021
First submitted
26 Sep 2017
Last updated
12 Jul 2021
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kaller S, Morris N, Biggs MA, Baba CF, Rafie S, Raine-Bennett TR, Creinin MD, Berry E, Micks EA, Meckstroth KR, Averbach S, Grossman D. Pharmacists' knowledge, perspectives, and experiences with mifepristone dispensing for medication abortion. J Am Pharm Assoc (2003). 2021 Nov-Dec;61(6):785-794.e1. doi: 10.1016/j.japh.2021.06.017. Epub 2021 Jun 18.

    PubMed 34281806

  • Grossman D, Baba CF, Kaller S, Biggs MA, Raifman S, Gurazada T, Rafie S, Averbach S, Meckstroth KR, Micks EA, Berry E, Raine-Bennett TR, Creinin MD. Medication Abortion With Pharmacist Dispensing of Mifepristone. Obstet Gynecol. 2021 Apr 1;137(4):613-622. doi: 10.1097/AOG.0000000000004312.

    PubMed 33706339

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Mifepristone and Training on mifepristone dispensing in people with Pregnancy Related and Abortion Early, run by Daniel Grossman at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Pharmacists Who Objected to Participate in Dispensing Mifeprex (time frame: End of the study, month 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03320057, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2021.

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