A Phase 4 interventional study of Mifepristone and Training on mifepristone dispensing in Pregnancy Related and Abortion Early, sponsored by Daniel Grossman. Completed at 6 sites in United States. Open to female participants aged 15 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-07-12.
Sponsored by Daniel Grossman · Phase 4, Interventional, and Health services research
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.
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.
Patient Inclusion Criteria:
Patient Exclusion Criteria:
Contraindications for medication abortion
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
Pharmacists providing services at one of the study pharmacies during the study
Other: Training on mifepristone dispensing
Patients will receive Mifeprex® (mifepristone) by pharmacy rather than standard care at clinic visit
Pharmacists were offered a training on medication abortion and mifepristone dispensing
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.
Time frame: End of the study, month 24
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
Time frame: End of the study, month 24
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?"
Time frame: Day 2 following initial medication abortion visit
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"
Time frame: Up to 6 weeks after initial visit
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
Time frame: Up to 6 weeks after initial visit
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.
Time frame: Before and after the intervention, approximately month 1 and month 18 of the study to assess differences in knowledge
Patient Recruitment: Study recruitment began in July 2018 and was halted before reaching our desired sample size in March 2020 owing to the coronavirus disease 2019 (COVID-19) pandemic, which limited the ability to have research staff in clinical facilities and lengthen patient visits for the purposes of research consent. Pharmacist Recruitment: We invited all pharmacists providing services at the study pharmacies to participate in the study and dispense mifepristone to study patients.
| Milestone | Medication Abortion Patients | Pharmacist Providing Services at One of the Study Pharmacies During the Study |
|---|---|---|
| Started | 266 | 60 |
| Patient's clinical outcome information obtained | 262 | 0 |
| Received pharmacist training | 0 | 56 |
| Pharmacists completed baseline survey | 0 | 47 |
| Completed | 260 | 43 |
| Not completed | 6 | 17 |
| Withdrew: Lost to follow-up | 4 | 17 |
| Withdrew: Did not take mifepristone or misoprostol | 2 | 0 |
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.
| Participants | Pharmacists |
|---|---|
| Number of Pharmacists Who Objected to Participate in Dispensing Mifeprex | 4 |
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
| Participants | Pharmacists |
|---|---|
| Number of Pharmacists Who Report Being Satisfied With Pharmacy Dispensing of Mifeprex | 36 |
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?"
| Participants | Medication Abortion Patients |
|---|---|
| Number of Participants Who Report Being Satisfied With Obtaining Mifeprex in the Pharmacy | 230 |
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"
| Participants | Medication Abortion Patients |
|---|---|
| Number of Participants With a Complete Abortion With Medication Alone and Who do Not Require a Surgical Procedure to Complete the Abortion | 243 |
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
| Participants | Medication Abortion Patients |
|---|---|
| Number of Participants With an Adverse Event | 4 |
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.
| score on a scale | Pharmacists |
|---|---|
| Baseline knowledge score | 0.51 ± 0.21 |
| Endline knowledge score | 0.64 ± 0.24 |
Collected over Patients: Up to 6 weeks after initial visit Pharmacists: study duration including training, mifepristone dispensing, survey data collection (approximately 24 months). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Medication Abortion Patients | 0/260 (0%) | 0/260 (0%) | 4/260 (1.5%) |
| Pharmacists | 0/60 (0%) | 0/60 (0%) | 0/60 (0%) |
| Event | Medication Abortion Patients | Pharmacists |
|---|---|---|
| DehydrationGeneral disorders | 1/260 | 0/60 |
| Heavy uterine bleedingReproductive system and breast disorders | 1/260 | 0/60 |
| Pelvic Inflammatory DiseaseReproductive system and breast disorders | 1/260 | 0/60 |
| Swelling in cheeksSkin and subcutaneous tissue disorders | 1/260 | 0/60 |
The baseline analysis population includes patient study participants having medication abortion and receiving mifepristone at a study pharmacy. Pharmacist participants are not reported here as baseline demographics were not collected from them.
| Age, Continuous(years) | Medication Abortion Patients |
|---|---|
| Median | 28 (16 to 44) |
| Age, Customized(Participants) | Medication Abortion Patients |
|---|---|
| Age, Categorical — 16-20 years | 22 |
| Age, Categorical — 21-24 years | 45 |
| Age, Categorical — 25-29 years | 78 |
| Age, Categorical — 30-34 years | 69 |
| Age, Categorical — 35-44 years | 46 |
| Sex: Female, Male(Participants) | Medication Abortion Patients |
|---|---|
| Female | — |
| Male | — |
| Race/Ethnicity, Customized(Participants) | Medication Abortion Patients |
|---|---|
| Race and ethnicity, Categorical — Non-Hispanic White | 99 |
| Race and ethnicity, Categorical — Non-Hispanic Black | 29 |
| Race and ethnicity, Categorical — Hispanic | 65 |
| Race and ethnicity, Categorical — Asian or Pacific Islander | 45 |
| Race and ethnicity, Categorical — Alaska Native or Native American | 2 |
| Race and ethnicity, Categorical — Other and mixed race and ethnicity | 19 |
| Race and ethnicity, Categorical — Missing | 1 |
| Region of Enrollment(participants) | Medication Abortion Patients |
|---|---|
| United States | 260 |
| Education, Categorical(Participants) | Medication Abortion Patients |
|---|---|
| High school or less | 39 |
| Some college or professional school | 93 |
| College degree | 90 |
| Advanced degree | 28 |
| Missing | 10 |
| Relationship status, Categorical(Participants) | Medication Abortion Patients |
|---|---|
| Neither married nor in a relationship | 84 |
| Married | 54 |
| Committed relationship | 110 |
| Missing | 12 |
| Parity(Participants) | Medication Abortion Patients |
|---|---|
| Nulliparous | 171 |
| Parous | 89 |
3 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
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