Trial Outcomes & Findings for Medication Abortion Via Pharmacy Dispensing (NCT NCT03320057)
NCT ID: NCT03320057
Last Updated: 2021-07-12
Results Overview
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.
COMPLETED
PHASE4
326 participants
End of the study, month 24
2021-07-12
Participant Flow
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.
Research staff assessed 499 patients for eligibility, of whom 233 were ineligible (n=163) or declined to participate (n=70). We enrolled 266 patient participants, all of whom received the study medications from the pharmacy. We invited 72 pharmacists working at six study pharmacy sites to participate in the study, including training to dispense mifepristone and completion of the baseline survey.
Participant milestones
| Measure |
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)
Mifepristone: Patients will receive Mifeprex® (mifepristone) by pharmacy rather than standard care at clinic visit
|
Pharmacist Providing Services at One of the Study Pharmacies During the Study
All pharmacists providing services at one of the study pharmacies during the study were invited to participate in the training on dispensing mifepristone and surveys. Only trained pharmacists were eligible to participate in the endline survey.
|
|---|---|---|
|
Overall Study
STARTED
|
266
|
60
|
|
Overall Study
Patient's Clinical Outcome Information Obtained
|
262
|
0
|
|
Overall Study
Received Pharmacist Training
|
0
|
56
|
|
Overall Study
Pharmacists Completed Baseline Survey
|
0
|
47
|
|
Overall Study
COMPLETED
|
260
|
43
|
|
Overall Study
NOT COMPLETED
|
6
|
17
|
Reasons for withdrawal
| Measure |
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)
Mifepristone: Patients will receive Mifeprex® (mifepristone) by pharmacy rather than standard care at clinic visit
|
Pharmacist Providing Services at One of the Study Pharmacies During the Study
All pharmacists providing services at one of the study pharmacies during the study were invited to participate in the training on dispensing mifepristone and surveys. Only trained pharmacists were eligible to participate in the endline survey.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
17
|
|
Overall Study
Did not take mifepristone or misoprostol
|
2
|
0
|
Baseline Characteristics
Medication Abortion Via Pharmacy Dispensing
Baseline characteristics by cohort
| Measure |
Medication Abortion Patients
n=260 Participants
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)
Mifepristone: Patients will receive Mifeprex® (mifepristone) by pharmacy rather than standard care at clinic visit
|
|---|---|
|
Age, Continuous
|
28 years
n=260 Participants
|
|
Age, Customized
Age, Categorical · 16-20 years
|
22 Participants
n=260 Participants
|
|
Age, Customized
Age, Categorical · 21-24 years
|
45 Participants
n=260 Participants
|
|
Age, Customized
Age, Categorical · 25-29 years
|
78 Participants
n=260 Participants
|
|
Age, Customized
Age, Categorical · 30-34 years
|
69 Participants
n=260 Participants
|
|
Age, Customized
Age, Categorical · 35-44 years
|
46 Participants
n=260 Participants
|
|
Race/Ethnicity, Customized
Race and ethnicity, Categorical · Non-Hispanic White
|
99 Participants
n=260 Participants
|
|
Race/Ethnicity, Customized
Race and ethnicity, Categorical · Non-Hispanic Black
|
29 Participants
n=260 Participants
|
|
Race/Ethnicity, Customized
Race and ethnicity, Categorical · Hispanic
|
65 Participants
n=260 Participants
|
|
Race/Ethnicity, Customized
Race and ethnicity, Categorical · Asian or Pacific Islander
|
45 Participants
n=260 Participants
|
|
Race/Ethnicity, Customized
Race and ethnicity, Categorical · Alaska Native or Native American
|
2 Participants
n=260 Participants
|
|
Race/Ethnicity, Customized
Race and ethnicity, Categorical · Other and mixed race and ethnicity
|
19 Participants
n=260 Participants
|
|
Race/Ethnicity, Customized
Race and ethnicity, Categorical · Missing
|
1 Participants
n=260 Participants
|
|
Region of Enrollment
United States
|
260 participants
n=260 Participants
|
|
Education, Categorical
High school or less
|
39 Participants
n=260 Participants
|
|
Education, Categorical
Some college or professional school
|
93 Participants
n=260 Participants
|
|
Education, Categorical
College degree
|
90 Participants
n=260 Participants
|
|
Education, Categorical
Advanced degree
|
28 Participants
n=260 Participants
|
|
Education, Categorical
Missing
|
10 Participants
n=260 Participants
|
|
Relationship status, Categorical
Neither married nor in a relationship
|
84 Participants
n=260 Participants
|
|
Relationship status, Categorical
Married
|
54 Participants
n=260 Participants
|
|
Relationship status, Categorical
Committed relationship
|
110 Participants
n=260 Participants
|
|
Relationship status, Categorical
Missing
|
12 Participants
n=260 Participants
|
|
Parity
Nulliparous
|
171 Participants
n=260 Participants
|
|
Parity
Parous
|
89 Participants
n=260 Participants
|
|
History of abortion, Categorical
None
|
165 Participants
n=260 Participants
|
|
History of abortion, Categorical
Previous medication abortion
|
48 Participants
n=260 Participants
|
|
History of abortion, Categorical
Previous procedural abortion only
|
40 Participants
n=260 Participants
|
|
History of abortion, Categorical
Missing
|
7 Participants
n=260 Participants
|
|
Gestational age at initial visit, Continuous
|
46 days
n=260 Participants
|
|
Gestational age at initial visit, Categorical
49 days or less
|
176 Participants
n=260 Participants
|
|
Gestational age at initial visit, Categorical
50-56 days
|
43 Participants
n=260 Participants
|
|
Gestational age at initial visit, Categorical
57-63 days
|
32 Participants
n=260 Participants
|
|
Gestational age at initial visit, Categorical
64-70 days
|
9 Participants
n=260 Participants
|
PRIMARY outcome
Timeframe: End of the study, month 24Population: Pharmacists invited to participate in mifepristone dispensing
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.
Outcome measures
| Measure |
Medication Abortion Patients
n=72 Participants
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)
Mifepristone: Patients will receive Mifeprex® (mifepristone) by pharmacy rather than standard care at clinic visit
|
|---|---|
|
Number of Pharmacists Who Objected to Participate in Dispensing Mifeprex
|
4 Participants
|
PRIMARY outcome
Timeframe: End of the study, month 24Population: Pharmacists at study pharmacist who were trained to dispense mifepristone and completed an endline survey
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
Outcome measures
| Measure |
Medication Abortion Patients
n=43 Participants
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)
Mifepristone: Patients will receive Mifeprex® (mifepristone) by pharmacy rather than standard care at clinic visit
|
|---|---|
|
Number of Pharmacists Who Report Being Satisfied With Pharmacy Dispensing of Mifeprex
|
36 Participants
|
SECONDARY outcome
Timeframe: Day 2 following initial medication abortion visitPopulation: Patient participants who completed Day 2 survey 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?"
Outcome measures
| Measure |
Medication Abortion Patients
n=252 Participants
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)
Mifepristone: Patients will receive Mifeprex® (mifepristone) by pharmacy rather than standard care at clinic visit
|
|---|---|
|
Number of Participants Who Report Being Satisfied With Obtaining Mifeprex in the Pharmacy
|
230 Participants
|
SECONDARY outcome
Timeframe: Up to 6 weeks after initial visitPopulation: Patient participants with abortion outcome information
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"
Outcome measures
| Measure |
Medication Abortion Patients
n=260 Participants
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)
Mifepristone: Patients will receive Mifeprex® (mifepristone) by pharmacy rather than standard care at clinic visit
|
|---|---|
|
Number of Participants With a Complete Abortion With Medication Alone and Who do Not Require a Surgical Procedure to Complete the Abortion
|
243 Participants
|
SECONDARY outcome
Timeframe: Up to 6 weeks after initial visitPopulation: Patients with follow-up data from clinical data or survey responses
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
Outcome measures
| Measure |
Medication Abortion Patients
n=260 Participants
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)
Mifepristone: Patients will receive Mifeprex® (mifepristone) by pharmacy rather than standard care at clinic visit
|
|---|---|
|
Number of Participants With an Adverse Event
|
4 Participants
|
SECONDARY outcome
Timeframe: Before and after the intervention, approximately month 1 and month 18 of the study to assess differences in knowledgePopulation: We compared knowledge scores for pharmacists at baseline and endline. We excluded from the baseline knowledge analyses four respondents who participated in the study training on medication abortion prior to taking the baseline survey and one person from the overall knowledge analyses because they only completed four items.
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.
Outcome measures
| Measure |
Medication Abortion Patients
n=53 Participants
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)
Mifepristone: Patients will receive Mifeprex® (mifepristone) by pharmacy rather than standard care at clinic visit
|
|---|---|
|
Difference in Pharmacists' Mean Knowledge Score Related to Medication Abortion
Baseline knowledge score
|
0.51 score on a scale
Standard Deviation 0.21
|
|
Difference in Pharmacists' Mean Knowledge Score Related to Medication Abortion
Endline knowledge score
|
0.64 score on a scale
Standard Deviation 0.24
|
Adverse Events
Medication Abortion Patients
Pharmacists
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Medication Abortion Patients
n=260 participants at risk
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)
Mifepristone: Patients will receive Mifeprex® (mifepristone) by pharmacy rather than standard care at clinic visit
|
Pharmacists
n=60 participants at risk
Pharmacists providing services at one of the study pharmacies during the study and consenting to training
|
|---|---|---|
|
General disorders
Dehydration
|
0.38%
1/260 • Number of events 1 • Patients: Up to 6 weeks after initial visit Pharmacists: study duration including training, mifepristone dispensing, survey data collection (approximately 24 months)
Patients: A medical problem that required patients to go to the hospital, emergency department or a doctor's office (other than regularly scheduled follow-up visit) since receiving the abortion pill. Pharmacists: Any untoward/unfavorable medical occurrence, including any abnormal sign, symptom, or disease, temporally associated with participation in training, mifepristone dispensing, or survey data collection, whether or not considered related to their participation in the research.
|
0.00%
0/60 • Patients: Up to 6 weeks after initial visit Pharmacists: study duration including training, mifepristone dispensing, survey data collection (approximately 24 months)
Patients: A medical problem that required patients to go to the hospital, emergency department or a doctor's office (other than regularly scheduled follow-up visit) since receiving the abortion pill. Pharmacists: Any untoward/unfavorable medical occurrence, including any abnormal sign, symptom, or disease, temporally associated with participation in training, mifepristone dispensing, or survey data collection, whether or not considered related to their participation in the research.
|
|
Reproductive system and breast disorders
Heavy uterine bleeding
|
0.38%
1/260 • Number of events 1 • Patients: Up to 6 weeks after initial visit Pharmacists: study duration including training, mifepristone dispensing, survey data collection (approximately 24 months)
Patients: A medical problem that required patients to go to the hospital, emergency department or a doctor's office (other than regularly scheduled follow-up visit) since receiving the abortion pill. Pharmacists: Any untoward/unfavorable medical occurrence, including any abnormal sign, symptom, or disease, temporally associated with participation in training, mifepristone dispensing, or survey data collection, whether or not considered related to their participation in the research.
|
0.00%
0/60 • Patients: Up to 6 weeks after initial visit Pharmacists: study duration including training, mifepristone dispensing, survey data collection (approximately 24 months)
Patients: A medical problem that required patients to go to the hospital, emergency department or a doctor's office (other than regularly scheduled follow-up visit) since receiving the abortion pill. Pharmacists: Any untoward/unfavorable medical occurrence, including any abnormal sign, symptom, or disease, temporally associated with participation in training, mifepristone dispensing, or survey data collection, whether or not considered related to their participation in the research.
|
|
Reproductive system and breast disorders
Pelvic Inflammatory Disease
|
0.38%
1/260 • Number of events 1 • Patients: Up to 6 weeks after initial visit Pharmacists: study duration including training, mifepristone dispensing, survey data collection (approximately 24 months)
Patients: A medical problem that required patients to go to the hospital, emergency department or a doctor's office (other than regularly scheduled follow-up visit) since receiving the abortion pill. Pharmacists: Any untoward/unfavorable medical occurrence, including any abnormal sign, symptom, or disease, temporally associated with participation in training, mifepristone dispensing, or survey data collection, whether or not considered related to their participation in the research.
|
0.00%
0/60 • Patients: Up to 6 weeks after initial visit Pharmacists: study duration including training, mifepristone dispensing, survey data collection (approximately 24 months)
Patients: A medical problem that required patients to go to the hospital, emergency department or a doctor's office (other than regularly scheduled follow-up visit) since receiving the abortion pill. Pharmacists: Any untoward/unfavorable medical occurrence, including any abnormal sign, symptom, or disease, temporally associated with participation in training, mifepristone dispensing, or survey data collection, whether or not considered related to their participation in the research.
|
|
Skin and subcutaneous tissue disorders
Swelling in cheeks
|
0.38%
1/260 • Number of events 1 • Patients: Up to 6 weeks after initial visit Pharmacists: study duration including training, mifepristone dispensing, survey data collection (approximately 24 months)
Patients: A medical problem that required patients to go to the hospital, emergency department or a doctor's office (other than regularly scheduled follow-up visit) since receiving the abortion pill. Pharmacists: Any untoward/unfavorable medical occurrence, including any abnormal sign, symptom, or disease, temporally associated with participation in training, mifepristone dispensing, or survey data collection, whether or not considered related to their participation in the research.
|
0.00%
0/60 • Patients: Up to 6 weeks after initial visit Pharmacists: study duration including training, mifepristone dispensing, survey data collection (approximately 24 months)
Patients: A medical problem that required patients to go to the hospital, emergency department or a doctor's office (other than regularly scheduled follow-up visit) since receiving the abortion pill. Pharmacists: Any untoward/unfavorable medical occurrence, including any abnormal sign, symptom, or disease, temporally associated with participation in training, mifepristone dispensing, or survey data collection, whether or not considered related to their participation in the research.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place