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This study aims to evaluate the feasibility, acceptability, and effectiveness of dispensing mifepristone via a mail-order pharmacy. The investigators will recruit patients at up to 10 primary care and internal medicines sites not currently providing abortion services around the country, as well as abortion clinic sites. Patients will go through routine in clinic visits to determine eligibility and then will receive the medications in the mail at their preferred address. The investigators will survey patients 3 and 14 days after the initial clinic visit and interview providers at the end of the study.
This is a prospective cohort study of patients obtaining medication abortion via mifepristone dispensed from an online mail order pharmacy. After an initial pilot test with 25 patients, the investigators will identify 10 clinics to participate in the study. The study team will train primary care providers not currently providing abortion to provide medication abortion with the medications dispensed via mail order pharmacy. The investigators aim to recruit up to 650 patients for this study across all the sites. Patients will come in for an initial consult visit at the study site and then receive their medications at a preferred address within 3 days of the initial visit. Study participants will fill out surveys about their experience and feedback about the acceptability of the process; this will occur at 3 and 14 days after the initial recruitment visit. The investigators will also collect clinic data from patients and clinic sites to track clinical outcomes. And the investigators will interview providers at the end of the study to better understand their experiences prescribing mifepristone via mail-order.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Medication Abortion Patients | Experimental | Oral Mifepristone 200 mg, followed by misoprostol 800 mcg administered buccally (at 24-48 hours following mifepristone) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mifepristone | Drug | Patients will have MifeprexⓇ (mifepristone) shipped to a preferred address via an online mail order pharmacy rather than standard care at clinic visit. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability: Satisfaction With Mail-Order Dispensing of Medication Abortion | Percentage of participants reporting whether they were satisfied with receiving the medications by mail, by abortion instance. | Day 14 following initial medication abortion visit |
| Acceptability: Would Use Mail-Order Dispensing Again | Percentage of participants reporting they would prefer to receive medications by mail for future medication abortion, by abortion instance. | Day 14 following initial medication abortion visit |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility: Proportion of Patients Who Receive Medications by Day 2 and Day 3 | Percentage of participants who received the medications by mail-order pharmacy by Day 2 and Day 3, by abortion instance. | Day 3 following initial medication abortion visit |
| Feasibility: Confidentiality Maintained When Receiving Medications by Mail |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Grossman, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Highland Hospital | Oakland | California | 94602 | United States | ||
| Children's Hospital Oakland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38956609 | Derived | Raifman S, Gurazada T, Beaman J, Biggs MA, Schwarz EB, Gold M, Grossman D. Primary care and abortion provider perspectives on mail-order medication abortion: a qualitative study. BMC Womens Health. 2024 Jul 3;24(1):382. doi: 10.1186/s12905-024-03202-z. | |
| 34555420 | Derived | Grossman D, Raifman S, Morris N, Arena A, Bachrach L, Beaman J, Biggs MA, Hannum C, Ho S, Schwarz EB, Gold M. Mail-order pharmacy dispensing of mifepristone for medication abortion after in-person clinical assessment. Contraception. 2022 Mar;107:36-41. doi: 10.1016/j.contraception.2021.09.008. Epub 2021 Sep 20. |
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536 patients were consented and enrolled as part of this study. Four participants enrolled twice and were analyzed based on their abortion instance, leading to 540 abortions analyzed as part of this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Medication Abortion Patients | Oral Mifepristone 200 mg, followed by misoprostol 800 mcg administered buccally (at 24-48 hours following mifepristone) Mifepristone: Patients will have MifeprexⓇ (mifepristone) shipped to a preferred address via an online mail order pharmacy rather than standard care at clinic visit. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Medication Abortion Patients | Oral Mifepristone 200 mg, followed by misoprostol 800 mcg administered buccally (at 24-48 hours following mifepristone) Mifepristone: Patients will have MifeprexⓇ (mifepristone) shipped to a preferred address via an online mail order pharmacy rather than standard care at clinic visit. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Acceptability: Satisfaction With Mail-Order Dispensing of Medication Abortion | Percentage of participants reporting whether they were satisfied with receiving the medications by mail, by abortion instance. | Posted | Count of Units | Number of abortions | Day 14 following initial medication abortion visit | Number of abortions | Number of abortions |
|
|
Follow-up data were collected among participants up to six weeks after initial medication abortion visit.
Adverse events were defined as any unscheduled visits, including emergency department visits, for symptoms possibly related to the medication abortion. Serious adverse events were defined as death, hospitalization, blood transfusion, or surgery.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Medication Abortion Patients | Oral Mifepristone 200 mg, followed by misoprostol 800 mcg administered buccally (at 24-48 hours following mifepristone) Mifepristone: Patients will have MifeprexⓇ (mifepristone) shipped to a preferred address via an online mail order pharmacy rather than standard care at clinic visit. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hemorrhage requiring blood transfusion | Reproductive system and breast disorders | FDA | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bleeding | Reproductive system and breast disorders | FDA | Systematic Assessment |
Lack of randomization may limit generalizability. Clinical sites that agreed to participate had at least 1 motivated clinician and a supportive administrative environment and were located in states with relatively few abortion restrictions. Study participants were open to mail-order dispensing, but this option may not be acceptable/feasible for all patients. The study was not powered to precisely estimate safety outcomes. Satisfaction may be overestimated due to social desirability bias.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Natalie Morris | University of California, San Francisco | (415) 353-4724 | natalie.morris@ucsf.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 25, 2021 | Jun 18, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 12, 2021 | Jun 18, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D015735 | Mifepristone |
| ID | Term |
|---|---|
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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Prospective Cohort
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Percentage of participants who reported that confidentiality was maintained when they received the medications by mail-order pharmacy, by abortion instance. |
| Day 3 following initial medication abortion visit |
| Clinical Effectiveness of Mail-Order Medication Abortion | Percentage of participants who experienced a complete medication abortion, by abortion instance. | Up to 6 weeks after initial medication abortion visit. |
| Clinical Safety of Mail-Order Medication Abortion | Percentage of participants who experience adverse events related to the abortion, by abortion instance. | Up to 6 weeks after initial medication abortion visit. |
| Provider Acceptability of Mail-Order Dispensing of Medication Abortion | Provider acceptability will be assessed qualitatively through open-ended interviews with providers and staff involved in the study. | Up to 3 months after data collection completed. |
| Oakland |
| California |
| 94609 |
| United States |
| Planned Parenthood Rocky Mountains | Denver | Colorado | 80218 | United States |
| Christiana Care Health System | Wilmington | Delaware | 19899 | United States |
| Atlanta Comprehensive Wellness Clinic | Atlanta | Georgia | 30324 | United States |
| Albert Einstein College of Medicine | New York | New York | 10461 | United States |
| Southern Tier Women's Health Services | Vestal | New York | 13850 | United States |
| Delaware County Women's Center | Chester | Pennsylvania | 19013 | United States |
| Allegheny Reproductive Health Center | Pittsburgh | Pennsylvania | 15206 | United States |
| Brown Family Medicine | Pawtucket | Rhode Island | 02860 | United States |
| Lifespan | Providence | Rhode Island | 02905 | United States |
| years |
|
| Age, Customized | Count of Participants | Participants |
|
| Sex: Female, Male | Sex/Gender data not collected | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Educational level | Count of Participants | Participants |
|
| Parity | Count of Participants | Participants |
|
| Prior abortion experience | Count of Participants | Participants |
|
| Counts |
|---|
| Participants |
|
| Number of abortions |
|
|
| Primary | Acceptability: Would Use Mail-Order Dispensing Again | Percentage of participants reporting they would prefer to receive medications by mail for future medication abortion, by abortion instance. | Posted | Count of Units | Number of abortions | Day 14 following initial medication abortion visit | Number of abortions | Number of abortions |
|
|
|
| Secondary | Feasibility: Proportion of Patients Who Receive Medications by Day 2 and Day 3 | Percentage of participants who received the medications by mail-order pharmacy by Day 2 and Day 3, by abortion instance. | Posted | Count of Units | Number of abortions | Day 3 following initial medication abortion visit | Number of abortions | Number of abortions |
|
|
|
| Secondary | Feasibility: Confidentiality Maintained When Receiving Medications by Mail | Percentage of participants who reported that confidentiality was maintained when they received the medications by mail-order pharmacy, by abortion instance. | Posted | Count of Units | Number of abortions | Day 3 following initial medication abortion visit | Number of abortions | Number of abortions |
|
|
|
| Secondary | Clinical Effectiveness of Mail-Order Medication Abortion | Percentage of participants who experienced a complete medication abortion, by abortion instance. | Posted | Count of Units | Number of abortions | Up to 6 weeks after initial medication abortion visit. | Number of abortions | Number of abortions |
|
|
|
| Secondary | Clinical Safety of Mail-Order Medication Abortion | Percentage of participants who experience adverse events related to the abortion, by abortion instance. | Posted | Count of Units | Number of abortions | Up to 6 weeks after initial medication abortion visit. | Number of abortions | Number of abortions |
|
|
|
| Secondary | Provider Acceptability of Mail-Order Dispensing of Medication Abortion | Provider acceptability will be assessed qualitatively through open-ended interviews with providers and staff involved in the study. | Clinicians and staff involved in implementing a mail-order dispensing model for medication abortion were invited to complete qualitative interviews to share their experiences with non-in-person dispensing of mifepristone. These clinicians and staff were not officially enrolled as participants in the study, but rather contributed perspectives as clinic employees on the feasibility and acceptability of such a model. | Posted | Number | participants | Up to 3 months after data collection completed. |
|
|
|
| 0 |
| 510 |
| 3 |
| 510 |
| 21 |
| 510 |
| Hospitalization | Reproductive system and breast disorders | FDA | Systematic Assessment |
|
| Pain | Reproductive system and breast disorders | FDA | Systematic Assessment |
|
| Nausea/vomiting | General disorders | FDA | Systematic Assessment |
|
| Infection | Reproductive system and breast disorders | FDA | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | FDA | Systematic Assessment |
|
| Incomplete abortion | Surgical and medical procedures | FDA | Systematic Assessment | Less than 5% of medication abortion cases lead to incomplete abortions; in these cases, the patients visited the emergency department with symptoms and received aspiration procedures to complete their abortions |
|
| Dehydration | General disorders | FDA | Systematic Assessment |
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| Vaginitis | Reproductive system and breast disorders | FDA | Systematic Assessment |
|
| Shortness of breath | Respiratory, thoracic and mediastinal disorders | FDA | Systematic Assessment |
|
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| D011083 |
| Polycyclic Compounds |
| Title | Measurements |
|---|---|
|