Mifepristone
DrugPatients will have MifeprexⓇ (mifepristone) shipped to a preferred address via an online mail order pharmacy rather than standard care at clinic visit.
NCT Number: NCT03913104
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.
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Notify Me15 year and older
Female
Interventional
Phase 4
Children's Hospital Oakland, Oakland, California, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients will have MifeprexⓇ (mifepristone) shipped to a preferred address via an online mail order pharmacy rather than standard care at clinic visit.
Time frame: Day 14 following initial medication abortion visit
Percentage of participants reporting whether they were satisfied with receiving the medications by mail, by abortion instance.
Time frame: Day 14 following initial medication abortion visit
Percentage of participants reporting they would prefer to receive medications by mail for future medication abortion, by abortion instance.
Time frame: Day 3 following initial medication abortion visit
Percentage of participants who received the medications by mail-order pharmacy by Day 2 and Day 3, by abortion instance.
Time frame: Day 3 following initial medication abortion visit
Percentage of participants who reported that confidentiality was maintained when they received the medications by mail-order pharmacy, by abortion instance.
Time frame: Up to 6 weeks after initial medication abortion visit.
Percentage of participants who experienced a complete medication abortion, by abortion instance.
Time frame: Up to 6 weeks after initial medication abortion visit.
Percentage of participants who experience adverse events related to the abortion, by abortion instance.
Time frame: Up to 3 months after data collection completed.
Provider acceptability will be assessed qualitatively through open-ended interviews with providers and staff involved in the study.
Daniel Grossman, MD
Other
Feasibility and Acceptability of Dispensing Mifepristone Via Mail Order Pharmacy
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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