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Trial record 1 of 5 for:    Daniel Grossman
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Mail Order Mifepristone Study

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ClinicalTrials.gov Identifier: NCT03913104
Recruitment Status : Recruiting
First Posted : April 12, 2019
Last Update Posted : October 5, 2020
Sponsor:
Information provided by (Responsible Party):
Daniel Grossman, University of California, San Francisco

Tracking Information
First Submitted Date  ICMJE April 3, 2019
First Posted Date  ICMJE April 12, 2019
Last Update Posted Date October 5, 2020
Actual Study Start Date  ICMJE January 5, 2020
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 10, 2019)
Proportion of patients who report positive experience. [ Time Frame: Day 14 following initial medication abortion visit ]
Proportion of patients reporting whether they would use the mail order service again if they needed another abortion.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 10, 2019)
  • Proportion of patients who report timely delivery of medication. [ Time Frame: Day 3 following initial medication abortion visit ]
    Proportion of patients who receive medications by Day 2 and Day 3 and proportion of patients who indicate their confidentiality was maintained when receiving medications by mail. The investigators will also estimate the proportion of patients who report that medications were lost, stolen or damaged.
  • Proportion of patients who have a complete abortion [ Time Frame: Up to 6 weeks after initial medication abortion visit. ]
    Using electronic health record data related to abortion, the investigators will estimate the proportion of patients who experience a complete abortion and the proportion of patients who experience complications, including adverse or severe adverse events.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Mail Order Mifepristone Study
Official Title  ICMJE Feasibility and Acceptability of Dispensing Mifepristone Via Mail Order Pharmacy
Brief Summary 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 10-15 primary care and internal medicines sites not currently providing abortion services around the country. 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.
Detailed Description 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 15-20 clinics and/or medical facilities not currently providing medication abortion to participate in the study. The study team will train primary care providers to provide medication abortion with the medications dispensed via mail order pharmacy. The investigators aim to recruit approximately 400 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Prospective Cohort
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE
  • Abortion Early
  • Pregnancy Related
Intervention  ICMJE Drug: Mifepristone
Patients will have MifeprexⓇ (mifepristone) shipped to a preferred address via an online mail order pharmacy rather than standard care at clinic visit.
Study Arms  ICMJE Experimental: 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)
Intervention: Drug: Mifepristone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 10, 2019)
425
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2023
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Women seeking medication abortion through 63 days gestation
  • Eligible for MifeprexⓇ at a study site
  • English or Spanish speaking
  • Willing and able to participate in the study, including willing and able to receive medications at home or other preferred address within 3 days of initial medication abortion visit

Exclusion Criteria:

  • Not pregnant
  • Not seeking medication abortion
  • under the age of 15
  • Over 63 days gestation
  • Contraindicated for medication abortion
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 15 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Rana Barar, MPH 510-986-8974 rana.barar@ucsf.edu
Contact: Sarah Raifman, MSc 510-986-8970 sarah.raifman@ucsf.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03913104
Other Study ID Numbers  ICMJE 18-26819
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Daniel Grossman, University of California, San Francisco
Study Sponsor  ICMJE University of California, San Francisco
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Daniel Grossman, MD University of California, San Francisco
PRS Account University of California, San Francisco
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP