Mail Order Mifepristone Study

NCT ID: NCT03913104

Last Updated: 2024-08-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 536 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-05
• Study Completion Date: 2023-07-30

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 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.

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 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.

Conditions

Abortion Early; Pregnancy Related

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Medication Abortion Patients

Oral Mifepristone 200 mg, followed by misoprostol 800 mcg administered buccally (at 24-48 hours following mifepristone)

Group Type: EXPERIMENTAL

Mifepristone

Intervention Type: DRUG

Patients will have MifeprexⓇ (mifepristone) shipped to a preferred address via an online mail order pharmacy rather than standard care at clinic visit.

Interventions

Mifepristone

Patients will have MifeprexⓇ (mifepristone) shipped to a preferred address via an online mail order pharmacy rather than standard care at clinic visit.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 15 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Daniel Grossman, MD

OTHER

Sponsor Role: lead

Responsible Party

Daniel Grossman, MD

Professor and Director of ANSIRH

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Daniel Grossman, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

Highland Hospital

Oakland, California, United States

Children's Hospital Oakland

Oakland, California, United States

Planned Parenthood Rocky Mountains

Denver, Colorado, United States

Christiana Care Health System

Wilmington, Delaware, United States

Atlanta Comprehensive Wellness Clinic

Atlanta, Georgia, United States

Albert Einstein College of Medicine

New York, New York, United States

Southern Tier Women's Health Services

Vestal, New York, United States

Delaware County Women's Center

Chester, Pennsylvania, United States

Allegheny Reproductive Health Center

Pittsburgh, Pennsylvania, United States

Brown Family Medicine

Pawtucket, Rhode Island, United States

Lifespan

Providence, Rhode Island, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 38956609 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34555420 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

18-26819

Identifier Type: -

Identifier Source: org_study_id