Advance Provision of Medication Abortion

Summary

This mixed-methods study follows a prospective cohort of participants receiving Mifeprex® (mifepristone) by a clinician in advance of a potential unintended pregnancy. Women participating in this study will be assessed by a clinician and provided Mifeprex® and misoprostol in a clinical setting. To assess acceptability of this service delivery model among participants, and feasibility of implementing a larger randomized controlled trial, the study will survey participants, evaluate any clinical outcomes recorded during clinical visits, and interview participants about their experiences participating in the study.

Conditions

• Early Abortion

Interventions

DRUG

Mifeprex® (Mifepristone 200 mg)

Participants will receive Mifeprex® (mifepristone 800 mcg) from a clinician when they are not pregnant. Participants who have an unintended pregnancy during the study period and would like to have a medication abortion will consult with a clinician for an over-the-phone evaluation of contraindications and gestational age. Participants who take the medications will be evaluated again in-person at a subsequent follow-up visit.

DRUG

Misoprostol 800 mcg

Participants will receive misoprostol from a clinician when they are not pregnant. Participants who have an unintended pregnancy during the study period would like to have a medication abortion will consult with a clinician for an over-the-phone evaluation of contraindications and gestational age. Participants who take the medications will be evaluated again in-person at a subsequent follow-up visit.

DRUG

ella® (ulipristal acetate emergency contraception 30 mg)

Participants will receive one dose of ella (emergency contraception) from a clinician at the same time of receiving mifepristone and misoprostol, in case the participant should have unprotected intercourse or failed contraception and want to prevent unintended pregnancy.

DIAGNOSTIC_TEST

AccuHome® Pregnancy OTC Test

Participants will receive 6 AccuHome® pregnancy tests, which are midstream urine pregnancy tests and provide results within 3 minutes. Participants may request additional tests to be mailed to them by the study at any time.

Sponsors & Collaborators

• University of California, San Francisco

  lead OTHER

Principal Investigators

• Daniel Grossman, MD · University of California, San Francisco

Study Design

Allocation

NA

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

40 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-01-31

Primary Completion

2021-01-31

Completion

2021-01-31

FDA Drug

Yes