Advance Provision of Medication Abortion

• Status: Withdrawn
• Trial end date: 2021-01-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of California, San Francisco
• Treatments: Mifepristone; Misoprostol; Ulipristal acetate

Criteria

Inclusion Criteria:

• Between 18 and 40 years old

• Speak and read English or Spanish

• Have female reproductive anatomy

• Report a history of regular menses (>24 and <38 days ) in the past 3 years (other than during pregnancy)

• Not currently pregnant and not desiring to be pregnant in the next year

• Report having had a medication abortion with mifepristone and misoprostol at some point in the past

• Hemoglobin ≥10 g/dL

• Do not report a history of ectopic pregnancy

• Do not report a history of a hemorrhagic disorder or currently taking anticoagulants (or plan to start taking anticoagulants during study period)

• Do not report a history of chronic adrenal failure

• Do not report a history of inherited porphyria

• Do not report an allergy to mifepristone or misoprostol

• Are not currently taking long-term corticosteroid therapy (>1 week)

• Considered at-risk for unintended pregnancy, defined as: those who report being sexually active (vaginal sex with a male); have not been told by a clinician that they cannot become pregnant; have not been sterilized and whose current sexual partner(s) has not been sterilized; who are not using a long-acting reversible contraceptive (LARC) or hormonal contraceptive; who use withdrawal, rhythm method, barrier method(s), spermicide, emergency contraception, and/or no method of contraception

• Say they would seek abortion if they became pregnant in the next year, and who do not express a preference for surgical abortion

• Willing and able to provide informed consent

• Have access to a working cellphone with them at the time of enrollment and are willing to receive calls and text messages from study staff

• Are planning to live within 25 miles of the study site for the 6 month study period

Exclusion Criteria:

• Younger than 18 years or older than 40 years

• Cannot speak and read English or Spanish

• Do not have female reproductive anatomy

• Report a history of irregular menses in the past 3 years

• Hemoglobin <10 g/dL

• Report a history of having an ectopic pregnancy

• Report a history of a hemorrhagic disorder or currently taking anticoagulants (or plan to start taking anticoagulants during study period)

• Report a history of chronic adrenal failure

• Report a history of inherited porphyria

• Report an allergy to mifepristone or misoprostol

• Currently taking long-term corticosteroid therapy (>1 week)

• Are not considered at-risk for unintended pregnancy, defined as: those who do not report being sexually active (vaginal sex with a male), have been told by a clinician they cannot become pregnant, have been sterilized or whose current sexual partner(s) has been sterilized, have an IUD or contraceptive implant in place, or currently taking hormonal contraception (oral contraceptive pills, patch or vaginal ring)

• Currently pregnant or desiring to become pregnant in the next year

• Have not had a medication abortion in the past

• Say if they became pregnant in the next year, they would not seek abortion or are unsure whether they would seek abortion; or who indicate a preference for surgical abortion Unwilling or unable to provide informed consent

• Do not have access to a working cellphone with them at the time of enrollment and are unwilling to receive calls or text messages from study staff

• Are not planning to live within 25 miles of the study site for the 6 month study period