Advance Provision of Medication Abortion

NCT03829696 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: A128753_02
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (3)

• Proportion of participants satisfied with the advance provision model

  Proportion of participants who report being "somewhat satisfied" or "very satisfied" when asked "How satisfied are you with the advance provision model?"

  Participants who do not take Mifeprex® will be surveyed 6 months following study enrollment. Participants who take Mifeprex® at any point during the 6 month study period will be surveyed one week after taking Mifeprex®.

• Proportion of participants who are confident that they could use the abortion pills correctly if they got pregnant and decided to have an abortion using the advance provision model

  Proportion of participants who report "somewhat confident" or "completely confident" when asked "If you got pregnant and wanted an abortion in the next few months, how confident do you feel that you could use the abortion pills correctly?"

  Participants who do not take Mifeprex® will be surveyed 6 months following study enrollment. Participants who take Mifeprex® at any point during the 6 month study period will be surveyed one week after taking Mifeprex®.

• Proportion of participants who would recommend the advance provision model to a friend

  Proportion of participants who report "probably yes" or "definitely yes" when asked "Would you recommend getting the abortion pills in advance instead of going to a clinic to a friend?"

  Participants who do not take Mifeprex® will be surveyed 6 months following study enrollment. Participants who take Mifeprex® at any point during the 6 month study period will be surveyed one week after taking Mifeprex®.

Secondary Outcomes (5)

• Response rate to check-in and end-of-study surveys

  End of the study, month 12

• Number of participants who take Mifeprex®

  End of study, month 12

• Among participants who take Mifeprex®: Number of participants who take Mifeprex® and misoprostol correctly

  End of study, month 12

• Among participants who take Mifeprex®: Gestational age at time of abortion

  End of study, month 12

• Among participants who take Mifeprex®: Number of participants with an adverse event

  Up to 6 weeks after reported use of Mifeprex®

Study Arms (1)

Non-pregnant women

EXPERIMENTAL

Participants will be provided Mifeprex® (oral mifepristone 200 mg) and misoprostol 800 mcg to be administered buccally (at 24-48 hours following mifepristone) or vaginally (as soon as 6 hours following mifepristone) if unintended pregnancy occurs during the study period and the participant would like to end of the pregnancy. Participants who test positive for pregnancy will consult with a study clinician over the phone prior to administering mifepristone and misoprostol, and will then attend an in-person follow-up visit. All participants will be provided with a single dose of ella® (ulipristal acetate emergency contraception 30 mg) by a clinician at the beginning of the study, as well as 6 AccuHome® midstream urine pregnancy tests.

Drug: Mifeprex® (Mifepristone 200 mg); Drug: Misoprostol 800 mcg; Drug: ella® (ulipristal acetate emergency contraception 30 mg); Diagnostic Test: AccuHome® Pregnancy OTC Test

Interventions

Mifeprex® (Mifepristone 200 mg) DRUG

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.

Non-pregnant women

Misoprostol 800 mcg DRUG

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.

Non-pregnant women

ella® (ulipristal acetate emergency contraception 30 mg) DRUG

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.

Non-pregnant women

AccuHome® Pregnancy OTC Test DIAGNOSTIC_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.

Non-pregnant women

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Females at-risk of unintended pregnancy
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead

Related Publications (2)

• FDA (2016).

  BACKGROUND

• Biggs MA, Ralph L, Raifman S, Foster DG, Grossman D. Support for and interest in alternative models of medication abortion provision among a national probability sample of U.S. women. Contraception. 2019 Feb;99(2):118-124. doi: 10.1016/j.contraception.2018.10.007. Epub 2018 Nov 15.

  PMID: 30448203 BACKGROUND

MeSH Terms

Interventions

Mifepristone; Misoprostol; ulipristal acetate

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• Daniel Grossman, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Department of Obstetrics, Gynecology and Reproductive Sciences and Director of Advancing New Standards in Reproductive Health (ANSIRH)

Model Details: Prospective cohort

Study Record Dates

• First Submitted: January 9, 2019
• First Posted: February 4, 2019
• Study Start: January 1, 2020
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2021
• Last Updated: May 30, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share