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OpenTrials
Completed

NCT Number: NCT05848908

Advanced Provision of Care

This study aims to evaluate advanced provision of an anti-progestin with a prostaglandin for future use (in the next 12 months) in individuals at risk for pregnancy but not desiring a pregnancy.

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Key information

Conditions

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

OHSU

Portland, Oregon, 97239, United States

About this study

The purpose of this study is to learn more about counseling via telemedicine and advanced provision of medications to individuals at risk for pregnancy but before they are pregnant. If they experience this event, then they may subsequently have immediate access to the care they need plus an established connection with a health provider.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 to 40 years old at time of consent
  • Anatomically capable of pregnancy
  • Self-reported 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
  • Say they would seek to end the pregnancy if they became pregnant in the next year and who do not express a preference for an in office procedure
  • At-risk for unintended pregnancy defined as:
  • those who report being sexually active (vaginal sex with partners with sperm)
  • have not been told by a clinician that they cannot become pregnant
  • have not had a permanent contraception procedure and whose current sexual partner(s) has not had a permanent contraception procedure
  • who are not using a long-acting reversible contraceptive (LARC)
  • Willing and able to provide informed consent
  • Willing/able to receive phone calls from study staff and complete electronic surveys distributed by EMR or email
  • Planning to live within the state of Oregon or Washington for the 12 month study period.

Exclusion criteria

  • Less than 18 and older than 40 years old at the time of consent
  • Any medical contraindications to MAB (hemorrhagic disorder or will be taking anticoagulants during study period, chronic adrenal failure or will be taking long term corticosteroids >1 week during study period, inherited porphyria, or an allergy to mifepristone or misoprostol)
  • Currently pregnant or desiring pregnancy in the next year
  • State they would not seek to end a pregnancy if they became pregnant in the next year or who express a preference for an in office procedure
  • History of ectopic pregnancy

Treatment and study plan

Telehealth Visit

Other

telemedicine visit and follow-up surveys

Primary outcomes

  1. The proportion of participants reporting confidence in key steps of taking medications

    Time frame: Enrollment to 12 months

    The proportion of participants reporting confidence in key steps of taking medications in follow-up surveys

  2. Proportion of participants reporting satisfaction with the process

    Time frame: Enrollment to 12 months

    Proportion of participants reporting satisfaction with the process in follow up surveys

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
May 8, 2023
Registry last updated
Aug 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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