Advanced Provision of Care

NCT ID: NCT05848908

Last Updated: 2025-08-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-28
• Study Completion Date: 2025-06-30

Brief Summary

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.

Detailed Description

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.

Conditions

Pregnancy Related

Study Design

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

Study Groups

Telehealth Visit

telemedicine visit and follow-up surveys

Group Type: EXPERIMENTAL

Telehealth Visit

Intervention Type: OTHER

telemedicine visit and follow-up surveys

Interventions

Telehealth Visit

telemedicine visit and follow-up surveys

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

Alison Edelman

Clinical Instructor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

OHSU

Portland, Oregon, United States

Countries

United States

Other Identifiers

STUYD00025095

Identifier Type: -

Identifier Source: org_study_id