Advanced Provision of Care

NCT05848908 | Completed

• 1 other identifier: STUYD00025095
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy Related

Keywords

Counseling, telehealth

Outcome Measures

Primary Outcomes (2)

• The proportion of participants reporting confidence in key steps of taking medications

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

  Enrollment to 12 months

• Proportion of participants reporting satisfaction with the process

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

  Enrollment to 12 months

Study Arms (1)

Telehealth Visit

EXPERIMENTAL

telemedicine visit and follow-up surveys

Other: Telehealth Visit

Interventions

Telehealth Visit OTHER

telemedicine visit and follow-up surveys

Telehealth Visit

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

OHSU

Portland, Oregon, 97239, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Instructor

Study Record Dates

• First Submitted: April 28, 2023
• First Posted: May 8, 2023
• Study Start: June 28, 2023
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: August 5, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)