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.

Study Overview

• Status: Completed
• Conditions: Pregnancy Related
• Intervention / Treatment: Other: Telehealth Visit

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97239
      • OHSU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Telehealth Visit; telemedicine visit and follow-up surveys	Other: Telehealth Visit; telemedicine visit and follow-up surveys

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Oregon Health and Science University

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2023
• Primary Completion (Actual): June 30, 2025
• Study Completion (Actual): June 30, 2025

Study Registration Dates

• First Submitted: April 28, 2023
• First Submitted That Met QC Criteria: April 28, 2023
• First Posted (Actual): May 8, 2023

Study Record Updates

• Last Update Posted (Actual): August 5, 2025
• Last Update Submitted That Met QC Criteria: July 31, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Counseling, telehealth
• Other Study ID Numbers: STUYD00025095

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No