Advanced Provision of Care | NCT05848908

Studies
Advanced Provision of Care

NCT05848908

Sponsor

Oregon Health and Science University

Status

Completed

Last Update Posted

Aug 5, 2025Actual

Enrollment

50Actual

Phase

Not Applicable

Conditions

Pregnancy Related

Interventions

Telehealth Visit

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 28, 2023Actual

Primary Completion Date

Jun 30, 2025Actual

Completion Date

Jun 30, 2025Actual

First Submitted Date

Apr 28, 2023

First Submission Date that Met QC Criteria

Apr 28, 2023

First Posted Date

May 8, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 31, 2025

Last Update Posted Date

Aug 5, 2025Actual

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Label	Type	Description	Intervention Names
Telehealth Visit	Experimental	telemedicine visit and follow-up surveys	Other: Telehealth Visit

Name	Type	Description	Arm Group Labels	Other Names
Telehealth Visit	Other	telemedicine visit and follow-up surveys	Telehealth Visit

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided