Clinical trial NCT05848908: Advanced Provision of Care
Official title: Advanced Provision of Care
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pregnancy Related
Keywords: Counseling, telehealth
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2023-05-08
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: The proportion of participants reporting confidence in key steps of taking medications
timeFrame: Enrollment to 12 months
measure: Proportion of participants reporting satisfaction with the process
timeFrame: Enrollment to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: OHSU
state: Oregon
Study officials:
References: