Advanced Provision of Care

Pregnancy Related Clinical Trial

Official title:

Advanced Provision of Care

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05848908
• Other study ID #: STUYD00025095
• Status: Recruiting
• Phase: N/A
• Start date: June 28, 2023
• Est. completion date: June 2025

Study information

• Verified date: July 2023
• Source: Oregon Health and Science University
• Contact: Women's Health Research Unit Department of Ob/Gyn
• Phone: 503-494-3666
• Email: whru[@]ohsu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 2025
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Pregnancy Related

Intervention

Other:
• Telehealth Visit
telemedicine visit and follow-up surveys

Locations

Country	Name	City	State
United States	OHSU	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Proportion of participants reporting satisfaction with the process	Proportion of participants reporting satisfaction with the process in follow up surveys	Enrollment to 12 months