Pregnancy RelatedNCT05848908
Advanced Provision of Care
A study testing Telehealth Visit in people with Pregnancy Related, run by Oregon Health and Science University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related
- What is being tested?
- Telehealth Visit
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jun 2023to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Pregnancy Related
- Being tested
- Telehealth Visit
- Keywords
- Counseling, telehealth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telehealth VisitOther
telemedicine visit and follow-up surveys
| Study group | Role | What they receive |
|---|---|---|
| Telehealth Visit | Experimental | telemedicine visit and follow-up surveys Receives: Other: Telehealth Visit |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Enrollment to 12 months
Proportion of participants reporting satisfaction with the process
Proportion of participants reporting satisfaction with the process in follow up surveys
Measured: Enrollment to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2023
- Study start28 Jun 2023
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alison Edelman, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05848908
- Sponsor's protocol ID
- STUYD00025095
- Status last verified
- Jul 2025
- First submitted
- 28 Apr 2023
- Last updated
- 5 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advanced Provision of Care
- ClinicalTrials.gov ID
- NCT05848908
- Acronym / sponsor ID
- STUYD00025095
- Conditions
- Pregnancy Related
- Keywords
- Counseling, telehealth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- 28 Jun 2023 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 8 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Telehealth Visit | Experimental | Other: Telehealth Visittelemedicine visit and follow-up surveys |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telehealth Visittelemedicine visit and follow-up surveys | Other | Telehealth Visit |
Primary outcome
The proportion of participants reporting confidence in key steps of taking medications
Time frame: Enrollment to 12 months
The proportion of participants reporting confidence in key steps of taking medications in follow-up surveys
Proportion of participants reporting satisfaction with the process
Time frame: Enrollment to 12 months
Proportion of participants reporting satisfaction with the process in follow up surveys
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telehealth Visit in people with Pregnancy Related, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of participants reporting confidence in key steps of taking medications (time frame: Enrollment to 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2025.