Support for Just-In-Time Consent for Prenatal Screening
Official title: Supporting Just-In-Time Consent for Prenatal Screening: The INFORM Study
Run by Case Western Reserve University · NCT07557303 · Data updated 2026-11-12
This study tests a short set of information cards delivered on a phone to help pregnant people decide about prenatal screening.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 1400 (estimated) |
| Sponsor | Case Western Reserve University Academic / other |
| Locations | 3 sites (San Francisco, California and 2 other locations) |
| Status | Recruiting |
| Started | September 10, 2026 |
| Main results expected | June 30, 2028 |
| Study ends | June 30, 2028 |
| Registry record updated | September 22, 2026 |
| Trial ID | NCT07557303 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Pregnant individuals up to 24 weeks gestation who are receiving care at UNC Chapel Hill, UCSF Benioff/ZSFG, or UF Health Jacksonville, and who can read or understand English or Spanish.
✕Probably not a fit
Individuals who do not choose or need prenatal screening, or who do not engage with the information cards, may not experience a benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Participants are pregnant individuals at select sites who will receive a mobile information intervention before their routine prenatal screening discussion. The study compares those who receive the intervention with those who do not, in addition to standard care. The goal is to see if the intervention increases confidence in decision-making about screening. Inclusion requires being 18 or older, able to read/speak English or Spanish, and up to 24 weeks gestation; participants must be at a collaborating site and have not yet been offered prenatal screening for the current pregnancy. The intervention focuses on noninvasive prenatal testing information and informed consent concepts.
Why it matters
Potential benefit: If successful, the intervention could help pregnant people feel more confident about their screening decisions.
How similar studies have gone: Previous approaches using patient-facing information aids have shown potential to support informed decision-making in prenatal care, but this exact just-in-time consent approach is novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Currently pregnant and receiving care at a participating collaborative site - University of North Carolina, Chapel Hill; Zuckerberg Chan San Francisco General Hospital; University of Florida Health, Jacksonville. * 18 years of age and older * Able to read, speak, and understand English or Spanish * Has not previously been offered prenatal genetic screening for the current pregnancy * 24 weeks (6 months) gestational age or less Exclusion Criteria: * Not pregnant, not a patient at a partner clinical site * Younger than 18 years of age * Not being able to read, speak, and understand English or Spanish * Has previously been offered prenatal genetic screening for the current pregnancy * Greater than 24 weeks gestational age (6 months)
Where it's running
-
Zuckerberg Chan San Francisco General Hospital
San Francisco, California, United States Recruiting -
University of Florida Health
Jacksonville, Florida, United States Recruiting -
University of North Carolina
Chapel Hill, North Carolina, United States Recruiting
Study contacts
- Principal investigator: Marsha Michie, PhD — Case Western Reserve University
- Study coordinator: Sabina Rubeck, MPH
- Email: sabina.rubeck@case.edu
- Phone: 216-368-2547
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.