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Supporting Just-In-Time Consent for Prenatal Screening: The INFORM Study
Sponsor: Case Western Reserve University
Summary
This clinical trial is about prenatal genetic screening. It will test an intervention to help people make decisions about screening. The intervention is a short set of information cards about screening. This intervention is for pregnant participants. They will use the intervention on their mobile phone before they see their doctor. The study has one main question: * Do participants who use the intervention feel more confident when they make a decision about screening? Researchers will compare participants who use the intervention to participants who do not. All participants will have their usual care when they visit their doctor. What will participants do? * Participants must be pregnant. They will sign up for the study before their first doctor's visit for their pregnancy. This is the visit where their doctor usually talks with them about screening. * Some participants will use the intervention before their first doctor's visit. Other participants will not use it. * All participants will talk with a researcher on the phone after their first doctor's visit. * Participants who use the intervention will answer a short survey on their phone. * A few participants who use the intervention will talk with a researcher a second time on the phone.
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1400
Start Date
2026-05
Completion Date
2028-06-30
Last Updated
2026-04-29
Healthy Volunteers
Yes
Conditions
Interventions
Mobile-based Educational Intervention
A mobile-based informational tool that participants will access through a QR code prior to the clinical encounter in which they will be offered prenatal genetic screening. This tool will provide clear and concise information about prenatal genetic screening to support pregnant participants in making an informed decision.
Locations (3)
Zuckerberg Chan San Francisco General Hospital
San Francisco, California, United States
University of Florida Health
Jacksonville, Florida, United States
University of North Carolina
Chapel Hill, North Carolina, United States