Clinical Trial

Supporting Just-In-Time Consent for Prenatal Screening: The INFORM Study

Not Yet Recruiting
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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.
Protocol Amendment History 2 changes
critical Trial status changed: Recruiting → Not Yet Recruiting 2026-07-24
critical Recruitment opened 2026-07-19
Trial Details
NCT Number NCT07557303
Lead Sponsor Case Western Reserve University
Collaborators: National Human Genome Research Institute (NHGRI)
Conditions Delivery of Health Care, Genetic Testing, Humans, Pregnancy, Noninvasive Prenatal Testing, Informed Consent, Internet-Based Intervention, Self Efficacy +4 more
Enrollment 1,400 participants
Start Date 2026-08-01
Primary Completion 2028-06-30 (estimated)
Study Completion 2028-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-07-23