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

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Recruitment opened Show 4 more changesShow less
    • Start date changed from estimate of Aug 1, 2026 to Sep 10, 2026
    • Eligibility criteria expanded, about 10 words
    • Site details revised at 3 of 3 sites
    • Publications: details revised at 2 of 2 entries
  2. Trial status changed: Recruiting → Not Yet Recruiting
    • Site details revised at 3 of 3 sites
    v6
  3. Recruitment opened
    • Start date: May 29, 2026 to Aug 1, 2026
    v5
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Aug 1, 2026 to May 29, 2026
    • Site details revised at 3 of 3 sites
    v4
  5. Start date: May 2026 to Aug 1, 2026v3
  6. Re-verified, no change to tracked fieldsv2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07557303
Lead Sponsor Case Western Reserve University
Collaborators: National Human Genome Research Institute (NHGRI)
Conditions
(from sponsor)		 Delivery of Health Care, Genetic Testing, Humans, Pregnancy, Noninvasive Prenatal Testing, Informed Consent, Internet-Based Intervention, Self Efficacy +4 more
Related terms Health Education
Enrollment 1,400 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov