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

Starting soon · Not applicable

Conditions studied: Delivery of Health Care, Genetic Testing, Humans, Pregnancy, Noninvasive Prenatal Testing, Informed Consent, Internet-Based Intervention, Self Efficacy, Pregnant People, Decision Making, Health Education, Patient Education as Topic/Method

In brief

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 facts

Study ID

NCT07557303

Run by

Case Western Reserve University

People needed

1400

Starts

2026-08-01

Expected to finish

2028-06-30

Last updated by the study team

2026-07-23

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 is running

• 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

Full record on ClinicalTrials.gov

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