Supporting Just-In-Time Consent for Prenatal Screening: The INFORM Study (NCT07557303) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Supporting Just-In-Time Consent for Prenatal Screening: The INFORM Study
United States1,400 participantsStarted 2026-05
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Decision Self-Efficacy
Timeframe: The scale is completed up to 168-hours (7 calendar days) post-prenatal screening visit.