Supporting Just-In-Time Consent for Prenatal Screening: The INFORM Study
Case Western Reserve University · with National Human Genome Research Institute (NHGRI) · NCT07557303
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18+ · Women only
- Healthy volunteers
- Accepted
- Study type
- Interventional · Not applicable
- Target enrollment
- 1400
- US sites recruiting
- 3
- Study start
- September 10, 2026
- Record last updated
- September 22, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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.
Being studied: Mobile-based Educational Intervention
Conditions: 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
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
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)
Recruiting US locations
Zuckerberg Chan San Francisco General Hospital
San Francisco, CA 94158
Site contact: Miriam Kuppermann, MPH, PhD · 415-502-4089 · miriam.kuppermann@ucsf.edu
University of Florida Health
Jacksonville, FL 32209
Site contact: Niamh Condon, DO, FACOOG · 904-383-1037 · Niamh.Condon@jax.ufl.edu
University of North Carolina
Chapel Hill, NC 27599
Site contact: Neeta Vora, MD · (984) 974-2131 · Neeta_vora@med.unc.edu
Study contacts (from the official record)
- Sabina Rubeck, MPH · 216-368-2547 · sabina.rubeck@case.edu
- Harlie Custer, MA, MPH · (216) 368-5914 · harlie.custer@case.edu
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