Recruiting

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

Sponsor:

Case Western Reserve University

Code:

NCT07557303

Conditions

Delivery of Health Care

Genetic Testing

Humans

Pregnancy

Noninvasive Prenatal Testing

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

Mobile-based Educational Intervention

Study Details

Brief 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.

Conditions

Delivery of Health Care

Genetic Testing

Humans

Pregnancy

Noninvasive Prenatal Testing

Study ID

NCT07557303

Start date

Sep 10, 2026

Status verified date

Sep, 2026

Completion date

Jun 30, 2028

Anticipated

Primary completion date

Jun 30, 2028

Anticipated

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

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)

Study Design

Enrollment

1400 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Mobile-based Educational Intervention

Participants in the intervention arm will access a mobile-based educational tool that provides concise, culturally appropriate information about prenatal genetic screening prior to their clinical visit. Immediately after viewing the intervention, participants will complete an online, 6-question acceptability survey. Participants will then complete a one-time structured quantitative telephone interview within one hundred sixty-eight hours (seven days) of their clinician visit to assess their experience with the intervention and to measure decisional self-efficacy. A select subset of participants will participate in an additional qualitative telephone interview to assess the efficacy and usability of the intervention.

no intervention: Standard of Care

Participants in the standard-of-care arm will receive routine clinical care, including the usual information and counseling provided by clinicians regarding prenatal genetic screening. Participants will complete a one-time structured quantitative telephone interview within one hundred sixty-eight hours (seven days) of their clinician visit to assess their experience being offered prenatal genetic screening and measure decisional self-efficacy.

Interventions

Mobile-based Educational Intervention

A mobile-based informational tool that participants will access through a Quick Response (QR) code prior to the clinical encounter in which they will be offered prenatal genetic screening. This tool will provide clear and concise information about prenatal genetic screening to support pregnant participants in making an informed decision.

Primary outcome measure

Decision Self-Efficacy [ Time Frame: The scale is completed up to 168-hours (7 calendar days) post-prenatal screening visit. ]

Central Contacts and Locations

Central contacts

Sabina Rubeck, MPH

216-368-2547 sabina.rubeck@case.edu

Harlie Custer, MA, MPH

(216) 368-5914 harlie.custer@case.edu

Locations

Zuckerberg Chan San Francisco General Hospital

Recruiting

San Francisco, California, United States, 94158

Contacts

Miriam Kuppermann, MPH, PhD

415-502-4089 miriam.kuppermann@ucsf.edu

Kimberly Coleman-Phox, MPH

415-476-6406 kimberly.coleman-phox@ucsf.edu

University of Florida Health

Recruiting

Jacksonville, Florida, United States, 32209

Contacts

Niamh Condon, DO, FACOOG

904-383-1037 Niamh.Condon@jax.ufl.edu

Julie Nowak

julie.nowak@jax.ufl.edu

University of North Carolina

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Neeta Vora, MD

(984) 974-2131 Neeta_vora@med.unc.edu

Amber Ivins, MSCR

amber_ivins@med.unc.edu

More Information

Sponsor

Case Western Reserve University

Last update posted

Sep 22, 2026

Last verified

Sep, 2026

Keywords

Non-invasive prenatal screening (NIPS)
Non-Invasive Prenatal Testing (NIPT)
Cell-free DNA (cfDNA)
Prenatal genetic screening
Informed consent
Decision making
Surveys and Questionnaires
Informed choice
Educational intervention
Decision Regret
Decision Satisfaction

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-24. This information was provided to ClinicalTrials.gov by Case Western Reserve University on 2026-09-22. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.