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NCT Number: NCT07557303

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

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.

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Key information

Conditions

Delivery of Health Care Adherence Interventions Behavior Decision Making Genetic Testing Health Behavior Health Education Humans Informed Consent Internet-based Intervention Medication Adherence Noninvasive Prenatal Testing Patient Acceptance of Health Care Patient Compliance Patient Education as Topic/Method Pregnancy Pregnant People Self Efficacy Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Zuckerberg Chan San Francisco General Hospital, San Francisco, California, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Mobile-based Educational Intervention

Behavioral

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 outcomes

Decision Self-Efficacy

Time frame: The scale is completed up to 168-hours (7 calendar days) post-prenatal screening visit.

Decision self-efficacy is measured using a slightly adapted version of the "Decision Self-Efficacy Scale" developed by A. O'Connor and colleagues at the Ottawa Hospital Research Institute and is available at https://decisionaid.ohri.ca. The scale contains eleven questions about a patient's decision-making process. The scale was adapted to ask questions about the context of prenatal genetic screening and utilizes a three-point response scale. Response choices and corresponding point values are: "A lot confident (4), a little confident (2), and not confident (0)". The values from each response are summed, divided by 11 and multiplied by 100 to give a score range from 0 to 100. Zero indicates no confidence and 100 indicates extreme confidence. A researcher administers the scale over the phone, once to each participant, within 168-hours after the medical appointment where participants are offered prenatal genetic screening. It should take no more than 5-10 minutes to complete.

Study contacts

Contact information is provided by the study sponsor or research team.

Harlie Custer, MA, MPH

CONTACT

[email protected]

(216) 368-5914

Sabina Rubeck, MPH

CONTACT

[email protected]

216-368-2547

Sponsors and collaborators

Lead sponsor

Case Western Reserve University

Other

Collaborators

National Human Genome Research Institute (NHGRI)

Registry information

Important dates

Study start: 2026
Primary completion: 2028
Study completion: 2028
First posted: Apr 29, 2026
Registry last updated: Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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