Improving prenatal genetic testing decisions for better outcomes
Official title: Engaging Patients in Prenatal Genetic Testing Decisions as a Pathway to Improve Obstetric Outcomes
Run by The Cleveland Clinic · NCT06382636 · Data updated 2026-11-12
This study is testing a new AI tool to help pregnant patients and their partners make better decisions about genetic testing during their pregnancy.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 50 Years |
| Sex | Women only |
| Enrollment | 600 (estimated) |
| Sponsor | The Cleveland Clinic Academic / other |
| Locations | 3 sites (Cleveland, Ohio and 2 other locations) |
| Status | Recruiting |
| Started | May 6, 2024 |
| Main results expected | February 28, 2027 |
| Study ends | February 28, 2027 |
| Registry record updated | August 3, 2026 |
| Trial ID | NCT06382636 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are pregnant individuals who are offered routine aneuploidy screening and diagnostic testing and can read and speak English.
✕Probably not a fit
Patients who are under 18 years of age, not currently pregnant, or unable to provide informed consent may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to enhance the decision-making process for pregnant patients regarding Prenatal Screening and Diagnostic Testing (PS&D) by utilizing an innovative AI-powered engagement tool called OPUS. The trial will involve a randomized cluster design, focusing on the perspectives of patients, their partners, and healthcare providers. Through in-depth interviews and diverse participant recruitment, the study seeks to understand how social determinants and healthcare settings influence informed decision-making in prenatal care. The ultimate goal is to empower patients with the necessary resources to make informed choices about genetic testing.
Why it matters
Potential benefit: If successful, this study could lead to improved obstetric outcomes by enabling patients to make more informed decisions regarding prenatal genetic testing.
How similar studies have gone: Other studies have shown success with similar patient engagement approaches, indicating potential for positive outcomes in this area.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Able to read and speak English * Able to provide consent to participate in the study * Offered routine aneuploidy screening and diagnostic testing Exclusion Criteria: * Less than 18 years of age * Not currently pregnant or an intrauterine pregnancy has not yet been established * Unable to provide informed consent for research participation * Unable to read and speak English
Where it's running
-
Cleveland Clinic
Cleveland, Ohio, United States Recruiting -
Neighborhood Family Practice
Cleveland, Ohio, United States Not yet recruiting -
MetroHealth Medical Center
Cleveland, Ohio, United States Not yet recruiting
Study contacts
- Principal investigator: Ruth Farrell, MD, MA — The Cleveland Clinic
- Study coordinator: Ruth Farrell, MD, MA
- Email: farrelr@ccf.org
- Phone: 216-445-7085
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.