Pharmacogenetic testing for mothers and children
Knowledge and Attitudes Regarding Pharmacogenetic Testing Among Children With Chronic Conditions and Pregnant Women
This study is testing if providing educational videos about genetic testing for medications at different times helps pregnant women and children understand and use this information better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 500 (estimated) |
| Sex | All |
| Sponsor | Vanderbilt University Medical Center Academic / other |
| Locations | 2 sites (Nashville, Tennessee and 1 other locations) |
| Trial ID | NCT05037305 on ClinicalTrials.gov |
What this trial studies
This project aims to enhance the understanding and implementation of pharmacogenetic testing for children and pregnant women. It will involve collecting DNA samples and demographic information from participants, followed by a survey assessing knowledge and attitudes towards pharmacogenetics. Participants will be randomized into two groups, one receiving an educational video about pharmacogenetic testing at the time of results, and the other receiving it later. The study seeks to address gaps in pharmacogenetic data, particularly for underrepresented populations.
Who should consider this trial
Good fit: Ideal candidates include pregnant women aged 18 and older who are receiving care at Vanderbilt University Medical Center and children aged 0 to 16 whose parents consent to participate.
Not a fit: Patients who have undergone prior pharmacogenomic testing or those with recent organ transplants may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized and effective medication management for mothers and children based on their genetic profiles.
How similar studies have performed: While pharmacogenetic testing has been explored in various populations, this specific focus on pregnant women and children is relatively novel and under-researched.
Eligibility criteria
Show full inclusion / exclusion criteria
Maternal Inclusion Criteria: * Provide consent in English or Spanish * Primary care at VUMC * Adult women aged 18 and older * Currently pregnant 12 to 30 weeks gestational age * Completed or scheduled first prenatal visit at VUMC clinic * Intent to deliver at VUMC or affiliate * Agrees to receive findings from pharmacogenomic testing * Allow access their medical record Exclusion Criteria: * Stem cell or solid organ transplant * Recent transfusion within the previous 2 months * Inability to provide DNA sample for testing * Prior pharmacogenomic testing * Pregnant women undergoing in vitro fertilization or assisted reproductive technologies Pediatric Inclusion Criteria: * Provide consent (parent/guardian) and/or assent (child) in English or Spanish * Primary care or subspecialty care at VUMC * Aged 0 to 16 * Parent (0-16 years) and child (12-16 years) agree for both parent and child to receive findings from pharmacogenomic testing * Parent (0-16 years) and child (12-16 years) allow access their medical record * Have a chronic health condition. Exclusion: * Stem cell or solid organ transplant * Recent transfusion within the previous 2 months * Inability to provide DNA sample for testing * Prior pharmacogenomic testing
Where this trial is running
Nashville, Tennessee and 1 other locations
- Monroe Carell Jr. Children's Hospital at Vanderbilt — Nashville, Tennessee, United States (Recruiting)
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (Recruiting)
Study contacts
- Study coordinator: Sabrina E Holley, MD
- Email: sabrina.e.holley@vumc.org
- Phone: 6158754491
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.