Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:16 AM
Ignite Modification Date:
2025-12-25 @ 3:16 AM
NCT ID:
NCT05037305
Eligibility 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
Healthy Volunteers:
True
Sex:
ALL
Study:
NCT05037305
Study Brief:
Protocol Section:
NCT05037305