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 @ 4:15 AM
Ignite Modification Date:
2025-12-25 @ 4:15 AM
NCT ID:
NCT03718520
Eligibility Criteria:
Inclusion Criteria:
* pregnant women who are receiving prenatal care at the University of Colorado Hospital at Anschutz (UCH) or Denver Health Medical Center.
* maternal positive urine toxicology screen for cannabis at any clinical prenatal visit or self-report of cannabis during pregnancy at a clinical visit
* greater than ≥ 28 weeks gestation,
* aged ≥18 years,
* expecting a singleton birth,
* live in Colorado, and plan to deliver at UCH or Denver Health Medical Center .
* Inclusion criteria for unexposed controls will be identical to that of exposed cases with the exception that they cannot have a positive toxicology screen for cannabis or self-reported cannabis use during pregnancy.
Exclusion Criteria (for unexposed cases and controls):
* use of tobacco, alcohol or other drugs during pregnancy,
* serious chronic diseases (cancer, psychiatric diseases, steroid-dependent asthma, pre-existent diabetes mellitus of any kind),
* mothers who subsequently experience a fetal death or deliver a premature infant (\< 37 weeks of gestation).
* Postnatal exclusions will include failure to collect meconium samples at birth, infant neurological trauma, other neurological conditions in the infant (e.g., epilepsy),
* suspicion of metal in body or other MRI contraindications in either the mother or infant.
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT03718520
Study Brief:
Protocol Section:
NCT03718520