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:
2025-12-24 @ 9:48 PM
Ignite Modification Date:
2025-12-24 @ 9:48 PM
NCT ID:
NCT01603732
Eligibility Criteria:
Inclusion Criteria:
* For Fetal pts:
* HLHS or variant diagnosis
* Other Congenital Heart Disease
* Greater than or = 20wks gestation
* For Healthy moms:
* No diagnosis of Congenital Heart Disease
* Greater than or = 20wks gestation
Exclusion Criteria:
* For fetal pts \& healthy controls:
* Mom less than 18 years old
* Twins or multiple gestations
* Pregnancy affected by 2 or more congenital anomalies( in addition to heart defects)
* Pregnancy affected by OB complications like pre-eclampsia
* Known history of chromosomal anomaly or carrier status
* Pregnancy result of fertility treatment including in vitro fertilization
* Emotionally distress
* Mom received blood transfusion or immunoglobin infusion within 6 months of the pregnancy.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT01603732
Study Brief:
Protocol Section:
NCT01603732