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 @ 4:13 PM
Ignite Modification Date:
2025-12-24 @ 4:13 PM
NCT ID:
NCT05334966
Eligibility Criteria:
Inclusion Criteria:
* Group A, C: Fetuses with hypoplastic left sided structures or at risk of coarctation of the aorta and ALL of the following
* Any mitral annulus, aortic annulus, left ventricular end-diastolic dimension, or aortic diameter z-score less than or equal to 3.0
* Right-left ventricular size discrepancy with no other explanation of discrepancy
* Retrograde blood flow in the aortic arch from the ductus arteriosus
* Left to right flow across the foramen ovale
* Group B: Healthy Fetal controls
* Mothers undergoing screening fetal echo for family history of CHD with a normal echo.
* Mothers undergoing fetal echocardiography for suspected heart disease with a normal echo
* Mothers evaluated in the fetal center with normal ultrasound
* Group D:
Fetuses with hypoplastic left sided structures or at risk of coarctation of the aorta and any of the following
* Any mitral annulus, aortic annulus, left ventricular end-diastolic dimension, or aortic diameter z-score less than or equal to 2.0
* Right-left ventricular size discrepancy with no other explanation of discrepancy
* Continuous Doppler flow in the aortic arch concerning for coarctation
* Significantly less aortic flow than pulmonary artery flow
* Severe atrial septal aneurysm with possible obstruction of mitral valve flow
* Left superior vena cava to coronary sinus with dilated coronary sinus.
* Retrograde blood flow in the aortic arch from the ductus arteriosus
* Hypoplastic left heart syndrome (HLHS) and variants of HLHS
* Total anomalous pulmonary venous return
Exclusion criteria:
* Multiple gestations
* Persistent arrhythmia
* Very poor ultrasound images, defined by the inability to reliably measure/evaluate all included cardiac structures (valve annuli, branch pulmonary arteries, PFO, and arch)
* Major extra cardiac anomalies
* Aneuploidy
* Maternal conditions that may alter fetal hemodynamics, including moderate to severe HTN requiring medication in pregnancy, preeclampsia, major or unrepaired maternal congenital heart disease, obstructive sleep apnea, severe asthma (non-responsive to inhaled steroid therapy), restrictive lung disease, severe anemia, maternal chronic renal disease known placentation abnormality (complete placenta previa, accrete, or percreta), and antiphospholipid ab syndrome
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT05334966
Study Brief:
Protocol Section:
NCT05334966