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 @ 3:03 AM
Ignite Modification Date:
2025-12-25 @ 3:03 AM
NCT ID:
NCT00759733
Eligibility Criteria:
Inclusion Criteria:
Potential subjects for the cardiac disease in pregnancy cohort:
1. At least 18 years of age
2. Cardiac disease as per Clark's Maternal Mortality Associated with Pregnancy: Group 1 (mortality less than 1%) atrial septal defect, ventricular septal defect, patent ductus arteriosus, pulmonic or tricuspid valve disease, corrected tetrology of Fallot, bioprosthetic valve, mitral stenosis with NYHA class I and II functional status Group 2 (mortality 5-15%) mitral stenosis with NYHA class III and IV functional status, aortic stenosis, coarctation of aorta without valvular involvement, uncorrected tetrology of Fallot, previous myocardial infarction, Marfan syndrome with normal aorta, mitral stenosis with atrial fibrillation, artificial valve Group 3 (mortality 25-50%) pulmonary hypertension, coarctation of aorta with valvular involvement, Marfan syndrome with aortic involvement (7)
3. Other significant cardiac disease not listed above
4. Other medical disorders, such as diabetes mellitus, chronic hypertension, asthma, other endocrine disorders, et cetera, will be acceptable
5. Diagnosis of a least a single intrauterine pregnancy, multiple gestation acceptable
Potential subjects for pregnancy without cardiac disease cohort:
1. At least 18 years of age
2. Absence of significant cardiac disease, minor cardiac disorders such as mitral valve prolapse without arrythmia
3. Other medical disorders, not directly related to cardiac disease, such as diabetes mellitus, chronic hypertension, asthma, other endocrine disorders et cetera, will be acceptable
4. Diagnosis of at least a single intrauterine pregnancy, multiple gestation acceptable
Exclusion Criteria:
1. Less than 18 years of age
2. Non-viable pregnancy such as a threatened spontaneous miscarriage, or ectopic pregnancy
3. Planned termination of pregnancy, either elective or medically indicated based on history
4. Inability to complete informed consent process or participate in the study protocol
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT00759733
Study Brief:
Protocol Section:
NCT00759733