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 @ 10:42 PM
Ignite Modification Date:
2025-12-24 @ 10:42 PM
NCT ID:
NCT06997835
Eligibility Criteria:
Inclusion Criteria:
Gestational age \<10 weeks Singleton pregnancy confirmed by first-trimester ultrasound
Primary caregiver availability: At least one primary caregiver (spouse or parent) who:
1. Demonstrates adequate verbal communication and literacy skills (assessed by standardized evaluation)
2. Voluntarily participates in the study with signed informed consent
Metabolic risk factors meeting ≥1 criterion:
1. Pre-pregnancy BMI \>24 kg/m²
2. Maternal age ≥35 years at conception
3. Documented history of polycystic ovary syndrome (PCOS)
4. Fasting blood glucose (FBG) ≥5.1 mmol/L in early pregnancy
5. Parental history of diabetes mellitus (either parent)
6. Previous gestational diabetes mellitus (GDM)
7. History of macrosomia (birth weight ≥4000g)
8. Adverse obstetric history including:
Preterm delivery (\<37 weeks) Stillbirth or fetal demise Congenital malformations Neonatal death or unexplained neonatal death
Exclusion Criteria:
Pre-existing medical conditions:
1. Chronic hypertension (diagnosed pre-pregnancy)
2. Renal disorders (e.g., chronic kidney disease stage ≥3)
3. Cardiovascular diseases (e.g., coronary artery disease, heart failure)
Prohibited medication use during pregnancy including:
1. Indomethacin
2. Phentolamine
3. Diuretics (e.g., furosemide, hydrochlorothiazide)
4. Phenytoin
5. Systemic corticosteroids (e.g., cortisone, prednisone)
Activity-limiting comorbidities:
a) Severe medical complications contraindicating physical activity (e.g., unstable angina, advanced respiratory failure)
Healthy Volunteers:
False
Sex:
FEMALE
Study:
NCT06997835
Study Brief:
Protocol Section:
NCT06997835