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 @ 6:28 PM
Ignite Modification Date:
2025-12-24 @ 6:28 PM
NCT ID:
NCT03696368
Eligibility Criteria:
Inclusion Criteria:
* Singleton gestation
* Gestational age ≤ 20+0 confirmed via American Congress of Obstetrics and Gynecology (ACOG) ultrasound dating guidelines
* 18 years old or greater at time of consent
Exclusion Criteria:
* Pre pregnancy diagnosis of Type 1 Diabetes or Type 2 Diabetes or Screening Hemoglobin A1C that is greater than or equal to 6.5% or two abnormal values on a 3 hours Oral Glucose Tolerance Test (100g load) before 20 weeks gestation
* Pre pregnancy chronic usage of systemic steroids (inhaled and short term usage acceptable)
* Planned pregnancy termination
* Unable to provide informed consent in English or Spanish
* Major fetal anomalies as listed below that are known prior to enrollment. If these are discovered after enrollment, the participant may be allowed to participate, unless the discovered fetal anomaly is a lethal anomaly.
Major Fetal Anomalies to be Excluded:
* Congenital diaphragmatic hernia
* Congenital cystic adenomatoid malformation
* Pleural effusions
* Chylothorax
* Bronchogenic cyst
* Bronchopulmonary sequestration
* Anomalous pulmonary venous return
* Tricuspid atresia
* Mitral atresia
* Double right ventricle
* Ebstein's malformation
* Pulmonary atresia
* Hypoplastic left heart syndrome
* Aortic coarctation
* Fetal arrhythmias (tachycardia or bradycardia)
* Transposition of the great vessels
* Tetrology of Fallot
* Double outlet right ventricle
* Aortic stenosis
* Holoprosencephaly
* Anencephaly
* Dandy-Walker malformation or variant
* Septo-optic dysplasia
* Neural tube defect
* Vein of Galen aneurysm
* Bilateral renal agenesis
* Cystic renal disease (polycystic or multicystic)
* Any genitourinary lesion accompanied by oligohydramnios at \<24 weeks
* Obstructive uropathy
* Horseshoe kidney
* Megacystis microcolon
* Achondrogenesis
* Thanatophoric dysplasia
* Thoracic dysplasia
* Osteogenesis imperfect
* Short rib polydactyly
* Any skeletal defect associated with small thorax
* Hypophosphatemia
* Any karyotypic abnormality
* Any suspected genetic syndrome
* Cleft lip/palate
* Micrognathia
* Hydrops
* Fetal anemia (\<35% on cordocentesis)
* Neck mass
* Gastroschisis
* Omphalocele
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT03696368
Study Brief:
Protocol Section:
NCT03696368