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 @ 10:01 PM
Ignite Modification Date:
2025-12-24 @ 10:01 PM
NCT ID:
NCT00912132
Eligibility Criteria:
* INCLUSION CRITERIA:
* Singleton, viable pregnancy
* 8 plus 0 - 13 plus 6 weeks of gestation
* Maternal age 18 - 40 years
* BMI 19.0 -29.9kg/m(2) for low risk group; BMI 30.0 - 45.0kg/m(2) for obese group
* Firm LMP
* LMP-date and ultrasound date match within 5 days for gestation estimates between 8 weeks + 0 days and 10 weeks + 6 days, 6 days for those between 11 weeks + 0 days and 12 weeks + 6 days, and 7 days for estimates between 13 weeks + 0 days and 13 weeks + 6 days
* No confirmed or suspected fetal congenital structural or chromosomal anomalies
* Expect to deliver at one of the participating hospitals
* No previous participation in the NICHD Fetal Growth Study
EXCLUSION CRITERIA:
* Smoked cigarettes or used illicit drugs in the six months
* Used illicit drugs in the past year
* Having at least 1 alcoholic drink per day
* Conception by ovulation stimulation drugs or assisted reproductive technology
* Chronic hypertension or renal disease under medical supervision
* Asthma requiring weekly medication
* Diabetes mellitus
* Thyroid disease under medical supervision
* Autoimmune disorder (rheumatoid arthritis, lupus, antiphospholipid antibody syndrome,scleroderma)
* Hematologic disorders (chronic anemia, sickle cell disease thrombocytopenia coagulation defects, thrombophilia)
* Cancer
* HIV or AIDS
* Epilepsy or seizure on medication or occurrence within 2 years
* Psychiatric disorder (bipolar disorder, depression, anxiety disorder currently requiring medication)
* Current anorexia nervosa or bulimia
* Previous severe preclampsia, eclampsia, HELLP syndrome
* Previous stillbirth or neonatal death
* Previous very preterm birth (less than 34 weeks)
* Previous low birthweight (less than 2,500 g)
* Previous macrosomia (greater than or equal to 4,500 g)
The following criteria apply only to obese women only:
* Chronic hypertension or high blood pressure requiring two or more medications
* Diabetes while not pregnant
* Chronic renal disease under medical supervision
* Autoimmune disease (rheumatoid arthritis, lupus, antiphospholipid antibody syndrome, scleroderma)
* Psychiatric disorder (bipolar disorder, depression, anxiety disorder currently requiring medication)
* Cancer (currently receiving treatment)
* HIV or AIDS
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT00912132
Study Brief:
Protocol Section:
NCT00912132