Status:
COMPLETED
The National Standard for Normal Fetal Growth
Lead Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Pregnancy
Fetal Growth
Eligibility:
FEMALE
18-40 years
Brief Summary
Normal fetal growth is a critical component of a healthy pregnancy and the long-term health of the offspring. Pivotal to understanding the dynamics of human fetal growth and to defining normal and abn...
Detailed Description
Summary and aims: Normal fetal growth is a critical component of a healthy pregnancy and the long-term health of the offspring. Pivotal to understanding the dynamics of human fetal growth and to defi...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
May 19 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 25 2013
Estimated Enrollment :
2802 Patients enrolled
Trial Details
Trial ID
NCT00912132
Start Date
May 19 2009
End Date
August 25 2013
Last Update
March 29 2022
Active Locations (11)
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1
University of Alabama
Birmingham, Alabama, United States
2
Fountain Valley Regional Hospital
Fountain Valley, California, United States, 92708
3
University of California-Long Beach
Long Beach, California, United States, 90806
4
University of California, Irvine Medical Center
Orange, California, United States, 92668