The National Standard for Normal Fetal Growth

Completed

Conditions studied: Pregnancy, Fetal Growth

In brief

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 abnormal fetal growth is the development of standards for fetal growth. The study's purpose was to establish standards for normal fetal growth and size for gestational age for 4 racial/ethnic groups of pregnant women with the eventual creation of individualized standards for fetal growth and improvements in fetal weight estimation. These data for a contemporary cohort of pregnant women should provide data for clinical management.

Key facts

Study ID

NCT00912132

Run by

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

People needed

2802

Starts

2009-05-19

Expected to finish

2013-08-25

Last updated by the study team

2022-03-29

Who can join

Age: 18 and older, up to 40. Sex: female. Healthy volunteers: accepted.

You may not qualify if…

• 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)

Where it is running

• University of Alabama — Birmingham, Alabama, United States
• Fountain Valley Regional Hospital — Fountain Valley, California, United States
• University of California-Long Beach — Long Beach, California, United States
• University of California, Irvine Medical Center — Orange, California, United States
• Christiana Care Health Services — Newark, Delaware, United States
• Northwestern University — Chicago, Illinois, United States
• Saint Peters University Hospital — New Brunswick, New Jersey, United States
• New York Presbyterian Healthcare System — Flushing, New York, United States
• Columbia University — New York, New York, United States
• Women and Infants — Providence, Rhode Island, United States
• Medical University of South Carolina — Charleston, South Carolina, United States

Full record on ClinicalTrials.gov

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