PregnancyNCT00912132
The National Standard for Normal Fetal Growth
An observational study of Pregnancy and Fetal Growth, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 11 sites in United States.
Trial 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 abnormal fetal growth is the development of standards for fetal growth. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, Fetal Growth
- How many people
- 2,802 participants
- Where
- 11 sitesUnited States
- Study dates
- 19 May 2009to 25 Aug 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Women with singleton gestations (n=2,802) were enrolled from 12 U.S. clinical centers. Women were enrolled between 8w0d and 13w6d gestation, as measured by last menstrual period dating consistent with obstetrical ultrasonology.
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 28Show fewer
- 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
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
University of Alabama
Birmingham, Alabama
Medical University of South Carolina
Charleston, South Carolina
Northwestern University
Chicago, Illinois, 60611
New York Presbyterian Healthcare System
Flushing, New York, 11355
Fountain Valley Regional Hospital
Fountain Valley, California, 92708
University of California-Long Beach
Long Beach, California, 90806
Saint Peters University Hospital
New Brunswick, New Jersey, 08901
Columbia University
New York, New York, 10032-3784
Christiana Care Health Services
Newark, Delaware
University of California, Irvine Medical Center
Orange, California, 92668
Women and Infants
Providence, Rhode Island, 02905
About this study
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.
Read the 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 defining normal and abnormal fetal growth is the development of standards for fetal anthropometric parameters measured longitudinally throughout gestation, which, in turn, can be used to develop interval velocity curves and customized for genetic and physiological factors. We propose to conduct a multi-center prospective observational study (1) to establish a standard for normal fetal growth (velocity) and size for gestational age in the U.S. population; (2) to create an individualized standard for fetal growth potential; and (3) to improve accuracy of fetal weight estimation.
Eligibility:
- Healthy, low-risk pregnant women (both obese and nonobese) between the ages of 18 and 40 from each of the following four self-identified race/ethnicity backgrounds: African American, Asian, Caucasian, and Hispanic.
Design:
- Observational cohort design where pregnant women are recruited prior to 13 weeks gestation and followed throughout pregnancy and delivery for women having livebirths.
- After a sonogram at enrollment (10-13 weeks), women were randomized to receive sonograms according to one of the following four schedules: schedule A: 16, 24, 30, 34, and 38 weeks; schedule B: 18, 26, 31, 35, and 39 weeks; schedule C: 20, 28, 32, 36, and 40 weeks; schedule D: 22, 29, 33, 37, and 41 weeks.
- An enrollment interview was followed by depression screening, physical activity, anthropometric assessment and ultrasonology screening for measurement of fetal growth, and at each of the 5 subsequent visits.
- Uterine artery and fetal Doppler studies at selected gestational weeks.
- Women were asked to provide blood samples at enrollment and at follow-up visits at 16-22 weeks, 24-29 weeks, and 34-37 weeks of gestation.
- Neonatal anthropometry completed for all infants within 12-24 hours after birth.
- Cord blood, plasma, and placenta samples were collected for a smaller subsample of newborns.
- Post-study evaluations: Women who were diagnosed with gestational diabetes during pregnancy were asked to return for a follow-up visit 6 weeks after delivery.
Enrollment:
Final recruitment included 2,802 women with singleton pregnancies of which 2,334 were healthy, low-risk women with pre-pregnancy body mass indices (BMI) between 19-29.9 kg/m2. The racial/ethnic distribution of participating women were: Caucasians (n=614), African American (n=611), Hispanics (n=649), and Asians (n=460), and reflects natality characteristics of contemporary U.S. births. An additional 468 obese women (BMI 30-44.9 kg/m2) were also recruited.
Quality Control:
The quality of the ultrasound measures was guaranteed by implementation of: (1) a comprehensive quality control protocol for ante hoc training and credentialing of all site sonographers, developed by the sonology center at Columbia University, and (2) a rigorous protocol for post hoc quality control, whereby a random sample of all scans, stratified by clinical site and visit, was re-measured for accuracy and reliability.
- Conditions
- Pregnancy, Fetal Growth
- Keywords
- Fetal Growth, Pregnancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Low risk singleton cohort | Women with singleton gestations were enrolled between 8w0d and 13w6d and followed up to nine months (2009-2013) in this prospective cohort study. A sub-set of women with and without gestational diabetes were followed up to 6 weeks postpartum. Enrollment was based upon a predefined set of criteria including medical/reproductive history and pre-pregnancy body mass index. Women with a body mass index between 19.0-29.9 kg/m2 were in the low-risk cohort. | |
| Obese cohort | Women with singleton gestations were enrolled between 8w0d and 13w6d and followed up to nine months (2009-2013) in this prospective cohort study. A sub-set of women with and without gestational diabetes were followed up to 6 weeks postpartum. Enrollment was based upon a predefined set of criteria including medical/reproductive history and pre-pregnancy body mass index. Women with a body mass index between 30.0-44.9 kg/m2 were in the obese cohort. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Establish a standard for normal fetal growth (velocity) and size for gestational age in the U.S. population.
Fetal growth trajectories were created using 2-D ultrasound fetal biometry including biparietal diameter, head circumference, humerus length, abdominal circumference, and femur length using standardized protocols. Estimated fetal weight (EFW) was calculated.
Fetal growth trajectories were created using linear mixed models with cubic splines for estimating racial/ethnic specific fetal growth curves for size, methods that accounted for the variation across individual fetuses. For EFW and each individual anthropometric parameter, we tested for overall differences in the racial/ethnic-specific curves using a likelihood-ratio test. When the global test was significant (<.05 level), we tested for week-specific differences by race/ethnicity using Wald tests at each week of gestation. These tests were conducted on the estimated curves with and without adjustment for maternal characteristics.
A fetal growth velocity standard by maternal race/ethnicity was also created.
Measured: 3 years
Create an individualized standard for fetal growth potential.
Individualized and customized fetal growth models will be created using two- dimensional ultrasound measures. Individualized or customized definitions of small for gestational age or large for gestational age will be compared to the NICHD Fetal Growth Study singleton standard cut-points of 10th and 90th percentiles, respectively, to see if they improve detection of maternal and neonatal health outcomes.
Improve accuracy of fetal weight estimation.
Since the last ultrasound exam is scheduled at term, it was expected that many women would deliver within 3 days after the last ultrasound exam. A formula (or formulas) to estimate fetal weight will be created using a multiple linear regression to include not only the 2-D and 3-D sonographic measurements but also factors such as maternal height and weight, sex of the fetus, and glucose challenge test result. We will identify a formula that provides the best estimate of fetal weight, and apply that formula to a validation group. If the sample size allows, we will randomly split the whole cohort into two groups: one group for testing and the other for validation. If the statistical power is insufficient for splitting, we will use cross-validation.
Secondary outcomes (4)
Construct an individualized standard for fundal height.
We will reevaluate the sensitivity and specificity of the current approach to using fundal height to monitor fetal growth. We will produce an individualized standard for fundal height. We will compare the new standard with the current approach with regard to true positive and true negative values.
Collect blood samples for an etiology study of gestational diabetes and a prediction study of fetal growth restriction and/or overgrowth.
Blood samples were collected at enrollment, visit 1, visit 2 and visit 4.
Collect placental tissues and cord blood in selected cases and controls for studies on the etiology of idiopathic fetal growth restriction.
Placental tissue and cord blood at delivery were collected in selected IUGR cases and controls. Placental DNA samples were genotyped. DNA methylation and RNA were quantified.
Collect dietary intake data to study the association between nutrition and fetal growth.
Food frequency questionnaire was collected at enrollment and 24-h dietary recall at visit 1, visit 2, visit 3, and visit 4.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2009 (estimated)
- Study start19 May 2009
- Primary completion25 Aug 2013
- Study completion25 Aug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (46)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,802 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Germaine M Louis, M.D., Principal investigator, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00912132
- Sponsor's protocol ID
- 999909152
- Other IDs
- 09-CH-N152
- Status last verified
- Mar 2022
- First submitted
- 30 May 2009
- Last updated
- 29 Mar 2022
- Results posted
- No
- Individual data sharing
- Yes: Pregnancy and postpartum data will be made accessible in documented repositories and electronic archives after completion of the studies' analytical phases.
Publications
Zhang C, Hediger ML, Albert PS, Grewal J, Sciscione A, Grobman WA, Wing DA, Newman RB, Wapner R, D'Alton ME, Skupski D, Nageotte MP, Ranzini AC, Owen J, Chien EK, Craigo S, Kim S, Grantz KL, Louis GMB. Association of Maternal Obesity With Longitudinal Ultrasonographic Measures of Fetal Growth: Findings From the NICHD Fetal Growth Studies-Singletons. JAMA Pediatr. 2018 Jan 1;172(1):24-31. doi: 10.1001/jamapediatrics.2017.3785.
PubMed 29131898Grantz KL, Grewal J, Kim S, Grobman WA, Newman RB, Owen J, Sciscione A, Skupski D, Chien EK, Wing DA, Wapner RJ, Ranzini AC, Nageotte MP, Craigo S, Hinkle SN, D'Alton ME, He D, Tekola-Ayele F, Hediger ML, Buck Louis GM, Zhang C, Albert PS. Unified standard for fetal growth: the Eunice Kennedy Shriver National Institute of Child Health and Human Development Fetal Growth Studies. Am J Obstet Gynecol. 2022 Apr;226(4):576-587.e2. doi: 10.1016/j.ajog.2021.12.006. Epub 2021 Dec 11. No abstract available.
PubMed 34906542Grantz KL, Kim S, Grobman WA, Newman R, Owen J, Skupski D, Grewal J, Chien EK, Wing DA, Wapner RJ, Ranzini AC, Nageotte MP, Hinkle SN, Pugh S, Li H, Fuchs K, Hediger M, Buck Louis GM, Albert PS. Fetal growth velocity: the NICHD fetal growth studies. Am J Obstet Gynecol. 2018 Sep;219(3):285.e1-285.e36. doi: 10.1016/j.ajog.2018.05.016. Epub 2018 May 24.
PubMed 29803819Buck Louis GM, Grewal J, Albert PS, Sciscione A, Wing DA, Grobman WA, Newman RB, Wapner R, D'Alton ME, Skupski D, Nageotte MP, Ranzini AC, Owen J, Chien EK, Craigo S, Hediger ML, Kim S, Zhang C, Grantz KL. Racial/ethnic standards for fetal growth: the NICHD Fetal Growth Studies. Am J Obstet Gynecol. 2015 Oct;213(4):449.e1-449.e41. doi: 10.1016/j.ajog.2015.08.032.
PubMed 26410205Hediger ML, Fuchs KM, Grantz KL, Grewal J, Kim S, Gore-Langton RE, Buck Louis GM, D'Alton ME, Albert PS. Ultrasound Quality Assurance for Singletons in the National Institute of Child Health and Human Development Fetal Growth Studies. J Ultrasound Med. 2016 Aug;35(8):1725-33. doi: 10.7863/ultra.15.09087. Epub 2016 Jun 27.
PubMed 27353072Grewal J, Grantz KL, Zhang C, Sciscione A, Wing DA, Grobman WA, Newman RB, Wapner R, D'Alton ME, Skupski D, Nageotte MP, Ranzini AC, Owen J, Chien EK, Craigo S, Albert PS, Kim S, Hediger ML, Buck Louis GM. Cohort Profile: NICHD Fetal Growth Studies-Singletons and Twins. Int J Epidemiol. 2018 Feb 1;47(1):25-25l. doi: 10.1093/ije/dyx161. No abstract available.
PubMed 29025016McElwee ER, Lee S, Babineau V, Ferguson PL, Hunt KJ, Grantz KL, Grobman WA, Wapner RJ, Skupski DW, Sciscione A, Wing DA, Nageotte MP, Chien EK, Tita AT, Takacs L, Monk C, Newman RB. Mid-pregnancy uterine artery Dopplers and child neurodevelopment. Pregnancy (Hoboken). 2025 Jul 31;1(5):e70076. doi: 10.1002/pmf2.70076. eCollection 2025 Sep.
PubMed 42597042Martin SL, Grantz KL, Grobman W, Sciscione A, Skupski D, Palomares K, Wapner R, Vena JE, Newman RB, Hunt K, Tita A; ECHO National Fetal Growth Study Consortium. Childhood neurodevelopmental outcomes following hypertensive disorders of pregnancy. Pregnancy Hypertens. 2026 Jun 8;45:101483. doi: 10.1016/j.preghy.2026.101483. Online ahead of print.
PubMed 42259106Guivarch C, Wu J, Lu R, Grewal J, Yu G, Li LJ, Yang J, Pang WW, Wang DD, Weir NL, Tsai MY, Albert PS, Chen Z, Zhang C. Plasma amino acids in early pregnancy and fetal growth trajectories across pregnancy: findings from a multi-racial U.S. pregnancy cohort. Eur J Nutr. 2026 Feb 14;65(2):55. doi: 10.1007/s00394-025-03875-8.
PubMed 41689644Guivarch C, Wu J, Lu R, Grewal J, Yu G, Li LJ, Yang J, Pang WW, Wang DD, Weir NL, Chen Z, Tsai MY, Zhang C. Longitudinal plasma amino acids during pregnancy and neonatal anthropometry: findings from the NICHD Fetal Growth Studies-Singleton Cohort. BMC Med. 2025 Jun 9;23(1):343. doi: 10.1186/s12916-025-04146-3.
PubMed 40484929Le R, Biedrzycki RJ, Tekola-Ayele F. Maternal obesity and ancestry distance in influencing birth outcomes. Int J Obes (Lond). 2025 Aug;49(8):1532-1542. doi: 10.1038/s41366-025-01783-9. Epub 2025 Apr 12.
PubMed 40221546Wagner KA, Chen Z, Hinkle SN, Gleason JL, Lee W, Grobman WA, Owen J, Newman RB, Skupski DW, He D, Sherman S, Gore-Langton RE, Zhang C, Grewal J, Grantz KL. Relationship between gestational weight gain with fetal body composition and organ volumes in the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Fetal Dimensional Study: a prospective pregnancy cohort. Am J Clin Nutr. 2025 Feb;121(2):367-375. doi: 10.1016/j.ajcnut.2024.12.007. Epub 2025 Jan 16.
PubMed 39909708Li LJ, Lu R, Rawal S, Birukov A, Weir NL, Tsai MY, Wu J, Chen Z, Zhang C. Maternal plasma phospholipid polyunsaturated fatty acids in early pregnancy and thyroid function throughout pregnancy: a longitudinal study. Am J Clin Nutr. 2024 Apr;119(4):1065-1074. doi: 10.1016/j.ajcnut.2024.02.016. Epub 2024 Feb 24.
PubMed 38408725Saeed H, Wu J, Tesfaye M, Grantz KL, Tekola-Ayele F. Placental accelerated aging in antenatal depression. Am J Obstet Gynecol MFM. 2024 Jan;6(1):101237. doi: 10.1016/j.ajogmf.2023.101237. Epub 2023 Nov 25.
PubMed 38012987Mitro SD, Sundaram R, Buck Louis GM, Peddada S, Chen Z, Kannan K, Gleason JL, Zhang C, Grantz KL. Associations of Pregnancy Per- and Polyfluoroalkyl Substance Concentrations and Uterine Fibroid Changes across Pregnancy: NICHD Fetal Growth Studies - Singletons Cohort. Environ Health Perspect. 2023 May;131(5):57007. doi: 10.1289/EHP11606. Epub 2023 May 24.
PubMed 37224071
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The National Standard for Normal Fetal Growth
- ClinicalTrials.gov ID
- NCT00912132
- Acronym / sponsor ID
- 999909152
- Conditions
- Pregnancy, Fetal Growth
- Keywords
- Fetal Growth, Pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,802 participants (actual)
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Study start
- 19 May 2009
- Primary completion
- 25 Aug 2013 (actual)
- Study completion
- 25 Aug 2013 (actual)
- First posted
- 3 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 defining normal and abnormal fetal growth is the development of standards for fetal anthropometric parameters measured longitudinally throughout gestation, which, in turn, can be used to develop interval velocity curves and customized for genetic and physiological factors. We propose to conduct a multi-center prospective observational study (1) to establish a standard for normal fetal growth (velocity) and size for gestational age in the U.S. population; (2) to create an individualized standard for fetal growth potential; and (3) to improve accuracy of fetal weight estimation.
Eligibility:
- Healthy, low-risk pregnant women (both obese and nonobese) between the ages of 18 and 40 from each of the following four self-identified race/ethnicity backgrounds: African American, Asian, Caucasian, and Hispanic.
Design:
- Observational cohort design where pregnant women are recruited prior to 13 weeks gestation and followed throughout pregnancy and delivery for women having livebirths.
- After a sonogram at enrollment (10-13 weeks), women were randomized to receive sonograms according to one of the following four schedules: schedule A: 16, 24, 30, 34, and 38 weeks; schedule B: 18, 26, 31, 35, and 39 weeks; schedule C: 20, 28, 32, 36, and 40 weeks; schedule D: 22, 29, 33, 37, and 41 weeks.
- An enrollment interview was followed by depression screening, physical activity, anthropometric assessment and ultrasonology screening for measurement of fetal growth, and at each of the 5 subsequent visits.
- Uterine artery and fetal Doppler studies at selected gestational weeks.
- Women were asked to provide blood samples at enrollment and at follow-up visits at 16-22 weeks, 24-29 weeks, and 34-37 weeks of gestation.
- Neonatal anthropometry completed for all infants within 12-24 hours after birth.
- Cord blood, plasma, and placenta samples were collected for a smaller subsample of newborns.
- Post-study evaluations: Women who were diagnosed with gestational diabetes during pregnancy were asked to return for a follow-up visit 6 weeks after delivery.
Enrollment:
Final recruitment included 2,802 women with singleton pregnancies of which 2,334 were healthy, low-risk women with pre-pregnancy body mass indices (BMI) between 19-29.9 kg/m2. The racial/ethnic distribution of participating women were: Caucasians (n=614), African American (n=611), Hispanics (n=649), and Asians (n=460), and reflects natality characteristics of contemporary U.S. births. An additional 468 obese women (BMI 30-44.9 kg/m2) were also recruited.
Quality Control:
The quality of the ultrasound measures was guaranteed by implementation of: (1) a comprehensive quality control protocol for ante hoc training and credentialing of all site sonographers, developed by the sonology center at Columbia University, and (2) a rigorous protocol for post hoc quality control, whereby a random sample of all scans, stratified by clinical site and visit, was re-measured for accuracy and reliability.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low risk singleton cohort | – | –Women with singleton gestations were enrolled between 8w0d and 13w6d and followed up to nine months (2009-2013) in this prospective cohort study. A sub-set of women with and without gestational diabetes were followed up to 6 weeks postpartum. Enrollment was based upon a predefined set of criteria including medical/reproductive history and pre-pregnancy body mass index. Women with a body mass index between 19.0-29.9 kg/m2 were in the low-risk cohort. |
| Obese cohort | – | –Women with singleton gestations were enrolled between 8w0d and 13w6d and followed up to nine months (2009-2013) in this prospective cohort study. A sub-set of women with and without gestational diabetes were followed up to 6 weeks postpartum. Enrollment was based upon a predefined set of criteria including medical/reproductive history and pre-pregnancy body mass index. Women with a body mass index between 30.0-44.9 kg/m2 were in the obese cohort. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women with singleton gestations (n=2,802) were enrolled from 12 U.S. clinical centers. Women were enrolled between 8w0d and 13w6d gestation, as measured by last menstrual period dating consistent with obstetrical ultrasonology.
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (28 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Establish a standard for normal fetal growth (velocity) and size for gestational age in the U.S. population.
Time frame: 3 years
Fetal growth trajectories were created using 2-D ultrasound fetal biometry including biparietal diameter, head circumference, humerus length, abdominal circumference, and femur length using standardized protocols. Estimated fetal weight (EFW) was calculated. Fetal growth trajectories were created using linear mixed models with cubic splines for estimating racial/ethnic specific fetal growth curves for size, methods that accounted for the variation across individual fetuses. For EFW and each individual anthropometric parameter, we tested for overall differences in the racial/ethnic-specific curves using a likelihood-ratio test. When the global test was significant (<.05 level), we tested for week-specific differences by race/ethnicity using Wald tests at each week of gestation. These tests were conducted on the estimated curves with and without adjustment for maternal characteristics. A fetal growth velocity standard by maternal race/ethnicity was also created.
Create an individualized standard for fetal growth potential.
Individualized and customized fetal growth models will be created using two- dimensional ultrasound measures. Individualized or customized definitions of small for gestational age or large for gestational age will be compared to the NICHD Fetal Growth Study singleton standard cut-points of 10th and 90th percentiles, respectively, to see if they improve detection of maternal and neonatal health outcomes.
Improve accuracy of fetal weight estimation.
Since the last ultrasound exam is scheduled at term, it was expected that many women would deliver within 3 days after the last ultrasound exam. A formula (or formulas) to estimate fetal weight will be created using a multiple linear regression to include not only the 2-D and 3-D sonographic measurements but also factors such as maternal height and weight, sex of the fetus, and glucose challenge test result. We will identify a formula that provides the best estimate of fetal weight, and apply that formula to a validation group. If the sample size allows, we will randomly split the whole cohort into two groups: one group for testing and the other for validation. If the statistical power is insufficient for splitting, we will use cross-validation.
4 secondary outcomes
Construct an individualized standard for fundal height.
Collect blood samples for an etiology study of gestational diabetes and a prediction study of fetal growth restriction and/or overgrowth.
Collect placental tissues and cord blood in selected cases and controls for studies on the etiology of idiopathic fetal growth restriction.
Collect dietary intake data to study the association between nutrition and fetal growth.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2022.
- Background: PubMed 29131898Zhang C, Hediger ML, Albert PS, Grewal J, Sciscione A, Grobman WA, Wing DA, Newman RB, Wapner R, D'Alton ME, Skupski D, Nageotte MP, Ranzini AC, Owen J, Chien EK, Craigo S, Kim S, Grantz KL, Louis GMB. Association of Maternal Obesity With Longitudinal Ultrasonographic Measures of Fetal Growth: Findings From the NICHD Fetal Growth Studies-Singletons. JAMA Pediatr. 2018 Jan 1;172(1):24-31. doi: 10.1001/jamapediatrics.2017.3785.
- Background: PubMed 34906542Grantz KL, Grewal J, Kim S, Grobman WA, Newman RB, Owen J, Sciscione A, Skupski D, Chien EK, Wing DA, Wapner RJ, Ranzini AC, Nageotte MP, Craigo S, Hinkle SN, D'Alton ME, He D, Tekola-Ayele F, Hediger ML, Buck Louis GM, Zhang C, Albert PS. Unified standard for fetal growth: the Eunice Kennedy Shriver National Institute of Child Health and Human Development Fetal Growth Studies. Am J Obstet Gynecol. 2022 Apr;226(4):576-587.e2. doi: 10.1016/j.ajog.2021.12.006. Epub 2021 Dec 11. No abstract available.
- Background: PubMed 29803819Grantz KL, Kim S, Grobman WA, Newman R, Owen J, Skupski D, Grewal J, Chien EK, Wing DA, Wapner RJ, Ranzini AC, Nageotte MP, Hinkle SN, Pugh S, Li H, Fuchs K, Hediger M, Buck Louis GM, Albert PS. Fetal growth velocity: the NICHD fetal growth studies. Am J Obstet Gynecol. 2018 Sep;219(3):285.e1-285.e36. doi: 10.1016/j.ajog.2018.05.016. Epub 2018 May 24.
- Results publication: PubMed 26410205Buck Louis GM, Grewal J, Albert PS, Sciscione A, Wing DA, Grobman WA, Newman RB, Wapner R, D'Alton ME, Skupski D, Nageotte MP, Ranzini AC, Owen J, Chien EK, Craigo S, Hediger ML, Kim S, Zhang C, Grantz KL. Racial/ethnic standards for fetal growth: the NICHD Fetal Growth Studies. Am J Obstet Gynecol. 2015 Oct;213(4):449.e1-449.e41. doi: 10.1016/j.ajog.2015.08.032.
- Results publication: PubMed 27353072Hediger ML, Fuchs KM, Grantz KL, Grewal J, Kim S, Gore-Langton RE, Buck Louis GM, D'Alton ME, Albert PS. Ultrasound Quality Assurance for Singletons in the National Institute of Child Health and Human Development Fetal Growth Studies. J Ultrasound Med. 2016 Aug;35(8):1725-33. doi: 10.7863/ultra.15.09087. Epub 2016 Jun 27.
- Results publication: PubMed 29025016Grewal J, Grantz KL, Zhang C, Sciscione A, Wing DA, Grobman WA, Newman RB, Wapner R, D'Alton ME, Skupski D, Nageotte MP, Ranzini AC, Owen J, Chien EK, Craigo S, Albert PS, Kim S, Hediger ML, Buck Louis GM. Cohort Profile: NICHD Fetal Growth Studies-Singletons and Twins. Int J Epidemiol. 2018 Feb 1;47(1):25-25l. doi: 10.1093/ije/dyx161. No abstract available.
- Derived from this study: PubMed 42597042McElwee ER, Lee S, Babineau V, Ferguson PL, Hunt KJ, Grantz KL, Grobman WA, Wapner RJ, Skupski DW, Sciscione A, Wing DA, Nageotte MP, Chien EK, Tita AT, Takacs L, Monk C, Newman RB. Mid-pregnancy uterine artery Dopplers and child neurodevelopment. Pregnancy (Hoboken). 2025 Jul 31;1(5):e70076. doi: 10.1002/pmf2.70076. eCollection 2025 Sep.
- Derived from this study: PubMed 42259106Martin SL, Grantz KL, Grobman W, Sciscione A, Skupski D, Palomares K, Wapner R, Vena JE, Newman RB, Hunt K, Tita A; ECHO National Fetal Growth Study Consortium. Childhood neurodevelopmental outcomes following hypertensive disorders of pregnancy. Pregnancy Hypertens. 2026 Jun 8;45:101483. doi: 10.1016/j.preghy.2026.101483. Online ahead of print.
- Derived from this study: PubMed 41689644Guivarch C, Wu J, Lu R, Grewal J, Yu G, Li LJ, Yang J, Pang WW, Wang DD, Weir NL, Tsai MY, Albert PS, Chen Z, Zhang C. Plasma amino acids in early pregnancy and fetal growth trajectories across pregnancy: findings from a multi-racial U.S. pregnancy cohort. Eur J Nutr. 2026 Feb 14;65(2):55. doi: 10.1007/s00394-025-03875-8.
- Derived from this study: PubMed 40484929Guivarch C, Wu J, Lu R, Grewal J, Yu G, Li LJ, Yang J, Pang WW, Wang DD, Weir NL, Chen Z, Tsai MY, Zhang C. Longitudinal plasma amino acids during pregnancy and neonatal anthropometry: findings from the NICHD Fetal Growth Studies-Singleton Cohort. BMC Med. 2025 Jun 9;23(1):343. doi: 10.1186/s12916-025-04146-3.
- Derived from this study: PubMed 40221546Le R, Biedrzycki RJ, Tekola-Ayele F. Maternal obesity and ancestry distance in influencing birth outcomes. Int J Obes (Lond). 2025 Aug;49(8):1532-1542. doi: 10.1038/s41366-025-01783-9. Epub 2025 Apr 12.
- Derived from this study: PubMed 39909708Wagner KA, Chen Z, Hinkle SN, Gleason JL, Lee W, Grobman WA, Owen J, Newman RB, Skupski DW, He D, Sherman S, Gore-Langton RE, Zhang C, Grewal J, Grantz KL. Relationship between gestational weight gain with fetal body composition and organ volumes in the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Fetal Dimensional Study: a prospective pregnancy cohort. Am J Clin Nutr. 2025 Feb;121(2):367-375. doi: 10.1016/j.ajcnut.2024.12.007. Epub 2025 Jan 16.
- Individual participant dataSharing planned: Yes. Pregnancy and postpartum data will be made accessible in documented repositories and electronic archives after completion of the studies' analytical phases.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Germaine M Louis, M.D. principal investigator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy and Fetal Growth, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Establish a standard for normal fetal growth (velocity) and size for gestational age in the U.S. population. (time frame: 3 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00912132, which also lists 46 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2022.