Fetal Growth RestrictionNCT03266198
Fetal 3D Study (Fetal Body Composition and Volumes Study)
An observational study of Fetal Growth Restriction and Fetal Growth Abnormality, run by Katherine Grantz at 1 site in United States.
Trial summary
Normal fetal growth is a critical component for a healthy pregnancy and for ensuring the health and well-being of infants throughout childhood and adolescence. One promising area of research suggests that changes in fetal soft tissue may be the earliest changes that occur in pathologic growth. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fetal Growth Restriction, Fetal Growth Abnormality
- How many people
- 2,809 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Apr 2016to 15 Sep 2019
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Participants from the NICHD Fetal Growth Studies-Singletons and Twin Gestations
Who may be able to join
- Women with ultrasound data collected from the NICHD Fetal Growth Studies-Singletons and Twin Gestations
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fetal Body Composition and Volumes Study
Normal fetal growth is a critical component for a healthy pregnancy and for ensuring the health and well-being of infants throughout childhood and adolescence. One promising area of research suggests that changes in fetal soft tissue may be the earliest changes that occur in pathologic growth. Three-dimensional volume assessments may be used to detect changes in fetal lean mass, fat mass, and organ size that result from pathologic growth earlier than conventional 2D measures. This knowledge may lead to interventions that could minimize or prevent pregnancy and newborn health problems in the future.
Read the detailed description
The NICHD Fetal Growth Study was a multi-site, prospective cohort study designed to establish a standard for normal fetal growth (velocity) and size for gestational age in the U.S. population. For the singleton study, 2,334 low-risk, non-obese gravidas were recruited from each of 4 self-identified race/ethnicity backgrounds. An additional 468 obese women and 171 dichorionic twin gestations were recruited. After an initial sonogram in the first trimester, women were randomized to serial ultrasonology schedules. Each schedule comprised five additional sonograms for fetal biometry (six in twins) plus additional image and 3D volume acquisition for later analysis.
Ultrasound measurements at each follow-up visit included standard fetal biometrics ((BPD, HC, AC, FL) and the following volumes in the singleton study if they were able to be obtained: 1st trimester: fetus and gestational sac; 2nd and 3rd trimesters: head, cerebellum, face, chest, heart, abdomen, pelvis, arm and thigh. In twins, the volumes collected were 1st trimester: fetus and gestational sac and in the 2nd and 3rd trimesters the thigh. In addition to ultrasound, this study recorded maternal anthropometrics and a brief interview to capture changes in health status, stress and depression, and physical activity at each follow-up visit. Blood draws at baseline and at targeted gestational ages were obtained for the eventual identification of biomarkers indicative of fetal growth were collected. After delivery, neonatal anthropometric measures were assessed, placental biospecimens were collected, and select information about the obstetrical course and newborn status were abstracted from medical charts.
The Fetal 3D Study is being conducted to catalog and perform 2 Dimensional (2D) and 3 Dimensional (3D) measurement of the obstetrical ultrasound images in the existing bank of singleton and twin gestations collected from the NICHD Fetal Growth Studies. The research study aims to understand the relationship between gravid diseases and longitudinal changes in fetal body composition (subcutaneous fat, lean mass) and organ measurements (in singletons) over the course of pregnancy.
- Conditions
- Fetal Growth Restriction, Fetal Growth Abnormality
- Being tested
- No intervention
- Medical subject headings
- Fetal Growth Retardation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Standards for fetal body composition and organ volumes by maternal race/ethnicity
Growth trajectories in singletons and dichorionic twin pregnancies will be created using two- and selected three-dimensional ultrasound measures. Measures in singletons include fetal body composition from 2D abdominal circumference, arm and thigh volumes; cerebellum; adrenal glands; kidneys; liver; pancreas; lungs; first trimester gestational sac, embryo and placenta, using standardized protocols. Measures in twins include 2D abdominal circumference and thigh volumes, and first trimester gestational sac, embryo and placenta.
Measurements will be performed using stored ultrasound images and 3D volumes that were collected in the NICHD Fetal Growth Studies - Singleton and Twins ClinicalTrials.gov Identifier: NCT00912132 and NCT01369940, respectively. Women were recruited during the first trimester and followed until delivery. Each woman had scheduled ultrasound examinations, one at enrollment and five during follow-up visits (six for twins).
Measured: 3 years
Comparison of fetal 2D and 3D in pregnancies with complications with fetuses in the singleton standard
The study will assess the relationship between gravid diseases and longitudinal changes in fetal body composition (subcutaneous fat and lean body mass) and organ volumes, and compare to those fetuses growing under optimal circumstances (i.e., singleton gestations included in the development of the fetal growth standard.
Measured: 3 years
Investigation of organ volumes (and ratios to fetal weight) and mass (fat) size in association with gravid or neonatal complications, such as kidney to fetal weight in fetal growth restriction, and liver to fetal weight in diabetes, by race/ethnicity
Measured: 3 years
Exploration of factors that influence these associations
The study will determine whether potentially modifiable factors including maternal BMI, weight gain, longitudinal changes in maternal body composition, and nutrition and lifestyle factors modifies the relationship between longitudinal changes in fetal body composition (subcutaneous fat and lean body mass) and organ volumes and gravid diseases, and whether they vary by plurality (singleton or twin).
Measured: 3 years
Biomarkers in relation to fetal body composition and 3D volumes
Longitudinal data will compare singleton and twin gestations with respect to maternal biomarkers of fetal growth, well-being and maternal nutritional status using banked biospecimens to determine if the biomarkers ranges established for singletons are applicable to twin gestations.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2017
- Study start27 Apr 2016
- Primary completion15 Sep 2019
- Study completion15 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Fetal Growth RestrictionStudies 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
- Retrospective
- Enrolment
- 2,809 participants (actual)
Sponsor and investigators
- Lead sponsor
- Katherine Grantz
- Sponsor type
- US National Institutes of Health
- Collaborators
- Baylor College of Medicine
- Responsible party
- Sponsor-investigator, Katherine Grantz, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03266198
- Sponsor's protocol ID
- 16-CH-N071
- Status last verified
- Jan 2022
- First submitted
- 25 Aug 2017
- Last updated
- 13 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: This project will generate de-identified data derived from human subjects along with various types of analysis to identify unique points of interest and relationships to relevant associated data such as phenotype and/or social states. All information necessary to interpret the data, such as study protocols, data collection instruments, or survey tools will be clearly documented. Data generated by this project will be shared through the NICHD Data and Specimen Hub (DASH), an NIH-funded/-approved public repository.
Publications
McElwee 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 42597042Wagner 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 39909708
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fetal Body Composition and Volumes Study
- ClinicalTrials.gov ID
- NCT03266198
- Acronym / sponsor ID
- 16-CH-N071
- Conditions
- Fetal Growth Restriction, Fetal Growth Abnormality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,809 participants (actual)
- Lead sponsor
- Katherine GrantzUS National Institutes of Health
- Collaborators
- Baylor College of Medicine
- Study start
- 27 Apr 2016 (actual)
- Primary completion
- 15 Sep 2019 (actual)
- Study completion
- 15 Sep 2019 (actual)
- First posted
- 30 Aug 2017 (actual)
- 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 for a healthy pregnancy and for ensuring the health and well-being of infants throughout childhood and adolescence. One promising area of research suggests that changes in fetal soft tissue may be the earliest changes that occur in pathologic growth. Three-dimensional volume assessments may be used to detect changes in fetal lean mass, fat mass, and organ size that result from pathologic growth earlier than conventional 2D measures. This knowledge may lead to interventions that could minimize or prevent pregnancy and newborn health problems in the future.
Detailed description
The NICHD Fetal Growth Study was a multi-site, prospective cohort study designed to establish a standard for normal fetal growth (velocity) and size for gestational age in the U.S. population. For the singleton study, 2,334 low-risk, non-obese gravidas were recruited from each of 4 self-identified race/ethnicity backgrounds. An additional 468 obese women and 171 dichorionic twin gestations were recruited. After an initial sonogram in the first trimester, women were randomized to serial ultrasonology schedules. Each schedule comprised five additional sonograms for fetal biometry (six in twins) plus additional image and 3D volume acquisition for later analysis.
Ultrasound measurements at each follow-up visit included standard fetal biometrics ((BPD, HC, AC, FL) and the following volumes in the singleton study if they were able to be obtained: 1st trimester: fetus and gestational sac; 2nd and 3rd trimesters: head, cerebellum, face, chest, heart, abdomen, pelvis, arm and thigh. In twins, the volumes collected were 1st trimester: fetus and gestational sac and in the 2nd and 3rd trimesters the thigh. In addition to ultrasound, this study recorded maternal anthropometrics and a brief interview to capture changes in health status, stress and depression, and physical activity at each follow-up visit. Blood draws at baseline and at targeted gestational ages were obtained for the eventual identification of biomarkers indicative of fetal growth were collected. After delivery, neonatal anthropometric measures were assessed, placental biospecimens were collected, and select information about the obstetrical course and newborn status were abstracted from medical charts.
The Fetal 3D Study is being conducted to catalog and perform 2 Dimensional (2D) and 3 Dimensional (3D) measurement of the obstetrical ultrasound images in the existing bank of singleton and twin gestations collected from the NICHD Fetal Growth Studies. The research study aims to understand the relationship between gravid diseases and longitudinal changes in fetal body composition (subcutaneous fat, lean mass) and organ measurements (in singletons) over the course of pregnancy.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Participants from the NICHD Fetal Growth Studies-Singletons and Twin Gestations
Key inclusion criteria (1 listed)
- Women with ultrasound data collected from the NICHD Fetal Growth Studies-Singletons and Twin Gestations
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | – |
Primary outcome
Standards for fetal body composition and organ volumes by maternal race/ethnicity
Time frame: 3 years
Growth trajectories in singletons and dichorionic twin pregnancies will be created using two- and selected three-dimensional ultrasound measures. Measures in singletons include fetal body composition from 2D abdominal circumference, arm and thigh volumes; cerebellum; adrenal glands; kidneys; liver; pancreas; lungs; first trimester gestational sac, embryo and placenta, using standardized protocols. Measures in twins include 2D abdominal circumference and thigh volumes, and first trimester gestational sac, embryo and placenta. Measurements will be performed using stored ultrasound images and 3D volumes that were collected in the NICHD Fetal Growth Studies - Singleton and Twins ClinicalTrials.gov Identifier: NCT00912132 and NCT01369940, respectively. Women were recruited during the first trimester and followed until delivery. Each woman had scheduled ultrasound examinations, one at enrollment and five during follow-up visits (six for twins).
Comparison of fetal 2D and 3D in pregnancies with complications with fetuses in the singleton standard
Time frame: 3 years
The study will assess the relationship between gravid diseases and longitudinal changes in fetal body composition (subcutaneous fat and lean body mass) and organ volumes, and compare to those fetuses growing under optimal circumstances (i.e., singleton gestations included in the development of the fetal growth standard.
Investigation of organ volumes (and ratios to fetal weight) and mass (fat) size in association with gravid or neonatal complications, such as kidney to fetal weight in fetal growth restriction, and liver to fetal weight in diabetes, by race/ethnicity
Time frame: 3 years
Exploration of factors that influence these associations
Time frame: 3 years
The study will determine whether potentially modifiable factors including maternal BMI, weight gain, longitudinal changes in maternal body composition, and nutrition and lifestyle factors modifies the relationship between longitudinal changes in fetal body composition (subcutaneous fat and lean body mass) and organ volumes and gravid diseases, and whether they vary by plurality (singleton or twin).
Biomarkers in relation to fetal body composition and 3D volumes
Time frame: 3 years
Longitudinal data will compare singleton and twin gestations with respect to maternal biomarkers of fetal growth, well-being and maternal nutritional status using banked biospecimens to determine if the biomarkers ranges established for singletons are applicable to twin gestations.
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 13 Jan 2022.
- 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 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. This project will generate de-identified data derived from human subjects along with various types of analysis to identify unique points of interest and relationships to relevant associated data such as phenotype and/or social states. All information necessary to interpret the data, such as study protocols, data collection instruments, or survey tools will be clearly documented. Data generated by this project will be shared through the NICHD Data and Specimen Hub (DASH), an NIH-funded/-approved public repository.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fetal Growth Restriction and Fetal Growth Abnormality, run by Katherine Grantz at 1 site 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 1 inclusion and 1 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 13 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Standards for fetal body composition and organ volumes by maternal race/ethnicity (time frame: 3 years). The study lists 5 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 NCT03266198, which also lists 2 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 13 Jan 2022; AzTrials last refreshed its copy on 31 Oct 2026.