Fetal 3D Study (Fetal Body Composition and Volumes Study)

NCT03266198 | Completed

• 1 other identifier: 16-CH-N071
• Study Type: observational
• Target: 2,809
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Fetal Growth Restriction; Fetal Growth Abnormality

Outcome Measures

Primary Outcomes (5)

• 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).

  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.

  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

  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).

  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.

  3 years

Interventions

No intervention OTHER

No intervention

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Participants from the NICHD Fetal Growth Studies-Singletons and Twin Gestations

You may qualify if:

• Women with ultrasound data collected from the NICHD Fetal Growth Studies-Singletons and Twin Gestations

You may not qualify if:

• None

Sponsors & Collaborators

• Katherine Grantz: lead
• Baylor College of Medicine: collaborator

Study Sites (1)

Baylor College of Medicine

Houston, Texas, United States

Location

Related Publications (1)

• Wagner 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.

  PMID: 39909708 DERIVED

MeSH Terms

Conditions

Fetal Growth Retardation

Condition Hierarchy (Ancestors)

Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Investigator

Study Record Dates

• First Submitted: August 25, 2017
• First Posted: August 30, 2017
• Study Start: April 27, 2016
• Primary Completion: September 15, 2019
• Study Completion: September 15, 2019
• Last Updated: January 13, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be shared at the time of publication or shortly thereafter.
• Access Criteria: Any use of this data by a secondary party after submission to the designated repositories must be shared by that party according to the permissions granted by the original consent form of the study participants unless additional permissions are obtained. Secondary parties must adhere to the NIH Human Data Sharing guidelines for broad data sharing and to the limitations for use set forth by the Institutional Certification associated with this project.

Locations

US (1)