Clinical trial NCT03266198: Fetal 3D Study (Fetal Body Composition and Volumes Study)
Official title: Fetal Body Composition and Volumes Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fetal Growth Restriction
Fetal Growth Abnormality
Lead sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Sponsor class: NIH
Collaborators: name: Baylor College of Medicine
First posted: 2017-08-30
Enrollment: 2809
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants from the NICHD Fetal Growth Studies-Singletons and Twin Gestations

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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* None

Primary outcomes:
measure: Standards for fetal body composition and organ volumes by maternal race/ethnicity
timeFrame: 3 years
measure: Comparison of fetal 2D and 3D in pregnancies with complications with fetuses in the singleton standard
timeFrame: 3 years
measure: 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
timeFrame: 3 years
measure: Exploration of factors that influence these associations
timeFrame: 3 years
measure: Biomarkers in relation to fetal body composition and 3D volumes
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
References: