Fetal 3D Study (Fetal Body Composition and Volumes Study)
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 3/15/2019 |
| Start Date: | April 27, 2016 |
| End Date: | July 15, 2019 |
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.
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.
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.
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.
Inclusion Criteria:
- Women with ultrasound data collected from the NICHD Fetal Growth Studies—Singletons
and Twin Gestations
Exclusion Criteria:
We found this trial at
1
site
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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