Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT00340171 |
| Other study ID # |
999997068 |
| Secondary ID |
OH97-CH-N068 |
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
December 4, 1997 |
| Est. completion date |
November 5, 2012 |
Study information
| Verified date |
February 2023 |
| Source |
National Institutes of Health Clinical Center (CC) |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Fetal growth abnormalities, such as macrosomia and intrauterine growth retardation, are an
important cause for increased perinatal mortality in the United States. Toward this end,
accurate fetal weight determinations are very important for guiding prenatal care.
Three-dimensional ultrasound is a recent technology that provides a new way to evaluate the
fetus. This technique allows one to arbitrarily scan through a digital ultrasound volume
dataset, visualize organs from different perspectives, and render anatomical features through
computer processing. It also allows the retrospective measurement of distances and volumes
even in the physical absence of the patient.
A maximum of 400 pregnancies will be serially studied by three-dimensional ultrasound to
characterize the growth of volume parameters such as the fetal thigh. This information will
be applied to the Rossavik model of individualized growth assessment. The technique allows
growth evaluation by comparing various ultrasound measurements or birth characteristics to
the individual growth standards specified by the prediction model. Newborn infant body
composition will also be studied within 48 hours of delivery.
A separate cross-sectional study of up to 2,577 fetuses will allow development of birth
weight prediction models based upon fetal volume measurements and further analysis of fetal
growth abnormalities. Individual growth curve standards utilizing these volume parameters
should allow one to evaluate deviations from expected growth or birth weight by using each
fetus as its own control.
Description:
Fetal growth abnormalities, such as macrosomia and intrauterine growth retardation, are an
important cause for increased perinatal mortality in the United States. Toward this end,
accurate fetal weight determinations are very important for guiding prenatal care.
Three-dimensional ultrasound is a recent technology that provides a new way to evaluate the
fetus. This technique allows one to arbitrarily scan through a digital ultrasound volume
dataset, visualize organs from different perspectives, and render anatomical features through
computer processing. It also allows the retrospective measurement of distances and volumes
even in the physical absence of the patient.
This protocol consists of two study arms and emphasizes the ability of 3D ultrasound to
reliably measure fetal soft tissue as an index of generalized nutritional status. The
longitudinal arm will enroll 400 pregnancies to allow the use of 2D and 3D ultrasonography
for characterizing serial growth patterns of sonographic parameters throughout pregnancy.
This approach compares ultrasound measurements or birth characteristics to individual growth
standards specified by Rossavik prediction models. After delivery, a maximum of 329 newborn
infants, resulting from the same pregnancies, will have correlative photographs and
measurements of their head, abdomen, thigh, skin folds, weight, and crown-heel length taken
to classify growth outcome. Noninvasive air displacement plethymography will be used to
measure neonatal percent body fat and lean body mass after delivery. Infant body composition
data will allow the precise classification of neonatal growth outcome for subsequent
correlation to prenatal sonographic studies. The cross-sectional arm of this protocol will
allow sonographic studies of 2,577 fetuses with similar correlative neonatal evaluation of
1,212 infants for a total of 3,789 subjects. The results will be used to develop a new fetal
weight estimation models that combine 2D and 3D sonographic parameters to improve accuracy
and precision of these predictions. A maximum of 50 newborns from this cross-sectional arm
will also be re-evaluated for infant body composition at 1 and 2 weeks following delivery to
document changes in percent body fat and fat-free mass. Therefore, the subject recruitment
ceiling would be (2,577 mothers + 1,212 infants) + (400 mothers + 329 infants) or 4,518 total
subjects for this Protocol.
