Fetal Growth Retardation Clinical Trial
Official title:
Automated Fetal Weight Estimation: A Multicenter Validation Using Fractional Limb Volume
This trial is a collaborative study between 4 sites worldwide. A total of 600 research subjects will be enrolled. We will investigate the validity of using 5D Limb Volume software to improve on estimated fetal weight predictions over a broad range of gestational ages. The purpose is to compare the accuracy and precision of birth weight predictions based on this new technology as compared to the current 2D birth weight prediction models.
Ultrasound has been used for over 20 years to estimate fetal weight prior to birth. Sometimes
this estimation is not always similar to what the baby actually weighs. In addition to the
regular measurements taken at routine ultrasound exams, 3D ultrasound of the baby's arm and
leg soft tissue may give us more precise information on how much the baby weighs. This
measurement is called fractional limb volume. Fractional limb volume (FLV) is a soft tissue
measurement of the arm or thigh that can be used to evaluate body composition. This
measurement mostly reflects the fat and muscle development with a small amount of bone.
The recent introduction of 5D Limb Volume software (Samsung, Seoul, Korea) now makes it
possible to efficiently and reproducibly measure semi-automated FLV using a computer guided
technique.
Subjects will receive one ultrasound scan 4-7 days before their delivery. Both 2D and 3D
measurements will be taken. These measurements will then be used to estimate fetal weight. We
will compare estimated weight to actual birth weight in order to determine the accuracy and
precision of the 5D Limb Volume technology. This data may also be used to develop new weight
estimation models that could provide better accuracy and/or precision than what is currently
provided using published methods.
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