Macrosomia, Fetal Clinical Trial
Official title:
Customized Versus Population Fetal Growth Curves: A Randomized Controlled Pilot Trial
Fetal growth abnormalities is one of the most common problems faced in modern obstetrics. The
association between low birth weight and perinatal death as well as severe morbidity is well
known. Since fetal weight cannot be measured directly, obstetricians use estimates of fetal
weight obtained by utilizing various ultrasonographic measurements to diagnose growth
abnormalities. Currently in clinical practice, the majority of fetal ultrasound centers
employ population-based fetal growth curves that have been previously published and updated
to estimate fetal weight percentiles. Up to 70% of neonates found to be below the 10%
percentile for estimated fetal weight in population-based growth curves are actually
constitutionally small; that is a neonate deemed "small" based on standardized growth curves
but in reality have reached its appropriate growth potential in relation to its genetic
predisposition.
An equally difficult clinical scenario is fetal macrosomia. A recent meta-analysis revealed
that the sensitivity and specificity of ultrasound detection of fetal macrosomia ranges from
15-79%. When compared with neonates with normal birth weight, the odds ratio of emergency
cesarean delivery and shoulder dystocia are increased significantly.
Various ultrasound parameters have been tested in an effort to detect both fetal compromise
prior to the development of permanent damage and allow differentiation between true fetal
growth abnormalities and normal growth potential. Recent reports have introduced the concept
of customized fetal growth curve which uses physiological variables to report an adjusted
fetal growth assessment. To date, the use of customized fetal growth curves has not been
evaluated prospectively. Furthermore, this strategy has not been compared to standard
population-based fetal growth curves currently used in clinical practice to determine which
would be the most ideal for use in clinical practice.
The primary research question is: are customized fetal growth curves more accurate than
population-based fetal growth curves at predicting abnormalities in fetal growth, defined as
small-for-gestational age or large-for-gestational age at birth in newborns of high-risk
pregnancies? Randomly, participants will be assigned to either having fetal growth reported
by customized or population bases growth curves.
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