Reference range of fetal myocardial area by three-dimensional ultrasonography and its applicability in fetuses of pre-gestational diabetic women.

Objective To determine the reference range for the myocardial area in healthy fetuses using three-dimensional (3D) ultrasonography and validate these results in fetuses of pregnant women with pre-gestational diabetes mellitus (DM). Methods This cross-sectional retrospective study included 168 healthy pregnant women between gestational weeks 20 and 33+6 days. The myocardial area was measured using spatio-temporal image correlation (STIC) in the four-chamber view. Polynomial regression models were used, and the goodness of fit of the models were evaluated by the coefficient of determination (R2). Intra- and inter-observer reproducibility was determined using the concordance correlation coefficient (CCC). Validation was performed in 30 pregnant women with pre-gestational DM. Results There was a strong correlation (R2=0.71, P<0.0001) between myocardial area and gestational age. There was good intra- and inter-observer reproducibility, with a CCC of 0.86 and 0.83, respectively. However, there was no significant difference in the mean myocardial area between healthy fetuses and fetuses of women with pre-gestational DM (0.11 cm2, P=0.55). Conclusion The reference range was determined for the myocardial area in fetuses, and there was no significant difference in this variable between healthy fetuses and the fetuses of women with pre-gestational DM.