To evaluate the accuracy of two portable ultrasound machines (PUM) in assessing fetal biometry and estimated gestational age (EGA). This was a secondary analysis of data from the Fetal Age Machine Learning Initiative, an observational study of pregnant women in the USA and Zambia. Each participant underwent ultrasound assessment by an experienced sonographer using both a high-specification ultrasound machine (HSUM) and a PUM (Butterfly iQ or Clarius C3) to measure fetal biometry and calculate EGA at each visit. By comparing paired PUM and HSUM scans, we estimated agreement between individual biometry measurements and aggregate gestational age estimates by reporting mean difference, intraclass correlation coefficient (ICC) and Bland-Altman plots, adjusting for trend. Between April and December 2021, 818 participants contributed 1386 paired PUM-HSUM ultrasound investigations, of which 991 PUM scans were obtained using the Butterfly iQ device and 395 using the Clarius C3 device. Gestational age at scan ranged from 7 to 38 weeks. Compared with HSUM, the Butterfly iQ PUM had a mean difference of -0.20 (95% CI, -0.60 to 0.20) days in the first trimester and -0.68 (95% CI, -0.93 to -0.44) days in the second/third trimesters. Compared with HSUM, the Clarius C3 PUM had a mean difference of -0.47 (95% CI, -1.11 to 0.18) days in the first trimester and -1.67 (95% CI, -2.10 to -1.25) days in the second/third trimesters. ICCs were 0.989 or greater throughout. Increasing gestational age was associated with increasing error and absolute error in EGA and fetal biometry. Both PUM devices demonstrated a modest trend toward underestimation of EGA with advancing gestational age in second/third-trimester scans, compared with HSUM. The Butterfly iQ and Clarius C3 PUM devices were highly accurate in performing fetal biometry in a diverse population from the USA and Zambia. © 2023 International Society of Ultrasound in Obstetrics and Gynecology.
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