Routine third-trimester ultrasound for the detection of small-for-gestational age in low-risk pregnancies (ROTTUS study): randomized controlled trial

Objective: To compare the proportion of small-for-gestational-age (SGA) infants detected by routine third-trimester ultrasound vs those detected by selective ultrasound based on serial symphysis-fundus height (SFH) measurements (standard care) in low-risk pregnancy.

Methods: This was an open-label randomized controlled trial conducted at a hospital in Kenya between May 2018 and February 2020. Low-risk pregnant women were randomly allocated (ratio of 1:1) to routine ultrasound for fetal growth assessment between 36 + 0 and 37 + 6 weeks' gestation (intervention group) or to standard care, which involved a selective growth scan on clinical suspicion of fetal growth abnormality based on serial SFH measurements (control group). During ultrasound examination, fetal growth was assessed by measurement of the abdominal circumference (AC), and AC < 10^th centile was used to diagnose a SGA fetus. The main prespecified outcomes were the detection of neonatal SGA, defined as birth weight < 10^th centile, and of severe neonatal SGA, defined as birth weight < 3^rd centile. The predictive performance of routine third-trimester ultrasound and selective ultrasound based on serial SFH measurements was determined using receiver-operating-characteristics (ROC)-curve analysis.

Results: Of 566 women assessed for eligibility, 508 (89.8%) were randomized, of whom 253 were allocated to the intervention group and 255 to the control group. Thirty-six babies in the intervention group and 26 in the control group had a birth weight < 10^th centile. The detection rate of SGA infants by routine third-trimester ultrasound vs that by standard care was 52.8% (19/36) vs 7.7% (2/26) (P < 0.001) and the specificity was 95.5% (191/200) and 97.9% (191/195), respectively (P = 0.08). The detection rate of severe SGA was 66.7% (12/18) by routine ultrasound vs 8.3% (1/12) by selective ultrasound based on SFH measurements (P < 0.001), with specificities of 91.7% (200/218) and 98.1% (205/209), respectively (P = 0.006). The area under the ROC curve of routine third-trimester ultrasound in prediction of SGA was significantly greater than that of selective ultrasound based on SFH measurements (0.92 (95% CI, 0.87-0.96) vs 0.68 (95% CI, 0.58-0.77); P < 0.001).

Conclusions: In low-risk pregnancy, routine ultrasound performed between 36 + 0 and 37 + 6 weeks is superior to selective ultrasound based on serial SFH measurements for the detection of true SGA, with high specificity. © 2021 International Society of Ultrasound in Obstetrics and Gynecology.