Quality control of ultrasound at 11 to 14 weeks of gestation: results from the China Early Pregnancy Ultrasound Cohort.

Objective: To assess the quality control (QC) of ultrasound scanning at 11-14 weeks of gestation during the first stage in the China Early Pregnancy Ultrasound Cohort (CEPUC).

Methods: A stratified random sampling strategy was employed for QC on ultrasound images from 525 single fetuses between 11 and 13 ⁺⁶ weeks of gestation across nine hospitals. The QC process consisted of two elements: (1) the retention of 17 types of ultrasound scans and (2) the assessment of each scan's content, which was scored out of 47 points. QC was performed twice: initially through hospital self-assessment (self-QC) and a subsequent review by the cohort team (second QC). The QC scores were calculated and compared across different groups using the Chi-square test, Fisher's exact test, or the Wilcoxon signed-rank test.

Results: The median number of retained ultrasound scans per person was 16.0 (interquartile range: 15.0-17.0). The median scores for self-QC and second QC were 44 points (interquartile range: 40-47) and 43 points (interquartile range: 38-46), respectively. The second QC scores were significantly lower than the self-QC scores (P < 0.001), with 225 cases (42.9%) scoring lower and 280 cases (53.3%) scoring equally. Excluding image magnification, the three items with the lowest scoring rates among the other 37 were: (1) coronal view of the cervical spine to the sacrum (62.3%), (2) assessing regurgitation in the tricuspid valve spectrum of the heart (63.4%), and (3) obtaining a three-dimensional (3D) image of the choroid plexus Sect. (78.1%).

Conclusions: QC in ultrasound is crucial for multicenter cohort studies, ensuring consistency and reliability across various sites. Both subjective and objective measurements should be seriously considered.