Objective To explore the prenatal screening value of cleft lip and palate score based on two-dimensional ultrasound transverse section method for fetal cleft lip and palate. Methods A retrospective design was adopted. A total of 73 fetuses diagnosed or suspected of having cleft lip and palate by prenatal ultrasound at the General Hospital of Northern Theater Command from March 2020 to May 2025 were selected as study subjects. According to the results of postnatal specialist facial examination, they were divided into the cleft lip and palate group (n=51) and the non-cleft lip and palate group (n=22). Two-dimensional ultrasound transverse section images of all fetuses were collected, and ultrasound scores of
different types of cleft lip and palate were analyzed. Receiver operating characteristic (ROC) curve and Kappa consistency analysis were used to evaluate the diagnostic efficacy of the cleft lip and palate score and its consistency with the gold standard diagnosis. Statistical analysis was performed using the independent sample t-test, one-way analysis of variance and χ 2 test. Results Among the 73 fetuses diagnosed or suspected of cleft lip and palate by prenatal ultrasonography, 51 fetuses were confirmed as cleft lip and palate by facial examination after birth or induced labor, including 6 cases (11.76%) of simple cleft lip, 40 cases (78.43%) of cleft lip and palate, 5 cases (9.80%) of median cleft lip and palate. The scores of palatal horizontal plate visualization, pterygoid process, complete maxilla with alveolar ridge, palatal inclination angle and total score of cleft lip and palate in cleft lip and palate group were significantly lower than those in non-cleft lip and palate group, and the differences were statistically significant (all P<0.001 ). There were statistically significant differences in the scores of palatal horizontal plate visualization, pterygoid process, complete maxilla with alveolar ridge, palatal inclination angle and total score of cleft lip and palate in children with different types of cleft lip and palate (all P<0.001 ). The results of ROC curve analysis showed that the area under the curve (AUC) of the cleft lip and palate score based on the two-dimensional ultrasound transverse section method for the diagnosis of fetal cleft lip and palate was 0.957 (95% CI: 0.920-0.994). The sensitivity of the score cut-off value of 4 points was 95.00%, and the specificity was 92.50%. The score was calculated to take the optimal cut-off value of 4 points. 48 cases of fetal cleft lip and palate (≤4 points) and 25 cases of non-fetal cleft lip and palate (>4 points) were diagnosed. The sensitivity of the diagnosis of fetal cleft lip and palate was 94.12% (48/51), the specificity was 100.00% (22/22), and the positive predictive value was 100.00% (48/48), the negative predictive value was 88.00% (22/25), which was in good agreement with the gold standard diagnosis (Kappa=0.906, P<0.001). Conclusion The cleft lip and palate score based on two-dimensional ultrasound transverse section method has the advantages of simple, intuitive and easy to obtain. It has a high value in the diagnosis of fetal cleft lip and palate. When the score is ≤ 4 points, clinicians need to be highly vigilant.