First-Trimester Evaluation of Cleft Lip and Palate by A Novel Two-Dimensional Sonographic Technique: A Prospective Study.

OBJECTIVES: The study aims to evaluate the value of the mandible transection head-side shifting method (MTHSM) by 2-dimensional sonography in the screening of fetal cleft lip and palate (CLP) during the nuchal translucency scans. METHODS: A total of 7,336 fetuses enrolled for first-trimester aneuploidy screening were included in this prospective study. A sequential scanning approach from the mandible transection toward the head was used for the assessment of the palate in the midsagittal, axial, and coronal sections. Observe the continuity of the palatal line, upper alveolar ridge, and primary palate. All fetuses were followed by second-trimester scans and postnatal evaluation. RESULTS: A total of 18 cases of CLP were identified in the first trimester based on this method. Out of 18, 9 (50.0%) were unilateral CLP, 4 (22.2%) were bilateral CLP, and 5 (27.8%) were median CLP. There were no false-positive results found. Three were missed but confirmed in the second-trimester anomaly scan, including 2 cases of isolated cleft palate (CP) and one of isolated cleft lip (CL). Firsttrimester diagnosis of CLP using MTHSM had a sensitivity of 85.7%, a specificity of 100%, a positive predictive value of 100%, and a negative predictive value of 99.9%. CONCLUSION: The mandible transection head-side shifting method is feasible in assessing CLP at the time of routine first-trimester sonographic screening.