NCT05785338

Trial Observationnal

Diagnosis of Fetal Isolated Cleft Palate Using Assessment of the Posterior Hard Palate Angle

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 81 (actual)
• Sponsor: Poitiers University Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: —

Summary

The aim of this retrospective longitudinal study was to describe a key factor in the prenatal diagnosis of isolated cleft palate on the axial transverse view, in order to provide better understanding, detection and diagnosis of this anomaly.

Detailed description

Objective: The study aims to evaluate the role of the posterior hard palate angle in the prenatal diagnosis of cleft palate. Methods: Stored images of the axial transverse view of the fetal secondary palate, obtained at three-level ultrasounds, were used to evaluate the posterior border of the hard palate. The investigators studied the visualization of the posterior nasal spine and the presence of a gap within the hard palate. The investigators also assessed the posterior angle of the hard palate, formed by the posterior borders of the palatine bones next to the most posterior middle point of the palatine bone. The study population comprised 65 consecutive pregnancies of unaffected cases and 17 pregnancies with 24 assessments at different time points, suspected for a cleft palate without cleft lip, including 7 cases of cleft palate, 4 cases of high arched palate and 6 false positive cases.

Conditions

• Fetal Anomaly
• Ultrasound

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Posterior angle of the hard palate	Fetal ultrasound

Timeline

• Start date: 2023-01-15
• Primary completion: 2023-03-10
• Completion: 2023-03-10
• First posted: 2023-03-27
• Last updated: 2023-08-03

Locations

1 site across 1 country: France