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NCT05785338 Clinical Trial

Trial Observationnal

Ultrasound Clinical Trial

— CLEFTPALATDIAG  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05785338
Other study ID # Trial Observationnal
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 15, 2023
Est. completion date March 10, 2023

Study information
Verified date March 2023
Source Poitiers University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 81
Est. completion date March 10, 2023
Est. primary completion date March 10, 2023
Accepts healthy volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria: - all patients suspected for a cleft palate without cleft lip referred to the Multidisciplinary Center for Prenatal Diagnosis in Poitiers (France) between January 2019 and January 2023. Exclusion Criteria for the control group: - major congenital anomalies or chromosomal aberration, - premature rupture of the membranes, - fetal demise, - patients aged under 18 years. - If the available images did not allow the evaluation of the hard palate, the case was excluded from further consideration.

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Posterior angle of the hard palate
Fetal ultrasound

Locations
Country Name City State
France CHU Poitiers Poitiers

Sponsors (1)
Lead Sponsor Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Rate of cleft palate without cleft lip Presence of cleft palate without cleft lip in postnatal exam derivery
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