Trial Observationnal

Completed

• Conditions: Ultrasound; Fetal Anomaly
• Interventions: Diagnostic Test: Posterior angle of the hard palate

• Registration Number: NCT05785338
• Lead Sponsor: Poitiers University Hospital

Brief 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.

Study Timeline

• Study Start: 2023-01-15
• Status Verified: 2023-03
• Primary Completion: 2023-03-10
• Study Completion: 2023-03-10
• Study First Submitted: 2023-03-11
• Study First Submitted QC: 2023-03-24
• Study First Posted: 2023-03-27
• Last Update Submitted: 2023-08-01
• Last Update Posted: 2023-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 81

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.

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
affected	Posterior angle of the hard palate	patiente suspected for a cleft palate without cleft lip
control	Posterior angle of the hard palate	unaffected cases

Primary Outcome Measures

Name	Time	Method
Rate of cleft palate without cleft lip	derivery	Presence of cleft palate without cleft lip in postnatal exam

Trial Locations

Locations (1)

CHU Poitiers; 🇫🇷 Poitiers, France