Trial Observationnal

NCT ID: NCT05785338

Last Updated: 2023-08-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 81 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-01-15
• Study Completion Date: 2023-03-10

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.

Conditions

Fetal Anomaly; Ultrasound

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

affected

patiente suspected for a cleft palate without cleft lip

Posterior angle of the hard palate

Intervention Type: DIAGNOSTIC_TEST

Fetal ultrasound

control

unaffected cases

Posterior angle of the hard palate

Intervention Type: DIAGNOSTIC_TEST

Fetal ultrasound

Interventions

Posterior angle of the hard palate

Fetal ultrasound

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

Gap within the hard palate and the no visualization of the nasal spine

Eligibility Criteria

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

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Poitiers University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Iglika Simeonova-Brachot, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Poitiers

Locations

CHU Poitiers

Poitiers, , France

Countries

France

Other Identifiers

Trial Observationnal

Identifier Type: -

Identifier Source: org_study_id