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Trial Observationnal (CLEFTPALATDIAG)

P

Poitiers University Hospital

Status

Completed

Conditions

Fetal Anomaly
Ultrasound

Treatments

Diagnostic Test: Posterior angle of the hard palate

Study type

Observational

Funder types

Other

Identifiers

NCT05785338
Trial Observationnal

Details and patient eligibility

About

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.

Full 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.

Enrollment

81 patients

Sex

Female

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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 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.

Trial design

81 participants in 2 patient groups

affected
Description:
patiente suspected for a cleft palate without cleft lip
Treatment:
Diagnostic Test: Posterior angle of the hard palate
control
Description:
unaffected cases
Treatment:
Diagnostic Test: Posterior angle of the hard palate

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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