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Trial Observationnal

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05785338
Acronym
CLEFTPALATDIAG
Enrollment
81
Registered
2023-03-27
Start date
2023-01-15
Completion date
2023-03-10
Last updated
2023-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fetal Anomaly, Ultrasound

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.

Interventions

DIAGNOSTIC_TESTPosterior angle of the hard palate

Fetal ultrasound

Sponsors

Poitiers University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years

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.

Design outcomes

Primary

MeasureTime frameDescription
Rate of cleft palate without cleft lipderiveryPresence of cleft palate without cleft lip in postnatal exam

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026