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Completed

NCT Number: NCT05785338

Trial Observationnal

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

CHU Poitiers

Poitiers, 86000, France

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Posterior angle of the hard palate

Diagnostic Test

Fetal ultrasound

Other names: Gap within the hard palate and the no visualization of the nasal spine

Primary outcomes

  1. Rate of cleft palate without cleft lip

    Time frame: derivery

    Presence of cleft palate without cleft lip in postnatal exam

Sponsors and collaborators

Lead sponsor

Poitiers University Hospital

Other

Registry information

Official study title

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

Acronym: CLEFTPALATDIAG

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 27, 2023
Registry last updated
Aug 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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