Trial Observationnal

NCT05785338 | Completed

• 1 other identifier: Trial Observationnal
• Study Type: observational
• Target: 81
• Locations: 1 country
• Sites: 1

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.

Conditions

Fetal Anomaly; Ultrasound

Outcome Measures

Primary Outcomes (1)

• Rate of cleft palate without cleft lip

  Presence of cleft palate without cleft lip in postnatal exam

  derivery

Study Arms (2)

affected

patiente suspected for a cleft palate without cleft lip

Diagnostic Test: Posterior angle of the hard palate

control

unaffected cases

Diagnostic Test: Posterior angle of the hard palate

Interventions

Posterior angle of the hard palate DIAGNOSTIC_TEST

Fetal ultrasound

Also known as: Gap within the hard palate and the no visualization of the nasal spine

affected; control

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: pregnancy
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

We included all patients suspected for a cleft palate without cleft lip (18 pregnant women with 24 assessments at different time points), referred to the Multidisciplinary Center for Prenatal Diagnosis in Poitiers (France) between January 2019 and January 2023. We compared the suspected group with 65 unaffected consecutive singleton pregnancies between 17 and 37 weeks, identified from our ultrasound database from June 2022 to Auguste 2022.

You may qualify if:

• \- 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Poitiers University Hospital: lead

Study Sites (1)

CHU Poitiers

Poitiers, 86000, France

Location

MeSH Terms

Conditions

Congenital Abnormalities

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Iglika Simeonova-Brachot, MD

  CHU Poitiers

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2023
• First Posted: March 27, 2023
• Study Start: January 15, 2023
• Primary Completion: March 10, 2023
• Study Completion: March 10, 2023
• Last Updated: August 3, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)