Trial Observationnal (CLEFTPALATDIAG)

August 1, 2023 updated by: Poitiers University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

81

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Poitiers, France, 86000
        • CHU Poitiers

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

N/A

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
affected
patiente suspected for a cleft palate without cleft lip
Diagnostic test: Posterior angle of the hard palate
Fetal ultrasound
Other Names:
  • Gap within the hard palate and the no visualization of the nasal spine
control
unaffected cases
Diagnostic test: Posterior angle of the hard palate
Fetal ultrasound
Other Names:
  • Gap within the hard palate and the no visualization of the nasal spine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of cleft palate without cleft lip
Time Frame: derivery
Presence of cleft palate without cleft lip in postnatal exam
derivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Poitiers University Hospital

Investigators

  • Principal Investigator: Iglika Simeonova-Brachot, MD, CHU Poitiers

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2023

Primary Completion (Actual)

March 10, 2023

Study Completion (Actual)

March 10, 2023

Study Registration Dates

First Submitted

March 11, 2023

First Submitted That Met QC Criteria

March 24, 2023

First Posted (Actual)

March 27, 2023

Study Record Updates

Last Update Posted (Actual)

August 3, 2023

Last Update Submitted That Met QC Criteria

August 1, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Trial Observationnal

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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