Fetal AnomalyCLEFTPALATDIAGNCT05785338
Trial Observationnal
An observational study of Fetal Anomaly and Ultrasound, run by Poitiers University Hospital at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Fetal Anomaly, Ultrasound
- What is being tested?
- Posterior angle of the hard palate
- How many people
- 81 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jan 2023to 10 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Fetal Anomaly, Ultrasound
- Being tested
- Posterior angle of the hard palate
- Medical subject headings
- Congenital Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Posterior angle of the hard palateDiagnostic test
Also called Gap within the hard palate and the no visualization of the nasal spine
Fetal ultrasound
| Study group | Role | What they receive |
|---|---|---|
| affected | patiente suspected for a cleft palate without cleft lip Receives: Diagnostic Test: Posterior angle of the hard palate | |
| control | unaffected cases Receives: Diagnostic Test: Posterior angle of the hard palate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of cleft palate without cleft lip
Presence of cleft palate without cleft lip in postnatal exam
Measured: derivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2023
- Study start15 Jan 2023
- Primary completion10 Mar 2023
- Study completion10 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal AnomalyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Iglika Simeonova-Brachot, MD, Principal investigator, CHU Poitiers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05785338
- Sponsor's protocol ID
- Trial Observationnal
- Acronym
- CLEFTPALATDIAG
- Status last verified
- Mar 2023
- First submitted
- 11 Mar 2023
- Last updated
- 3 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosis of Fetal Isolated Cleft Palate Using Assessment of the Posterior Hard Palate Angle
- ClinicalTrials.gov ID
- NCT05785338
- Acronym / sponsor ID
- CLEFTPALATDIAG / Trial Observationnal
- Conditions
- Fetal Anomaly, Ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 15 Jan 2023 (actual)
- Primary completion
- 10 Mar 2023 (actual)
- Study completion
- 10 Mar 2023 (actual)
- First posted
- 27 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| affected | – | Diagnostic Test: Posterior angle of the hard palatepatiente suspected for a cleft palate without cleft lip |
| control | – | Diagnostic Test: Posterior angle of the hard palateunaffected cases |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Age groups
- Adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Posterior angle of the hard palateAlso: Gap within the hard palate and the no visualization of the nasal spineFetal ultrasound | Diagnostic test | affected, control |
Primary outcome
Rate of cleft palate without cleft lip
Time frame: derivery
Presence of cleft palate without cleft lip in postnatal exam
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Iglika Simeonova-Brachot, MD principal investigator
CHU Poitiers
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fetal Anomaly and Ultrasound, run by Poitiers University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of cleft palate without cleft lip (time frame: derivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2023.