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Antenatal Diagnosis of Coarctations of the Aorta.

Antenatal Diagnosis of Coarctations of the Aorta. Prospective Observational Study.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03303768
Acronym
CoA
Enrollment
20
Registered
2017-10-06
Start date
2017-09-01
Completion date
2018-08-29
Last updated
2019-05-14

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

Conditions

Coarctation of Aorta

Brief summary

Prenatal diagnosis of coarctation is difficult because the ductus arteriosus masks the isthmus narrowing. The problem lies in the fact that it is difficult to assert in utero diagnosis and to predict severity of neonatal symptomatology. However, it is essential to try to establish the diagnosis since it has been shown that the prenatal diagnosis improves survival and reduces morbidity.

Interventions

DIAGNOSTIC_TESTUltrasound

Investigation of relevant ultrasound signs to improve the antenatal diagnosis of coarctation of the aorta by calculating the sensitivity and specificity of these different signs

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* pregnant or having given birth in the last 12 months in one of the participating centers * have had an ultrasound screening in the 2nd or 3rd trimester * addressed or being addressed to the Pluridisciplinary Center for Prenatal Diagnosis for suspected coarctation of isolated aorta in front of: ventricular asymmetry at the aegis of the left ventricle or the large vessels at the aorta, discovered during a screening ultrasound second or third quarter. * be able to understand and follow the ins and outs of the study * Have been informed of the study and have not objected to it

Exclusion criteria

* Associated complex cardiac disease (transposition of large vessels, atrioventricular duct, right ventricle with double outlet) with the exception of inter ventricular communications * Left ventricular hypoplasia * Suspicion of interruption of the aortic arch

Design outcomes

Primary

MeasureTime frameDescription
Search for ultrasound risk factors associated with diagnosis coarctation of the aorta24h after birthCalculation of sensitivity, specificity and ROC (Receiver Operating Characteristic) curves of the different ultrasound parameters according to post-natal confirma-diagnosis of coarctation of the aorta in order to create a score to improve the antenatal diagnosis of coarctation the aorta.

Countries

France

Outcome results

None listed

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