Antenatal Diagnosis of Coarctations of the Aorta.

Coarctation of Aorta Clinical Trial

— CoA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03303768
• Other study ID #: 69HCL17_0477
• Status: Completed
• Start date: September 1, 2017
• Est. completion date: August 29, 2018

Study information

• Verified date: May 2019
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 29, 2018
• Est. primary completion date: August 29, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Coarctation
• Coarctation of Aorta

Intervention

Diagnostic Test:
• Ultrasound
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

Locations

Country	Name	City	State
France	Service de Gynécologie Obstétrique Diagnostic Anténatal ; Hôpital Femme Mère enfant	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Search for ultrasound risk factors associated with diagnosis coarctation of the aorta	Calculation 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.	24h after birth