Antenatal Diagnosis of Coarctations of the Aorta.

Completed

• Conditions: Coarctation of Aorta
• Interventions: Diagnostic Test: Ultrasound

• Registration Number: NCT03303768
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-09-01
• Study First Submitted: 2017-09-28
• Study First Submitted QC: 2017-10-05
• Study First Posted: 2017-10-06
• Primary Completion: 2018-08-29
• Study Completion: 2018-08-29
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-13
• Last Update Posted: 2019-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pregnant women	Ultrasound	Pregnant woman with suspected coarctation of isolated aorta or woman followed in the last 12 for suspected coarctation of the aorta isolated during pregnancy

Primary Outcome Measures

Name	Time	Method
Search for ultrasound risk factors associated with diagnosis coarctation of the aorta	24h after birth	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.

Trial Locations

Locations (1)

Service de Gynécologie Obstétrique Diagnostic Anténatal ; Hôpital Femme Mère enfant; 🇫🇷 Bron, France