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OpenTrials
Completed

NCT Number: NCT03303768

Antenatal Diagnosis of Coarctations of the Aorta.

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.

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Key information

Conditions

Coarctation of Aorta Aortic Coarctation Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Service de Gynécologie Obstétrique Diagnostic Anténatal ; Hôpital Femme Mère enfant

Bron, 69677, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultrasound

Diagnostic Test

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

Primary outcomes

  1. Search for ultrasound risk factors associated with diagnosis coarctation of the aorta

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: CoA

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Oct 6, 2017
Registry last updated
May 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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