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Antenatal Diagnosis of Coarctations of the Aorta. (CoA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03303768
Recruitment Status : Completed
First Posted : October 6, 2017
Last Update Posted : May 14, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Coarctation of Aorta Diagnostic Test: Ultrasound

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Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Antenatal Diagnosis of Coarctations of the Aorta. Prospective Observational Study.
Actual Study Start Date : September 1, 2017
Actual Primary Completion Date : August 29, 2018
Actual Study Completion Date : August 29, 2018

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pregnant woman with suspected coarctation of isolated aorta or woman followed in the last 12 for suspected coarctation of the aorta isolated during pregnancy.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03303768


Locations
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France
Service de Gynécologie Obstétrique Diagnostic Anténatal ; Hôpital Femme Mère enfant
Bron, France, 69677
Sponsors and Collaborators
Hospices Civils de Lyon

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03303768     History of Changes
Other Study ID Numbers: 69HCL17_0477
First Posted: October 6, 2017    Key Record Dates
Last Update Posted: May 14, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Aortic Coarctation
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities