CoA: Antenatal Diagnosis of Coarctations of the Aorta.

Sponsor
Hospices Civils de Lyon (Other)
Overall Status
Completed
CT.gov ID
NCT03303768
Collaborator
(none)
20
1
11.9
1.7

Study Details

Study Description

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 Phase
  • Diagnostic Test: Ultrasound

Study Design

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 :
Sep 1, 2017
Actual Primary Completion Date :
Aug 29, 2018
Actual Study Completion Date :
Aug 29, 2018

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Service de Gynécologie Obstétrique Diagnostic Anténatal ; Hôpital Femme Mère enfant Bron France 69677

Sponsors and Collaborators

  • Hospices Civils de Lyon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT03303768
Other Study ID Numbers:
  • 69HCL17_0477
First Posted:
Oct 6, 2017
Last Update Posted:
May 14, 2019
Last Verified:
May 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 14, 2019