Antenatal Diagnosis of Coarctations of the Aorta.

NCT03303768 | Completed

• 1 other identifier: 69HCL17_0477
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Coarctation of Aorta

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

Interventions

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

Pregnant women

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Service de Gynécologie Obstétrique Diagnostic Anténatal ; Hôpital Femme Mère enfant

Bron, 69677, France

Location

MeSH Terms

Conditions

Aortic Coarctation

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2017
• First Posted: October 6, 2017
• Study Start: September 1, 2017
• Primary Completion: August 29, 2018
• Study Completion: August 29, 2018
• Last Updated: May 14, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)