Status:
UNKNOWN
Early Detection of Severe Heart Disease in Fetuses at High Risk of Heart Disease
Lead Sponsor:
University Hospital, Grenoble
Conditions:
Heart Diseases
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
The main objective of the work is to evaluate, in the French health care system, the performance of early ultrasound screening for severe heart disease between 11 and 14SA in high-risk populations.
Detailed Description
Numerous studies have shown a link between increased nuchal translucency and heart disease. Although high-risk fetal populations are identified between 11 and 13 SA on clinical and biological criteria...
Eligibility Criteria
Inclusion
- Pregnant women whose fetus is at high risk for congenital heart disease:
- Nuchal translucency measurement on T1 echo ≥3.5mm
- Cardiac or extra-cardiac morphological abnormality suspected on the T1 screening echo
- First degree family history for the fetus (patient, spouse, 1st children of the couple) of significant congenital cardiopathy (excluding AIC, muscular VIC or persistent CA).
Exclusion
- Multiple Pregnancies
- non-emancipated minors, persons unable to express their consent.
- Lack of affiliation to a social security scheme.
- Subject in a period of exclusion from another study,
- Subject under administrative or judicial supervision
- Subject cannot be contacted in case of emergency
Key Trial Info
Start Date :
November 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 2 2022
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT04407728
Start Date
November 15 2020
End Date
November 2 2022
Last Update
November 5 2020
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