Early Detection of Severe Heart Disease in Fetuses at High Risk of Heart Disease (PRECAFOET)

Grenoble Alpes University Hospital Center (CHU)

Status: Unknown

Conditions: Heart Diseases

Treatments: Other: early ultrasound screening

Study type: Interventional

Funder types: Other

Identifiers

NCT04407728

38RC20.009

Details and patient eligibility

About

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.

Full 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 and by screening ultrasound (Echo T1), cardiac morphology analysis is routinely performed only during 2nd trimester fetal morphology ultrasound between 18 and 22 SA (EchoMorpho-T2) inducing a difficult wait for the couple.

The development of increasingly efficient ultrasound probes has made it possible to explore the foetal heart at an earlier stage. International learned societies recommend an early morphological examination with heart-centered slices before 14 weeks in high-risk situations. This practice is not systematic in France and no study has evaluated its feasibility and impact in a French care network.

Enrollment: 500 estimated patients

Sex: Female

Ages: 18+ months old

Volunteers: No Healthy Volunteers

Inclusion criteria

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 criteria

• 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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500 participants in 1 patient group

precocious EchoMorpho-T1

Experimental group

Description:

Women whose fetus is at high risk of congenital heart disease after the 1st trimester screening echo (EchoT1), will benefit from an early morphological ultrasound centered on the heart (EchoMorpho-T1) by a sonographer referent between 11 and 14 weeks +/- of an early fetal heart ultrasound (EchoCoeur-T1) between 11 and 15 weeks by a cardio-pediatrician in the event of an abnormality with the EchoMorpho-T1.

Treatment:

Other: early ultrasound screening