Early Detection of Severe Heart Disease in Fetuses at High Risk of Heart Disease

Not Applicable

• Conditions: Heart Diseases
• Interventions: Other: early ultrasound screening

• Registration Number: NCT04407728
• Lead Sponsor: University Hospital, Grenoble

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 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.

Study Timeline

• Study First Submitted: 2020-05-25
• Study First Submitted QC: 2020-05-25
• Study First Posted: 2020-05-29
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-04
• Last Update Posted: 2020-11-05
• Study Start: 2020-11-15
• Primary Completion: 2022-05-02
• Study Completion: 2022-11-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 500

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
precocious EchoMorpho-T1	early ultrasound screening	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.

Primary Outcome Measures

Name	Time	Method
early ultrasound screening	1 day	Calculation of the sensitivity and specificity of screening for severe heart disease using EchoMorpho-T1. Specificity will be privileged in order to avoid the anxiety-producing nature of false positives.