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

NCT04407728 | Unknown DMC

• 1 other identifier: 38RC20.009
• Study Type: interventional
• Target: 500
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Heart Diseases

Outcome Measures

Primary Outcomes (1)

• early ultrasound screening

  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.

  1 day

Study Arms (1)

precocious EchoMorpho-T1

EXPERIMENTAL

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.

Other: early ultrasound screening

Interventions

early ultrasound screening OTHER

Women whose fetus is at high risk of congenital heart disease at the end of the 1st trimester screening ultrasound (EchoT1), will benefit from an early heart-centered morphological ultrasound (EchoMorpho-T1) by a referring sonographer between 11 and 14 SA +/- an early fetal cardiac ultrasound (EchoCoeur-T1) between 11 and 15 SA by a cardio-paediatrician in case of EchoMorpho-T1 abnormality. The results of the early morphological and cardiac ultrasounds will be compared with those of the 2nd trimester ultrasound at 18-22SA (EchoMorpho-T2) and +/- of the fetal cardiac ultrasound between 18SA and 24SA (Gold standard) or, failing this, with the anatomopathological examination when it is available if a medical termination of pregnancy took place before the EchoMorpho-T2.

precocious EchoMorpho-T1

Eligibility Criteria

• Age: 18 Months+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• Multiple Pregnancies
• non-emancipated minors, persons unable to express their consent.
• Lack of affiliation to a social security scheme.
• Subject under administrative or judicial supervision
• Subject cannot be contacted in case of emergency

Sponsors & Collaborators

• University Hospital, Grenoble: lead

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Central Study Contacts

Matthias LACHAUD, PH

CONTACT

0476769495; MLachaud@chu-grenoble.fr

Lora PEJOT, CRA

CONTACT

0476766561; LPejot@chu-grenoble.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2020
• First Posted: May 29, 2020
• Study Start: November 15, 2020
• Primary Completion: May 2, 2022
• Study Completion: November 2, 2022
• Last Updated: November 5, 2020

Record last verified: 2020-11