Early Detection of Severe Heart Disease in Fetuses at High Risk of Heart Disease
NCT ID: NCT04407728
Last Updated: 2020-11-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
500 participants
INTERVENTIONAL
2020-11-15
2022-11-02
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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precocious EchoMorpho-T1
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.
early ultrasound screening
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.
Interventions
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early ultrasound screening
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Months
FEMALE
No
Sponsors
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University Hospital, Grenoble
OTHER
Responsible Party
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Central Contacts
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Other Identifiers
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38RC20.009
Identifier Type: -
Identifier Source: org_study_id