Evaluation of the Diagnostic Performance of Specialized Fetal Cardiac Ultrasound in the CPDPN - Arc Alpin Network
NCT ID: NCT04866537
Last Updated: 2021-04-29
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
679 participants
OBSERVATIONAL
2020-10-30
2021-05-01
Brief Summary
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\*ACC-CHD : Anatomic and Clinical Classification of Congenital Heart Defects
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Detailed Description
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Within the Arc-Alpin network, pregnant women for whom an abnormality is detected in the fetus during the screening ultrasound, then benefit from a diagnostic ultrasound, to confirm the detected abnormality. Then, the patient's file will be studied within the CPDPN of the Alpine Arc, and the patient will then be referred to a doctor specializing in the diagnosed fetal pathology. The latter will prescribe additional examinations to characterize as much as possible the diagnosed pathology, in order to develop a course of action to be taken, and to establish a prognosis for this fetus (specialized ultrasound, MRI, amniocentesis, etc.)
As part of the diagnosis of fetal heart disease, the woman will be referred to cardio-pediatricians at the Couple Enfant Hospital in Grenoble, who will perform a so-called specialized 2nd line ultrasound in order to clarify the diagnosis, to develop a course of action to take, and establish a prognosis for this unborn child.
We therefore want to study the diagnostic performance of specialized 2nd line fetal cardiac ultrasound in the CPDPN network of the Alpin Arc, by comparing the diagnosis established following the 2nd line fetal echocardiography with the reference examination (test of reference) which is the postnatal cardiac ultrasound.
Conditions
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Study Design
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CASE_ONLY
RETROSPECTIVE
Study Groups
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Pregnant women who received a fetal heart ultrasound between 2015 and 2019.
Pregnant women who received a fetal heart ultrasound between 2015 and 2019.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
FEMALE
No
Sponsors
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University Hospital, Grenoble
OTHER
Responsible Party
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Principal Investigators
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Eline DURAND
Role: PRINCIPAL_INVESTIGATOR
CHU GRENOBLE ALPES - IFPS - Département de Maïeutique
Locations
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Centre Hospitalier Universitaire GRENOBLE ALPES
Grenoble, Auvergne-Rhône-Alpes, France
Countries
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Other Identifiers
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2020-A01842-37
Identifier Type: -
Identifier Source: org_study_id
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