Clinical trial NCT04866537: Evaluation of the Diagnostic Performance of Specialized Fetal Cardiac Ultrasound in the CPDPN - Arc Alpin Network
Official title: Evaluation of the Diagnostic Performance of Specialized Fetal Cardiac Ultrasound in the CPDPN - Arc Alpin Network From 2015 to 2019 Descriptive, Retrospective, Single-center Study Over 5 Years.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Defects, Congenital
Ultrasonography, Prenatal
Keywords: Heart Defects, Congenital / diagnostic imaging
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2021-04-29
Enrollment: 679
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant women who have had a fetal heart ultrasound performed by a cardiac pediatrician at the Hopital Couple Enfant in Grenoble between 2015 and 2019.

Brief summary: To evaluate the diagnostic performance of antenatal echocardiography with regard to the main diagnosis of heart disease made by cardio-pediatricians at the couple-child hospital in Grenoble according to the ACC-CHD classification, in pregnant women who have had a fetal heart ultrasound between 2015 and 2019.

\*ACC-CHD : Anatomic and Clinical Classification of Congenital Heart Defects

Detailed description: This work is in line with the desire of the Pluridisciplinary Center for Pre-Natal Diagnosis (CPDPN) of the Arc Alpin network, to assess their professional practices regarding the prenatal diagnosis of heart disease over the last five years from 2015 to 2019, and so identify areas for improving their care.

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.

Eligibility criteria: Inclusion Criteria:

* Pregnant women who have had a fetal heart ultrasound performed by a cardiac pediatrician at the Hopital Couple Enfant in Grenoble between 2015 and 2019.

Exclusion Criteria:

- No

Primary outcomes:
measure: Evaluation of the diagnostic performance of antenatal echocardiography with regard to the main diagnosis of heart disease made by cardio-pediatricians at the Grenoble couple-child hospital according to the ACC-CHD classification.
timeFrame: 5 years
Secondary outcomes:
measure: Evaluation of the diagnostic performance of antenatal echocardiography with regard to the main diagnosis of heart disease made by cardio-pediatricians in each pathology sub-category of the ACC-CHD classification.
timeFrame: 5 years
measure: Evaluation of the diagnostic performance of antenatal echocardiography with regard to secondary diagnoses of heart disease made by cardio-pediatricians.
timeFrame: 5 years
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Centre Hospitalier Universitaire GRENOBLE ALPES
state: Rhône-Alpes
Study officials:
affiliation: CHU GRENOBLE ALPES - IFPS - Département de Maïeutique
name: Eline DURAND
role: PRINCIPAL_INVESTIGATOR
References: