Evaluation of the Diagnostic Performance of Specialized Fetal Cardiac Ultrasound in the CPDPN - Arc Alpin Network

Heart Defects, Congenital Clinical Trial

— Qualicard  

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.

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04866537
• Other study ID #: 2020-A01842-37
• Status: Enrolling by invitation
• Start date: October 30, 2020
• Est. completion date: May 1, 2021

Study information

• Verified date: April 2021
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 679
• Est. completion date: May 1, 2021
• Est. primary completion date: May 1, 2021
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Congenital Abnormalities
• Heart Defects, Congenital
• Ultrasonography, Prenatal

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire GRENOBLE ALPES	Grenoble	Rhône-Alpes

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Sensitivity of fetal echocardiography to the primary diagnosis of heart disease made by cardio-pediatricians.	5 years
Secondary	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.	Sensitivity of fetal cardiac ultrasound to the main heart disease diagnosis made by cardio-pediatricians in each pathology subcategory of the ACC-CHD classification.	5 years
Secondary	Evaluation of the diagnostic performance of antenatal echocardiography with regard to secondary diagnoses of heart disease made by cardio-pediatricians.	Sensitivity of fetal echocardiography to secondary heart disease diagnosis made by cardio-pediatricians in each pathology subgroup.	5 years