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

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.

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Heart Defects, Congenital; Ultrasonography, Prenatal

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.

• Study Type: Observational
• Enrollment (Actual): 679

Contacts and Locations

Study Locations

• France
  • Rhône-Alpes
    • Grenoble, Rhône-Alpes, France, 38000
      • Centre Hospitalier Universitaire Grenoble Alpes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Pregnant women who received a fetal heart ultrasound between 2015 and 2019.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble
• Investigators: Principal Investigator: Eline DURAND, CHU GRENOBLE ALPES - IFPS - Département de Maïeutique

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2020
• Primary Completion (Anticipated): May 1, 2021
• Study Completion (Anticipated): May 1, 2021

Study Registration Dates

• First Submitted: April 28, 2021
• First Submitted That Met QC Criteria: April 28, 2021
• First Posted (Actual): April 29, 2021

Study Record Updates

• Last Update Posted (Actual): April 29, 2021
• Last Update Submitted That Met QC Criteria: April 28, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Heart Defects, Congenital / diagnostic imaging
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Cardiovascular Abnormalities; Congenital Abnormalities; Heart Defects, Congenital
• Other Study ID Numbers: 2020-A01842-37

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No