Evaluation of the Diagnostic Performance of Specialized Fetal Cardiac Ultrasound in the CPDPN - Arc Alpin Network
Qualicard
1 other identifier
observational
679
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2020
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 30, 2020
CompletedFirst Submitted
Initial submission to the registry
April 28, 2021
CompletedFirst Posted
Study publicly available on registry
April 29, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2021
CompletedApril 29, 2021
April 1, 2021
6 months
April 28, 2021
April 28, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
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.
5 years
Evaluation of the diagnostic performance of antenatal echocardiography with regard to secondary diagnoses of heart disease made by cardio-pediatricians.
5 years
Study Arms (1)
Pregnant women who received a fetal heart ultrasound between 2015 and 2019.
Pregnant women who received a fetal heart ultrasound between 2015 and 2019.
Eligibility 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.
You may qualify if:
- 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.
You may not qualify if:
- \- No
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre Hospitalier Universitaire GRENOBLE ALPES
Grenoble, Auvergne-Rhône-Alpes, 38000, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eline DURAND
CHU GRENOBLE ALPES - IFPS - Département de Maïeutique
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 28, 2021
First Posted
April 29, 2021
Study Start
October 30, 2020
Primary Completion
May 1, 2021
Study Completion
May 1, 2021
Last Updated
April 29, 2021
Record last verified: 2021-04