NCT04866537

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
679

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 28, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 29, 2021

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
Last Updated

April 29, 2021

Status Verified

April 1, 2021

Enrollment Period

6 months

First QC Date

April 28, 2021

Last Update Submit

April 28, 2021

Conditions

Keywords

Heart Defects, Congenital / diagnostic imaging

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

Age18 Years+
Sexfemale
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

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

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Eline DURAND

    CHU GRENOBLE ALPES - IFPS - Département de Maïeutique

    PRINCIPAL INVESTIGATOR

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

Locations