Clinical Trials Logo

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT04866537
Other study ID # 2020-A01842-37
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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

Study Design


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
See also
  Status Clinical Trial Phase
Recruiting NCT05330338 - Genetics of Ventriculo-arterial Discordance N/A
Withdrawn NCT03405636 - Xeltis Pulmonary Valved Conduit Safety and Performance Study N/A
Completed NCT02443662 - Colloid Osmotic Pressure in Patients With Fontan Circulation
Terminated NCT02519335 - Use of the Cardioprotectant Dexrazoxane During Congenital Heart Surgery: Proposal for Pilot Investigation Phase 1
Completed NCT01835392 - Neuroprotective Effects of Remote Ischemic Preconditioning (RIPC) During Infant Cardiac Surgery N/A
Completed NCT00371891 - Ontario Multidetector Computed Tomographic (MDCT) Coronary Angiography Study (OMCAS) Phase 4
Completed NCT03035552 - CTICU Pacifier Activated Music Player and Mother's Voice N/A
Recruiting NCT04581668 - Impact of NAVA Ventilation on Brain Oxygenation and Perfusion in Children With Congenital Heart Disease N/A
Completed NCT03049540 - Effect of Phosphodiesterase-5 Inhibition With Tadalafil on SystEmic Right VEntricular Size and Function Phase 3
Completed NCT02377674 - Safety and Performance of the COR-VG-001 Conduit in Pediatric Patients for Extracardiac Total Cavopulmonary Connection N/A
Completed NCT01679275 - Pre-operative Cerebral Oxygenation in Neonates With Congenital Heart Disease
Terminated NCT00543309 - Effects of Perioperative Nesiritide or Milrinone Infusion on Recovery From Fontan Surgery Phase 2
Completed NCT03957512 - Livet Skal Leves (A Life to Live)
Recruiting NCT06005428 - Effectiveness of CRD-4730 in Participants With Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT) Phase 2
Recruiting NCT02691689 - Genes Associated With Development of Pulmonary Arterial Hypertension in Patients With Congenital Shunt Lesions N/A
Completed NCT02306057 - Fluid Balance in Children Undergoing Fontan Surgery N/A
Recruiting NCT02157597 - NIRS Guidance Trail in Children's Heart Surgery N/A
Completed NCT01570933 - Feasibility Study Over the NAVA Mode in Noninvasive Ventilation After Cardiac Surgery in Infants. Phase 4
Completed NCT00396877 - Efficacy And Safety Of Clopidogrel In Neonates /Infants With Systemic To Pulmonary Artery Shunt Palliation Phase 3
Completed NCT00443599 - SPECS: Safe Pediatric Euglycemia in Cardiac Surgery N/A