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RECRUITING
NCT05698277

Automated Fetal Cardiac Function in Babies Affected by Heart Diseases

Sponsor: Anna Erenbourg

View on ClinicalTrials.gov

Summary

The goal of this international multicentre prospective observational cohort study with a nested case-control study is to test some automated fetal heart functional parameters in healthy babies compared to those affected by a congenital heart condition. The main questions it aims to answer are: * If there is a significant difference between the two populations of infants * Whether these parameters could significantly improve the predictive value of actual cardiovascular profile score to predict hydrops Participants will be offered two automated cardiac function assessments between 27+6 and 29+6 gestational weeks and between 34+6 and 36+6 weeks of gestation. Functional parameters will be compared between the two study groups and evaluated over time.

Official title: Automated Fetal Cardiac Function Parameters in Congenital Heart Disease

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

495

Start Date

2023-05-01

Completion Date

2028-02-01

Last Updated

2024-12-10

Healthy Volunteers

Yes

Interventions

DIAGNOSTIC_TEST

Automated fetal cardiac function evaluation

Evaluation of ultrasound parameters by automated algorithms. Ultrasound assessed parameters are: 1. Pulsed wave Doppler Modified Left and Right Myocardial performance indices 2. Spatio-temporal image correlation Tricuspid, Mitral and Septal Annular Plane Systolic Excursion

Locations (7)

Royal Hospital for Women

Sydney, New South Wales, Australia

Sheba Medical Center

Tel Aviv, Israel

San Salvatore Hospital L'Aquila

L’Aquila, Italy

Vittore Buzzi Children's Hospital

Milan, Italy

Institute for Maternal and Child Health IRCCS Burlo Garofolo

Trieste, Italy

Centre Hospitalier de Mayotte

Mamoudzou, Mayotte

Medical Center Ujastek

Krakow, Poland