Language: BG BG
← Back to results
Recruiting NCT05698277

Automated Fetal Cardiac Function in Babies Affected by Heart Diseases

Conditions: Congenital Heart Defect Cardiac Function

Sponsor: Anna Erenbourg

trial.available_in: БГ
Overview
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.
Description
Investigation Plan Participating patients will be offered a fetal cardiac function echocardiography between 27+6 and 29+6 weeks of gestation and another between 34+6 and 36+6 weeks. At the stage patients will come in to carry out fetal cardiac function echocardiography they will already know whether the baby is affected by congenital heart disease since malformation screening is carried out between 18 and 20 gestational weeks and will have already been undertaken. In the remote case of detecting an undiagnosed fetal malformation during one of the research scans, patients will be reassured, and appointments arranged at Maternal and Fetal medicine (MFM) clinic for further consultation along with notification of to their own treating doctor. Every participant will be assigned a study number following recruiting order of participation. De-identification will be undertaken at image acquisition by the doctors prior to image review by the engineers. Researchers will access an online patients' form system, collect the assigned patients' number and add the necessary outcomes information. Ultrasound images will be saved locally in the ultrasound machine by the same assigned patient's study number and uploaded to a specific Microsoft (OneDrive) folder created in Sydney. This data will be stored for a minimum of 5 years after publication, then the data record will be securely destroyed in accordance with the University of New South Wales (UNSW) Records Disposal processes. The research ultrasound scans will be performed by a trained sonographer using either a clinical ultrasound system or a research ultrasound system that is Therapeutic Goods Administration (TGA) approved for research imaging. The machine used clinically is made by one of the common commercial manufacturers (in this case General Electric E10) and is an identical model to that used in the Department of Maternal and Fetal Medicine. The machine used for research porpoises is called Vantage 256 and it is manufactured by a private company in the United States (Verasonics). It uses the same fundamental electronic circuitry and transducer design as conventional commercial machines, and in fact uses the same transducers as the commercial machines. However, the way that the ultrasound is delivered differs. Instead of transmitting beams as used in conventional ultrasound machines, Verasonics scans the area of interest by unfocused waves, allowing high quality images with a limited number of compounded plane-waves, and reduced acquisition time. Women will be placed in a semi-recumbent position, as standard for pregnancy ultrasounds. After routine biometry, the research fetal cardiac function ultrasound will be carried out. Each fetal cardiac function examination will include the following parameters: 1. Fetal biometric parameters (biparietal diameter, head circumference, abdominal circumference, femur diaphysis length) 2. Standard fetal Doppler parameters (umbilical artery, medial cerebral artery
Who can participate
Inclusion Criteria: * Inclusion criteria for the CHD Group are as follows: singleton pregnancies; gestational age between 19+6 and 36+6 weeks gestation, determined by the last menstrual period and confirmed by first trimester ultrasound; isolated congenital cardiac anomaly diagnosed. * Inclusion criteria for the Control Group are as follows: singleton pregnancies; gestational age between 19+6 and 27+6 weeks gestation, determined by the last menstrual period and confirmed by first trimester ultrasound; no congenital cardiac anomaly diagnosed Exclusion Criteria common to the 2 groups (Cases and Controls): * Fetuses whose mothers have comorbidities that have been proven to potentially affect cardiac function including: * intrahepatic cholestasis * pre-gestational and gestational diabetes * preeclampsia * growth restricted fetuses defined as estimated fetal weight or abdominal circumference \<3rd percentile for GA * Fetuses with other structural extracardiac anomalies at ultrasound examination * Fetuses affected by any diagnosed genetic abnormalities
Locations 5
Australia (1)
Royal Hospital for Women
Sydney , New South Wales
Israel (1)
Sheba Medical Center
Tel Aviv
NOT_YET_RECRUITING
Italy (1)
San Salvatore Hospital L'Aquila
L’Aquila
NOT_YET_RECRUITING
Mayotte (1)
Centre Hospitalier de Mayotte
Mamoudzou
NOT_YET_RECRUITING
Poland (1)
Medical Center Ujastek
Krakow
NOT_YET_RECRUITING
Beata Radzymińska-Chruściel
Technical details
Status
Recruiting
Study type
OBSERVATIONAL
Sex
Female only
Minimum age
18 Years
Healthy volunteers
No
Start date
01.05.2023
Completion date
01.02.2028
Registry ID
NCT05698277
Source
anzctr
trial.inquiry_btn

Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.