Automated Fetal Cardiac Function Parameters in Congenital Heart Disease

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.