Feasibility of Pulsenmore’s home ultrasound technology in monitoring high-risk pregnancies

Pulsenmore's Home Ultrasound: a self-operated, clinician-guided home ultrasound device designed for single use and has a total of 150 minutes of scan video and the mobile app is available for iOS and Android smartphones and be downloaded free of charge. The device comprises a handheld, portable ultrasound transducer integrated with a smartphone application for users and a clinician web-viewer dashboard. The user's smartphone is attached to a cradle on the transducer, functioning as a probe while leveraging its power supply, processing capabilities, and communication features. The device is currently being adopted in Israel, Germany, Switzerland, Brazil, and the USA for clinical purpose. The handheld ultrasound enables pregnant women to connect their personal smartphones to a dedicated device and application, allowing them to perform ultrasound imaging scans from the comfort of their homes. These scans are transmitted seamlessly to a remote hospital / clinic for analysis and evaluation, focusing on essential fetal vitality parameters such as amniotic fluid, fetal heart rate and movements. The results are then communicated back to the patients, fostering a continuous and personalized healthcare experience. The use of the device is intended and only permitted to use together with the guidance and oversight of a healthcare professional. The device does not replace any treatment or advice to be provided by healthcare professional. No content or information that may be available through the device constitutes or should be substituted for health, medical or other professional advice. Therefore, for this study, women will maintain their standard antenatal care and only the Clinician-guided mode will be utilized. As this is a new workflow in Australia, this trial is not intended to replace any current care with the woman; the remote monitoring will be an additional surveillance. After randomization for intervention group and receiving the device, participants will be instructed to download the Pulsenmore application in their smartphones and will receive direct instructions on how to use the device and perform the scan (the in-person training will be delivered by the research sonographer using standardized instructions of use). The first appointment will be booked one week after enrolment. For this first and following appointments, a unique procedure key or link will be generated for the patient from the Clinician Dashboard and will allow the participant to connect in the Clinician-guided mode. The QR code or SMS link will only be available for the appointments booked and will be sent to the participants by e-mail or as a text message. Without the QR code or link, participants will not be able use the device. The participants should scan the QR code or click on the link to connect to the application and to start their appointments. The scan will be completed by the participants during the appointment and will be guided by the research sonographer and research clinician. Each participant may have up to five guided appointments, depending on the gestational age at enrolment and the time spent for scanning, and the time interval between appointments will be determined by clinical judgement. The telehealth appointment involves interactions through the device platform (Clinician Dashboard), where the participant engages with the sonographer, who will guide them in performing the scan. The scan report will then be reviewed by a Maternal-Fetal Medicine consultant, who will communicate the results and provide further advice to the participant.