Background:Mobile medical devices for self-patient use are a rapidly evolving section of telehealth. We examined the INSTINCT® ultrasound system, a portable, self-operated ultrasound device attached to a commercial smartphone for remote fetal assessment. We aimed to evaluate whether it is feasible to use remote fetal assessment during pregnancy.Materials and Methods:This is an observational noninterventional trial. We included women with a singleton fetus at 14 + 0 to 39 + 6 gestational weeks. Each participant received the device for a self-use period of 7-14 days and was instructed to perform one to three scans a day. Participants completed a self-assessment questionnaire to evaluate safety and usability (i.e., user experience and satisfaction). Each scan was evaluated for fetal heart activity, amniotic fluid volume, fetal tone, fetal body, and breathing movements.Results:One hundred women, completing 1,360 self scans, used the device for 8.1 ± 1.5 days, performing an average of 13.6 ± 6.2 scans each. There were no device-related serious adverse events. Success in detection was 95.3% for fetal heart activity, 88.3% for body movements, 69.4% for tone, 92.2% for normal amniotic fluid volume, and 23.8% for breathing movements. Interobserver agreement was 94.4% for fetal heart rate activity, 85.9% for body movements, 69.5% for fetal tone, 86.9% for amniotic fluid volume, and 94.0% for breathing movements. Self-assessed user experience was rated at 4.4/5, whereas device satisfaction was rated at 3.9/5.Conclusion:The INSTINCT ultrasound system is a feasible solution for remote sonographic fetal assessment. Further studies are needed to assess its role and impact in telehealth antenatal care and fetal surveillance.
Keywords: fetal monitoring; home; mobile; self-operated; telemedicine; ultrasound.