Mobile Self-Operated Home Ultrasound System for Remote Fetal Assessment During Pregnancy

Background: Mobile medical devices for self-patient use are a rapidly evolving section of telehealth. We examined the INSTINCT(R) 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.