bridging the gap in fetal heart rate monitoring: introduction and evaluation of an acoustic-based smart belt for real-time, passive, mother-centered monitoring with extensive multicenter validation

Fetal heart rate (fhr) monitoring facilitates the early detection of pregnancy abnormalities. current methods, such as cardiotocography (ctg), provide accurate fhr measurements but are neither continuous nor real-time, and require clinical settings. this study presents a smart belt for fhr monitoring utilizing acoustic signal processing without transmitting high-frequency waves. the device is designed for maternal use and features real-time analysis. to evaluate its user-friendliness for mothers and clinical validity endorsed by physicians, questionnaires were administered to 637 individuals and 225 physicians. this follows a multi-year product development and patenting process reported herein. cronbach's alpha values indicated suitable reliability of the questionnaire items. results showed that 75.5% of physicians validated the questionnaire data and deemed the recommended usage frequency of the smart belt appropriate at 5-15 times for healthy mothers and 10-15 times for high-risk individuals from fetal heart formation onwards. a decision tree algorithm was employed to identify correlations and relationships among the various variables.