To Assess the Accuracy, Sensitivity and Specificity of Fetal Heart Rate (FHR) and Uterine Activity (UA) from Abdominal ECG and EMG Electrodes in Comparison with Conventional Cardiotocography (CTG) Machine
Background: FHR and UC are two vital parameters that need to be monitored during the intrapartum period which can help reduce death from preventable causes during the intrapartum period. CTG is the currently used tool for intrapartum monitoring, but being expensive, bulky, and dependent on skilled healthcare workers for interpretation of results makes it unsuitable for use in healthcare settings. KEYAR is an affordable, portable, wearable, and easy to use continuous FHR and UC monitoring device. This study aims to validate Keyar with gold standard FHR DHR and UC monitoring device CTG. Subjects and Methods:Prospective study was conducted to compare a test device (KEYAR) with a gold standard device (cardiotocography) for 38 participants in Rangadore Memorial Hospital, Bangalore, India. The inclusion criteria included more than 36 weeks of gestational age, singleton pregnancy and cephalic presentation. The procedure for using both devices to monitor FHR and UC was explained to the participants. Data analysis was done with Microsoft EXCEL (Microsoft Corporation) and Python Jupyter Notebook. Results: The accuracy, sensitivity and specificity of Fetal Heart Rate (FHR) was found to be 92.92, 72.7 and 66.7% respectively, in comparison with conventional cardiotocography (CTG) machines for 38 participants. The FHR reliability was computed as 97.33%. The maximum FHR accuracy was found to be 99.7%. The accuracy computed for 41 datasets for the total number of contractions in 10 min was 90.24% and for the average duration of contraction for 1 contraction was 92.68% with respect to the CTG graphs. Conclusions: Gestational age (GA) does not play a significant role in determining the comparative accuracy with CTG. However, it was noted that we would require significantly more data for a detailed analysis. More research can be done to explore less GA and other presentations.
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