Evaluation of The Fetal Heart Rate Monitoring with The Non-Invasive Electrocardiography Signals.

Abstract

Fetal heart rate monitoring is a crucial element in determining the health of the fetus during pregnancy. In this paper, we evaluate the fetal heart rate (FHR) and maternal heart rate (MHR) between our non-invasive fetal monitoring system, Femom, developed by a Biorithm and the Huntleigh computerized cardiotocography (cCTG) together with the Sonicaid FetalCare3 software by comparing the accuracy, sensitivity, and reliability through using Bland-Altman analysis, Positive Percent Agreement (PPA) and Intraclass Correlation Coefficient (ICC) respectively. Femom device is a part of the Femom system which collects abdominal electrocardiogram (aECG) signals. Femom sever then processes the collected signals to generate FHR and MHR using novel algorithms. We collected data from 285 pregnant participants who were at least of 28 weeks of gestational age. FHR accuracy consists of mean bias and limit-of-agreement (LoA). The FHR bias is 0.05 beat per minute (BPM) and LoA is [-8.7 8.8] with 95% confidence interval (95% CI) measured using Bland Altman analysis. The PPA of 90.9% reflects FHR sensitivity. Reliability is measured with absolute ICC and consistency ICC. The absolute ICC is of 88% and consistency ICC of 94%. For MHR evaluation, accuracy is measured using Bland Altman analysis which provided a bias of 0.35 BPM and LoA of [-7 6.2] with 95% CI. The MHR sensitivity calculated using PPA is 98% while the MHR reliability is with the absolute value of 99% and consistency ICC of 99%.