Abstract

OBJECTIVES: To compare short-term variation (STV) outputs from a novel self-applied non-invasive fetal electrocardiography (NIFECG) device with those obtained on computerized cardiotocography (cCTG). Technological and algorithmic limitations and mitigation strategies were also evaluated. METHODS: This was a prospective cohort study of women with a singleton pregnancy over 28 + 0 weeks' gestation attending a tertiary London hospital for cCTG assessment between June 2021 and June 2022. Women underwent concurrent monitoring with both NIFECG and cCTG for up to 1 h. Postprocessing of NIFECG data using various filtering methods produced NIFECG-STV (eSTV) values, which were compared with cCTG-STV (cSTV) outputs. Linear correlation, mean bias, precision and limits of agreement were assessed for STV derived by the different methods of computation and mathematical correction. RESULTS: Overall, 306 concurrent NIFECG and cCTG traces were collected from 285 women. Fully filtered eSTV was correlated very strongly with cSTV (r = 0.911, P < 0.001), but generated results only in 142/306 (46.4%) 1-h traces owing to the removal of traces with lower-quality signals. Partial filtering generated more eSTV data (98.4%), but with a weak correlation with cSTV (r = 0.337, P < 0.001). The difference in STV between the monitors (eSTV - cSTV) increased with signal loss; in traces with > 60% signal loss, the values became highly discrepant. Removal of traces with > 60% signal loss resulted in a stronger correlation with cSTV, while still generating eSTV results for 65% of traces. Correcting these remaining eSTV values for signal loss using linear regression analysis further improved correlation with cSTV (r = 0.839, P < 0.001). CONCLUSIONS: The discrepancy between STV computed by NIFECG and cCTG necessitates signal filtering, exclusion of poor-quality traces and eSTV correction. This study demonstrates that, with such correction, NIFECG is able to produce STV values that are strongly correlated with those of cCTG. This evidence base for NIFECG monitoring and interpretation is a promising step forward in the development of safe and effective at-home fetal heart-rate monitoring. © 2023 The Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of International Society of Ultrasound in Obstetrics and Gynecology.