Consumer insights from a feasibility study on remote and extended use of a novel non-invasive wearable fetal electrocardiogram monitor

Abstract

The COVID-19 pandemic accelerated the adoption of telehealth and remote monitoring in obstetric care. This study assessed pregnant patients' perceptions before and after using a novel non-invasive fetal electrocardiogram (NI-FECG) device. The trial is prospectively registered on the Australia New Zealand Clinical Trials Registry (ANZCTRN12621001260819; submitted June 9th, 2021; approved September 17th, 2021). Seventy participants from 36 weeks' gestation completed pre- and post-use surveys. Interest in continuous and home fetal monitoring was high (79% and 90%, respectively). Post-use, 89% reported satisfaction; over 90% comfortable wearing and removing the sensor. Extended use was acceptable to 76%, and only 3% reported high skin irritation. Sentiment analysis highlighted themes of reassurance, convenience, and reduced anxiety. Some suggested smaller, wireless design. Analysis by natural language processing and clustering provided deeper insights. Findings support strong interest in at-home fetal monitoring; further refinement and education are needed to enhance acceptability. Future research should assess long-term effects on anxiety and clinical outcomes.

Fig. 1. Research grade device used in this trial.

This figure presents the research-grade device used in the study, consisting of a wearable sensor patch (a) and a hardware unit (b) for acquiring electrophysiological data. The current iteration of the commercial-grade device can be accessed at https://www.kalihealthcare.com/.

Fig. 2. Summary of participants’ responses to pre-use questionnaire.

This figure illustrates the distribution of participant responses to the study questionnaires. a shows the proportions and 95% confidence intervals (CI) of high-score responders to the pre-use questionnaire. b presents the distribution of participant responses to the pre-use questionnaire.

Fig. 3. Natural language processing insights on post-use questionnaire responses.

This figure provides NLP-based sentiment analysis of participant responses. a depicts polarity and subjectivity scores of textual responses to the various post-use questions. b shows sentiment changes from pre-use to post-use regarding willingness to use the device beyond 24 hours.