HeraBeat study

I thought some may be interested in reading the HeraBEAT paper.  It has been published as a Preprint on MedRxiv
https://doi.org/10.1101/2020.11.18.20190959

Preprints are the study reports in a publishable format that are released so that interested people (clinicians/scientists etc) have access to the latest research while the formal manuscript is being considered for publication in a traditional journal.  The assumption is that knowledgable readers can review the data themselves prior to the journals peer-review process: notably, a lot of COVID research is released this way for rapid distribution. Most good journals advise (some are now insisting) that research is submitted to a preprint server as everyone knows that peer-review can take months (longer now during COVID).  The preprint can change depending upon further review (all versions are visible and changes clearly marked) but when the article is formally published it is then locked.

For those who want to know more background and details, I would recommend reading the whole article but the abstract has an overview of the results.

Summary of the summary is that the device works very well.
Abstract

Objective To evaluate the accuracy, reliability, clinical utility, and usability of HeraBEAT, a wireless fetal and maternal heart rate monitor (HBM) when used by clinicians and pregnant women to monitor fetal heart rate (FHR).
Methods We recruited women aged 18 years or older with a singleton pregnancy of ≥12 weeks gestation. FHR recordings were performed using the HBM and cardiotocography (CTG) to determine comparative accuracy. The HBM was then used by clinicians and participants in the antenatal clinic with the latter then using the device unassisted to record at home. The women rated the HBM using the System Usability Scale (SUS).
Results A total of 81 participants provided 126 recordings for analysis. The accuracy of the HBM was excellent compared with CTG, with limits of agreement (95%) between −1.5 and +0.9 beats per minute (bpm) and a mean difference of −0.29 bpm. The FHR was detected on 100% of occasions by clinicians (52 recordings) and participants when used in the clinic (42 recordings) and at home (32 recordings). Home users took an average of 1.1 minutes to detect the FHR and recorded a continuous trace of >1 minute in 94% of occasions, with an average total trace time of 4.4 minutes. The FHR trace was deemed to be clinically useful in 100% of clinician recordings and 97% of home recordings. There was no effect from body mass index, gestational age, pregnancy history, or placental position. The HBM ranked in the 96–100th percentile on the SUS for usability and learnability.
Conclusions The HBM was accurate and easy for clinicians and participants to use. The data recorded at home was equivalent to that obtained in the clinic using current assessment protocols for low-risk pregnancies, allowing the device to be used in telehealth consultations.
Clinical Trial Registration Australian New Zealand Clinical Trial Registry, https://www.anzctr.org.au ACTRN12620000739910.