Patient-delivered FHR monitors are available, but there have been issues with usability, accuracy and reliability, signal noise, differentiation of fetal from maternal heart rate (MHR), inadequate recording duration, and cost 7. However, accurate and reliable measurement of FHR outside clinical environments has proven more difficult.
Tocography is easily performed directly by women through simple available technology. However, certain crucial aspects of antenatal care have so far been hard to deliver in a telemedicine antenatal care model 4. The addition of telehealth allows women to access antenatal care remotely without causing detrimental maternal and fetal outcomes 5, 6. Since the COVID-19 pandemic, the introduction of telehealth consultations into maternity care has become standard 4, 5. To introduce home-based fetal cardiography monitoring into the standard care model, we need to ensure the device is equivalent to the clinic standard CTG device in terms of accuracy and clinical interpretability and to show equivalence when used by women at home unsupervised. However, this research used FHR traces of less than 5 min duration and did not investigate the suitability of using the HBM for the longer recordings required for NST examinations (10–20 min). In addition, the device was easy to use 3. Our previous research showed that when this HBM was used in low-risk pregnancies, the results were accurate and as clinically useful as those obtained by handheld fetal Dopplers. HeraBEAT (HeraMED, Netanya, ISRAEL) is a medical-grade, low-cost, wireless, self-guided fetal and maternal heartbeat monitor (HBM) designed for self-administration from 12 weeks of gestation. We have previously described using a FHR monitor for intermittent auscultation by clinicians and when self-administered by women 3. FHR and movement data are combined to estimate fetal hypoxia at the time of the test, reported as reactive or non-reactive (definitions and assessment criteria: Box 1), which is used to judge fetal health and guide clinical interventions. In high-risk pregnancies and emergencies, a Non-Stress Test examination (NST) is performed using cardiotocography (CTG) to collect comprehensive FHR data (fetal cardiography) for >10 minutes and to assess uterine contractions (tocography) 2. This process is known as intermittent auscultation (IA) 1. During routine low-risk antenatal consultations, the fetal heart rate is measured briefly by a handheld doppler device, a DeLee-Hillis stethoscope, or a Pinard horn, depending on available skills and resources. The fetal heart rate (FHR) and heart rate variability are used as indicators of fetal wellbeing in utero. It is usable by expectant mothers with minimal training. The HBM is as accurate as gold-standard CTG, and provides equivalent clinical information enabling use in non-stress test analyses conducted outside of hospitals. The monitor ranked in the 96–100 th percentile for usability and learnability.
They achieved the required length of recording required for non-stress test analysis. Thirty-four (100%) women successfully detected the FHR and obtained clinically useful cardiographic data using the device at home unsupervised. Both methods were equally interpretable by Obstetricians, and had similar signal loss ratios. The FHR was detected on all occasions and confirmed to be different from the maternal heart rate. The accuracy of the HBM was excellent, with limits of agreement (95%) for mean fetal heart rate (FHR) between 0.72 and −1.78 beats per minute. Sixty-three women had paired clinic-based HBM and CTG recordings, providing 6982 fetal heart rate measures for point-to-point comparison from 126 min of continuous recording. Women then used the HBM unsupervised and rated the experience. Initially, participants had paired HBM and CTG examinations performed in the clinic.
We compared the accuracy, clinical interpretability, and user experience of a patient-administered, wireless, fetal heartbeat monitor (HBM) designed for home use, to CTG. New technologies may permit home-based, self-administered examinations. Fetal Cardiography is usually performed using in-hospital Cardiotocographic (CTG) devices to assess fetal wellbeing.
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