Harnessing technology to enable all women mobility in labour and birth: feasibility of implementing beltless non-invasive fetal ECG applying the NASSS framework

Abstract

Background A new wireless and beltless monitoring device utilising fetal and maternal electrocardiography (ECG) and uterine electromyography, known as ‘non-invasive fetal ECG’ (NIFECG) was registered for clinical use in Australia in 2018. The safety and reliability of NIFECG has been demonstrated in controlled settings for short periods during labour. As far as we are aware, at the time our study commenced, this was globally the first trial of such a device in an authentic clinical setting for the entire duration of a woman’s labour. Methods This study aimed to assess the feasibility of using NIFECG fetal monitoring for women undergoing continuous electronic fetal monitoring during labour and birth. Women were eligible to participate in the study if they were at 36 weeks gestation or greater with a singleton pregnancy, planning to give birth vaginally and with obstetric indications as per local protocol (NSW Health Fetal Heart Rate Monitoring Guideline GL2018_025. 2018) for continuous intrapartum fetal monitoring. Written informed consent was received from participating women in antenatal clinic prior to the onset of labour. This single site clinical feasibility study took place between January and July 2020 at the Royal Hospital for Women in Sydney, Australia. Quantitative and qualitative data were collected to inform the analysis of results using the NASSS (Non-adoption, Abandonment, Scale up, Spread and Sustainability) framework, a validated tool for analysing the implementation of new health technologies into clinical settings. Results Women responded positively about the comfort and freedom of movement afforded by the NIFECG. Midwives reported that when no loss of contact occurred, the device enabled them to focus less on the technology and more on supporting women’s physical and emotional needs during labour. Midwives and obstetricians noticed the benefits for women but expressed a need for greater certainty about the reliability of the signal. Conclusion The NIFECG device enables freedom of movement and positioning for labouring women and was well received by women and the majority of clinicians. Whilst measurement of the uterine activity was reliable, there was uncertainty for clinicians in relation to loss of contact of the fetal heart rate. If this can be ameliorated the device shows potential to be used as routinely as cardiotocography (CTG) for fetal monitoring. This is the first time the NASSS framework has been used to synthesise the implementation needs of a health technology in the care of women during labour and birth. Our findings contribute new knowledge about the determinants for implementation of a complex technology in a maternity care setting. Trial registration The Universal Trial Number is reU1111-1228-9845 and the Australian and New Zealand Clinical Trial Registration Number is 12619000293167p. Trial registration occurred on the 20 February, 2019. The trial protocol may be viewed at http://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=377027

Evaluation and patient experience of wireless noninvasive fetal heart rate monitoring devices

“…18,26 In addition, reported skin irritation from the electrodes does not prevent women from reusing the NI-FECG. 20,27 The aforementioned studies evaluated several NI-FECG devices: Avalon-Beltless, 27 Femom, 4…”

“…Previous research has shown that women prefer the comfort of the NI‐FECG device over the DU device 18,26 . In addition, reported skin irritation from the electrodes does not prevent women from reusing the NI‐FECG 20,27 . The aforementioned studies evaluated several NI‐FECG devices: Avalon‐Beltless, 27 Femom, 4 Monica‐AN24, 17,20,21,25,26 Monica‐Novii 18,19 and Nemo 23,24 .…”

Ambulatory antenatal fetal electrocardiography in high-risk pregnancies (AMBER): protocol for a pilot prospective cohort study

“…Existing literature on a similar NIFECG device (Monica AN24, Monica Healthcare, Nottingham, UK) using the same signal acceptance criteria have reported a success rate as low as 49% of the collected traces meeting this criteria 19–21. Moreover, we estimate an additional 30% trace exclusion due to technical issues arising from using a novel device 22. Therefore, we anticipate that we will need to recruit 200 participants to obtain 100 participants with interpretable and informative traces.…”

“…[19][20][21] Moreover, we estimate an additional 30% trace exclusion due to technical issues arising from using a novel device. 22 Therefore, we anticipate that we will need to recruit 200 participants to obtain 100 participants with interpretable and informative traces. Open access…”

Tending to the machine: The impact of intrapartum fetal surveillance on women in Australia

“…CEFM involves the use of electronic devices to monitor the fetal heart rate and uterine contractions continuously throughout labour [ 1 ]. CEFM may be conducted via a cardiotocograph (CTG) either in wired, or wireless forms, internal scalp electrode (FSE) which involves a spiral electrode being inserted into the fetal scalp or breech [ 2 , 3 ], or non-invasive fetal electrocardiogram (NIFECG), a wireless and beltless monitoring device which has more recently become available on the Australian market [ 4 ]. All forms of CEFM provide real-time information on the fetal heart rate pattern in conjunction with the measurement of uterine activity.…”