Novii Wireless Patch System for maternal and fetal monitoring

Level of innovation

Four experts agreed that Novii is an innovative technology, while 2 experts said that it is a variation of standard care. All experts agreed that apart from standard care practice, no other similar technologies are currently available to the NHS. This device is novel because it is wireless and therefore does not need to be adjusted when moving, increasing mobility and comfort and the device is attached to the abdomen and not the baby's scalp.

Potential patient impact

All clinical experts noted that using Novii can allow increased mobility. The experts also noted that Novii is more comfortable and less invasive than applying electrodes to the baby's scalp. Also, it can be used in early labour before membrane rupture and fetal heart rate can still be monitored while the woman is positioned for epidural. Overall, experts noted that Novii is unlikely to change the current pathway or improve clinical outcomes, but it can potentially lead to a better birth experience.

Four experts noted that Novii would be of benefit to people who need continuous fetal monitoring but wish to remain mobile during labour. Five experts agreed that people with a high body mass index would benefit, however 1 expert noted that the evidence for this is currently limited.

Potential system impact

Two experts noted that Novii could lead to a reduction in more invasive methods of fetal heart rate monitoring, with 1 expert noting a potential reduction in time and cost compared with fitting more invasive methods. One expert noted better quality monitoring. One expert said that Novii can potentially increase patient safety if there are fewer episodes of signal loss. Another expert said that using this technology may lead to better outcomes for labour and potentially reduce the demand for pain relief.

Six experts noted that Novii is likely to cost more than standard care, and 1 expert felt unable to comment on the costs. One expert noted that Novii is perhaps not appropriate during advanced labour and may need to be used in addition to the current doppler technology.

Three experts mentioned Novii potentially having a positive impact on midwife time as there is no need to readjust the belt. However, 1 expert noted that there is no evidence to support this and another expert clarified that midwives are attending people in labour for other reasons apart from cardiotocography (CTG) monitoring. Other experts expected little resource impact and 1 expert noted that the main resource impact would be the purchase of the device. One expert noted that currently only GE monitors are compatible with Novii and that resources are needed to ensure existing monitors can accept input from Novii.

Five experts expressed the need for training midwives on how to use Novii.

None of the experts were aware of any safety issues surrounding this technology.

General comments

Five experts agreed that it has the potential to eventually replace standard care, and 1 expert said that it is in addition to standard care. One expert said that sometimes there is unexplained loss of signal during the second stage of labour. Another expert noted that currently it cannot replace doppler monitoring, which is needed to fill in any gaps in monitoring during the second stage of labour. This potentially puts babies at risk as it takes time to switch monitors. Experts raised other issues with the usability of the technology including the inability to use Novii in multiple pregnancies and whether the patches would be affected by sweat and other bodily fluids.

One expert said that there is other wireless monitoring technology available but that this technology is particularly effective for women with a high body mass index. Two experts said that it cannot be used in a birth pool, unlike the Philips wireless system.

Experts noted that the main barriers to adoption in organisations or the NHS would be the additional costs, the need for specific fetal monitors and whether Novii can be integrated into existing infrastructures (for example, CTG outputs available on screens in the midwives' station).

One expert noted that evidence on the signal quality using the Novii system for uterine contractions is far less convincing than that for the fetal heart rate signal. All experts agreed that further research would be useful to address the uncertainty in the evidence base.