Advice

The technology

The technology

Novii Wireless Patch System (GE Healthcare) is a fetal and maternal monitor used to measure the heart rates of fetus and mother, and the activity of the uterus. It is used in labour when cardiotocography (CTG) monitoring of heart rates and uterus activity is needed. Novii Wireless Patch System is attached to the lower abdomen with multiple adhesive patches and connects wirelessly to the monitoring unit. Novii Wireless Patch System integrates with the Corometrics CTG monitor (GE healthcare), where clinical data are displayed, printed and available for transfer to the hospitals central perinatal surveillance system.

Innovations

The company claims that the wireless capability of Novii allows the wearer to move around during monitoring. It also claims that Novii's abdominal fetal electrocardiography (fECG) technology means once it acquires a signal, it does not need to be readjusted as the baby moves or if the transducer changes position away from the baby's heart. Also, a benefit of the multiple patches with ECG electrode areas is their ability to automatically detect and change to the strongest signal produced during monitoring, particularly when the woman or baby moves. The company claims that the Novii system can measure uterine contractions by detecting the electrical signal from the uterine muscle and processing it into a contraction pattern. This can be interpreted in the same way as a tocodynamometer (Toco), a device that monitors and records uterine contractions. It also claims that the Novii system provides a better performance than Toco, which indirectly measures the surface tension changes on the surface of the abdomen. The company claims that in people with a high body mass index (BMI), Novii is more effective than wired monitoring with a transducer and belt. Novii may also reduce the need to apply an electrode to the baby's head. The company states that maternal heart rates (MHR) and fetal heart rates (FHR) are simultaneously monitored through 1 patch. The maternal ECG has a bigger amplitude and different morphological shape than the fetal ECG. The maternal ECG can be detected and separated from the fetal ECG. This helps to avoid the MHR and FHR being confused.

Current care pathway

CTG monitoring in the NHS is done predominantly through wired transducers. An ultrasound transducer is directed towards the baby's heart to monitor FHR and a separate Toco transducer monitors the abdominal surface tension changes caused by uterine contractions. Both transducers need specialist placement for good quality signals. The transducers are held in place by an elastic belt attached by wires to a static monitor, and the belt must be readjusted as the baby moves. MHR is not monitored by default, although some monitors can do this.

Monitoring FHR, uterine contractions and the baby's position is more difficult in women who are obese. These women are likely to have more complications. Also, growth restriction is more likely to have been missed from earlier scans, making accurate fetal monitoring particularly important in the intrapartum period. Fetal monitoring for women with a BMI over 30 kg/m2 is based on the woman's preference and obstetric indications.

The following NICE Pathways have been identified as relevant to this care pathway:

Population, setting and intended user

Novii Wireless Patch System is indicated for women who are at more than 36 completed weeks (37.0), in labour, with singleton pregnancies. CTG should be offered when there are risk factors present during late pregnancy and labour. These include maternal pulse over 120 beats per minute, high blood pressure, protein in urine, high maternal temperature, vaginal blood loss, premature rupture of membranes, presence of significant meconium, unusual pain, abnormal positioning of the baby or umbilical cord, fetal growth restriction, low FHR or reduced movement of the baby.

Novii Wireless Patch is not suitable for multiple pregnancies and does not transmit a signal while immersed in a birthing pool, although the company states it can be used in the shower.

The technology will be used by midwives. Obstetricians will also be involved in the interpretation of the clinical data. Training to use Novii Wireless Patch System is needed and provided onsite by the company after purchase of the equipment. The training is included in the cost of the device. Training materials and training videos are also available.

Costs

Technology costs

The company states that Novii Wireless Patch System consists of the following components:

  • GE Novii system: £4,995

  • GE Novii Patch: £35 per person

  • GE Corometrics 259cx Maternal Fetal Monitor: £6,600. Only needed if the NHS trust does not have a GE Corometrics monitor.

There are also costs for temperature monitoring, blood pressure cuffs and, if needed, fetal scalp monitoring (see cost of standard care for details).

Costs of standard care

The company states that the costs for using CTG in labour and birth is around £7,000, depending on different options. Aside from the fetal monitor, options include a cart, temperature monitoring, external display and other accessories such as blood pressure cuffs and additional transducers.

  • Belt: £2 to £5 per person.

  • Gel: approximately £1 per person.

  • Fetal scalp electrode: £12 (excluding gloves, attachment pad). Multiple electrodes may be needed.

  • Ultrasound transducer: approximately £300 (reusable).

  • Toco transducer: approximately £300 (reusable).

Resource consequences

The company states that the technology is currently only used in Barnsley Hospital NHS trust.

The company states that although Novii Wireless Patch System is more expensive than CTG, the technology is expected to be resource releasing. This is because less midwife time will be needed as the monitor does not need to be readjusted. The technology can also be used in people with a high BMI, which may reduce the need for more invasive monitoring techniques such as applying electrodes to the baby's scalp. Novii Wireless Patch System displays MHR and FHR separately, so there is less chance of MHR and FHR confusion. As Novii Wireless Patch System allows the wearer to move around it is likely to lead to less stress for the woman, and research shows increased maternal movement results in reduced pain, shorter duration of labour and fewer caesarean sections.

Better monitoring may also reduce costs in the long term, through reduced cerebral palsy and clinical negligence cases for NHS trusts.