In a world first, an Australian company has successfully engineered a groundbreaking fetal monitoring device that promises to dramatically improve childbirth outcomes.
Developed by Perth-based medtech company VitalTrace, the new device – called DelivAssure – is a miniaturised electrochemical biosensor designed to continuously measure fetal lactate levels during labour.
The technology represents a major leap forward in fetal monitoring and could help reduce birth complications, misdiagnoses and unnecessary emergency interventions such as caesarean sections.
The technology builds on the existing fetal scalp electrode (FSE) system and offers an alternative to cardiotocography (CTG) – the current standard for monitoring fetal heart rate. While CTG is highly sensitive, it is not very specific. It can detect when something might be wrong, but it often cannot confirm whether a baby is truly in distress.
“The CTG is poorly correlated with fetal distress,” Dr Julian Shapley, Chief Operations Officer at VitalTrace, told create. “That lack of specificity leaves obstetricians without crucial information to make decisions, leading to missed or delayed diagnosis of neonatal hypoxia/asphyxia and unnecessary interventions, such as emergency caesarean sections, which come with their own risks.”
In Australia, approximately three in every 1000 babies suffer from severe neonatal asphyxia – a condition where the baby is deprived of adequate oxygen during birth. Tragically, about half of these infants either do not survive or live with lifelong disabilities such as cerebral palsy. Early and accurate detection of fetal distress is essential to reducing these outcomes.
DelivAssure addresses this critical need by continuously measuring fetal lactate levels, a reliable biochemical marker that reflects how well the baby is coping during labour. When lactate levels rise, it signals that the baby may not be receiving sufficient oxygen, prompting cells to switch from normal oxygen-dependent (aerobic) metabolism to less efficient oxygen-free (anaerobic) metabolism.
“Lactate is a well-known biochemical marker for anaerobic metabolism and fetal compromise. However, the current method of acquiring a lactate reading involves taking a highly invasive, awkward and time-consuming blood sample from the baby while it is still in the birth canal,” Shapley said.
“The CTG is also inaccurate with a 70 per cent false positive rate, resulting in unnecessary interventions and potentially poor health outcomes for both mother and baby, including misdiagnosis that can cause brain damage and cerebral palsy.”
Current methods of acquiring lactate also only provide only a single data point; this system delivers continuous lactate readings, offering both early warning signs and confirmation to support better clinical decision-making.
Building on existing tech
Existing FSEs are already used in approximately 40 per cent of births globally, but they are limited to measuring only fetal heart rate. DelivAssure adds to this by incorporating an enzyme-based electrochemical system specifically designed to detect lactate, Shapely said.
“The sensor is built on a modified FSE and has a miniaturised metal spiral and micro-needle at its tip. Once inserted into the birth canal and positioned against the baby’s scalp, the device begins real-time monitoring of interstitial fluid,” Shapely said.
“It’s engineered with specialised chemical coatings and layered membrane technology to ensure high specificity for lactate – and nothing else.
To transmit live data securely and reliably from the sensor during childbirth, the system uses an encrypted form of Bluetooth. However, integrating wireless communication into a hospital environment presented significant engineering challenges.
“Wireless coexistence was one of our biggest engineering hurdles,” Shapley said. “Hospitals are full of medical equipment operating on different frequencies. We had to ensure DelivAssure wouldn’t interfere with other systems or lose connection.”
The team had to ensure full compatibility with hospital electronic medical records systems, as well as meet stringent patient safety standards. Robust cybersecurity was a critical focus throughout development.
“Cybersecurity was a key part of our design work. We collaborated with international test houses to validate system integrity and hospital compatibility.”
Clinical trials and manufacturing
The monitoring system has recently completed its first round of clinical trials, which were conducted at Royal North Shore, King Edward Memorial, Monash and Box Hill Hospitals.
“The system was tested on 10 fetuses and the initial results exceeded our expectations. We’re now planning for broader trials as we move toward commercial scaling.”
Following VitalTrace’s successful first clinical trial, their next focus is to complete final optimisation to ensure that every sensor across hundreds of thousands of units will have the same precision and performance.
“The sensors are composed of a number of different layers that need to be of active material and protective material.”
It means the layers must be deposited with such consistency that every device responds identically or at least within a very small tolerance.
“Getting true repeatability from sensor to sensor and batch to batch – that’s the defining hurdle – and that is where the science passes to engineering.”
