Childbirth monitoring technology has barely changed since the 1960s

VitalTrace was founded to improve the safety for mothers and babies during childbirth - babies being some of our youngest and most vulnerable patients. We are passionate about eliminating the unnecessary health, psychological and economic burdens from inaccurate childbirth monitoring.

This project will progress development and clinical testing of a continuous lactate sensor, with the potential to revolutionise fetal monitoring during labour globally.

Current fetal monitoring technology is inaccurate, subjective and creates difficulties for clinicians leading to complications for mothers and babies. VitalTrace is developing DelivAssureTM, a breakthrough technology designed to continuously monitor clinically validated biomarkers to reduce fetal morbidities and wirelessly transmit readings to an associated display monitor.

The funding awarded through the Clinical Translation and Commercialisation Medtech grant, will help design and run VitalTrace's first clinical trial, testing DelivAssureTM, a novel continuous lactate biosensor, which has already received Breakthrough Device designation from the US FDA.

A wonderful feature from one of VitalTrace's clinical and commercial advisors, Vinayak Smith, on the role of innovative technologies to reduce the risk of litigation in obstetrics!

“Cardiotocography (CTG) has been used for foetal heartrate (FHR) surveillance since the 1970s, as a means of detecting foetal hypoxia and guiding clinical decisions around delivery timing.

Despite the length of its usage, there is yet to be convincing evidence that CTG reduces birth asphyxia, stillbirths, caesareans or instrumental deliveries.

Although the technology is good at providing reassurance when foetal heartrates are ‘normal’, it is less useful at working out the prognosis of ‘abnormal’ heartrates, explains Dr. Vinayak Smith, of Monash University and the Royal Australian and New Zealand College of Obstetricians and Gynaecologists.

“It is not easy for two clinicians to agree or interpret the same CTG output the same way,” said Dr. Smith ahead of the Obstetric Malpractice Conference.

“Heartrates which look normal are easy to trust, whereas abnormal ones could mean anything. The CTG doesn’t tell us how worried we should be when a heartrate doesn’t look quite right.

“As a result, FHR red flags can be wrongfully dismissed by the clinician, leading to ‘preventable’ delivery complications or, in extreme cases, foetal deaths.

“Conversely, false alarms can lead to unnecessary clinical intervention and greater numbers of (precautionary) C-sections – a procedure which is risky for both mother and baby.”

Aside from the risk of healthcare complications, CTG reliability issues expose clinicians to legal culpability.

With 20 percent of obstetrics claims involving CTG – and obstetrics accounting for a significant proportion of medico legal disputes – it is widely agreed that better foetal monitoring solutions are needed.”

See the full article here.

VitalTrace and our associated partners are honoured to announce that our BioMedTech Horizons bid has been successfully awarded a $797,276 grant from the MTPConnect and Dr Daniel Grant. This funding will accelerate VitalTrace's capacity to create prototype devices, fast-tracking our steps to commercialisation ready for advanced manufacturing and clinical trials activity.

MTPConnect Managing Director and CEO, Dr Daniel Grant, says this round focused predominantly on the development of pre-commercial prototypes that are entering human clinical trials.

“From the five selected projects, patients of the future are set to benefit from new medical devices for blindness and vision impairment, improved neonatal resuscitation, precision monitoring of fetal complications during birth, real-time atrial fibrillation/cardiac monitoring for patients at home and patient matched spinal implants,” Dr Grant said.

Read the announcement here.

We are excited by the opportunity this funding presents to improve the future of childbirth monitoring!