Childbirth monitoring technology has barely changed since the 1960s

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 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.

From Prof. Jonathan Morris, VitalTrace - Chief Medical Officer

I had the wonderful opportunity to present VitalTrace’s pre-clinical data in the highly regarded Society for Maternal-Fetal Medicine 2025 Pregnancy Meeting in Denver, Colorado. This is the premier pregnancy meeting in USA. Our abstract was one of the 104 selected for presentation out of more than 2,000 submitted speaking to the significance and magnitude of the accomplishments we have achieved.

SMFM was a great opportunity to connect with obstetricians allowing VitalTrace to build invaluable relationships with leading practitioners and forming alliances to prepare the company for future activity in the United States and beyond. There was very strong interest in DelivAssure from leaders in Boston, Washington, Texas, East Virginia, New York and Philadelphia amongst others.

Some particularly notable feedback:

From Dr Emily Reiff (Brigham and Women’s Hospital, Harvard Medical School),

“I was fascinated by your study of real-time fetal lactate monitoring and think that innovation like this is what is needed for effective intrapartum management.”
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From Dr Justin Lappen (Cleveland Clinic),

“The whole team thought that DelivAssure would assist with Class II CTG dilemmas.”

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It was reinvigorating to see such strong support for continuous lactate monitoring and reinforces our confidence to launch DelivAssure in the United States.