There’s been a lot of media hype about a new WA-made invention that claims to reduce emergency caesareans and prevent brain injury during labour.
Developed by Perth medtech company VitalTrace, the device — now named DelivAssure™ — involves placing a small scalp electrode on the baby’s head during labour (after the waters have broken and the head is accessible). It continuously measures lactate levels.
It’s being described as “game-changing” and “world-first.”
But haven’t we been here before?
When CTG (cardiotocography) was introduced in the 1970s, it was celebrated as a revolutionary tool that would reduce brain injury and cerebral palsy by detecting fetal distress earlier. But decades of research have shown it didn’t deliver on that promise — instead, routine use in low-risk births led to more caesareans and instrumental deliveries, without any improvement in neonatal outcomes.
In fact, DelivAssure™ is being promoted as a solution to the very problem CTG failed to fix. It implicitly acknowledges that for all our monitoring technology, we’re still struggling to balance safety with over-intervention.
Most Babies Don’t Need Electrodes on Their Heads
They need time.
They need skilled, continuous support.
And they need a maternity system that trusts birth.
This device should not be used as routine care. It may have a place in high-intervention births, particularly inductions and augmented labours involving synthetic oxytocin (Syntocinon).
And while improving safety during these births is important, we also need to ask:
Why are we inducing and accelerating so many labours in the first place?
Why are we inventing new technologies to manage complications that, in many cases, we’ve created ourselves?
Let’s Talk About Syntocinon — The Real Elephant in the Birth Room
Syntocinon is one of the most commonly used drugs on labour wards. It’s powerful, and when used appropriately, it can be life-saving. But it also comes with serious risks — and it’s classified as a “black box” drug in the U.S., carrying the highest level of warning. (Clark 2009)
It can:
- Causes uterine hyperstimulation, where contractions come too fast or too strong with too little rest in between
- Reduce placental blood flow, compromising oxygen supply to the baby
- Increase the risk of fetal distress, emergency caesarean, uterine rupture, and, in rare cases, neonatal brain injury
Instead of addressing these risks at their source, we’ve created a device to detect the consequences sooner.
That’s not innovation — that’s crisis management.
How About This for Innovation Instead?
✅ Use Syntocinon only when truly needed
✅ Start low, go slow
✅ Monitor closely with clinical presence, not just machines
✅ Or better yet — support spontaneous physiological labour from the start
Do We Need to Reduce Caesareans? Absolutely.
WA’s caesarean section rate is currently 41.8% (April to June, 2025. WA Department of Health — Mothers and Babies Summary) — far higher than the WHO’s recommended maximum of 15%.
Reducing caesareans is a worthy goal. But we don’t need more gadgets to do that.
We need to return to the evidence on how to support physiological birth and reduce preventable interventions.
At present, we have zero evidence that the deliAssure™ will lower caesarean section rates, and the worry is that, like CTG monitoring and other birth tech, it might actually increase them.
Evidence-Based Ways to Lower Caesarean Rates
- Continuity of care with a known midwife
- Avoiding unnecessary induction of labour
- Limiting routine continuous CTG in low-risk labours
- Encouraging upright and active labour and birth positions
- Access to independent or physiological birth education
- Reducing early, non-medically indicated hospital admissions
- Debriefing and auditing caesarean indications
- Continuous support in labour (e.g. doulas)
- Updating the definition of active labour (start at 6 cm, not 4)
- Giving women more time in labour — including second stage
- Recognising physiological plateaus in labour as normal
These aren’t new ideas. We’ve had the evidence for years. What’s missing is the systemic will to act on it.
But back to DelivAssure™
What Is Lactate Monitoring?
Fetal scalp lactate monitoring aims to provide a real-time snapshot of the baby’s metabolic status. Lactate is a byproduct of anaerobic metabolism — when cells aren’t getting enough oxygen. The theory is that rise in lactate may suggest the baby is becoming hypoxic and may need help.
This isn’t a new concept. Scalp blood sampling has been around for years, traditionally using pH analysis. But pH sampling can be fiddly — it requires more blood and is prone to sampling failure. That’s where lactate monitoring is being positioned as a simpler, more reliable alternative.
But Here’s the Problem
- While lactate may better indicate metabolic stress, clinical outcomes haven’t consistently improved when using lactate instead of pH (as seen in the FLAMINGO trial and Cochrane review).
- Lactate levels can also rise in non-hypoxic situations, like caput formation or maternal hyperventilation, which can lead to false positives.
- The optimal cut-off for lactate (e.g. 4.8 mmol/L) is still debated, especially given normal physiological rises during second-stage labour.
2021 research shows that lactate levels naturally rise in labour, especially in second stage. Some healthy babies exceed the 4.8 cut-off without being in distress. So, relying on a single number risks unnecessary interventions. (Rajala et al. 2021)
This study found that
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Lactate levels increased as labour progressed, with the highest levels found during the second stage.
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A significant proportion of healthy babies had lactate values ≥4.8 mmol/L without adverse neonatal outcomes.
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The mean lactate level was higher in the second stage compared to the first (statistically significant).
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The study raises questions about the validity of a single fixed cut-off for intervention.
And as the brilliant Dr Kirstin Small puts it:
“High lactate levels are a sign of fetal compensation in a low oxygen situation. They are not a sign of fetal distress or that harm is happening to the fetus and this is an improtant distinction”
“High lactate levels have some relationship with an increase chance of there being a poor outcome, but the relationship is poor…Most babies that have elevated lactate level are fine and have no consequesnces becauseit allowed them to cope in a low oxygen environment.”
If you want to understand this more and why so many of us are concerned about the media hype around the DelivAssure™, please watch this video: Understanding the VitalTrace Device: a critical conversation
Let’s look at the research into DelivAssure™
When it comes to research on the DelivAssure™ this is the paper I want to see, but it hasn’t been published yet. DelivAssure™: A novel fetal lactate sensor to improve detection of intrapartum fetal hypoxia. Pillow J, Hubble L, Morris J. Wang J, Shapley J, Chaplin T, Fox D, Kaushik A, Challenor M.
There is a study titled “Preclinical development of a continuous fetal lactate biosensor to detect acidosis”, published in May 2025, which assessed the DelivAssure™ device using a fetal sheep model:
They studied 3 pregnant sheep and their lambs to see if the device could accurately track these changes.
The lambs were delivered surgically while still attached to the placenta (so still receiving oxygen), and the sensor was inserted under their scalp — similar to how a fetal scalp electrode would be used in labour. Researchers then temporarily blocked the umbilical cord blood flow for about 10–15 minutes to mimic what might happen during birth when oxygen is reduced.
What Did They Find?
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9 sensors were tested — 6 worked well, and 5 showed a strong match with actual blood test results.
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The device detected lactate levels in the range used to guide decisions in labour (1.6–8.4 mmol/L).
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It also showed some correlation with other markers like oxygen and pH levels.
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A few sensors were slower to respond after oxygen was restored — possibly due to how fluids move under the skin.
Study Limitations:
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This was an animal study — it hasn’t been tested during human labour yet.
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Only 3 sheep were used, so we can’t draw strong conclusions from such a small sample
The bottom line is that this study of 3 ewes only validates technical feasibility (i.e. that the sensor correlates well with blood lactate) of the DelivAssure™. Neonatal outcomes were not measured, and as the lambs were all born surgically, they can’t say the device will lower caesarean births.
The study does not assess clinical outcomes or decision-making efficacy, which limits its ability to demonstrate the practical benefits of continuous lactate monitoring in improving neonatal or obstetric results.
Conflicts of interest
Several authors are directly affiliated with VitalTrace Pty Ltd, the company that developed the DelivAssure™ biosensor being tested:
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Arjun Kaushik and Michael Challenor are founders and shareholders.
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Maureen T. Ross Chaitya Shah , Ranjusha Rajagopalan, Hassan Mahmood , Jonathan M. Morris, and Lee J. Hubble are employees of the company.
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In addition, Maureen T. Ross, Chaitya Shah, Ranjusha Rajagopalan, Hassan Mahmood, Jonathan M. Morris, Lee J. Hubble, and J. Jane Pillow hold share options in the company.
These relationships represent financial stakes in the product’s success.
J. Pillow, L. Hubble, J. Morris, J, A.Kaushik, and M. Challenor are all authors of the DelivAssure: A novel fetal lactate sensor to improve detection of intrapartum fetal hypoxia too.
This doesn’t invalidate the results, but transparency matters
What has other research found?
The 2015 Cochrane Review by East et al. found that fetal scalp lactate monitoring was easier to perform than pH analysis — but it did not significantly improve birth outcomes.
The FLAMINGO trial, which aimed to assess whether adding lactate monitoring to CTG reduced interventions or improved outcomes, has still not published final results — despite starting in 2015. Preliminary data from 2021 (East et al.) stated, “We were unable to provide robust evidence of the effectiveness of FBSLM to improve the specificity of the CTG in the assessment of fetal wellbeing”.
The FLAMINGO Trial (East et al., 2021):
A Melbourne-based trial testing whether lactate monitoring reduces caesareans. It was underpowered due to low recruitment, but still showed:
- No difference in caesarean rates
- No improvement in newborn outcomes
- No data collected on cost-effectiveness or maternal satisfaction
Better Correlation ≠ Better Outcomes
While lactate shows better correlation with metabolic acidosis at birth than pH, detecting acidosis more accurately hasn’t been shown to:
- Change clinical decisions in labour
- Reduce interventions
- Improve long-term infant health
Most research measures short-term outcomes, like Apgar scores or umbilical artery pH — not cerebral palsy, developmental delay, or maternal satisfaction.
Misleading Marketing
I keep seeing promotional materials saying the DelivAssure™ is bettter than current “invasive” fetal blood sampling (FBS) techniques, implying that the DelivAssure™ device is not invasive. But this is misleading. While it may avoid repeated blood draws, it still requires vaginal insertion during labour and attachment directly to the baby’s scalp — a process that can only be done after the membranes have ruptured. which I would argue is all pretty invasive. Plus, it involves penetrating the baby’s skin, which classifies it as an invasive procedure by clinical and ethical standards. Downplaying the intervention and risks undermines fully informed consent. If we’re introducing new technology into such a sensitive and critical space as labour care, honesty about what it involves is not just important — it’s essential.
This Device Must Not Become “Standard Care” for All Births
from the VitalTrace website:
Obstetricians believe DelivAssure™ will be used in 70% of patients
This is the scary bit!
This technology may have a place in certain high-risk situations if the research establishes that it does more good than harm. But we need to be vigilant that it doesn’t quietly become standard for all labours. Time and time again, we’ve seen technologies or interventions designed for specific clinical scenarios creep into routine use, often without strong supporting evidence.
For example:
- Continuous CTG was originally intended for high-risk pregnancies but is now widely used in low-risk labours, despite evidence showing it increases caesarean rates without improving neonatal outcomes.
- Active third stage management was once used selectively but has become almost universal in hospital births.
- Syntocinon for “slow” labours is now routine, despite risks.
- Induction of labour was historically used for clear medical reasons, but is now frequently offered before 41 weeks in low-risk pregnancies.
- Epidurals, while valuable in many births, are often the default despite being associated with longer labours, more interventions and breastfeeding difficulties.
Without clear boundaries and scrutiny, well-meaning innovations can shift birth further away from physiology and increase intervention rates across the board.
Just because we can use a device doesn’t mean we should — especially when the default becomes intervention instead of support.
Applying this device requires rupturing the amniotic sac. But breaking the waters is not a benign act.
As Dr. Rachel Reed explains:
“The amniotic sac is not just a passive bag of fluid — it’s an active part of the birth process.”
Artificial rupture of membranes (ARM) to apply a device can:
- Increase the risk of infection
- Disrupt the hormonal flow of labour
- Remove natural protection and fetal mobility
- Create pressure to “hurry things along”, often leading to Syntocinon and caesarean
This device should not be used routinely in physiological labours — where patience, presence, and trust are what truly support safety.
Innovation Has Its Place — But So Does Physiology
Of course, we want to prevent harm. Of course, we want to detect fetal distress early and act when needed.
But real innovation in maternity care isn’t just about better gadgets.
It’s about respecting physiology.
It’s about supporting women, not managing them.
It’s about reducing the need for rescue in the first place.
This new WA device may be helpful in certain births. But it doesn’t solve the deeper problem:
Too many women are being subjected to unnecessary interventions that increase risk — and then offered more interventions to fix the fallout.
Until we shift our system to prioritise continuity, compassion, informed consent, and physiological birth, we’ll just keep inventing ways to manage the damage — instead of preventing it.
References
Alfirevic, Z., Devane, D., & Gyte, G. M. L. (2017). Continuous cardiotocography (CTG) as a form of electronic fetal monitoring (EFM) for fetal assessment during labour. Cochrane Database of Systematic Reviews, (2), CD006066. https://doi.org/10.1002/14651858.CD006066.pub3
American College of Obstetricians and Gynecologists (ACOG), & Society for Maternal-Fetal Medicine. (2014). Safe prevention of the primary cesarean delivery. Obstetric Care Consensus No. 1. Obstetrics & Gynecology, 123(3), 693–711. https://doi.org/10.1097/01.AOG.0000444441.04111.1d
Bohren, M. A., Hofmeyr, G. J., Sakala, C., Fukuzawa, R. K., & Cuthbert, A. (2017). Continuous support for women during childbirth. Cochrane Database of Systematic Reviews, (7), CD003766. https://doi.org/10.1002/14651858.CD003766.pub6
Cochrane Pregnancy and Childbirth Group. (2018). Discontinuation of oxytocin once the active phase of labour is established. Cochrane Database of Systematic Reviews, (8), CD012274. https://doi.org/10.1002/14651858.CD012274.pub2
Clark SL, Simpson KR, Knox GE, Garite TJ. (2009) Oxytocin: new perspectives on an old drug. Am J Obstet Gynecol. Jan;200(1):35.e1-6. doi: 10.1016/j.ajog.2008.06.010. Epub 2008 Jul 29. PMID: 18667171.
East, C. E., Leader, L. R., Sheehan, P., Henshall, N. E., & Colditz, P. B. (2015). Fetal scalp lactate sampling for fetal assessment in the presence of a non‐reassuring fetal heart rate trace. Cochrane Database of Systematic Reviews, (5), CD006174.
East, C. E., Miller, J., Colditz, P., & FLAMINGO Trial Group. (2021). The FLAMINGO trial: A randomised controlled trial of intrapartum fetal scalp lactate analysis plus cardiotocography versus cardiotocography alone. Australian and New Zealand Journal of Obstetrics and Gynaecology, 61(S1), 34.
Lawrence, A., Lewis, L., Hofmeyr, G. J., Dowswell, T., & Styles, C. (2013). Maternal positions and mobility during first stage labour. Cochrane Database of Systematic Reviews, (10), CD003934. https://doi.org/10.1002/14651858.CD003934.pub4
Rajala K, Mönkkönen A, Saarelainen H, Keski-Nisula L. (2021) Fetal lactate levels align with the stage of labour. Eur J Obstet Gynecol Reprod Biol. 2021 Jun;261:139-143. doi: 10.1016/j.ejogrb.2021.04.032. Epub Apr 24. PMID: 33934025.
Reed, R. (2018). The amniotic sac and labour. Midwife Thinking Blog. https://www.rachelreed.website/blog/amnioticsaclabour
Ross M. T., C. Shah, H. Powell, H. Kershaw, R. Rajagopalan, H. Mahmood, A. Gurney, et al. 2025. “Preclinical Development of a Continuous Fetal Lactate Biosensor to Detect Acidosis.” Pregnancy 1(3): e70017.
Sandall, J., Soltani, H., Gates, S., Shennan, A., & Devane, D. (2016). Midwife‐led continuity models versus other models of care for childbearing women. Cochrane Database of Systematic Reviews, (4), CD004667. https://doi.org/10.1002/14651858.CD004667.pub5
Uvnäs-Moberg, K., Ekström-Bergström, A., Buckley, S., Pajalic, Z., Hadjigeorgiou, E., Kotlowska, A., Lengler, L., & Nieuwenhuijze, M. (2019). Birth hormone physiology: Maternal and newborn adaptations during labour and birth – a review. Acta Paediatrica, 108(11), 2060–2070. https://doi.org/10.1111/apa.14963
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Western Australia Department of Health. (2025). Western Australia’s Mothers and Babies Summary – April to June 2025. https://www.health.wa.gov.au/Reports-and-publications/Western-Australias-Mothers-and-Babies-summary-information
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