Pregnancy
A labour of love: making pregnancy and childbirth safer with 80% more accurate foetal oxygen monitoring
By Annie Theriault, managing partner at Cross-Border Impact Ventures (CBIV)

For expecting mothers, the process of bringing life into the world has remained the same since the beginnings of mankind, but what has changed is the outcome.
Thanks to modern medicine, over the last century maternal deaths associated with childbirth have decreased by nearly 99 per cent in developed countries. And better outcomes for mothers lead to better outcomes for newborns, as well as the entire family.
Advancements in medical technology, coupled with access to high-quality prenatal care, have been game changers for maternal and newborn health. Ultrasounds, electronic foetal monitoring, and pulse oximetry have become table stakes in the delivery room, helping to detect and manage high-risk pregnancies and reducing complications in the delivery room.
Despite this progress, women in the US are still three times more likely to die from pregnancy-related complications than women in other developed countries, a statistic that is significantly worse for women of colour [1]. These are sobering facts for the world’s highest-income nation, as the World Health Organization considers prenatal care and infant mortality rates to be important measures of healthcare quality.
One factor contributing to this troubling statistic is the alarming exponential increase in unnecessary procedures such as the Caesarean section (C-section) to deliver babies.
When utilised appropriately, C-sections have saved millions of lives for mothers and babies, but also carry significant risks associated with major abdominal surgery that result in short- and long-term consequences for both mother and baby.
The increasing C-section rates are tied to increasing maternal morbidity and mortality, and is an issue that has recently received attention from Dr Jill Biden and the White House [2]. It is reported that over half of all C-sections are medically unnecessary – yet they have become so prevalent that one in three American women will deliver their baby through this surgical procedure [3].
Detecting foetal distress: heads or tails?
One company aiming to remedy this is Raydiant Oximetry out of San Ramon, California and Cork, Ireland. Founded in 2016 by Dr Neil Ray, a paediatric anaesthesiologist, Raydiant Oximetry is using the principles of pulse oximetry to more accurately detect foetal distress during labour and delivery to reduce the overuse of emergency C-sections and improve outcomes for both mother and baby.
Pulse oximetry technology is used to diagnose low oxygen levels in virtually every clinical setting, but no such technology has existed for foetuses in the labor ward. Raydiant Oximetry is on the path to commercialising Lumerah™, a low-cost and non-invasive photonics sensor that monitors foetal oxygenation during labour.
Every year in the US, approximately 3.4 million women (85 per cent of all births) are placed on foetal heart rate monitors during pregnancy [4]. However, current foetal monitoring technology has the accuracy of a coin toss in accurately predicting foetal distress [5].
The false positive rate for foetal heart rate monitors has been reported to be as high as 89 per cent and as a result, clinicians struggle to determine when an emergency intervention is truly indicated [6]. Emergency C-sections are consequently performed for medical-legal liability fears which drive up hospitalisation costs and leave mothers with increasing rates of postpartum depression and PTSD [7].
Lumerah promises to change all of this by detecting foetal distress more accurately with a non-invasive, transabdominal approach that directly measures foetal arterial blood oxygen levels. This will give clinicians more accurate data and insights, enabling them to make better-informed labor and delivery decisions.
In a recent clinical study completed at University of Texas Medical Branch (UTMB) in Galveston, Texas, Lumerah demonstrated a false positive rate of 19 per cent for detecting foetal distress [8].
The path to commercialisation
Although not yet commercially available, Lumerah is getting the attention it deserves because of its life-improving potential. The US Food and Drug Administration (FDA) has granted Lumerah the status of Breakthrough Device to expedite its market approval.
Most recently, Raydiant Oximetry was named by the National Institutes of Health (NIH) as one of six finalists in the RADx Tech Challenge, a competition to identify companies that are enhancing foetal health diagnostics. The company received US$75,000 to fund ongoing technology development, and is now in the running for a larger prize that will be announced in October.
Furthermore, Raydiant Oximetry recently received IDE approval from the FDA in April to initiate a clinical study of Lumerah at Eastern Virginia Medical School (EVMS) in Norfolk, Virginia. The study began in May and is expected to be completed by the end of 2024 [9].
Raydiant Oximetry’s innovation in the obstetrical space is just getting started with Lumerah. The company has developed the Daisy TM device as well. Daisy was developed to prevent postpartum haemorrhage (PPH) for a woman undergoing a C-section delivery, which complements other PPH devices on the market that treat PPH in women that had a vaginal delivery.
PPH is the leading cause of maternal mortality around the globe and takes the life of an expecting mother every four minutes [10]. A clinical study of Daisy was also initiated at EVMS this past May and expected to be completed by the end of 2024 [11].
Importantly, not only is the company aiming to transform maternal care in the US, but it is already working with global health funders and experts to ensure that these technologies also become accessible in low- and middle-income countries where, according to the WHO, nearly 95 per cent of all maternal deaths occurred in 2020 [12].
Keeping mothers and babies safe during labour and delivery
Raydiant Oximetry is creating a new benchmark in obstetrics care that will benefit countless mothers and babies around the world. The history of childbirth shows us how far we have come, but also how far we still need to go – especially in addressing inequalities.
Continued investment in transformative healthcare companies with a global lens can propel further progress in maternal and newborn health. Access to better health technology that transcends borders will benefit women, children, and the world at large.
Annie Theriault is a managing partner at Cross-Border Impact Ventures (CBIV), an impact venture capital firm investing in women’s, children’s and adolescents’ health technology companies addressing large international markets. Raydiant Oximetry is a CBIV portfolio company.
REFERENCES:
1 https://www.cdc.gov/nchs/data/hestat/maternal-mortality/2021/maternal-mortality-rates-2021.pdf
3 PMID 24565430
4 PMID 19546798
5 PMID 23009972
6PMID 14749646
7 PMID 35457767
8 https://clinicaltrials.gov/study/NCT05147584
9 https://clinicaltrials.gov/study/NCT06405984
10 PMID 17012482
11 https://clinicaltrials.gov/study/NCT06219538
12 Maternal mortality (who.int)

Pregnancy
Women with multiple health conditions face higher pregnancy risks, study shows

Women entering pregnancy with multiple long-term health conditions face higher risks of miscarriage and other complications, a UK study found.
Those with two or more pre-existing physical or mental health conditions had a 20 per cent higher risk of miscarriage than women with no long-term conditions.
They also had more than twice the risk of venous thromboembolism and around four times the risk of antenatal anxiety and depression.
The UK-wide research team analysed 2,225,701 pregnancies and birth events recorded between 2000 and 2022 across five datasets covering England, Scotland, Wales and Northern Ireland.
Women with multiple long-term conditions had a 69 per cent higher risk of nausea and vomiting during pregnancy and a 42 per cent higher risk of pre-eclampsia.
The women also had a 32 per cent higher risk of placental abruption and a 26 per cent higher risk of gestational diabetes.
Risks rose as the number of existing conditions increased.
Among women with three or more long-term conditions, the risk of venous thromboembolism was more than three-and-a-half times that of women with no long-term conditions.
Researchers said the findings had implications for maternity services, where care pathways are largely centred on individual conditions and may not adequately meet the needs of women with multiple long-term conditions.
Dr Kelly-Ann Eastwood, joint senior author and honorary lecturer at Queen’s University Belfast and consultant obstetrician at St Michael’s Hospital, Bristol NHS Foundation Trust, said the results “help define” the urgent clinical challenges facing women entering pregnancy with multiple long-term conditions and the clinicians caring for them across the UK.
“These findings highlight the pressing need to restructure existing maternity services to improve antenatal outcomes,” she added.
The authors cautioned that the study was observational and relied on routinely collected health records, meaning some conditions and outcomes may have been under-recorded, while residual confounding could not be excluded.
The researchers plan to examine birth and child outcomes and identify which combinations of long-term conditions carry the greatest risk.
Pregnancy
Ultrasound Direct extends Trice Imaging partnership

Ultrasound Direct has extended its Trice Imaging partnership for three years, adding a reporting tool across its 70-clinic UK network.
The private ultrasound provider will continue using the Tricefy platform for secure image storage and patient engagement, alongside TriceIQ for efficiency and productivity analytics.
It will also introduce Trice Workspace Reporting across its network. The companies say the tool will help standardise ultrasound reporting templates and workflows and reduce variation between clinics.
Ultrasound Direct carries out an estimated 120,000 patient scans each year across services including pregnancy, fertility, women’s health, men’s health and other diagnostic pathways.
Its network uses a large pool of sonographers working across different ultrasound systems and serves referral routes including self-referring patients, GPs and commercial partners.
Mike Steward, founding director at Ultrasound Direct, said: “Having worked with Trice Imaging since 2018, we first partnered to replace manual methods of providing scan images to expectant parents with Trice’s secure electronic image-sharing platform. Today, every study performed across the Ultrasound Direct Network is recorded and stored on Tricefy, while our clinical services have expanded considerably beyond pregnancy into fertility, women’s health, men’s health and other diagnostic pathways.”
He added: “To continue futureproofing our image management strategy across a network of 70 clinics, a large team of sonographers, varying ultrasound systems and a growing number of referral partners with different needs, we decided to extend with Trice Imaging. This includes the introduction of the new Trice Workspace Reporting module to help us scale and standardise our ultrasound reporting templates and workflow, reducing variability between clinics.”
The partnership began in 2018, initially focusing on replacing manual methods of sharing pregnancy scan images with expectant parents.
Johanna Wollert Melin, founder and chief executive of Trice Imaging Europe, said: “Ultrasound Direct has been a valued partner in the UK for 8 years.”
She added: “At the heart of the relationship is a willingness to explore new ideas, test new tools and the spirit to solve real challenges across a large and complex clinical network.”
Mark A. Samii, chief revenue officer at Trice Imaging, said: “We are delighted to retain and extend our relationship with Ultrasound Direct.”
He added: “The addition of Trice Workspace Reporting addresses a challenge we hear from multi-site providers globally – keeping reporting quality consistent across many users, systems, referral or payer relationships.”
Steward said Ultrasound Direct continues to see growing demand for private diagnostics alongside NHS care from self-referring patients and an increasingly diverse range of professional and commercial referral partners.
He added: “As that development continues, scalable digital infrastructure becomes increasingly important. Our focus is on ensuring that a growing national network can support consistent clinical workflows, different referral pathways and the technology requirements of the future, while continuing to provide patients with accessible diagnostic services.”
Fertility
Paracetamol use may impact future fertility, studies suggest

Paracetamol use in pregnancy was not linked to autism or ADHD, while separate research found reproductive differences in girls exposed before birth.
One study analysed health records from more than 120,000 children and found no increased risk of autism following prenatal paracetamol exposure.
A separate analysis of nearly 100,000 children also found no increased risk of ADHD among those born to mothers who used the painkiller during pregnancy.
Researchers from the Hong Kong Hospital Authority examined electronic health records covering pregnancies between January 2001 and December 2023.
The autism analysis included 124,333 children, who were nine years old on average and split almost evenly between males and females. There were 3,445 autism diagnoses, representing 2.8 per cent of the group.
The ADHD analysis involved 97,285 children, who were seven years old on average and also split evenly between males and females. There were 5,168 ADHD diagnoses, representing 5.3 per cent.
Women prescribed paracetamol during pregnancy were more likely to be older and have pre-existing conditions including psychiatric disorders, as well as reasons for taking the drug such as infection, fever or chronic pain.
No association was found between prenatal paracetamol exposure and either autism or ADHD.
The findings did not differ according to the trimester in which paracetamol was taken or whether use was intermittent or daily. Advanced maternal age, defined as pregnancy in women over 35, did not alter the findings.
The researchers wrote: “Paracetamol remains a safe and essential analgesic [pain reliever] and antipyretic [fever reducer] during pregnancy, whereas alternatives, such as NSAIDs and opioids carry well-documented risks.
“Unwarranted reluctance to use paracetamol could lead to undertreatment of pain and fever, or the use of more harmful alternatives, both posing risks to the pregnancy and developing fetus.”
The authors said women should assess paracetamol use with guidance from their doctor.
A separate study involving 685 pregnant women without pre-existing conditions and 302 infant daughters found associations between prenatal paracetamol exposure and differences in reproductive organs and hormone levels.
Researchers from Copenhagen University Hospital enrolled the women during their first trimester and assessed them during the first trimester, third trimester and again when their babies were three months old.
At around three months, infants experience a temporary rise in reproductive hormones sometimes called mini-puberty.
Pregnant participants completed questionnaires every two weeks about their use of pain medicines including paracetamol. Infant girls underwent ultrasound scans of their reproductive organs and blood tests to measure hormone levels.
Researchers also examined a separate group of 1,210 girls followed from infancy to adolescence whose mothers reported paracetamol use during the third trimester.
Three-month-old girls exposed to paracetamol before birth had an average 40 per cent smaller ovarian volume, 13 per cent smaller uterine volume and 23 per cent fewer ovarian follicles.
Girls exposed during the first trimester also had lower levels of Anti-Müllerian hormone, a marker of ovarian function.
Among the older girls, those exposed before birth were more likely to have smaller uteruses at puberty and smaller ovaries during their teenage years.
Dr Margit Bistrup Fischer, lead study author and postdoctoral researcher in the Department of Growth and Reproduction at Rigshospitalet hospital in Denmark, said: “Animal studies have demonstrated that impaired formation of ovarian follicles can lead to reduced fertility and earlier reproductive aging.
“Whether the differences observed in our study have implications for fertility and age at menopause in humans remains unknown and will require long-term follow-up of the girls in our cohort.”
She cautioned that women who had used paracetamol during pregnancy “should not be alarmed by our findings”, as the study found associations rather than direct causation and outcomes for individual women and children are unclear.
“Importantly, our study does not evaluate whether [acetaminophen] causes reproductive problems, nor does it provide evidence that prenatal exposure affects future fertility or age at menopause,” she said.
“Although we observed similar associations in an independent cohort, long-term follow-up is needed to determine whether these early-life differences have any clinical significance later in life.”
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