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)
A recent study developed a new “digital companion” to support the prevention and follow-up of maternal cardiovascular risk in women with pregnancy complications.
Cardiovascular disease, or CVD, is the leading cause of premature death and illness in women, yet sex-specific causes remain understudied and women are underrepresented in research.
Pregnancy complications, including hypertensive disorders of pregnancy, or HDP, and gestational diabetes mellitus, or GDM, are strong predictors of future CVD, with pregnancy itself acting as a natural stress test.
Despite CVD accounting for 35 per cent of female deaths worldwide in 2019, systematic postpartum prevention remains limited in practice and incidence continues to rise.
Myocardial infarction, commonly known as heart attack, and stroke are the main fatal CVD events in women. Up to one-third of women develop hypertension within a decade after HDP, especially as maternal age rises.
Obstetric guidelines have historically lacked clarity on early CVD prevention after HDP and GDM, often relying on expert consensus rather than evidence.
Some cardiology guidelines now recommend personalised approaches, such as periodic hypertension and diabetes screening. Norwegian guidelines recommend cardiovascular risk evaluation at three months and one year postpartum, but adherence in practice is uncertain.
Effective risk reduction requires intervention before middle age. The immediate postpartum period following HDP or GDM is a critical window for early detection and intervention, offering an opportunity to engage women in cardiovascular health management, particularly as pregnancy can encourage long-term lifestyle awareness.
Electronic health, or eHealth, refers to the use of digital technologies and electronic communication tools to support healthcare services, medical information management and related health activities.
Systematic, eHealth-supported postpartum prevention can improve maternal health literacy and long-term cardiovascular outcomes.
However, there is a significant gap in targeted, eHealth-based postpartum interventions for cardiovascular risk management after HDP and GDM, despite strong patient demand and international calls for coordinated digital health strategies.
Home blood pressure monitoring shows promise, but broader digital support remains limited.
A cardiovascular postpartum follow-up programme was created as a mobile app based on Norwegian and international guidelines.
The MumCare app was developed through co-creation involving users, stakeholders and clinical experts. Five qualitative interviews and 10 user testing sessions informed improvements.
This study primarily analysed the iterative co-creation process used to develop the app, rather than evaluating clinical outcomes.
The MumCare project team in Oslo included an IT expert, obstetricians, a midwife, a GP, two sociologists and two cardiologists, all with relevant experience in eHealth and women’s health. A medical student with technological and medical expertise also helped turn ideas into app features for young women.
User representatives from two national patient associations contributed to information, recruitment, design and testing of the MumCare app.
Both associations provided user perspectives and took part in interviews and app testing. Additional users with HDP or GDM at Oslo University Hospital were also involved throughout the co-creation process.
The app’s digital infrastructure prioritises security and privacy, using encryption, de-identification and two-factor authentication.
User data is stored securely on the app and, for research purposes and with consent, on a dedicated University of Oslo server in line with GDPR and Norwegian regulations.
A linear Stage-Gate model structured the co-creation process, dividing it into phases with quality checkpoints reviewed in project meetings.
This approach balanced internal development with external user feedback, helping ensure the app is evidence-based, technically robust and user-centred.
The MumCare app guides postpartum women through tracking blood pressure, weight, physical activity and lab results, and provides personalised feedback to support self-management, mainly during the first postpartum year.
It also includes educational resources such as videos and guideline-based information to support understanding and engagement.
The app is also designed to support the transition from specialist pregnancy care to long-term follow-up with general practitioners.
It is described as a “digital companion” or health coach and does not replace clinical diagnosis or function as a medical device.
The co-creation process followed four phases focused on technical and procedural development.
In phase 1, input from expert organisations and user representatives established the app’s technical foundation.
It also reminds users of the one-year postpartum follow-up with their GP, a key time to assess risk factors and future care needs.
User organisation representatives gave feedback in phase 1, directly guiding content and feature development.
Phase 2 interviews confirmed that users want to monitor cardiovascular risk factors after HDP and GDM.
The analysis highlighted three themes: self-care strategies and uncertainties about hypertension, the need for accessible health information, and a more personalised approach to blood pressure monitoring in the app.
Concerns were also raised that frequent monitoring or app use could increase stress or create a sense of burden.
In phase 3, the app’s design and features were revised in response to feedback to improve usability and make sure they met users’ needs.
These changes led to a more intuitive and supportive interface for women during and after pregnancy.
Phase 4 involved building a prototype based on the updated designs, followed by further refinements after testing by the project team and users. Initial pilot testing with a small number of users suggested the app met its objectives and functioned as intended.
The MumCare app was co-created with input from experts, user organisations and patients over four phases.
Early expert and organisational contributions helped define the app’s goals, while ongoing feedback from patients helped ensure the design and content reflected users’ real needs.
This collaborative approach resulted in an app tailored to support women with pregnancy complications.
The MumCare app is currently being evaluated in a randomised controlled clinical trial that began in June 2024, with results needed to determine whether it improves long-term cardiovascular outcomes.
The first patients have been dosed in a UK miscarriage trial testing a new intravaginal drug delivery platform for threatened miscarriage.
The FREEDOM study is evaluating 400mg progesterone Callavid in patients diagnosed with luteal phase insufficiency, a condition in which progesterone levels may be too low to support early pregnancy, increasing the risk of infertility and recurrent miscarriage.
Callavid uses a patented leak-free, tampon-like design intended to address the limitations of current vaginal treatments, which rely on self-administered pessaries, or vaginal suppositories, that can leak and may move during use.
The device is being developed by London-based Calla Lily Clinical Care, a medical technology company focused on women’s health. The trial is funded by the National Institute for Health and Care Research and run in collaboration with the Trial Management Unit at University Hospitals Coventry and Warwickshire NHS Trust.
According to the company, Callavid is positioned to become the world’s first drug-device combination product to support treatment of threatened miscarriage, as well as luteal phase support as part of assisted reproductive technologies, including in vitro fertilisation, or IVF.
The Government’s Renewed Women’s Health Strategy for England cites estimates ranging from 120,000 to 250,000 cases of miscarriage a year in the UK. Administering 400mg micronised progesterone twice daily is recommended by the National Institute for Health and Care Excellence for women who have suffered a previous miscarriage and experience bleeding during early pregnancy, known clinically as threatened miscarriage.
Current pessary delivery methods can result in uncertain placement and movement during use. These limitations can reduce the efficiency and consistency of drug absorption, potentially compromising delivery of the intended dose, and patients are regularly advised to lie horizontal for extended periods after each administration.
The FREEDOM trial is led by professor Siobhan Quenby MBE, an authority on miscarriage and preterm birth, and an honorary consultant at University Hospitals Coventry and Warwickshire NHS Trust. The study aims to evaluate safety, user acceptability and progesterone absorption, with the goal of providing evidence of improved usability in self-administration.
Quenby commented: “Through my clinical practice, I see the difficulties patients face with existing vaginal progesterone products at an already very stressful time. Callavid offers a promising new solution to ensure delivery of the correct progesterone dosage and give women greater confidence in their treatment. There is genuine excitement among both clinicians and patients at the prospect of Callavid progressing into clinical trials.”
Dr Lara Zibners, co-founder and chair of Calla Lily Clinical Care, added: “As a physician and entrepreneur, I believe we have a responsibility to create more effective, patient-centred solutions in women’s health. Having been through seven rounds of IVF myself, I have experienced how difficult progesterone treatment can be, and I am proud to be advancing an innovation shaped by both medical insight and lived experience.”
Thang Vo-Ta, co-founder and chief executive of Calla Lily Clinical Care, said: “Dosing the first patients in the FREEDOM study marks a critical milestone for Calla Lily Clinical Care. Callavid represents a differentiated delivery modality for a broad range of therapeutics in the pharma pipeline, and will create new opportunities to extend the lifecycle of existing drugs. This trial is a key step in demonstrating Callavid’s massive potential.”
A rare pregnancy complication has led to emergency surgery, including hysterectomies, after staff failed to detect it in affected women.
Scores of women have come forward to tell their stories of how they were affected by placenta accreta spectrum, or PAS, since the launch in February of a campaign to raise awareness among NHS staff and mothers-to-be of the dangers it poses.
One of them lost so much blood while giving birth that she has had to give up working as an NHS operating theatre nurse and suffers from PTSD.
Another lost six litres of blood and blames her daughter’s cerebral palsy on the stroke the child had while hospital staff were battling to save her life after an emergency caesarean section. Others have suffered permanent damage to their bladder or bowels.
Erin Cooper was never assessed for PAS even though she regularly bled heavily from 26 weeks into her pregnancy until she delivered her baby by emergency C-section at 33 weeks in 2024.
She said: “What I didn’t know, what no one had diagnosed, was that my placenta was abnormally and dangerously attached.
“The haemorrhage was catastrophic. I lost 4.5 litres of blood. I needed a massive blood transfusion, 13 units in total, and to save my life they had to perform a hysterectomy.
“It was like a murder scene. I now have PTSD around blood. I was a theatre nurse. I’ve had to change jobs and can no longer work in a patient-facing role.
“I get panicky when I hear sirens. I can’t drive past the hospital without feeling like I’m about to have a panic attack.
“I feel a deep loss of my womanhood. I’m now going into early menopause. Not a day goes by when I don’t think about being infertile at 33.”
PAS is associated with a history of C-section birth, while assisted fertility using in vitro fertilisation also increases the risk.
It occurs when the placenta, which gives the foetus nutrients and oxygen, grows too deeply into the wall of the woman’s uterus and blocks some or all of the cervix.
This makes the usual separation of the placenta from the uterus during birth difficult.
One hundred women who are concerned about how medical teams dealt with their PAS have contacted Amisha and Nik Adhia, who set up the Action for Accreta campaign.
The couple have collated the women’s experiences into a dossier of stories that vividly illustrate how often the condition goes undetected and the appalling physical consequences for those involved.
Seventy-five of the 100 cases are from around the UK and the others from abroad. In other cases, mothers suffered permanent damage to their bladder or bowels.
Six out of 10 of the 100 women say their PAS went undiagnosed, increasing the risk of them bleeding to death.
The 100 cases reveal “a dangerous gap in maternity care” and “systemic failures” that should prompt UK hospitals to do much more to train staff how to spot and treat PAS once it is diagnosed, say campaigners.
Politicians from all the main parties at Westminster are supporting their call for a major overhaul in how the NHS manages the condition.
Chloe Robinson from Burnley was taken to hospital in the middle of the night when she began bleeding heavily at home at 34 weeks pregnant in July 2024.
She said: “In theatre they discovered I had placenta accreta, something no one had suspected.
“They had to get several members of staff who were on call into the hospital because they weren’t prepared. I lost six litres of blood and had a hysterectomy to save my life.
“My daughter had a stroke, which I believe was due to the traumatic birth [and] she now has cerebral palsy.
“If they had found the condition before, none of this may have happened.”
A woman is at higher risk of PAS if she has had a previous birth by caesarean section because the placenta of her new pregnancy can attach itself to the scar of her C-section.
It is unclear exactly why IVF seems to also heighten the risk of the condition.
Doctors believe that the process of transferring and implanting an embryo into the woman during treatment may explain it, though they add that the extra risk posed by IVF is “small”.
Jeremy Hunt, the ex-health secretary who chairs Westminster’s all party parliamentary group on patient safety, urged NHS leaders to learn from the stories.
“Nik and Amisha have highlighted an important and under-recognised issue in maternity care,” she said.
“These stories and the Action for Accreta campaign highlight worrying gaps in how PAS is identified, recorded and managed across the NHS.
“Addressing these will require a more consistent, system-wide approach, including improved data, training and clinical preparedness.”
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