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)
Women who develop pre-eclampsia face a higher risk of chronic kidney disease and high blood pressure later in life, new research suggests.
The amount of protein found in the urine during pregnancy may help identify those at greatest risk of developing long-term health problems.
Pre-eclampsia usually involves high blood pressure and increased protein in the urine. Some women also experience severe headaches and changes to their vision.
The condition cannot be treated during pregnancy and, in some cases, labour must be induced early to protect both the woman and baby.
The study found that the condition may be linked to longer-term health problems.
Anne Høy Seemann Vestergaard, a medical doctor and PhD at the department of clinical medicine at Aarhus University, said: “What we can see is a clear association between pre-eclampsia and the development of high blood pressure, chronic kidney disease and cardiovascular disease later in life.”
The researchers found that the amount of protein passed in the urine during pregnancy was linked to the risk of developing chronic conditions after giving birth.
Protein in the urine can indicate that the kidneys are not filtering blood normally.
Vestergaard said: “The most surprising finding was how clearly the amount of protein in the urine during pre-eclampsia was linked to the risk of later high blood pressure and chronic kidney disease. Women with moderate to severe protein excretion had a higher risk of both conditions compared with women with low or no protein excretion.”
Among women with pre-eclampsia and moderate to severe levels of protein in the urine, around one in 20 developed chronic kidney disease within 10 years and around one in six developed high blood pressure.
Most women in the study did not develop long-term complications, but the researchers said the increased risk should still be taken seriously because the potential effects can be severe.
Vestergaard said: “At first glance, this may sound like a low number, but it represents a markedly increased risk when the groups are compared. In the group with pre-eclampsia and high levels of protein in the urine, around 1 in 20 women developed chronic kidney disease within ten years, including early stages of the disease, compared with around 1 in 100 in the group with lower or no protein excretion.”
She added: “That is a considerable number in light of the fact that chronic kidney disease is a potentially serious condition that can progress to kidney failure if isn’t diagnosed early.”
The findings suggest women who experience pre-eclampsia may benefit from more systematic monitoring after pregnancy.
Vestergaard said: “Our study suggests that these women may benefit from monitoring of blood pressure and kidney function after pregnancy.”
Light exercise and less sitting may reduce pregnant women’s risk of serious blood pressure complications, according to a new study.
Researchers have proposed a daily activity and sleep guide that they say was linked to a nearly 30 per cent lower risk of hypertensive disorders of pregnancy.
The suggested pattern includes fewer than eight hours of sedentary time, at least seven hours of light physical activity, around 22 minutes of more intense activity and nearly nine hours of sleep.
The University of Iowa-led study examined the daily behaviours of 470 pregnant women across all stages of pregnancy.
Participants wore monitors that measured physical activity over 24-hour periods and recorded how long they spent asleep.
Hypertensive disorders of pregnancy include chronic high blood pressure, gestational hypertension and pre-eclampsia.
Gestational hypertension is high blood pressure that develops during pregnancy, while pre-eclampsia is a potentially serious condition involving high blood pressure and signs that organs may be affected.
Sedentary behaviour means being mostly inactive, such as sitting or lying down.
Light physical activity can include casual walking, moving around the home or standing.
Moderate to vigorous activity includes movement such as brisk walking, where breathing and heart rate increase.
Kara Whitaker, associate professor in the department of health, sport, and human physiology at Iowa and corresponding author of the study, said: “We are identifying the optimal composition of movement behaviours across the day associated with the lowest risk of developing HDP and the most improved health outcomes.
“This blueprint holds for each and every trimester of pregnancy.”
Study participants were enrolled at sites in Iowa City, Pittsburgh and Morgantown, West Virginia.
The women wore activity and sleep monitors for at least one week during each trimester of pregnancy.
Four in five participants were non-Hispanic white and nearly a quarter lived in rural areas.
The data showed a steep rise in risk among pregnant women who were sedentary for more than 10 hours a day.
Women who increased light physical activity to at least four hours a day reduced their risk of hypertensive disorders of pregnancy to 15 per cent from 30 per cent.
Whitaker said: “Just moving around more seems to have significant health benefits.
“And I think it also may be a more feasible target for women who are pregnant who are not exercising regularly.”
The researchers said they were surprised that longer durations of moderate to vigorous physical activity did not appear to provide additional benefit.
Sleep beyond a certain duration also did not appear to bring major further benefits.
Whitaker said: “Through this study, we are providing evidence that reducing sedentary behaviour and engaging in light physical activity are important, and maybe more important, when it comes to pregnancy and health.”
The findings may be relevant beyond pregnancy because clinical research has shown that women who develop hypertensive disorders of pregnancy are more than twice as likely to develop heart disease later in life.
Cardiovascular disease includes conditions affecting the heart and blood vessels, such as heart disease and stroke.
Whitaker said: “We know that cardiovascular disease is the number one killer of women, and if we can intervene in pregnancy and prevent women from developing a hypertensive disorder of pregnancy, we are putting them on a better trajectory, away from cardiovascular disease and toward more optimal cardiovascular health.”
The study was published online on June 10.
A second study, published online on May 27, looked more closely at the ratio and type of sedentary behaviour and light physical activity linked to a lower risk of hypertensive disorders of pregnancy.
Whitaker is a lead co-author on that study.
Co-authors in the June 10 study include Alex Crisp, Jaemyung Kim, Karina Smith, Donna Santillan, Mark Santillan and Bridget Zimmerman, from Iowa; Jacob Gallagher, from Iowa State University; Melissa Jones, from Oakland University in Michigan; Bethany Barone Gibbs, Katrina Wilhite, Alexis Thrower and Iqra Sheikh, from West Virginia University; and Sabera Rahman, Janet Catov, Christopher Kline and Maisa Feghali, from the University of Pittsburgh.
The National Institutes of Health, the University of Iowa Institute for Clinical and Translational Science, the University of Pittsburgh Clinical and Translational Science Institute and the West Virginia Clinical and Translational Science Institute funded the research.
A £50m maternity consortium will bring together UK clinicians, researchers and communities to tackle the most critical gaps in maternal care.
Funding from the National Institute for Health and Care Research has established the NIHR Inequalities Challenge: Maternity Disparities Consortium under the leadership of the University of Birmingham and Newcastle University.
Higher education bodies, NHS organisations, community groups and voluntary organisations from across the UK will work together through the programme.
The NIHR has committed £50m over five years to support research led by clinicians, researchers and communities across the consortium.
Professor Joht Singh Chandan, consortium co-lead for research at the University of Birmingham, said: “National attention on maternity safety and equity has never been greater, but ambition must now be matched by evidence and implementation.
“Through this consortium, we will work across the UK to understand what works, for whom and in what contexts, and to ensure that research leads to practical changes in care for the women, babies and families who need them most.”
The launch comes at a pivotal moment for UK maternity care, with growing national attention on improving safety, equity and women’s experiences of care.
The government’s renewed Women’s Health Strategy highlights the need to improve care before and between pregnancies for underserved communities.
Against that backdrop, the consortium will generate the evidence, interventions and research capacity needed to help turn national ambition into practical improvements for women, babies and families.
University of Birmingham is leading work to improve maternity care pathways across the antenatal, intrapartum and postnatal periods.
Antenatal care covers pregnancy before labour, while intrapartum care refers to care during labour and birth.
The consortium will examine how women and families can be better supported before pregnancy and between pregnancies.
This includes improving access to advice and care that can help people prepare for pregnancy, manage existing health conditions and reduce risks before they build up.
Other research will focus on improving care during pregnancy, birth and the early weeks after birth.
This will include work on major causes of poor maternal health, such as high blood pressure, diabetes in pregnancy, obesity, perinatal mental health and complications during recovery after birth.
Professor Judith Rankin OBE, consortium co-lead for research and capacity development at Newcastle University, said: “This funding represents a critical opportunity to make the step change we need to improve outcomes for women and their babies.
“Alongside the research, the Consortium will be investing in tomorrow’s research leaders today to ensure we have the capacity to deliver on improving pregnancy outcomes, access to, and experience of, care.”
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