Pregnancy
Interview: On the hunt for the earliest signs of high-risk pregnancies
Californian biotech firm Mirvie is pioneering a new approach to high risk pregnancies, by tracking a unique molecular signal associated with a leading cause of stillbirth.
Its new platform – based on RNA, the nucleic acid present in all living cells – is the first to uncover the molecular signal for babies that are at risk of severe foetal growth restriction.
The RNA platform assesses maternal blood at 18 to 22 weeks to predict adverse pregnancy outcomes. It is able to identify high-risk pregnancies by analysing cell-free RNA, which can indicate placental and foetal health, potentially enabling early care interventions for better pregnancy outcomes.
Mirvie aims to personalise maternal care and integrate the platform into clinical practice, exploring targeted therapies based on RNA insights. Femtech World spoke to Dr. Thomas McElrath, vice president of clinical development, to find out more.
“We’ve never really had the ability to risk stratify patients for adverse outcomes in the third trimester, but this platform helps fill that gap,” says McElrath.
“As a clinician with nearly 30 years of experience, what I was taught – and what has been standard practice – is to assess someone’s risk based on their history.
“For instance, prior preterm delivery is considered a marker for high-risk pregnancy in subsequent pregnancies. However, this approach isn’t helpful for patients who haven’t experienced such problems or for those in their first pregnancy.
“This is where Mirvie’s platform comes in. It’s a blood test that identifies patterns of gene expression from the fetus, placenta, and mother. These patterns follow a highly regulated and normal progression throughout pregnancy.”
Drawing on the largest molecular study of pregnancy completed to date, researchers examined more than 5,000 geographically and demographically diverse pregnancies.
Analysing millions of maternal, foetal, and placental RNA messages using the Mirvie RNA platform, the technology was able to distinctly predict babies born with severe forms of growth restriction.
“Knowing what normal progression looks like allows us to identify deviations, enabling predictions about higher-risk outcomes.
“For example, we’ve already developed a test to predict a higher risk of preeclampsia. Our most recent test, focuses on predicting the risk of small-for-gestational-age infants. That’s the broad overview of the work we’re doing.”
Using the platform, researchers were able to successfully predict 60 per cent of babies with severe foetal growth restriction months in advance of delivery.
The Mirvie RNA platform found that severe growth restriction has a unique RNA signature independent of preeclampsia, chronic hypertension, and gestational diabetes, all of which can impact foetal growth.
McElrath says: “The key point here is that we believe we’re honing in on the pregnancies where the babies are unwell. These are babies more likely to have complications – we’re identifying 60 per cent, suggesting we’re likely detecting pregnancies where there’s already an underlying issue.
“That issue seems to lie in the functioning of the placenta. Whether it’s related to the maternal vascular supply to the placenta, an internal metabolic process within the placenta, another biochemical issue, or even something at the cellular level – that’s where the crux of the problem appears to be.
“We’re picking up signals of these issues, but there’s still much to uncover. Our next steps will involve determining exactly what’s going on. Is the issue coming from the baby itself? Is it the placenta? Or is it the maternal vascular supply? These are questions for future research.
“What we do know is that these are pregnancies that require closer monitoring. At around 18 to 20 weeks, we’re obtaining this critical information. By that stage, we’ve already performed an ultrasound to assess the baby’s size, yet we’re able to identify pregnancies that will benefit from additional follow-up in the third trimester.
“These are the ones who may need an extra couple of visits, because they’re at greater risk of having small babies – and such cases are at a significantly increased risk of stillbirth, which is devastating for any family.
“If we can use this information to identify and monitor potentially risky pregnancies before an adverse outcome occurs, it’s a win for everyone involved.”
McElrath believes that one of the challenges in obstetrics is that, historically, it has defined diseases in patients based on how they present when they walk into the clinic.
“Our definitions have been shaped by the condition at its end stage – rupture of membranes, hypertension and preeclampsia, preterm labour. We haven’t focused on defining diseases by what happens earlier in pregnancy,” he says.
“This is unlike the rest of medicine. For instance, if you’re at risk of a heart attack, we can identify high cholesterol or arterial plaques. If you’re at risk of a stroke, we can pinpoint hypercoagulability and similar factors. Most other fields of medicine work from understanding the pathology as it progresses towards the event. In obstetrics, we’ve been working backwards from the event itself.
“The advantage of this technology is that it starts to unravel those biological pathways that lead to clinical outcomes. It allows us to identify, for example, whether a baby is small due to a placental issue or a metabolic problem. We can begin to tease apart these causes, because treating every patient with the same approach isn’t as effective.
“If we can be more specific about what one patient needs compared to another, we’ll achieve far better outcomes. This is the direction obstetrics needs to move in if we want to make significant progress in improving pregnancy and maternal-foetal outcomes.”
Initially being launched in the US, Mirvie has also collaborated with research sites in the UK in order to make the platform available to all mothers everywhere as soon as possible.
“Our next initiative is to organise rollouts into various clinical settings,” says McElrath.
“We’ve received a great deal of positive feedback from clinician groups we’ve spoken to, including figures like the surgeon general for California and other public health leaders across parts of the US. They’ve shown interest in this because resources are limited – if you only have so much in your budget for maternal care, you need to know who needs it most.
“We’re seeing encouraging responses at the institutional level and are now at the stage where the platform will be introduced into a few clinical practices.”
The research is being presented at the Society for Maternal-Fetal Medicine annual meeting.
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.”
The University of Liverpool has secured £1.8m to test a device for postpartum bleeding and launch a new women’s health studio.
The PPH Butterfly is designed to help control postpartum haemorrhage, which is severe bleeding after childbirth and a leading cause of maternal death worldwide.
The funding will support research into how the device can be used in clinical practice and generate evidence to inform its wider adoption.
The university has launched the Women’s Health Innovation Studio, known as the WIN Studio, alongside the project.
The £1.8m initiative is predominantly funded by the National Institute for Health and Care Research, which is providing £1.5m, with additional support from the university.
The PPH Butterfly project will involve a multi-centre clinical trial across the UK and a global feasibility study looking at how practical it would be to use the device in different healthcare settings.
The WIN Studio is led by Andrew Weeks, professor of international maternal health care at the University of Liverpool and a senior investigator at the National Institute for Health and Care Research, and Dr Teesta Dey, a tenure track fellow in the department of women’s and children’s health.
Dr Dey will also lead the PPH Butterfly project.
Its work will cover conditions linked to female biology, including endometriosis, menopause and pregnancy-related complications.
It will also support technologies for diseases that affect women differently or disproportionately, even when they are not usually classed as gender-specific conditions.
Dr Dey said: “Women’s health has often been marginalised within healthcare systems and innovation markets, resulting in treatments, devices and care models that fail to adequately account for women’s specific needs. WIN Studio seeks to change this status quo and reconfigure how health technologies are conceived and delivered.
“The funding from NIHR for this £1.8m project is precisely the kind of innovation the WIN Studio exists to foster: clinically urgent, women-centred, and with the potential to save lives at scale.”
The studio recently hosted an event at Liverpool Women’s University Hospital as part of the Liverpool City Region Combined Authority’s Innovation Investment Fortnight.
Seven innovations are currently undergoing clinical testing through the studio, with three developed internally.
The studio will work closely with NHS University Hospitals Liverpool Group and provide clinical, regulatory and commercial support to people developing women’s health technologies.
It will also involve patients and members of the public in shaping research priorities and product development.
Its wider programme includes collaborations involving clinicians, engineers, economists, academics and policymakers.
The project team says the PPH Butterfly is a simple, low-cost device designed to control severe bleeding quickly and with minimal training.
According to the team, postpartum haemorrhage causes around 70,000 deaths globally each year, equal to about one death every seven minutes.
The device previously received £1.1m in funding from the National Institute for Health and Care Research.
The latest £1.5m grant will support a randomised UK trial, in which participants are allocated to different treatment groups by chance, and a global feasibility assessment.
Weeks said: “In an area where women face deep health inequalities, WIN Studio has a vital role to play. By working in partnership with the NHS, local government and communities, we can ensure that research leads to real-world impact.
“Liverpool has a highly integrated ecosystem of academic, clinical and commercial expertise. By bringing these together under a single platform, the WIN Studio aims to act as a national exemplar for equitable health innovation. Transforming the way medical technologies are developed is essential to addressing gender disparities in healthcare outcomes.”
Another product supported by the university, the LifeStart Trolley, has already reached commercialisation.
The small mobile resuscitation trolley allows newborn care to be carried out at the bedside while the baby’s umbilical cord remains intact, enabling delayed cord clamping.
Delayed cord clamping means waiting before cutting the cord so blood can continue flowing from the placenta to the baby after birth.
Clinical trials conducted around 10 years ago found that life-saving care could be provided successfully at the bedside using the trolley.
It was later commercialised by Inspiration Healthcare and is now used in more than 70 UK maternity units and in 36 countries, including Norway, Italy and the US.
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