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Research advances biological understanding of hypertensive disorders of pregnancy

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Diagnostics company Mirvie has announced the results of a breakthrough study that reveals new advances in the biological understanding of hypertensive disorders of pregnancy (HDP), including preeclampsia – a leading cause of maternal morbidity and mortality as well as preterm birth.

Researchers used data from more than 9,000 pregnancies within the multi-centre Mirvie-sponsored Miracle of Life prospective study to discover and validate RNA signatures capable of distinguishing between severe and mild hypertensive disorders of pregnancy, including preeclampsia, months before symptoms occur.

The paper also validates the predictive performance of Mirvie’s simple blood test to predict risk of preeclampsia early, at 17.5 to 22 weeks gestational age, in pregnancies without any pre-existing high-risk conditions.

“By the time a patient is symptomatic, it’s a race against the clock to try to get the baby to term and not risk the mother’s health,” said Dr. Kara Rood, a maternal-foetal medicine physician, one of the principal investigators of the study, and Clinical associate professor of Obstetrics and Gynaecology at The Ohio State University Wexner Medical Center.

 

 

“Current guidelines are not helping us identify which patients are truly at high risk and we need better tools. Mirvie’s preeclampsia risk prediction test can now improve risk assessment, helping women and their care teams be informed and take actions with the potential to delay onset or prevent the disease.”

Despite current guidelines from US Preventive Services Taskforce and the American College of Obstetrics and Gynaecology that use general maternal characteristics to identify pregnant women at increased risk for preeclampsia, rates of the disease have nearly doubled in the last decade and now affect one in 12 pregnancies.

Mirvie’s blood test uses RNA signatures to resolve this ambiguity, helping pregnant women and their providers focus on the one in four pregnancies that are truly at high risk, ensuring optimal care for the right patients.

The results of this study demonstrate that relying on molecular signals from the underlying biology is far more effective in determining whether risk for preeclampsia is high or low.

Validation results show the simple blood test can identify 91 per cent of pregnancies that will develop preterm preeclampsia in women aged over 35 without pre-existing high-risk conditions, months ahead of symptoms. Those with a low-risk result have 99.7 per cent probability of not developing preterm preeclampsia. The clinically validated blood test will soon be broadly available under the brand name Encompass.

“Over the last 100 years, we have relied on a reactive care model in pregnancy. This study represents a profound opportunity to move toward a proactive care model,” said Dr. Thomas McElrath, vice president of clinical development at Mirvie and a maternal-foetal medicine physician at Brigham and Women’s Hospital in Boston.

“Importantly, these results demonstrate for the first time the unique molecular signatures that distinguish between severe and mild hypertensive disorders of pregnancy, giving us confidence in a much more precise and personalised approach for at-risk pregnancies.”

Today, the adherence to known valuable interventions for pregnancies at high risk of preeclampsia such as daily aspirin is less than 50 per cent, even among high-risk patients. With a blood test available early in the second trimester, pregnant patients and care teams can intervene months before symptoms and more confidently implement an evidence-based prevention care plan to improve the chance for a full-term pregnancy and healthy delivery.

“We are thrilled with the results from our investments in this critical research and collaboration with more than a dozen internationally renowned experts in maternal-foetal medicine,” said Maneesh Jain, co-founder and CEO of Mirvie.

“Much like the discovery of molecular subtypes of breast cancer led to improved outcomes, the discovery of molecular subtypes in HDP offers a bright future for personalising pregnancy care and addressing the rising rates of births with complications.”

The novel findings add to the growing body of research demonstrating the use of the Mirvie RNA platform to predict pregnancy complications months in advance, including studies on preeclampsia risk prediction and preterm birth risk prediction, and research presented in January at the Society for Maternal-Foetal Medicine conference on prediction of fetal growth restriction.

Pregnancy

Women with multiple long-term conditions face increased pregnancy risks – study

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Women entering pregnancy with multiple conditions face a 20 per cent higher miscarriage risk and around four times the risk of anxiety and depression, new research has revealed.

The observational study found women with two or more pre-existing long-term physical or mental health conditions also had a 69 per cent higher risk of severe nausea and vomiting.

They had more than double the risk of venous thromboembolism, when a blood clot forms inside a vein, and a 42 per cent higher risk of pre-eclampsia, a pregnancy complication involving high blood pressure.

Dr Steven Wambua, research fellow in health data science at King’s College London and joint first author, said: “Maternity care is still largely organised around single health conditions, but one in five women now enters pregnancy with two or more.

“By harmonising five datasets covering all four UK nations, we could show consistently and across a much broader range of outcomes than before, that these women face higher risks and that risk climbs with every additional condition.”

Researchers from King’s College London, Queen’s University Belfast, Bristol NHS Foundation Trust, the University of Birmingham, Swansea University and the University of St Andrews analysed more than 2.2m pregnancies and birth events recorded between 2000 and 2022.

The data came from five datasets covering England, Scotland, Wales and Northern Ireland.

Around one in five pregnant women in the UK live with multiple long-term conditions, but their combined impact on pregnancy is poorly understood.

The study found risks rose with each additional condition. Women with three or more conditions had more than three-and-a-half times the risk of venous thromboembolism compared with women without long-term health conditions.

Women with multiple conditions also had a 32 per cent higher risk of placental abruption, when the placenta separates from the womb before birth, and a 26 per cent higher risk of gestational diabetes.

The researchers said maternity care pathways vary considerably and, where they exist, are often organised around individual conditions.

They said the findings highlight a need to restructure these pathways to address the complex needs of women living with multiple conditions.

Professor Krishnarajah Nirantharakumar, clinical professor of public health and health data science at King’s College London, MuM-PreDiCT principal investigator and joint senior author, said: “These findings make a strong case for recognising multiple long-term conditions as a marker of antenatal risk in its own right.

“That means identifying these women at maternity booking, assessing physical and mental health needs together, and joining up obstetric, primary care and mental health services around them.

“The near four-fold risk of antenatal anxiety and depression is particularly striking, and points to perinatal mental health support as an urgent priority.

Dr Kelly-Ann Eastwood of Bristol NHS Foundation Trust and Queen’s University Belfast, joint senior author, added: “Our results help define the urgent clinical challenges facing both women entering pregnancy with multiple long-term conditions, and clinicians caring for them across the UK.

“Supporting recommendations from recent national maternity and neonatal investigation reports, there is a critical need to address healthcare inequalities, and improve support for women with pre-existing mental health conditions.

“These findings highlight the pressing need to restructure existing maternity services to improve antenatal outcomes.

The authors cautioned that, because the study used routinely collected health records, some conditions and outcomes may have been under-recorded or recorded inconsistently.

Further work by the MuM-PReDiCT consortium will examine birth and child outcomes and identify which combinations of long-term conditions carry the greatest risk.

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Pregnancy

Climbing during pregnancy may be safer than long assumed, study finds

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Climbing during the third trimester was not linked to higher rates of self-reported pregnancy complications in a global study.

The findings provide direct evidence on an activity pregnant women have traditionally been advised to avoid because of concerns about falls.

Researchers surveyed 692 people about climbing during pregnancy, falls, maternal and baby health outcomes and their return to the activity after giving birth.

The study recorded almost 64,000 hours of climbing among participants.

During that time, participants reported 155 “hard falls”, defined as falls or catches forceful enough to be remembered or cause concern.

The rate of adverse clinical events, meaning negative medical outcomes affecting the pregnancy or baby, was 0.03 per 1,000 hours of climbing exposure. All babies in the study were born live.

Researchers found no significant difference in pregnancy or foetal health outcomes between participants who stopped climbing at or before 27 weeks and those who continued beyond that point.

The findings suggest continuing the activity into the third trimester was not associated with increased self-reported complications among those surveyed.

The survey also found 96 per cent of participants said that, despite concerns about climbing while pregnant, they felt “happy” or “very happy” that they had continued.

Margie Davenport, professor in the Faculty of Kinesiology, Sport, and Recreation and lead author of the study, said the preliminary findings challenge an assumption about maternal exercise that had been based on opinion rather than research.

She said: “For decades we have restricted pregnant women from activities like climbing due to concern for their health and the health of the baby, but our evidence suggests it’s beneficial for both mental and physical health.”

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Peripear wins Innovate UK Women in Innovation Award

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Medtech startup Peripear has won an Innovate UK award for developing a wearable designed to prevent perineal trauma during childbirth.

The Oxford-based company is developing a hands-free warm compress device for use on the perineum during the second stage of labour.

 

Peripear describes its product as the world’s first automated perineal thermotherapy wearable, designed to prevent perineal trauma during childbirth.

The device is intended to reduce severe tearing and episiotomies while improving maternal comfort.

Peripear has secured an Innovate UK Women in Innovation Award and a £74,974 grant.

The funding will support further product development ahead of the company’s planned first-in-human study.

Nina van Schaick, co-founder and chief operating officer of Peripear and midwife, said: “I’m sure I wasn’t the only one to see this gap.

“I was incredibly lucky to meet my co-founder, Eviatar Natan, right as my frustration about the lack of translation of evidence into practice had peaked.

“There was a proven mechanism that could reduce injuries occurring in up to 90 per cent of vaginal births, and it was being left out of clinical pathways simply because no standardised tool existed to deliver it.

 “I’m a farmer’s granddaughter, and when I started practising over 14 years ago, I asked: where is the tool I need to implement this evidence? I looked around and realised we were still asking clinicians to improvise.

“Peripear is what happens when the person who has lived the problem, both personally and professionally, meets the person who can help her build the solution.”

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