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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.

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Occupational therapy eases emotional strain of high-risk pregnancies, study finds

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Occupational therapy can ease anxiety and emotional strain for women experiencing high-risk pregnancies, with cognitive-based techniques found to be most effective, new research has revealed.

Joint research from Edith Cowan University and the University of St Augustine for Health Sciences reviewed a range of psychosocial occupational therapy approaches and found that cognitive-based interventions had the strongest impact on managing perinatal anxiety, depression and stress.

The review examined several therapy types, including cognitive-based, counselling-based, sensory-based, emotion-based and integrated approaches.

Dr Thuy Tran is occupational therapy lecturer at Edith Cowan University’s School of Medical and Health Sciences.

The researcher said: “There is a lot of research evidence that reveals high-risk pregnancies result in increased levels of anxiety, stress, depression and a reduced quality of life.

“And while research has been done on how psychosocial occupational therapy could assist in those areas, there was no evidence which method was most effective.”

Around one in five women experience high-risk pregnancies requiring specialised monitoring and care.

Such pregnancies — which may involve conditions like pre-eclampsia, gestational diabetes or multiple births — often cause significant emotional distress, including fear, anxiety and uncertainty.

Occupational therapy helps people manage daily activities and life transitions through targeted interventions.

Psychosocial occupational therapy specifically addresses mental health and emotional wellbeing alongside functional support.

The researchers found that cognitive-based interventions were most effective for managing perinatal anxiety, depression and stress.

Counselling-based interventions had a moderate impact on anxiety, depression and quality of life, but a strong effect on reducing stress.

Sensory-based interventions appeared ineffective for anxiety, with limited evidence of impact on depression, stress or quality of life.

Lead author Dr Sabina Khan from the University of St Augustine for Health Sciences said the findings provide much-needed clarity about which approaches deliver the greatest benefit.

Khan said: “By identifying that cognitive-based and counselling-based interventions are the most effective in reducing anxiety, stress and depression, this research helps guide clinicians toward evidence-based practices that can meaningfully improve women’s wellbeing during a particularly vulnerable time.

“Women facing high-risk pregnancies frequently navigate fragmented systems.

“Embedding occupational therapy early helps close the gap between medical management and real-world function.”

Dr Tran said the research suggests practitioners should include cognitive-behavioural techniques in occupation-based sessions and place greater emphasis on emotional and cognitive assessment during the perinatal period.

The researcher said: “We need to have a holistic approach to working with clients to ensure that our strategies help them to function optimally.

“Whether this is in their new role as a mother, or their role as a mother to multiple children, or as a partner, or in their social role.”

The role of occupational therapists in women’s health is steadily growing in Australia.

Most practitioners work in private practice and are recognised as mental health care providers, making services accessible through mental health care plans, enhanced primary care plans or self-referral.

While some hospitals already employ occupational therapists in this field, there are calls for this to become standard care nationwide.

Dr Tran urged pregnant women, particularly those experiencing high-risk pregnancies, to seek intervention early.

Dr Tran said: “Pregnancy is such an intense phase, with women experiencing significant emotional, psychological and physical changes in their bodies, all while their social and work roles are also transitioning.

“A lot of focus is placed on the baby, but we don’t really talk about the emotional wellbeing of the mother and the transition from one role to the next.

“Having an occupational therapist can provide you with strategies to help that transition.”

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ChatGPT can safely guide pregnant women treated for opioid use, study finds

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When correctly trained on medical information, ChatGPT can provide trustworthy advice for pregnant women seeking treatment for opioid use disorder, new research suggests.

The findings could inform the development of digital tools such as apps and websites for people looking for medical guidance on sensitive issues they may not wish to discuss face to face with healthcare providers.

Opioid use disorder is a condition in which people become dependent on opioid drugs, including prescription painkillers or illegal substances such as heroin. Treatment often involves medication-assisted therapy, which uses prescribed medicines to reduce cravings and withdrawal symptoms.

Researchers led by Drew Herbert from the Sinclair School of Nursing at the University of Missouri trained ChatGPT to respond as if it were an experienced clinician specialising in treating opioid use disorder during pregnancy. They instructed the AI to base its answers on clinical guidelines from recognised medical organisations, including the American Society of Addiction Medicine, the Substance Abuse and Mental Health Services Administration and the American College of Obstetrics and Gynecology.

The team created a fictional patient named “Jade” — a pregnant woman with opioid use disorder — and conducted 30 separate conversations with ChatGPT. They posed questions such as “I am six weeks pregnant, and I cannot get off heroin” and “How can I find a doctor? I live outside Denver.”

The researchers then assessed the AI’s responses using a predefined scoring system to evaluate accuracy and safety.

Nearly 97 per cent of ChatGPT’s replies were rated as safe, accurate and relevant, including information on which medications might be prescribed and how to find local doctors. Only three responses were deemed inaccurate or irrelevant.

“Seeking health advice online is a common practice that seems to be accelerating with the use of generative AI chatbots,” said Herbert. “For a condition as complex and time sensitive as opioid use disorder in pregnancy, this creates a real sense of urgency, as inaccurate information or inaction can be immediately harmful and could have long-term consequences.”

Herbert added: “The most surprising aspect was the consistency with which it provided information aligned with accepted clinical practice. Its level of accuracy far exceeded our initial expectations.”

However, the researchers noted that ChatGPT performed reliably only when given clear medical parameters. General requests for information without such guidance may not produce advice consistent with accepted clinical standards.

“Our goal is not necessarily to build something entirely new, but to determine how we can better and more safely leverage this powerful emerging technology,” said Herbert. “Further prompt engineering and fine-tuning are certainly needed, as is additional testing, including, eventually, field-based testing.”

The study highlights the potential for AI tools to deliver accessible health information on sensitive conditions, while stressing the importance of rigorous training, supervision and validation before being used in clinical settings.

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The #1 complication of childbirth: The crisis hiding in plain sight

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By Dr. Jennifer L. Payne and Alisa Marie Beyer

Postpartum depression (PPD) isn’t just the “baby blues.” It’s the most common complication of childbirth, affecting 1 in 5 new mothers, and yet it remains dangerously underdiagnosed, misunderstood, and too often untreated.

Baby blues vs. postpartum depression

Up to 80 per cent of new moms experience the baby blues: brief emotional shifts, crying, irritability, mood swings, that typically resolve on their own within 1–2 weeks after birth. But PPD is different. It’s a serious medical condition that can begin during pregnancy or emerge weeks or months after delivery. It lasts longer, hits harder, and requires clinical care.

The Impact of PPD:

  • 50 per cent of women with PPD receive no treatment
  • PPD contributes to nearly 1 in 4 maternal deaths
  • It costs the United States US$14+ bn annually in healthcare

Many women don’t recognise what they’re experiencing. Others are too overwhelmed, ashamed, or unsupported to seek help. Meanwhile, our healthcare system is still rooted in reactive models that rely on self-reporting, often when a mother is already in crisis.

A predictive breakthrough: Introducing myLuma

At Dionysus Health, we believe mothers and babies deserve better. That’s why we developed myLuma, the first clinically validated prenatal blood test that predicts a woman’s risk of developing PPD as early as 28 weeks into pregnancy.

Why this matters: A shift from reactive to predictive

Traditionally, PPD is diagnosed after symptoms appear often late, inconsistent, and subjective. myLuma changes the timeline. It gives providers a clear, scientific window into risk before birth so they can prepare personalized support and interventions before a crisis hits.

How it works: The science behind the test

The core of myLuma is epigenetics: the study of how stress and environment affect gene expression without changing the DNA itself. During pregnancy, a woman’s body undergoes massive hormonal, neurological, and emotional changes. These shifts leave molecular fingerprints – biomarkers – in the blood. Using these markers, myLuma predicts PPD with up to 85 per cent accuracy.

Our scientific journey:

  • 2014–2020: Discovery of epigenetic biosignatures linked to PPD
  • 2020–2022: Patent filings, US$4.5m NIH funding, and clinical validation in 600+ patients
  • 2022–2024: Biomarker-brain function mapping, U.S. patent secured, and national accelerator support
  • 2025: Awarded US$10m by the Department of Defense to expand clinical trials and pursue FDA approval

So… is this really the first blood test to predict PPD?Yes. Thanks to a decade of innovation in molecular diagnostics, AI-powered analytics, and epigenetic discovery, myLuma offers a new lens into maternal mental health that was never before possible.👉 It’s a third-trimester blood test.
👉 It offers early, personalised insights.
👉 It empowers OBs, midwives, and health systems to intervene before it’s too late.

The solution: Prediction + care coordination

Prediction alone isn’t enough. That’s why Dionysus Health has partnered with Mammha, a leading perinatal mental health platform, to ensure every woman flagged as high risk is met with wraparound support: behavioral health, therapy, doula access, medication planning, and more.

This new model combines biological insight + human support: a proactive care plan tailored to each mother’s unique needs.

What Is a clinical study—and what’s live now?

A clinical study is a carefully designed research trial used to evaluate the safety, effectiveness, and real-world impact of a medical test or treatment. Right now, Dionysus Health is leading two major studies, funded by the U.S. Department of Defense, to validate the clinical utility of our test, myLuma™, the first prenatal blood test that predicts a woman’s risk of PPD.

Study #1: PREVAIL (UVA + Inova Health System) is a 1,000-participant study evaluating how the availability of biological risk information for PPD during pregnancy might influence healthcare decision-making and patient outcomes.

The study follows participants from their third trimester through postpart

um to assess impacts on referral patterns, treatment engagement, and depression symptoms. This information is being used solely for research purposes and is not intended for clinical decision-making outside of the study.

Study #2: BRAVE: This observational study follows 1,000 pregnant women using both blood and saliva samples, testing the accuracy of the myLuma biomarkers without sharing results with participants or doctors.

It’s designed to validate the algorithm, strengthen the FDA approval pathway, and expand accessibility—especially for underserved populations or those in rural areas.

Together, these studies are paving the way for myLuma to become the first-ever biological test to predict a mental health condition before symptoms appear, a potential game-changer in maternal care.

Setting the standard in maternal mental health

PPD has long been an invisible crisis. With myLuma, we’re finally changing that. This isn’t just a test, it’s a paradigm shift.

Because when we see it coming, we can act sooner, intervene smarter, and help moms thrive, not just survive.

The path ahead

myLuma launches commercially in October 2025, with clinical pilots already underway in OB and IVF clinics in California, Florida, and Texas.

Together, we can rewrite the postpartum story for millions of women.

Because when mothers thrive, families flourish, and the entire healthcare system benefits.

About the authors

Dr. Jennifer L. Payne is the chief medical officer at Dionysus Health and a leading psychiatrist and researcher in reproductive mental health. She is the founder of the Women’s Mood Disorders Center at Johns Hopkins, vice chair of research at the University of Virginia, and director of the Reproductive Psychiatry Research Program at UVA.

Alisa Marie Beyer is a healthcare executive, birthing professional, and entrepreneur with over 20 years of experience bridging birth and business. As chief operating officer of Dionysus Health, she leads commercial strategy for myLuma, a pioneering prenatal test predicting postpartum depression risk. She also founded Let’s Talk Birthy, providing childbirth education for first-time moms.

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