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Addressing care disparities through research – Professor Shakila Thangaratinam takes the lead

Written by Louise Stanley on . Posted in Health inequalities, Maternal health.

Birmingham Women’s and Children’s Hospitals NHS Foundation Trust (BWC) – a founding member of BHP – has announced the appointment of Professor Shakila Thangaratinam to the new post of Research and Development Lead for its Women’s Hospital, and Deputy Director of Research and Development for the Trust. Shakila is BHP’s Academic Lead for Maternal Health and is a Consultant Obstetrician as well as Professor of Maternal and Perinatal Health at the University of Birmingham, where she leads the WHO Collaborating Centre for Global Women’s Health. Here, she explains what her new position will entail and her future ambitions towards improving outcomes for women in Birmingham, the region, and globally.

In my new role, I am keen to facilitate a seamless integration of academia and clinical practice, and nurture the research ambitions of our trainees, midwives, nurses and allied health professionals and Consultant colleagues across various disciplines. Women’s voices will be central to our research development and delivery, and I am particularly keen to minimise the health disparities based on gender, race and ethnicity and socio-economic status. We have a unique strength in caring for women across their life course in our Trust from their birth and childhood, to adolescence, reproductive and post-menopausal age; our research will aim to improve their health throughout this journey.

The new Research and Development Lead role has three clear objectives:

    • To undertake high quality research through improved engagement with women, their families and clinicians, and a clear, achievable, and relevant research strategy
    • To promote capacity-building in research with the tools, skills and career development which are critical to expand and sustain research activities
    • To work closely with patient and public involvement groups such as The Hildas, so that research work addresses the needs of women and families.

“By working closely with the recently established Dame Hilda Network, we hope to bring together clinicians, academics, women and policy makers working towards improving the health of women and their babies in the region, directly addressing the priorities set out by the Women’s Health Strategy nationally.

“In a digital age, we’re well placed to maximise the power of the data in clinical and academic work. We want all women who visit with us to be given the opportunity to be included in our clinical research. Participation in research itself has been shown to improve their outcomes.”

Learn more about BHP’s Maternal Health research

Drugs to delay preterm birth are safe for global reduction in neonatal death

Written by Louise Stanley on . Posted in Health inequalities, Maternal health.

Women around the world should be able to access the best drug treatments that help to delay preterm births and improve outcomes for newborns, suggests new research.

Researchers from BHP founder-member the University of Birmingham worked with colleagues from the World Health Organization to review 122 randomised trials – published between 1966 and 2021, involving 13,697 women and conducted in 39 countries including high, middle and low-income states. The study, published in Cochrane Reviews, has allowed researchers to create a league table of drugs that delay birth, called tocolytics, based on their effectiveness and side effects.

Women benefitted from all preterm delay treatments included in the meta-analysis of studies, although the research team noted that the effectiveness of different drugs was less clear in some of the studies. The team also looked at the side effects of different drugs and combinations, including the likelihood of having to stop treatment.

The team have bought together the evidence on the benefits as well as the harms of these treatments (compared to no treatment or placebo), to arm clinicians and policy makers around with world with the information to decide upon the best treatment for the women in their care in their specific setting.

Dr Amie Wilson, Research Fellow Global Maternal Health at the University of Birmingham said: “The findings show that the benefits of these drugs outweigh any risks associated with unwanted side effects. These treatments are leading to a significant reduction in the number of deadly preterm births, and we now need to further understand the effectiveness of tocolytics for specific groups depending on pregnancy length.

“Our previous research has led to the improvement of guidelines for use of tocolysis drug use to delay preterm birth in the UK. Knowing that this paper helped to inform the forthcoming recommendations of the World Health Organization on the use of tocolytics, we hope that many more women around the globe will have access to these drugs, and have healthier births.”

Dr Victoria Hodgetts Morton, NIHR Clinical Lecturer in Obstetrics at the University of Birmingham and co-author of the paper said: “Preterm birth is the most common reason why a newborn baby may die, and the leading cause of death in children under five years of age.

“Tocolytics aim to delay preterm birth and allow time for the women to receive medicines that can help with baby’s breathing and feeding if born preterm, and medicines that lower the chance of cerebral palsy of the infant. Crucially, a short delay in preterm birth can enable women to reach specialist care.”

    Professor Peter Brocklehurst responds to the Women’s Health Strategy

    Written by Louise Stanley on . Posted in Birmingham Health Partners, Maternal health.

    The Chair of the Birmingham Health Partners Commission which led the Healthy Mum, Healthy Baby, Healthy Future report has welcomed the first ever Women’s Health Strategy for England to tackle the gender health gap.

    The commission set out a raft of recommendations for the UK to lead the development of safe, effective and accessible medicines for use in pregnancy. The key ambitions in the Women’s Health Strategy which are aligned to the recommendations from the Healthy Mum, Healthy Baby, Healthy Future report include:

        • Boosting participation of pregnant women in clinical research, particularly clinical trials, key components to improving maternal health outcomes for women and their babies
        • A greater use of routine health data to improve outcomes for pregnant women
        • Improving the safety of medicines in pregnancy to ensure women have access to high quality and updated information about medicines that they may need to take during pregnancy

    Commenting on the Women’s Health Strategy, Professor Peter Brocklehurst, Professor of Women’s Health and Director of Research and Development for the Birmingham Clinical Trials Unit (BCTU), said:

    “I am really pleased to see that women’s health is being given the prominence it needs and I find the plans outlined in the Women’s Health Strategy encouraging. It is vital that women are treated as equal partners in the delivery of their care and that they have the option to be included in research and clinical trials that affect them. Over 50% of respondents to the initial call for evidence felt that pregnancy should be included in the strategy, providing a clear message that healthy pregnancies are a health priority for women, their families and society.

    “The focus on the importance of research to continue to improve health is also very encouraging, however, there is little mention of the research needed to ensure that new therapies, particularly safe and effective medicines, are developed for many of the women’s health problems highlighted in the report. Investment in discovery science and the need for close collaboration with other groups, particularly the pharmaceutical industry, is essential if we are to continue to improve health outcomes for women.  I look forward to building on these plans with colleagues in Government and across sectors to reduce the gender health gap, place women’s voices at the heart of research, increase participation in research and ultimately improve maternal health outcomes for women and future generations.”

    Baroness Thornton – the Shadow Women and Equalities Minister, recently spoke about the Healthy Mum, Healthy Baby, Healthy Future report during her statement to the House of Lords on the Women’s Health Strategy. The full debate can be watched here. (Baroness Thornton’s speech starts at 16:07:05 and is answered by Baroness Penn at 16:23:45, she ends her point on the report at 16:25:15).

    Healthy Mum, Healthy Baby, Healthy Future: Report Sets out Vision to Deliver Safe, Effective and Accessible Medicines for use in Pregnancy

    Written by Louise Stanley on . Posted in Birmingham Health Partners, Maternal health.

    In a UK-first report launched today, in the House of Commons, leading figures from charity, healthcare, industry, law and academia have outlined a collaborative vision for UK leadership to improve maternal health. The Healthy Mum, Healthy Baby, Healthy Future: The Case for UK Leadership in the Development of Safe, Effective and Accessible Medicines for Use in Pregnancy report proposes a clear roadmap to improve the lives of millions of people, not just for women while they are pregnant, but for future generations.

    Download the report Healthy Mum, Healthy Baby, Healthy Future: The Case for UK Leadership in the Development of Safe Medicines for Use in Pregnancy  [PDF, 2mb]

    Globally, over 800 women and 12,000 newborns die every day from preventable pregnancy-related complications – that is one woman and 17 babies every 2 minutes. Pregnancy complications affect two lives in one short period of time, yet only two medicines have ever been developed specifically for pregnancy-related conditions, and not a single new medicine for some of the most serious pregnancy-specific conditions has reached women in decades.

    Over the past year, a Birmingham Health Partners led Policy Commission – co-chaired by Baroness Manningham-Buller, Co-president of Chatham House and Professor Peter Brocklehurst, University of Birmingham – has heard from key stakeholders on how best to develop safe, effective and accessible medicines for use in pregnancy. Compelling evidence gathered throughout the process has informed eight critical recommendations which, if implemented by government, will successfully prevent needless deaths and find new therapeutics to treat life-threatening conditions affecting mothers and their babies.

    Key proposals include strengthening the UK’s research capabilities to address gaps in our biological knowledge; more effective clinical trials support; and harnessing collaborative partnerships between government, universities and the pharmaceutical industry. Importantly, the report advocates for women who have been historically excluded from clinical trials to be a vital part of future research, ensuring they are not left behind and can benefit from modern medical advances. The UK, with its existing track record of pregnancy research, and lifelong NHS health records, is uniquely placed to lead this overdue and vital reform, working alongside global partners to deliver real change.

    Commenting on the report, Co-chair, Baroness Manningham-Buller LG, DCB, FMedSci said: “When I was asked to become joint chair of the Commission that has produced this report, I am ashamed to say that I wasn’t aware that there was an acute problem. Despite being at Wellcome for twelve years and Imperial College for six, I had no idea that research into conception and pregnancy was largely neglected and that virtually no drugs had been developed and trialled for pregnant women in the many decades since thalidomide. This leaves women at the mercy both of general diseases, the diseases of pregnancy and drugs which are usually unlicensed. The evidence taken by the Commission in its inquiry convinces us that this urgently needs to change. We suggest how.”

    Co-chair, Professor Peter Brocklehurst said: “This report represents a clear and timely platform to improve the care we provide to pregnant and breastfeeding women, by increasing the availability of safe, effective and accessible medicines for their use. The Commission’s role was to provide a blueprint for action and will provide ongoing support in implementing the recommendations set out in this report, as there is an urgent need for action to address this underserved area of medical need. Without it, women and babies will continue to die when they could be saved. They will continue to experience long-term health effects, disability and distress, which might be avoided.

    “We strongly urge the scientific, clinical, industry, regulatory, governmental and public sectors to come together to address the recommendations of this Commission. The UK has the opportunity to transform maternal health across the world, improving the lives of mothers, their babies and future generations – let’s not waste it.”

    Yasmin Golding, campaigner from the Epilepsy Society, who continues to be affected by the lack of safe and effective medicines said: “As a mixed race woman with epilepsy there are pregnancy risks I cannot avoid, but many I should be able to in the age of modern medicine. This report gives me and other women hope that in the future they will be able to spend more time enjoying pregnancy and less worrying about avoidable risks that threaten them and their baby.”

    Sandra Igwe, founder of The Motherhood Group and Co-chair of the National Inquiry into Racial Injustice in Maternity Care welcomed the report by saying: “Giving a voice back to those who are ultimately the most affected is crucial, and an imperative step for us mothers advocating for ourselves. All women, regardless of race, age, and socioeconomic background should be allowed to have safe and effective medicine during their pregnancy. It’s key in building trust, offers more choice, and lowers potential health risks – a springboard in the right direction. These recommendations will specifically further help women like me, who due to the colour of our skin, face health inequalities within maternity care.”

    Find out more about Birmingham’s holistic and collaborative approach to maternal health research on our new research spotlight page

    Birmingham research shapes new miscarriage guidelines

    Written by Louise Stanley on . Posted in Clinical trials, Maternal health.

    Research led by BHP founder-member the University of Birmingham has helped to shape guidelines which could mean thousands of women with prior miscarriage, and bleeding in early pregnancy, could be eligible for treatment with progesterone each year.

    The updated guidance, announced today by the National Institute for Health and Care Excellence (NICE), follows a review of evidence by NICE’s independent guideline committee. The key evidence came from two trials – PRISM and PROMISE – led by the University of Birmingham in collaboration with Tommy’s National Centre for Miscarriage Research.

    The results of the clinical trials, published in January 2020, evidenced both the clinical and economic advantages of giving a course of self-administered twice daily progesterone pessaries to women with prior miscarriage from when they first present with early pregnancy bleeding up until 16 weeks of pregnancy. In such women, the treatment reduces miscarriage risk and increases livebirth chances.

    NICE’s updated guidance – ‘Ectopic pregnancy and miscarriage: diagnosis and initial management’ – recommends offering progesterone to women who have early pregnancy bleeding and who have previously had a miscarriage.  An ultrasound scan should be performed in these women, and if a fetal heartbeat is confirmed, NICE’s new guidelines recommend treatment with progesterone should continue until 16 weeks of pregnancy have been completed.  NICE’s independent guideline committee found that there was no evidence of benefit in women with early pregnancy bleeding but no previous miscarriage, nor in women with previous miscarriage but no early pregnancy bleeding in the current pregnancy.

    Progesterone is a hormone that is naturally secreted by the ovaries and placenta in early pregnancy and is vital to the attainment and maintenance of healthy pregnancies.

    PROMISE studied 836 women with unexplained recurrent miscarriages at 45 hospitals in the UK and the Netherlands, and found a 3% higher live birth rate with progesterone, but with substantial statistical uncertainty.

    PRISM studied 4,153 women with early pregnancy bleeding at 48 hospitals in the UK and found there was a 5% increase in the number of babies born to those who were given progesterone who had previously had one or more miscarriages compared to those given a placebo. The benefit was even greater for the women who had previous ‘recurrent miscarriages’ (i.e., three or more miscarriages) – with a 15% increase in the live birth rate in the progesterone group compared to the placebo group.

    Of the newly updated NICE guidance, Arri Coomarasamy, Professor of Gynaecology & Reproductive Medicine at the University of Birmingham and Director of Tommy’s National Centre for Miscarriage Research who led the PRISM and PROMISE trials, said: “After many years researching the use of progesterone and working to make treatment more accessible, today’s new miscarriage care guidelines from NICE include a very welcome change. Our research has shown that progesterone is an effective and safe treatment option, which could prevent 8,450 miscarriages a year in the UK – but we know it’s not yet reaching everyone who might benefit. This recommendation from NICE is an important step in tackling the current variation in miscarriage services across the country and preventing these losses wherever possible.”

    Tommy’s CEO Jane Brewin said: “It’s great to see NICE taking our progesterone research on board in their new miscarriage care guidelines, which will help save babies’ lives and spare parents’ heartache. Miscarriage is often dismissed as ‘one of those things’ we can’t do anything about – even by some healthcare professionals, who may not specialise in this area to know the latest evidence. We hear from women who were denied progesterone treatment when they should have been eligible, simply because their doctor wasn’t familiar with it, so we hope NICE’s recommendation will help end some of these inequalities in miscarriage care that add more pain to an already unbearable experience.”

    Meanwhile, Professor Coomarasamy was among the leading authors to lay bare the devastating impact of miscarriage and set out a raft of recommendations to improve treatment and care in a series of three research papers published in The Lancet in April 2021.

    Amongst the calls to action by the research team was for urgent changes to NHS policy, which currently provides exploratory testing for underlying causes of miscarriage for women only after they have experienced three consecutive miscarriages.  The team says many of the risks related to a miscarriage are present even after one or two miscarriages, and appropriate care should be provided to all women who have experienced one or more miscarriages.

    The Lancet ‘Miscarriage Matters’ series of papers formed part of a campaign by charity Tommy’s, including a petition to improve miscarriage care which has been signed by almost 230,000 supporters.

    Tommy’s National Centre for Miscarriage Research has also been working with the Royal College of Obstetricians and Gynaecologists (RCOG) to share the knowledge and recommendations from The Lancet research.  Now, RCOG has updated its miscarriage care guidelines taking The Lancet papers on board and encourages the NHS to adopt a graded model of care so that parents can get support after every loss and earlier access to specialist tests and treatments.

    In the revised guidelines, RCOG suggest that ‘recurrent miscarriage’ should be redefined so that losses don’t have to happen in a row for parents to receive support. Instead, they encourage doctors to use their discretion after two miscarriages if they suspect an issue might be causing the losses, and state that non-consecutive losses or those with different partners should still be treated as recurrent miscarriage.

    Meanwhile, in June this year Olivia Blake MP delivered Tommy’s petition to an Adjournment Debate in Parliament in support of the campaign, which led to the then Minister for Mental Health, Suicide Prevention and Patient Safety, Nadine Dorries MP, announcing that the Government would incorporate a number of the recommendations into the Women’s Health Strategy which will aim to improve the health and wellbeing of women across the country.

    Since then, Tommy’s CEO Jane Brewin has written a joint letter with Olivia Blake to new Health Minister Gillian Keegan MP, asking her to uphold Nadine Dorries’ promises in Parliament and meet with Tommy’s to discuss what happens next to make good miscarriage care widely and fairly available for everyone.

    Professor Coomarasamy said: “As we work to open the ‘black box’ of miscarriage in the hope of unpicking its causes and finding new therapies, the UK must change its approach to miscarriage care, not only to reduce the risk wherever possible but also to better support those who do tragically lose their babies.”

    Tommy’s CEO Jane Brewin said: “The right care can reduce the risk of miscarriage, and the right support can help parents if they experience loss – but that help isn’t reaching everyone across the UK after every miscarriage; this can and must change.

    “It’s great to see the Royal College taking forward Tommy’s recommendations from our Lancet research in their new care guidelines, so we can prevent more losses wherever possible but also better support those who do sadly lose their babies. We know what to do and how to do it, so now we need a commitment across the NHS to develop these care pathways and improve support for everyone.”

    In addition to the recommendations on tests and treatments for miscarriage, RCOG has also highlighted where research and evidence is lacking. This includes the health disparities facing women from Black, Asian or minority ethnic backgrounds, who were found to be at higher risk of having a miscarriage than White women in The Lancet research series. Researchers at the University of Birmingham have already begun work in this area, in partnership with Tommy’s National Centre for Miscarriage Research.

    An estimated 23 million miscarriages occur every year worldwide – equating to 44 pregnancy losses each minute.  Miscarriage (defined as the loss of a pregnancy before 24 weeks) costs the UK at least £471 million a year due to direct impact on health services and lost productivity. However, scientists expect costs surpass £1 billion per year when factoring in longer-term physical, reproductive and mental health impacts.

    New study aims to improve healthcare for pregnant women with multiple health conditions

    Written by Louise Stanley on . Posted in Health inequalities, Inflammation and chronic disease, Maternal health, Mental health.

    BHP founder-member the University of Birmingham is leading a new three-year UK-wide study aimed at improving healthcare and outcomes for pregnant women who have two or more active long-term health conditions.

    Currently, one in five pregnant women in the UK have two or more active long-term health conditions. These can be both physical conditions (like diabetes or raised blood pressure), and mental health conditions (such as depression or anxiety). Often women also have to take several medications to manage their different health needs.

    The new study, called Multimorbidity and Pregnancy: Determinants, Clusters, Consequences and Trajectories (MuM-PreDiCT), aims to use data-driven research to characterise and understand what makes having two or more long-term conditions more likely for pregnant women and the consequences for mother and child; and to predict and prevent adverse outcomes.

    MuM-PreDiCT will be divided into five research work packages:

        1. Examining how health conditions accumulate over time and identifying what makes a woman more at risk of developing two or more long-term health conditions before pregnancy.
        2. Exploring women’s experiences of care during pregnancy, birth and after birth, working together with families and health professionals to establish how care could be improved.
        3. Deeper delve into how having two or more long-term health conditions may affect pregnant women and their children by identifying outcomes that women, health professionals and researchers feel should be reported in research; examining how often women experience pregnancy complications; and exploring how frequently women and their children develop additional long-term ill health
        4. Investigating how taking combinations of medication may affect pregnant women with two or more long-term health conditions and their babies.
        5. Building a prediction model to help identify how likely a previously healthy pregnant woman will develop multiple long-term conditions after pregnancy.

    Professor Krish Nirantharakumar, of the University of Birmingham’s Institute of Applied Health Research and Principal Investigator of MuM-PreDiCT, said: “Having two or more health conditions is becoming more common in pregnant women as women are increasingly older when they start having a family and as obesity and mental health conditions are on the rise in general.

    “However, we don’t really understand what the consequences are of multiple health conditions or medications for mothers and babies.

    “This can make pregnancy, healthcare and managing medications more complicated. Without deeper understanding of the problem, women with several long-term health conditions may not have the best and safest experience of care before, during and after pregnancy because services have not been designed with their health needs in mind.”

    Dr Beck Taylor, Clinical Senior Lecturer at the University of Birmingham and Co-Investigator of MuM-PreDiCT, said: “Our research will provide valuable information to help women and clinicians make informed decisions and identify points for prevention and intervention. We will also explore the experiences of maternity care for women with two or more long-term conditions and work with families and health and social care professionals to produce recommendations on how to plan and design services that meet the needs of women and their families before, during and after pregnancy.”

    MuM-PreDiCT is being funded via the £20M UK Research and Innovation’s (UKRI) Strategic Priorities Fund (SPF) initiative ‘Tackling multi-morbidity at scale: Understanding disease clusters, determinants & biological pathways’. SPF is delivered by the Medical Research Council and National Institute for Health Research in partnership with the Economic and Social Research Council, and in collaboration with the Engineering and Physical Sciences Research Council. It is jointly funded by UKRI and the Department of Health and Social Care, through the NIHR.

    MuM-PreDiCT is being led by the University of Birmingham in collaboration with the University of Aberdeen, University of St Andrews, Swansea University, Queen’s University of Belfast, University of Ulster, The University of Manchester, Keele University, University Hospitals Bristol & Weston NHS Foundation Trust, Bradford Teaching Hospitals NHS Foundation Trust, and Guy’s & St Thomas’ NHS Foundation Trust.

    Siang Ing Lee, Academic Clinical Fellow at the University of Birmingham and MuM-PreDiCT, added: “We would like to extend our heartfelt gratitude to our amazing patient and public involvement (PPI) advisory group and PPI co-investigators who will play an integral part in MuM-PreDiCT.”