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Better treatment for miscarriage patients is also more cost effective

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

A new drug combination that is better at treating miscarriage is also more cost effective than current standard NHS treatment, finds a new study led by BHP founder-member the University of Birmingham and Tommy’s National Centre for Miscarriage Research.

A previous study by the same team and published in The Lancet in August last year, found that a combined drug treatment is more effective than the standard medication for women having miscarriages without symptoms – also known as missed, delayed or silent miscarriage.

Missed miscarriage occurs when a baby has died in the womb but the mother hasn’t had symptoms, such as bleeding or pain. Current hospital restrictions on surgery mean that many women face waiting for the miscarriage to happen by itself, which can take weeks and still might not happen, or being offered medication to speed the process along.

National guidelines recommend a treatment called misoprostol, which is successful in most cases – but some women wait anxiously for weeks, repeating the medication and eventually needing surgery.

The research published in The Lancet in August 2020 showed that misoprostol is more effective when combined with mifepristone, an anti-progesterone drug used to induce labour. The trial found that the combined drug treatment worked in 83% of cases, compared to 76% in the misoprostol and placebo group – and crucially, it reduced the need for surgery. One in four women (25%) given the placebo later needed an operation to complete the miscarriage, compared with less than one in five (18%) of those who had the new medication.

Now the team has carried out a further study to assess the cost-effectiveness of mifepristone and misoprostol combined compared with misoprostol alone for the medical management of a missed miscarriage.

The National Institute for Health Research (NIHR) funded study involved 711 women across 28 UK hospitals with a diagnosis of missed miscarriage in the first 14 weeks of pregnancy, who were randomly assigned to receive either mifepristone or a placebo drug followed by misoprostol two days later.

Published in the British Journal of Obstetrics and Gynaecology, the study found the new combined drug treatment was on average £182 cheaper for each successfully managed miscarriage than the current standard NHS medication.

As this is the largest ever study into the most effective medical treatment for missed miscarriage, and the results are so clear, researchers and campaigners are calling for guidance from the National Institute for Health and Care Excellence (NICE) to be updated in light of the newly published findings. In the meantime, Tommy’s experts encourage anyone diagnosed with missed miscarriage to ask their doctor about the combined drug treatment.

Senior author Tracy Roberts, Professor of Health Economics at the University of Birmingham, said: “Pregnancy loss causes heartbreak for millions of families, and it is crucial that we find better ways to care for everyone going through miscarriage. Our findings could have huge benefits if they’re translated into clinical practice, with better outcomes for patients and lower costs for care services.”

First author Dr Duby Okeke Ogwulu, of the University of Birmingham’s Institute of Applied Health Research, added: “We hope the NICE guidance will be updated in light of this new evidence, so that everyone who needs it has access to the most effective treatment.”

Tommy’s CEO Jane Brewin commented: “Besides the physical harm, miscarriage can have serious psychological consequences, which can be made worse by the trauma of a failed treatment forcing mothers to endure weeks of carrying a baby they know has died.

“One in four pregnancies ends in loss, and while our researchers work to understand how we can prevent this, it’s vital their latest findings are put into practice so that everyone going through miscarriage has the best possible care. Particularly given Covid-19 pressures on the NHS, our new study could be applied to make better use of precious resources, as well as reducing the toll miscarriage can take on parents.”

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, through direct impact on health services and lost productivity, but scientists expect the costs surpass £1 billion a year when factoring in longer-term physical and mental health impacts.

Claire Bromley, aged 32, from Sittingbourne in Kent, chose surgery when she had a miscarriage last year, as her previous experience when medication failed was so distressing.

Claire said: “The whole process took around 3 months and was extremely traumatic, so I hope this new drug will mean others don’t have to suffer like I did. I was told medication would take a few hours to work, but started bleeding and cramping in minutes, while stuck in hospital waiting for other prescriptions. Despite taking effect so fast, the medication didn’t work, so I was sent for surgery – and when that failed too, I had to take the pills again. With my second miscarriage, I chose surgery right away to avoid the risk of repeating such a long and painful treatment.”

Katy Allan, aged 43, from South Yorkshire has experienced multiple miscarriages and a range of treatment, initially having surgery that caused internal scarring and later choosing medication in the hope it would cause less damage.

Katy said: “The treatment for my third miscarriage was a four-month long nightmare, with several rounds of medication and hospital staff trying to physically remove the pregnancy while I was awake, ending in painful surgery; it was one of the most horrendous experiences of my life and I remain completely traumatised. I couldn’t move on physically or mentally because I was pregnant and not pregnant for months, with tests remaining positive and hormones still racing long after we heard those spine-shivering words of ‘I am so sorry but there is no heartbeat’. The long ordeal of treatment made miscarriage even harder so I hope this new research can help to prevent others from going through what I did.”

Revolutionising diagnosis and treatment of life-threatening post-partum haemorrhage

Written by Louise Stanley on . Posted in Early diagnosis and detection, Maternal health.

Post-partum haemorrhage (PPH) accounts for 27% of all maternal deaths worldwide, according to the World Health Organization (WHO). The burden of PPH disproportionately affects mothers from low- and middle-income countries, which account for 86% of all maternal deaths.

PPH is defined as blood loss from the genital tract of 500 ml or more within 24 hours of birth. PPH usually happens within a day of giving birth, but it can occur up to six weeks after a birth.

To find possible solutions to the terrible problem of PPH, researchers at BHP founder-member the University of Birmingham are conducting the E-MOTIVE trial based on the WHO ‘first response bundle’ in five countries: Kenya, Sri Lanka, South Africa, Tanzania and Nigeria.

Kristie-Marie Mammoliti, one of the lead researchers for the University of Birmingham explained the thinking behind the trial: “Surviving childbirth shouldn’t be a privilege; it should be the norm. Tragically this is not the case for so many women around the world. As PPH is the leading cause of maternal mortality globally, we are working together with our low– and middle-income country partners to find solutions to stop women from bleeding to death after childbirth.”

Professor Hadiza Galadanci, from one of the University’s partners in Nigeria, commented: “One of the most frightening sights in Obstetrics is to see blood pouring from a woman after birth and to try all you can to stop it and you are not able to. If E-MOTIVE strategy is implemented in low- and middle-income countries, the light at the end of the tunnel to reducing maternal deaths due to PPH will be bright.”

The E-MOTIVE trial has the potential to revolutionise how medical institutions diagnose and treat PPH, and remove it from the list of life-threatening conditions facing pregnant women.

As we approach International Mother’s Day on Sunday 9 May, it is important for everyone to care and be aware of the risks that women across the world face when bringing life into the world, and how these risks can be reduced.

a pregnant woman in a patterned dress sits on the edge of a hospital bed. a female doctor is speaking to her, with hands clasped.

End the postcode lottery in miscarriage care and treatment, say researchers

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

Leading experts at BHP founder-member the University of Birmingham and Tommy’s National Centre for Miscarriage Research are calling on the UK government to invest in early pregnancy units and recurrent miscarriage clinics to end the current care and treatment postcode lottery.

The calls come as the team has laid bare the devastating impact of miscarriage and sets out recommendations to improve treatment and care in a series of three articles published today in The Lancet.

Urgent changes should be made 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.

Miscarriage care must also go beyond current best practice to include long-term mental health support to those who need it, while high-risk groups should also be offered specialist help from pre-conception and throughout pregnancy, they say.

While the UK provides national statistics for losses such as stillbirth and neonatal death, it does not for miscarriage. The team is calling for the UK – and all countries globally – to routinely publish their national miscarriage statistics to provide a vital benchmark to improve from; accelerate further research; develop public health policy; and ultimately improve care and support for families.

Together, following analysis of systematic reviews; appraisal of existing guidelines; and a UK-wide conference of experts, the researchers have developed recommendations for healthcare practice grouped into three categories: diagnosis of miscarriage, prevention of miscarriage in women with early pregnancy bleeding, and management of miscarriage.

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.

Women have a 15% risk of miscarriage, and the team’s review of existing research shows risk factors for miscarriage include older age in both males and females, previous miscarriages, smoking, alcohol, and stress levels.

While the link between age and miscarriage is well established, the review uncovered a significant risk to black women, with 40% higher miscarriage rates in this group than their white counterparts. The researchers say further investigation is needed to understand the reasons for this stark contrast, and they are exploring whether it could be related to other health issues that more commonly affect black women that can complicate pregnancy, such as fibroid conditions and autoimmune disorders.

While some risk factors can be controlled, such as alcohol consumption and smoking, many cannot. Therefore, the researchers say care and support must be targeted at these higher-risk groups in addition to nation-wide changes to ensure quality services are consistently available to all.

The consequences of miscarriage are both physical, such as bleeding or infection, and psychological. The team of Tommy’s and University of Birmingham researchers found profound psychological effects on both parents – miscarriage almost quadrupled the risk of suicide, doubled the risk of depression, and similarly raised the risk of anxiety. Previous studies from another team at Tommy’s National Centre for Miscarriage Research showed that one in five mothers and one in twelve partners experience long-term symptoms of post-traumatic stress after loss.

Senior research author Arri Coomarasamy, Professor of Gynaecology & Reproductive Medicine at the University of Birmingham and Director of Tommy’s National Centre for Miscarriage Research, said: “Despite the many advances in miscarriage research and care, we are really just at the beginning, with many more avenues to investigate – for example, we need to understand why there is a higher rate of miscarriage in black women and why miscarriage is associated with an increased future risk of premature birth.

“We don’t even know exactly how many miscarriages happen in the UK; without this data, the scale of the problem is hidden, and addressing it will not be prioritised.

“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 variation in quality and availability of miscarriage care across the UK can lead to life-long problems for families already enduring an unbearable experience; it shouldn’t matter who you are or where you live, and you shouldn’t have to endure repeated heart-breaking losses before you get the right help.

“Everyone should be given care and advice after each miscarriage to reduce the chance of it happening again, with specialist support for those most at risk. Mothers’ care must consider their long-term risks, especially in future pregnancies, and both parents must be offered mental health support.

“We know what to do and how to do it – now we need a commitment from the NHS to put the knowledge we have into practice everywhere. With national targets to reduce premature birth and stillbirth, it’s time to prioritise miscarriage too.”

Recommendations outlined in The Lancet papers include:

    • Individualised care according to women’s and their partners’ needs and preferences.
    • Early pregnancy services focused on providing an effective ultrasound service and miscarriage management pathway, including medical management and surgical management.
    • Prescribing vaginal micronized progesterone for pregnant women with the dual risk factors of early pregnancy bleeding and a history of previous miscarriage.
    • Training for clinical nurse specialists and doctors to deliver comprehensive miscarriage care in dedicated early pregnancy units.
    • A defined and universally available minimum set of investigations and treatments to be offered to couples suffering recurrent miscarriages.
    • Screening and care for mental health issues and future obstetric risks incorporated into the care pathway for couples with a history of recurrent miscarriage.
    • Structured care using a ‘graded model’ where women are offered online healthcare advice and support, care in a nurse or midwife-led clinic, and care in a medical consultant-led clinic, according to clinical needs.

To find out more about the research, visit Tommy’s ‘Miscarriage Matters’ campaign, and sign a campaign petition stating mothers should not have to experience three miscarriages before they receive specialist care.

    close up of ultrasound, pregnant woman

    Midlands’ maternity triage system goes nationwide

    Written by Louise Stanley on . Posted in Maternal health.

    A maternity triage system developed by clinicians and researchers in the West Midlands has launched training online for the first time, becoming readily available to maternity teams across the UK.

    Midwives, obstetricians, and doctors across the NHS can now access the Birmingham Symptom-specific Obstetric Triage System (BSOTS) programme and training materials online for free via the Meridian Health Innovation Exchange – part of BHP member West Midlands Academic Health Network (WMAHSN).

    There is no standardised triage system in maternity care. The Birmingham Symptom Specific Triage System (BSOTS) assesses women presenting themselves with unexpected pregnancy related problems or concerns, and then allocates a colour code, so hospital staff can see at a glance who needs to be prioritised.

    Developed collaboratively between BHP founder members Birmingham Women’s and Children’s NHS Foundation Trust (BWC) and the University of Birmingham, supported by the WMAHSN and MidTECH Innovation, BSOTS was established to provide a standardised method of safely and efficiently assessing women when they attend with unexpected clinical concerns.

    Until now, there has been no consistent process available. BSOTS involves a brief standardised assessment of the women on presentation, followed by clear guidance developed to help midwives and clinicians determine the clinical urgency in which women need to be seen. This ensures that variation in treatment and outcomes is minimal and that participating maternity triage departments are working cohesively.

    An initial evaluation at BWC showed that BSOTS increased the number of women seen within 15 minutes of attendance to maternity triage from 38% (159/421) to 53% (209/391). The system also appeared to reduce the time between attendance to medical review for those who required it.

    By digitising the resources and training materials, trusts from further afield can sign up and implement the award-winning programme more easily and quickly than ever.

    BSOTS has been adopted by 34 maternity units in the UK with a further 20 in the process of implementation, and 17 awaiting training. Sunshine Hospital in Victoria, Australia are the first international maternity unit to implement BSOTS with interest from others. Participating Trusts have already noticed positive changes in work organisation and practices, along with a reduction in staff anxiety often associated with triage work.

    Its success in safeguarding women has seen the BSOTS programme gain support by the Royal College of Midwives (RCM) and the Royal College of Obstetricians and Gynaecologists (RCOG) who support  its implementation.

    The programme has also been recognised at the Health Service Journal (HSJ) Patient Safety Awards 2020, as Maternity and Midwifery Services Initiative of the Year and was shortlisted for its Patient Safety Innovation of the Year award.

    Helen Hunt, Patient Safety Assistant Programme Manager at WMAHSN, said: “We are so proud to be launching BSOTS on the Meridian Health Innovation Exchange. Streamlining the care of expecting mums is vital and taking the programme online will allow more NHS Trusts and maternity departments across the UK to take a step forward and help ensure that this happens nationwide. We’re so excited to see the roll out.”

    Sara Kenyon, Professor of Evidence Based Maternity Care at the University of Birmingham, added: “Previously, BSOTS training has been done either face-to-face or over Zoom, meaning that training and materials haven’t been as accessible to maternity teams as we would have liked.

    “However, the new electronic sign-up process makes it easier for maternity sites across the country to access the resources necessary to put BSOTS into practice and improve the way maternity triage work is managed.”

    Dr Nina Johns, Consultant Obstetrician at The Royal Wolverhampton NHS Trust and co-creator of BSOTS added: “The BSOTS programme has proved to be invaluable to midwives, obstetricians, and doctors across the UK; not only does it improve quality of care and the safety of pregnant women and staff, it also allows for better communication and creates a less stressful triage environment for staff.

    “We hope that by digitising the sign-up process, many more teams will be able to access and implement the service to improve safety & clinical safety in maternity triage.”

    Maternity teams will be able to sign up for access to the BSOTS training materials for free via the Meridian Health Innovation Exchange. Existing BSOTS users will also be able to sign up to access to the digital triage resources which can be used independently or in conjunction with BadgerNet.

    To find out more about BSOTS, or to sign up to the programme, visit the Meridian Health Innovation Exchange website.

     

    Birmingham maternity experts call for urgent action on pregnancy ‘drug drought’

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

    Leaders in maternal healthcare from Birmingham Health Partners (BHP) have called for lifesaving research into pharmaceuticals for use during pregnancy, in a new report which highlights the challenges of pregnancy-related complications, pre-term birth and pre-existing conditions.

    Globally, 2.7 million women and children die each year from causes related to pregnancy and childbirth – including one death every six minutes due to pre-eclampsia. As well as pregnancy-related health conditions which develop during pregnancy, expectant mothers may be diagnosed with infections such as COVID-19 or serious diseases including cancer, and many women enter pregnancy with pre-existing conditions like asthma, diabetes or depression. Despite this, only one new drug has been developed specifically for use in pregnancy in more than 30 years, and 73% of drugs used in pregnancy come with no safety information relating to their use by pregnant women.

    Experts from BHP’s founding members the University of Birmingham and Birmingham Women’s and Children’s NHS Foundation Trust are today urging politicians, clinicians, academia, industry, patients and research funders to end this ‘drug drought’ through developing and testing new and existing medicines in pregnancy, and help achieve the UK Government’s aim to halve maternal and infant deaths by 2025. The report, ‘Safe and Effective Medicines for Use in Pregnancy: A Call to Action’ sets out how this crucial research can be managed to de-risk research, mitigate safety concerns and give confidence to women and their clinicians.

    BHP’s Katie Morris, Professor of Obstetrics and Maternal Fetal Medicine, explained: “The COVID-19 pandemic and confusion surrounding the vaccine has brought into sharp focus the absence of pregnant women in most pharmaceutical trials. The lack of understanding of which drugs can be safely used in pregnancy combined with reluctance to develop new medicines for mothers-to-be adds up to a major global public health issue, but it’s one which could be reversed. With collaborative effort, we can stop excluding pregnant women and breastfeeding mothers from clinical research and give them access to the medicines they deserve.”

    Peter Brocklehurst, Professor of Women’s Health at BHP, commented: “Pregnancy complications, including pre-term birth and pre-eclampsia have a huge impact on families and society as a whole. The consequences of preterm birth alone cost the UK economy almost £3bn annually and, while we have the ability to tackle these issues for mothers at home and abroad, we have barely begun. Many of the women and babies who die during pregnancy and birth could be saved, and 15 million babies could be spared the disability and mortality risks linked with being born too early, if we act now.”

    Dr Sheuli Porkess, Medical Director at the Association of the British Pharmaceutical Industry, commented: “We completely agree on the need for action to address the needs of pregnant women and the lack of licensed medicines and treatments researched for use in pregnancy and breastfeeding.

    “We have already started work, including on better representation of pregnant women in the design of and recruitment for clinical trials. We are pleased to have Maternal Health reflected in our Memorandum of Understanding with Birmingham Health Partners and to be working with our members, BHP, the MHRA, HRA and others on this important area.”

    The report concludes that, through collaboration, research into medicines for pregnancy could be progressed at pace. By creating financial incentives for investment, building public-private partnerships, addressing regulatory gaps and hurdles and harnessing new technologies, the UK can directly impact the health, safety and wellbeing of pregnant women worldwide.

    ‘Safe and Effective Medicines for Use in Pregnancy: A Call to Action’ can be downloaded from https://www.birminghamhealthpartners.co.uk/wp-content/uploads/2021/01/21560-Policy-Commission-Maternal-Health-Report-AW-accessible.pdf. Its signatories – BHP Professors Katie Morris, Peter Brocklehurst, Arri Coomarasamy and Shakila Thangaratinam – will next establish a major policy commission to review evidence, opportunities and options for policy which will be integral to the formation of clear, multi-stakeholder recommendations to the UK Government.