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."
INFORMATION:
For more information please contact Emma McKinney, Media Relations Manager, University of Birmingham, on +44 7815607157. Alternatively, contact the Press Office out of hours on +44 (0)7789 921165.
Notes to Editors
* Ogwulu et al (May, 2021). 'Cost-effectiveness of mifepristone and misoprostol versus misoprostol alone for the management of missed miscarriage: an economic evaluation based on the MifeMiso Trial'. British Journal of Obstetrics and Gynaecology. Read the paper here: https://obgyn.onlinelibrary.wiley.com/doi/10.1111/1471-0528.16737
* References
*Chu et al (Aug, 2020). 'Mifepristone and misoprostol versus misoprostol alone for the management of missed miscarriage (MifeMiso): a randomised, double-blind, placebo-controlled trial'. The Lancet. DOI: 10.1016/S0140-6736(20)31788-8. The paper can be read here: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)31788-8/fulltext
* About the University of Birmingham
The University of Birmingham is ranked amongst the world's top 100 institutions, and its work brings people from across the world to Birmingham, including researchers and teachers and more than 6,500 international students from nearly 150 countries.
* About Tommy's
1 in 4 women will lose a baby during pregnancy or birth. Tommy's believes that every baby lost is one too many. Tommy's is a national charity that works tirelessly to reduce the UK's unacceptable rates of miscarriage, stillbirth and premature birth. Tommy's funds pioneering medical research to discover the causes of baby loss and helps women at every stage of their pregnancy journeys, supporting them and their partners with expert information and care. Tommy's wants to make pregnancy safer for all and ensure that excellent maternity care is available for every family, every baby, everywhere.
* About Tommy's National Centre for Miscarriage Research
Miscarriage is the most common pregnancy complication, with 1 in 4 women experiencing at least 1 miscarriage in their reproductive lifetime. Tommy's believes this can and must change - so in 2016, we opened the UK's first national centre for miscarriage research. It is the biggest research centre focused on miscarriage in Europe and a unique partnership between three universities (University of Birmingham, University of Warwick and Imperial College London) and four hospitals (Birmingham Women's Hospital, University Hospitals Coventry and Warwickshire, Queen Charlotte's Hospital and St Mary's Hospital), and includes a network of four specialist research clinics where women with a history of miscarriage can take part in research trials to access cutting-edge tests and treatments.
* About the National Institute for Health Research (NIHR)
The National Institute for Health Research (NIHR) is the nation's largest funder of health and care research. The NIHR:
- Funds, supports and delivers high quality research that benefits the NHS, public health and social care
- Engages and involves patients, carers and the public in order to improve the reach, quality and impact of research
- Attracts, trains and supports the best researchers to tackle the complex health and care challenges of the future
- Invests in world-class infrastructure and a skilled delivery workforce to translate discoveries into improved treatments and services
- Partners with other public funders, charities and industry to maximise the value of research to patients and the economy
- The NIHR was established in 2006 to improve the health and wealth of the nation through research, funded by the Department of Health and Social Care. In addition to its national role, the NIHR supports applied health research for the direct and primary benefit of people in low- and middle-income countries, using UK aid from the UK government.
