A new drug combination is more effective for women having miscarriages without symptoms than current standard NHS treatment, according to an NIHR funded study from Tommy’s National Centre for Miscarriage Research published today in The Lancet.
Missed miscarriage (also known as delayed or silent miscarriage) is 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. This new research shows that misoprostol is more effective when combined with mifepristone, an anti-progesterone drug used to induce labour.
Tommy’s researchers at the University of Birmingham studied 711 women across 28 UK hospitals with a diagnosis of missed miscarriage in the first 14 weeks of pregnancy, randomly assigning them to receive either mifepristone or a placebo drug followed by misoprostol 2 days later.
The trial found that the combined drug treatment worked in 83% of cases, compared to 76% in the placebo group – and crucially, it reduced the need for surgery. 1 in 4 women (25%) given the placebo later needed an operation to complete the miscarriage, compared with less than 1 in 5 (18%) of those who had the new medication.
Researchers are doing further analysis to see exactly how much money switching to this combined treatment could save healthcare providers, but these findings suggest it would be more cost-effective for the NHS. It would also be better for patients, such as Claire and Katy, who have shared their stories to highlight the need to improve miscarriage medication.
32-year-old Claire Bromley from Kent chose surgery when she miscarried this 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 suffer like I did.
“I was told the 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, it 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.”
34-year-old Katy Allan from Yorkshire has experienced multiple miscarriages and a range of treatment - initially having surgery, which caused internal scarring, so after that she chose medication hoping to avoid more problems. Katy said: “It was a 4 month long nightmare, with several rounds of medication and hospital staff trying to remove the pregnancy while I was awake, which then ended 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 waiting for treatment to work made the miscarriage even harder, so I hope this new research can help to prevent others going through what I did.”
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.
Dr Justin Chu from Tommy’s National Centre for Miscarriage Research, who led the study at the University of Birmingham’s Clinical Trials Unit, explained: “Particularly given the extra strain on the NHS in the Covid-19 pandemic, our findings could have huge benefits if they’re translated into clinical practice, with better outcomes for patients and lower costs for care services. 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: “1 in 4 women experience miscarriage, yet the myth persists that ‘these things just happen’ and it’s not worth investigating; we refuse to accept this. Besides the physical harm, miscarriage can have serious psychological and emotional consequences – as these stories of treatment failing shared alongside this new research make painfully clear. It’s vital that we find better ways to care for everyone going through miscarriage, while science continues to unpick how we can stop it from happening.”
Prof Andrew Shennan, clinical director of NIHR Clinical Research Network South London and professor of obstetrics at Kings College London, added: “This important NIHR-funded study presents compelling results indicating more effective treatments that can help women have better outcomes after miscarriage. The fact that the need for surgery is reduced using this new combination of drugs is a positive result for both patients and those who plan and provide NHS care services.”
For more information please contact Sophie Belcher, Communications Manager, University of Birmingham, on +44 7815607157. Alternatively, contact the Press Office out of hours on +44 (0)7789 921165.
This project was funded by the National Institute for Health Research (NIHR) HTA programme (ref 15/160/02). The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health and Social Care.
This work uses data provided by patients and collected by the NHS as part of their care and support and would not have been possible without access to this data. The NIHR recognises and values the role of patient data, securely accessed and stored, both in underpinning and leading to improvements in research and care. www.nihr.ac.uk/patientdata.
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.
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 3 universities (University of Birmingham, University of Warwick and Imperial College London) and 4 hospitals (Birmingham Women’s Hospital, University Hospitals Coventry and Warwickshire, Queen Charlotte’s Hospital and St Mary’s Hospital), and includes a network of 4 specialist research clinics where women with a history of miscarriage can take part in research trials to access cutting-edge tests and treatments.
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.