The MifeMiso trial
The MifeMiso trial was an important research study which looked at whether a single drug treatment (misoprostol) or a combination of drug treatments (mifepristone plus misoprostol two days later) is best for the medical management of missed miscarriage.
The results, published in 25 August 2020 in the Lancet , showed that the combination of drug treatments was the most effective option. A further study, published in the BJOG International Journal of Obstetrics & Gynaecology on 10 May 2021, showed that combined treatment was also cost-effective.
Treatment with mifepristone two days before misoprostol, led to the miscarriage resolving more quickly than treatment with misoprostol alone. The combined treatment also reduced the need for surgery following medical management, and was less costly overall.
We hope that this will lead to changes in the NICE guidance on the management of miscarriage (NG126).
We provide information about this research trial below, and you can read more about medical management of miscarriage here.
About the MifeMiso trial
MifeMiso was a randomised, double-blind, placebo-controlled trial:
Randomised: The women who took part were given either the treatment drug (mifepristone) or a placebo – a dummy drug that has no active ingredients. A computer made the selection so it was completely random.
Double-blind: The women in the study were not told whether they were taking the active medicine or the placebo – and neither were their doctors. So both were blinded to this information.
Placebo-controlled: Half the women in the study had the active medicine and half (the controls) had the placebo. The medicine that they received looked exactly the same to them and their doctors, but a completely separate group kept a record of which women had mifepristone and which had the placebo.
It is important to note that all women received misoprostol two days later, which is currently the recommended treatment for the medical management of miscarriage.
The MifeMiso trial is now complete, but here is the information that we provided while it was open:
Who can take part?
The researchers are recruiting women who:
- are aged over 16
- are in the first 13+6 weeks of pregnancy
- have had an ultrasound scan showing a missed miscarriage
- are willing to be selected at random to have either the treatment or a placebo, without knowing which they are given.
What would I need to do?
If you agree to take part, you will be given the first tablet to take by mouth whilst you are at the hospital. Two days later, you will be asked to take the second tablet. How you take this depends on your local hospital; it might involve you coming back to the hospital to insert the tablet into your vagina (rather like using a tampon) or you may take it by mouth. You would then need to come back to the hospital five days later for a check-up scan to see if your miscarriage is now resolved.
The trial team will collect most of their study information from your hospital notes but they may need to contact you to check some details. They will ask you to complete a short questionnaire to record how you are feeling at your hospital visits and upon discharge.
Once your miscarriage has resolved, you will also be asked to complete a questionnaire to record your experiences of taking part in the trial. With your permission, you may be asked to talk in depth with one of the dedicated research team members to provide a more in depth description of your experiences.
Where is it taking place?
The trial will recruit women from centres across England, Scotland and Wales. The following hospitals are currently recruiting patients:
- Birmingham: Birmingham Women’s Hospital
- Birmingham: Heartlands Hospital
- Bridgend: Princess of Wales Hospital
- Bristol: St Michael’s Hospital
- Bristol: Southmead Hospital
- Burnley: Burnley General Hospital
- Carshalton: St Helier Hospital
- Coventry: University Hospital
- Edinburgh: Royal Infirmary
- Epsom: Epsom Hospital
- Glasgow: Royal Infirmary
- Glasgow: Queen Elizabeth University Hospital
- Isleworth: West Middlesex University Hospital
- Liverpool: Women’s Hospital
- London: Chelsea and Westminster Hospital
- London: Kings College Hospital
- London: Newham University Hospital
- London: Royal London Hospital
- London: St Thomas’ Hospital
- London: University College Hospital
- London: Whipps Cross Hospital
- Newcastle: Royal Victoria Infirmary
- Nottingham: Queen’s Medical Centre
- Portsmouth: Queen Alexandra Hospital
- Southampton: Princess Anne Hospital
- Sunderland: Royal Hospital
- Swansea: Singleton Hospital
- Telford: Princess Royal Hospital
We’ll add new sites to the list as they open.
A personal experience
Emma took part in the MifeMiso trial.
After having two healthy pregnancies, I was shocked and very distressed to find at my 12 week scan that my third pregnancy had not progressed beyond six weeks – a missed miscarriage.
As I had not naturally miscarried the baby in the 6 weeks since the pregnancy ended, and surgery seemed so invasive, I decided [on] the medical option and chose to take part in the MifeMiso research trial. This way I could contribute to scientific knowledge and something good would come out of this experience.
She shares her experience here.
If you would like more information, or have questions or concerns about the trial, please contact the MifeMiso trial office at firstname.lastname@example.org. You may also like to visit the trial website.
If your questions are less medical/scientific and more about feelings or concerns, do contact us at email@example.com or call us on 01924 200799.
This study is funded by the NIHR HTA (project reference 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.