The MifeMiso trial
The MifeMiso trial is an important research study which is looking 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.
We provide information about it below, and you can read more about medical management of miscarriage here.
MifeMiso is a randomised, double-blind, placebo-controlled trial:
Randomised: The women who take part will be given either the treatment drug (mifepristone) or a placebo – a dummy drug that has no active ingredients. A computer makes the selection so it’s completely random.
Double-blind: The women in the study won’t be told whether they are taking the active medicine or the placebo – and neither will their doctors. So both are blinded to this information.
Placebo-controlled: Half the women in the study will have the active medicine and half (the controls) will have the placebo. The medicine that they receive will look exactly the same to them and their doctors, but a completely separate group will keep a record of which women have mifepristone and which have the placebo.
It is important to note that all women will receive misoprostol two days later, which is currently the recommended treatment for the medical management of miscarriage.
If you might be interested in taking part in the MifeMiso trial, here’s what you need to know:
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
- Burnley: Burnley General Hospital
- Carshalton: St Helier Hospital
- Coventry: University Hospital
- Edinburgh: Royal Infirmary
- 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.
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.