FAQs

MifeMiso is a randomised placebo-controlled trial of mifepristone and misoprostol versus misoprostol alone in the medical management of missed miscarriage. 

The MifeMiso trial will test the hypothesis that treatment with mifepristone plus misoprostol is superior to misoprostol alone for the resolution of miscarriage within 7 days in women diagnosed with missed miscarriage by pelvic ultrasound scan in the first 13+6 weeks of pregnancy.

Participants will be recruited from participating centres across the UK. Approximately 32 hospital units in the UK will contribute to the total, with more sites joining the study if required to randomise 710 women within two years.

Should the MifeMiso trial demonstrate a significant benefit from the intervention, it would provide important evidence for the combined use of these treatments for the timely resolution of miscarriage.

1. NICE guideline CG154 calls for a definitive trial to evaluate whether there is any benefit in using mifepristone in addition to misoprostol.

2. A patient survey supports the study. The survey (n=188) showed that 66% of women would consider taking part in the study (see protocol). 

3. A UK clinician survey supports the study. In the survey of 152 practitioners, 79% believed that a clinical trial is needed to investigate whether the mifepristone and misoprostol combination is more effective than misoprostol alone in the medical management of missed miscarriage (see protocol). 

4. The Association of Early Pregnancy Units, Early Pregnancy Clinical Studies Group, the Miscarriage Association and the Tommy’s Charity support this research.

5. If benefit is confirmed in the MifeMiso trial, women and the NHS stand to gain substantially. On the other hand, if mifepristone is found to be ineffective, treatment with mifepristone can be avoided.

6. Mifepristone treatment is cheap (£17.55 per 200mg oral tablet), and if benefit is confirmed, we expect rapid uptake of this intervention. 

A meeting will be held after the end of the study to allow discussion of the main results among the collaborators prior to publication. The success of the study will depend entirely on the wholehearted collaboration of a large number of doctors, nurses/midwives and others across the country. For this reason, the chief credit for the main results will be given not only to the central supervisory committees and/or organisers, but to all those who have collaborated in the trial. 

The University of Birmingham is acting as sponsor for the trial and Prof Arri Coomarasamy is the Chief Investigator. The administrative duties are being undertaken by Birmingham Clinical Trials Unit at the University of Birmingham.

The research costs of the MifeMiso trial are funded by a grant from the NIHR Health Technology Assessment (HTA) programme awarded to the University of Birmingham. 

Participating centres will be NHS hospitals, with at least one of the following:

• Dedicated EPAU where suspected miscarriages are managed
• Gynaecology ward

Each study centre must use an onsite pharmacy to dispense medications to participants, and be able to offer appointments for the women in a dedicated clinical setting. 

If there are any other questions you would like to see answered on this page, or if you're interested in participating in MifeMiso, please email the team at mifemiso@trials.bham.ac.uk