Mifepristone and Misoprostol Versus Misoprostol Alone in the Medical Management of Missed Miscarriage
Status:
Completed
Trial end date:
2020-01-09
Target enrollment:
Participant gender:
Summary
Miscarriage is the most common complication of pregnancy. As many as 15-25% of pregnancies
end in miscarriage, and the number of miscarriages in England is estimated to be
approximately 125,000 per year. Miscarriage often brings not only physical pain, bleeding and
risks of infection, but also psychological impacts on women and their families. This study
will focus on women whose pregnancy sac remains inside the womb (known as a missed
miscarriage) and opt for medical management of their miscarriage up to 13+6 weeks of
pregnancy. NICE currently recommends that a drug called misoprostol (a vaginal pessary or
oral tablet that makes the womb contract) should be used in the medical treatment of
miscarriage. However, there is evidence to suggest that combining this drug with mifepristone
(an oral tablet that reduces pregnancy hormones) may be more effective in treating
miscarriage. Therefore, to test this in a clinical trial, participants will be allocated at
random to receive either mifepristone followed by misoprostol, or a dummy drug (placebo)
followed by misoprostol. Neither the participants nor the researchers will know what
allocation is decided, which is necessary to test the treatments fairly. The main outcome of
interest will be whether miscarriage is complete within 7 days of randomisation. If
miscarriage is not complete then further treatment (more tablets or surgery) will be offered.
A number of other key outcomes, such as the need for an operation, will also be assessed. We
will also study the views and experience of the participants regarding the tablet treatment.
We anticipate that 710 women will be required to take part in the study to answer this
question with confidence. We estimate that we would be able to recruit this many women in two
years.
Phase:
Phase 3
Details
Lead Sponsor:
University of Birmingham
Collaborators:
Barts & The London NHS Trust Birmingham Women's NHS Foundation Trust City Hospitals Sunderland NHS Foundation Trust Heart of England NHS Trust King's College Hospital NHS Trust Liverpool Women's NHS Foundation Trust Oxford University Hospitals NHS Trust Queen Mary University of London Queen's Medical Centre Royal Infirmary of Edinburgh Royal Victoria Infirmary St Mary's Hospital, London The Leeds Teaching Hospitals NHS Trust University College London Hospitals University Hospital Southampton NHS Foundation Trust University Hospitals Coventry and Warwickshire NHS Trust University of Edinburgh University of Nottingham University of Southampton University of Warwick