Missed Miscarriage Clinical Trial
— MifeMisoOfficial title:
A Randomised Placebo-controlled Trial of Mifepristone and Misoprostol Versus Misoprostol Alone in the Medical Management of Missed Miscarriage
| Verified date | April 2020 |
| Source | University of Birmingham |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 711 |
| Est. completion date | January 9, 2020 |
| Est. primary completion date | January 9, 2020 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 16 Years and older |
| Eligibility |
Inclusion Criteria: - Women diagnosed with missed miscarriage by pelvic ultrasound scan in the first 13+6 weeks of pregnancy that choose to have medical management of miscarriage. - Age 16 years and over - Willing and able to give informed consent. Exclusion Criteria: - Women opting for alternative methods of miscarriage management (expectant or surgical) - Diagnosis of incomplete miscarriage. - Life threatening bleeding. - Contraindications to mifepristone or misoprostol use for example chronic adrenal failure, known hypersensitivity to either drug, haemorrhagic disorders and anticoagulant therapy, prosthetic heart valve or history of endocarditis, existing cardiovascular disease, severe asthma uncontrolled by therapy or inherited porphyria. - Participation in any other blinded, placebo-controlled trials of investigational medicinal products in pregnancy. - Previous participation in the MifeMiso trial - Woman not able to attend for day 6-7 ultrasound scan |
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | Birmingham Heartlands Hospital | Birmingham | |
| United Kingdom | Birmingham Women's Hospital | Birmingham | |
| United Kingdom | Southmead Hospital | Bristol | |
| United Kingdom | St Michael's Hospital | Bristol | |
| United Kingdom | Burnley General Hospital | Burnley | |
| United Kingdom | University Hospital Coventry | Coventry | |
| United Kingdom | Royal Infirmary of Edinburgh | Edinburgh | |
| United Kingdom | Epsom Hospital | Epsom | |
| United Kingdom | St Helier Hospital | Epsom | |
| United Kingdom | Glasgow Royal Infirmary | Glasgow | |
| United Kingdom | Queen Elizabeth University Hospital | Glasgow | |
| United Kingdom | Liverpool Women's Hospital | Liverpool | |
| United Kingdom | Chelsea and Westminster Hospital | London | |
| United Kingdom | Kings College Hospital | London | |
| United Kingdom | Newham University Hospital | London | |
| United Kingdom | Royal London Hospital | London | |
| United Kingdom | St Thomas' Hospital | London | |
| United Kingdom | University College Hospital London | London | |
| United Kingdom | West Middlesex Hospital | London | |
| United Kingdom | Whipps Cross University Hospital | London | |
| United Kingdom | Royal Victoria Infirmary | Newcastle | |
| United Kingdom | Queen's Medical Centre | Nottingham | |
| United Kingdom | Queen Alexandra Hospital | Portsmouth | |
| United Kingdom | Princess Anne Hospital | Southampton | |
| United Kingdom | Sunderland Royal Hospital | Sunderland | |
| United Kingdom | Princess of Wales Hospital | Swansea | |
| United Kingdom | Singleton Hospital | Swansea | |
| United Kingdom | Princess Royal Hospital | Telford |
| Lead Sponsor | Collaborator |
|---|---|
| University of Birmingham | 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 |
United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Outpatient or emergency visits | Number of outpatient or emergency visits | From randomisation until discharge from EPU care; assessed up to approximately 8 weeks | |
| Other | Inpatient admissions (nights in hospital) | Number of inpatient admissions (nights in hospital) | From randomisation until discharge from EPU care; assessed up to approximately 8 weeks | |
| Primary | Failure to spontaneously pass the gestational sac within 7 days after randomisation | To 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. | Within 7 days after randomisation | |
| Secondary | Surgical intervention to resolve the miscarriage (collected up to discharge from EPU care) | Surgical intervention to resolve the miscarriage | From randomisation until discharge from EPU care; assessed up to approximately 8 weeks | |
| Secondary | Surgical intervention to resolve the miscarriage up to and including day 7 post-randomisation | Surgical intervention to resolve the miscarriage | From randomisation until day 7 post-randomisation | |
| Secondary | Surgical intervention to resolve the miscarriage after day 7 post-randomisation to discharge from EPU care | Surgical intervention to resolve the miscarriage | From day 8 post-randomisation until discharge from EPU care; assessed up to approximately 8 weeks | |
| Secondary | Need for further doses of misoprostol up to day 7 post-randomisation | Need for further doses of misoprostol up to day 7 post-randomisation | After initial 800mcg dose of misoprostol at day 2 until day 7 post-randomisation | |
| Secondary | Need for further doses of misoprostol up to discharge from EPU care | Need for further doses of misoprostol up to discharge from EPU care | After initial 800mcg dose of misoprostol at day 2 until discharge from EPU care; assessed up to approximately 8 weeks | |
| Secondary | Overall patient satisfaction score (measured using the CSQ-8 questionnaire and collected upon discharge from EPU care). | Overall patient satisfaction score (measured using the CSQ-8 questionnaire and collected upon discharge from EPU care). | Within 6 weeks of discharge from EPU care | |
| Secondary | Patient quality of life (Index value and overall health status measured using the EQ-5D-5L questionnaire | Patient quality of life (Index value and overall health status measured using the EQ-5D-5L questionnaire and collected on date of randomisation, day 6-7 post-randomisation or day of follow-up USS if different to day 6-7 and day 21 +/- 2 days post-randomisation. If a woman obtains an initial positive pregnancy test result at day 21 +/- 2 days post-randomisation then a further EQ-5D-5L questionnaire is collected upon discharge from EPU care). | Completion on date of randomisation, day 6-7 post-randomisation or day of follow-up USS if different to day 6-7 and day 21 +/- 2 days post-randomisation. Completion of all patient quality of life assessments up to approximately 8 weeks post-randomisation | |
| Secondary | Duration of bleeding reported by woman (days). (collected up to discharge from EPU care) | Duration of bleeding reported by woman (days). (collected up to discharge from EPU care) | From randomisation until discharge from EPU care; assessed up to approximately 8 weeks | |
| Secondary | Diagnosis of infection associated with miscarriage requiring outpatient antibiotic treatment (collected up to discharge from EPU care) | Diagnosis of infection associated with miscarriage requiring outpatient antibiotic treatment (collected up to discharge from EPU care) | From randomisation until discharge from EPU care; assessed up to approximately 8 weeks | |
| Secondary | Diagnosis of infection associated with miscarriage requiring inpatient antibiotic treatment (collected up to discharge from EPU care) | Diagnosis of infection associated with miscarriage requiring inpatient antibiotic treatment (collected up to discharge from EPU care) | From randomisation until discharge from EPU care; assessed up to approximately 8 weeks | |
| Secondary | Negative pregnancy test result 21 days (± 2 days) after randomisation. | Negative pregnancy test result 21 days (± 2 days) after randomisation. | 21 days (± 2 days) after randomisation. | |
| Secondary | Time from randomisation to discharge from EPU care (described using summary statistics only) | Time from randomisation to discharge from EPU care. | Time from randomisation to discharge from EPU care; assessed up to approximately 8 weeks | |
| Secondary | Blood transfusion required (collected up to discharge from EPU care) | Blood transfusion required (collected up to discharge from EPU care) | From randomisation until discharge from EPU care; assessed up to approximately 8 weeks | |
| Secondary | Side effects (collected up to discharge from EPU care) | Side effects (collected up to discharge from EPU care) | From randomisation until discharge from EPU care; assessed up to approximately 8 weeks | |
| Secondary | Death (collected up to discharge from EPU care) | Death (collected up to discharge from EPU care) | From randomisation until discharge from EPU care; assessed up to approximately 8 weeks | |
| Secondary | Any serious complications (collected up to discharge from EPU care) | Any serious complications (collected up to discharge from EPU care) | From randomisation until discharge from EPU care; assessed up to approximately 8 weeks |