Mifepristone and Misoprostol Versus Misoprostol Alone in the Medical Management of Missed Miscarriage

• Status: Completed
• Trial end date: 2020-01-09
• Target enrollment: 0
• Participant gender: Female

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
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

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
• Treatments: Mifepristone; Misoprostol

Criteria

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