A randomised placebo-controlled trial of mifepristone and misoprostol versus misoprostol alone in the medical management of missed miscarriage
Aim: To investigate the clinical and cost-effectiveness of MifeMiso combination (mifepristone and misoprostol) versus misoprostol alone in the management of missed miscarriage.
Primary clinical objective: 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.
Key secondary objective: To test the hypothesis that the addition of mifepristone reduces the need for surgical intervention to resolve the miscarriage
Other secondary objectives:
1. To evaluate if the addition of mifepristone reduces the need for further doses of misoprostol
2. To evaluate if the addition of mifepristone improves other clinical outcomes including surgical intervention up to and including 7 days post-randomisation and after 7 days post-randomisation, duration of bleeding, infection, negative pregnancy test at 21 days post-randomisation, time from randomisation to discharge from EPU care, side effects and complications
3. To evaluate if the addition of mifepristone improves patient satisfaction
4. To assess the cost-effectiveness of the combination of mifepristone and misoprostol in the medical management of missed miscarriage
Economic objectives: To assess the cost-effectiveness of the combination of mifepristone and misoprostol in the medical management of missed miscarriage based on an outcome of additional cost per additional successfully managed miscarriage and additional cost per additional quality-adjusted life-year (QALY). Using a model-based economic evaluation we will further explore the cost-effectiveness of the medical management of missed miscarriage, as explored in the proposed trial, with alternative management strategies, such as surgical and expectant, based on available secondary sources.
Mixed-method evaluation objectives: To explore the satisfaction of patients who complete the trial protocol. The results of the satisfaction survey (CSQ-8) will act as a sampling frame to conduct semi-structured interviews to further investigate patient experiences and satisfaction with medical management of missed miscarriage.
NIHR HTA Funder Ref: 15/160/02
Sponsor Ref: RG_16-076
ISRCTN No.: 17405024
REC Ref: 17/WM/0017
IRAS No.: 201600
EudraCT No.: 2016-005097-35
Sponsor: University of Birmingham
Chief Investigator: Prof Arri Coomarasamy
Coordinating Centre: Birmingham Clinical Trials Unit, University of Birmingham
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.