The MifeMiso trial is a double blind, placebo-controlled trial 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.
Should the MifeMiso trial demonstrate a benefit from the intervention, it would provide important evidence for the combined use of these treatments for the timely resolution of miscarriage.
In order to recruit the required number of women needed to provide statistically reliable answers, and to maximise the clinical relevance of the findings, the trial is designed to fit in with routine hospital practice as far as possible, imposing minimal additional workload by keeping extra clinic-based tests and evaluations to a minimum.
Trial design - A randomised, parallel group, double-blind, placebo-controlled multicentre study, with health economic and mixed-methods evaluation.
Setting - Early pregnancy units and gynaecology departments.
Number of participants - We plan to randomise 710 women in total (355 participants each in the mifepristone and placebo arms).
Study interventions - A single dose of oral mifepristone 200mg, followed by a single dose of vaginal, oral or sublingual misoprostol 800mcg 2 days later, will be compared with an oral placebo tablet followed by a single dose of vaginal, oral or sublingual misoprostol 800mcg 2 days later.
Duration of study - It is anticipated that the trial will last for three years.
Randomisation - Participants will be randomised on-line via a secure internet facility in a 1:1 ratio through a third party independent Integrated Trial Management System (MedSciNet Clinical Trial Framework). A “minimisation” procedure using a computer-based algorithm will be used to avoid chance imbalances in the following important variables:
Maternal age (<30, ≥30 years), body mass index (<35, ≥35 kg/m2), previous parity (nulliparous, parous women), gestational age (<70, ≥70 days), amount of bleeding (PBAC score; ≤2, ≥3) and randomising centre