OBJECTIVE: Early pregnancy failure (EPF) is a common complication of pregnancy. Surgical intervention carries a risk of complications and, therefore, medical treatment appears to be a safe alternative. Unfortunately, the current medical treatment with misoprostol alone has complete evacuation rates between 53% and 87%. Some
reports suggest that sequential treatment with mifepristone and misoprostol leads to higher success rates than misoprostol alone.
METHODS: To evaluate the added value of mifepristone to current non-surgical treatment regimens in women with EPF we performed a systematic literature search. Electronic databases were searched: PubMed, Cochrane Library, Current Controlled Trials, and ClinicalTrials.gov. Clinical studies, both randomised and non-randomised trials, reporting on the added value of mifepristone to current non-surgical treatment regimens in women with EPF were included. Data of sixteen studies were extracted using a data extraction sheet (based on the Cochrane Consumers and Communication Review Group\'s data extraction template). The methodological quality was assessed using the Cochrane Collaboration Risk of Bias tool.
RESULTS: In five randomised and eleven non-randomised trials, success rates of sequential treatment with mifepristone and misoprostol in
case of EPF varied between 52% and 95%. Large heterogeneity existed in treatment regimens and comparators between studies.
CONCLUSIONS: The existing evidence is insufficient to draw firm conclusions about the added value of mifepristone to misoprostol alone. A sufficiently powered randomised, double blinded placebo-controlled trial is urgently required to test whether, in EPF, the sequential combination of mifepristone with misoprostol is superior to misoprostol only.