When is a pregnancy nonviable and what criteria should be used to define miscarriage?

In 2011, the first systematic review of the evidence behind the diagnostic criteria for miscarriage was published. It states, “findings were limited by the small number and poor quality of the studies,” and concluded that further studies were, “urgently required before setting future standards for the accurate diagnosis of early embryonic demise.” This implies that data used to define criteria to diagnose miscarriage are unreliable. The 2011 Irish Health Service executive review into miscarriage misdiagnosis highlighted this issue. In parallel to these publications a multicenter prospective study was published examining cut-off values for mean sac diameter (MSD) and embryo size to define miscarriage. The authors also published evidence on expected findings when ultrasonography is repeated at an interval. This led to guidance on diagnostic criteria for miscarriage in the UK changing. These new criteria state miscarriage be considered only when: an empty gestation sac has an MSD of ≥25 mm (with no obvious yolk sac), or embryonic crown rump length ≥7 mm (the latter without evidence of fetal heart activity). If in doubt, repeating scans at an interval is emphasized. It is axiomatic that decisions about embryonic viability must not be open to doubt. So it is surprising how little evidence exists to support previous guidance. Any clinician working in this area knows of women being wrongly informed that their pregnancy has failed. This cannot be acceptable and guidance in this area must be “failsafe.”