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Dispute about the INFANT study results


The manufacturers of the expert CTG alert system (K2/Guardian) used in the INFANT trial (Lancet Online. March 21st) were disappointed by the negative results and have published their own interpretation “A flawed design foreseen” alongside the Lancet paper. They claim that since adverse events were lower than expected in both groups the overall use of the K2 Guardian monitor reduces adverse outcomes, and issued a press release to this effect.

The Royal College of Obstetricians & Gynaecologists (RCOG) and the British Materno-Fetal Medicine Society (BMFMS) responded in an open letter to their members as follows: “The RCOG and BMFMS are concerned that the claims made in the press release are inaccurate and may be misleading to our members”.  The debate is likely to continue.  


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Commentaries by Editor Prof. Jim Thornton