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Dispute about the INFANT study results

08-May-2017

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. http://www.sciencedirect.com/science/article/pii/S0140673617307146 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