Regarding presentation of US randomized controlled STAN trial

On Thursday February 5th 2015 in San Diego, California, the US randomized controlled STAN trial* was presented as an oral abstract at The Pregnancy Meeting of the SMFM (Society for Maternal Fetal Medicine), attended by the Neoventa US team. Publication of this trial as a journal article is expected in 2016.

During the study, over 11’000 women were randomized either to fetal monitoring with EFM (CTG) + STAN or with EFM (CTG) only. The overall result was no difference in outcome between the two trial arms. Further details are expected in the full publication.

It is clear that both the STAN method’s application and the trial itself contain large differences as compared to European scientific evidence (previous European randomized controlled STAN trials) and clinical experience (observational STAN studies). Among the key differences in the trial were the STAN guidelines used. But there are also large differences in clinical practice between Europe and the US. In fact, the latter was stated in the oral presentation as the main reason for conducting the trial.

Neoventa remains fully committed and convinced of the advantages of using STAN technology in global clinical practice and we are looking forward to learning more about the US trial in the full publication. Our primary goal will then be to understand how the differences in STAN application and clinical practice compared to Europe lead to the study result, as well as to evaluate how the STAN method may be adapted to improve outcomes in the United States.

Christian Pitulia, COO Neoventa Medical AB

* Note the STAN Trial was conducted by the U.S. National Institutes of Health, National Institute of Child Health and Human Development.

 

# #