REVIEW OF CLINICAL EXPERIENCE WITH ATOSIBAN AND THE TRACTOCILE EFFICACY ASSESSMENT SURVEY IN EUROPE (TREASURE) STUDY PROTOCOL

SUMMARY A phase IV multinational, multicentre study has been designed – the Tractocile Efficacy Assessment Survey in Europe (TREASURE). The aim is to assess atosiban in the clinical setting, which is associated with fewer restrictions than in phase III trials. Atosiban is to be compared with ‘usual care’ in women eligible for treatment, and will also be evaluated as deferred or immediate treatment in women who have not yet fulfilled the diagnostic criteria for pre‐term labour. Exploring the use of atosiban beyond the normal indications may allow the identification of additional subpopulations of women who will benefit from early treatment. TREASURE will offer data on new diagnostic tools, investigate respiratory distress syndrome according to severity and record the use of antenatal steroids. It is hoped that additional information concerning the subtle differences in clinical practice will broaden our understanding of how to manage pre‐term labour and offer the chance to revise treatment guidelines. ( Int J Clin Pract 2003; 57(2): 121–127)