EXPRESSION OF CONCERN : Randomized controlled trial comparing ondansetron and placebo for the reduction of spinal anesthesia‐induced hypotension during elective cesarean delivery in Egypt

El Khouly, NI, Meligy, AM. Randomized controlled trial comparing ondansetron and placebo for the reduction of spinal anesthesia-induced hypotension during elective cesarean delivery in Egypt. Int J Gynecol Obstet. 2016; 135(2): 205-209. doi:10.1016/j.ijgo.2016.06.012. This Expression of Concern is for the above article, published online on 02 December 2016 in Wiley Online Library (wileyonlinelibrary.com), and is published by agreement between the journal Editor-in-Chief, Michael Geary; and John Wiley & Sons Ltd. Concerns were raised by a third party that the procedure detailed in the methods section indicates the study was not compatible with the standards of a randomized clinical trial. They noted that the details regarding the randomization procedure indicate that the authors used both alternating allocation and a random allocation sequence generated by a statistician. The editors noted this would indicate that the study does not employ a true clinical randomization. When asked to provide the randomization schedule, study data, ethical approval document, and clarification regarding the noted discrepancies, the authors noted that the approval document and data were no longer available. As these discrepancies cannot be resolved in the absence of the underlying data and study registration documents, an EOC is warranted to inform and alert readers.