EXPRESSION OF CONCERN: A Randomized Placebo-Controlled Trial of Preoperative Tranexamic Acid Among Women Undergoing...

Maged AM, Helal OM, El Sherbini MM, et al. A Randomized Placebo-Controlled Trial of Preoperative Tranexamic Acid Among Women Undergoing Elective Cesarean Delivery. Int J Gynecol Obstet. 2015;131(3): 265-268. doi: 10.1016/j.ijgo.2015.05.027 This Expression of Concern is for the above article, published online on 15 August 2015 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 on PubPeer [1] regarding numerical inconsistencies in Table 1. When the editorial team evaluated the published data and results, they confirmed the presence of several unusual patterns. For example: both groups ended with exactly 100 analyzed participants despite post-randomization exclusions; and multiple outcomes (including estimated blood loss, hematologic changes, platelet trends, and baseline characteristics) display improbably low variability or perfect balance. Combined with an unusually large reported-treatment effect, these features suggest the results may not reflect typical biological or clinical variability. The authors responded to a request for clarification, but they were unable to provide their raw study data as the study was conducted more than 10 years ago. Their responses to questions regarding these unusual patterns did not allay the concerns of the editorial team and publisher. Because the data are not available to alleviate concerns, an Expression of Concern is warranted, to inform and alert readers. [1] B. Mol, "A Randomized Placebo-Controlled Trial of Preoperative Tranexamic acid Among Women Undergoing Elective Cesarean Delivery," PubPeer (2026): https://pubpeer.com/publications/5A0500FF2EA96F99DEBC09A7CD038E.