Expression of Concern: “Low-Molecular-Weight Heparin for the Treatment of Unexplained Recurrent Miscarriage With Negative Antiphospholipid Antibodies: A Randomized Controlled Trial”

Sage Publishing and the Journal Editors hereby issue an expression of concern for the following article:

Shaaban OM, Abbas AM, Zahran KM, Fathalla MM, Anan MA, Salman SA. Low-Molecular-Weight Heparin for the Treatment of Unexplained Recurrent Miscarriage With Negative Antiphospholipid Antibodies: A Randomized Controlled Trial. Clinical and Applied Thrombosis/Hemostasis. 2017;23(6):567-572. doi:10.1177/1076029616665167

Sage Publishing was contacted by a reader of this article with concerns regarding the authenticity of the data. The reader cited concerns that this trial appears to be highly similar to an abstract poster presentation at the American Society of Reproductive Medicine’s 67^th Annual Meeting¹, but with slightly different data points.

The reader also states that the trial was retrospectively registered and the number of participants in the registration differs= from the reported numbers in the published article.

Further concerns were brought to our attention by a PubPeer post that shows the P values in Table 2 have been miscalculated, and that there may be an imbalance in the number of participants randomized between the control group and the treatment group in the abstract mentioned above.

The authors have explained that their clinical trial employed simple randomization rather than stratification randomization, so they were not expecting to observe a balanced distribution in their trial. They explained that participant enrollment numbers differ, because the abstract presentation focused on the single center while the data from the second center was being processed. Further, they have stated that some of the numbers in their results, such as the pregnancy loss rate, are unusual due to the inclusion criteria requiring the participant to have three or more previous miscarriages. The journal editor believes some of these irregularities noted by the authors can be resolved with the author’s explanations.

The authors have been unable to provide the underlying raw data to validate their explanation due to data retention laws in their country. The authors have stated they may be able to retrieve the datasets manually from the centers where the trial was conducted, but this may take a significant amount of time.

This expression of concern will remain in place until the Journal receives the raw data requested and an Editorial assessment over any corrective action.