The Editor-in-Chief is issuing an Editorial Expression of Concern for this article. After publication concerns were raised about the reporting of this clinical trial. The Head of the Obstetrics and Gynecology Department, Faculty of Medicine, Ain Shams University, has informed the Editor-in-Chief that ethics approval was given for this study; however, the documentation is not available. Ain Shams University has not responded to a request to confirm that this study was conducted with appropriate ethical oversight. Radwa Rasheedy, Hazem Sammour, Abdellatif Elkholy and Yasmine Salim have not responded to correspondence from the publisher about this statement.