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This paper “Skin-to-Skin Contact after Cesarean Delivery: An Experimental Study” describes an experimental study conducted in order to elucidate the safety of the practice of early Skin-to-Skin Contact (SSC) of the mother and the newborn baby after Cesarean delivery (Gouchon, Gregori, Picotto, Patrucco, Nangeroni, & Di Giulio, 2010). The study also aimed at determining benefits of SSC on initial attachment to breast and the degree of maternal satisfaction with SSC. The study design chosen by the authors to conduct thus study was non-inferiority adaptive trial (Gouchon, Gregori, Picotto, Patrucco, Nangeroni, & Di Giulio, 2010).
By definition, non inferiority trails are trials which aim at demonstrating that a new treatment modality or intervention is not inferior to the existing standard of care in terms of its efficacy and safety profile (Snapinn, 2000).Studies have revealed that the most appropriate statistical analysis techniques to be used for non-inferiority trails are intent-to-treat analysis (ITT) and per-protocol (PP) analysis, and there is an ongoing debate over which of the aforementioned analysis techniques is more suitable (D’Agostino, Massaro, & Sullivan, 2003). While patients are analyzed in the groups they had been assigned to at the beginning of the study, in an intent-to-treat analysis (ITT), irrespective of whether they completed the entire course of treatment or not, per-protocol analysis only includes patients who completed the entire course of the assigned treatment. ...