Study design
The multicenter, prospective, randomized, open EPIC (Etude de Prévention de l’Incontinence par Césarienne) trial compared planned CS to planned VD for the second delivery in women with a history of a traumatic first delivery with anal sphincter lesions on endosonography and no self-reported anal incontinence at baseline.
Women were recruited in 6 maternity units in the Paris area (5 academic centers and 1 general hospital), between 01/04/2008 and 29/12/2014, with their written, informed consent for each of the 2 steps of the study. The study was approved by an ethics committee (Comité de Protection des Personnes Ile de France V, Paris, France).