Effect of a perineal protection device in vacuum-assisted births—a prospective randomized controlled interventional trial

The perineal protection device was not able to reduce the primary composite outcome of the study among women who gave birth by vacuum assistance. Although this was not the primary end point, a lower rate of mediolateral episiotomies was observed when the device was used correctly. As a limitation, difficulties with the application of the device occurred in 33% of cases. Nevertheless, no adverse events in association with the device were observed for either mother or child in our cohort.