A perineal protection device designed to protect the perineum during labor: a multicenter randomized controlled trial.

OBJECTIVE The objective of this study was to evaluate the protective effects of a new device for reducing perineal tears during vaginal childbirth. STUDY DESIGN A multicenter open randomized controlled trial (RCT) was performed in Helsingborg, Lund and Malmö, Sweden consisting of 1148 women. Women anticipating a vaginal delivery were either randomized to the intervention group (n=574 in which the perineal protection device was used, or a control group (n=574), in which the perineal protection device was not used. The main outcome measurements were incidence of vaginal and perineal tears (1st to 4th degree tears) and adverse effects on the parturient and newborn. RESULTS The incidences of first- and second-degree tears of the vagina (p=0.018) and perineum (p=0.005) were significantly reduced in the intervention group compared with the controls. In the intervention- and control group, 184 women (34.9%) and 142 (26.6%) showed no perineal tearing, respectively (p=0.034). Numbers needed to treat to avoid any perianal tearing was 12. The incidence of anal sphincter rupture (ASR) was the same in both groups (n=19; 3.4%). No negative effects on mother or child from using the device were observed. CONCLUSIONS The perineal protective device significantly reduced the incidence of first- and second-degree tears in the vagina and perineum during vaginal birth and also significantly increased the number of parturients with a fully intact posterior commissure. No significant reduction of ASR and no negative effects of the device were observed.