BackgroundBirth tears are common after vaginal birth with a prevalence of up to 85%, especially in vaginal-assisted births. As birth trauma can cause physical and psychological short-term and long-term maternal morbidity, it is essential to improve maternal outcome at birth. ObjectiveTo evaluate the effect of a perineal protection device on the rate of spontaneous birth tears in the posterior compartment in vacuum-assisted births, as well as the feasibility and safety of the device. Study DesignIn a prospective, randomized controlled interventional trial from July 2020 to October 2022 we evaluated the application of a perineal protection device in vacuum-assisted vaginal births in a tertiary care center. 1998 patients were asked for participation, and 1574 patients with singletons ≥ 36 weeks of gestation gave their informed consent before birth. Ultimately, 209 were included according to a power calculation performed in advance with a statistical power of 80% and a significance level of 5% in expectation to reduce the rate for the primary composite outcome by 20%. The primary composite outcome was the rate of low-grade perineal and/or vaginal tears in the posterior compartment. Secondary outcomes were the rate of high-grade perineal tears and episiotomies, the feasibility of the device, and its safety for mother and child. Descriptive statistics and a logistic regression analysis were performed in an “intention-to-treat” (ITT), a “per-protocol” (PP), and an “as-treated” (AT) analysis, using SPSS version 29.0.0.0 (IBM SPSS, Armonk, New York, USA) and the software “R” (The R Project for Statistical Computing, version 3.5.0). A p-value < 0.05 was considered statistically significant. ResultsOf the 1574 patients, 249 (15.8%) had an indication for vacuum-assisted vaginal birth, of which 217 (13.8%) were randomized. Another eight patients (0.5%) were excluded because of birth ending without vacuum-assistance. Of the remaining 209 patients, 105 formed the intervention group (application of the device), whereas 104 formed the control group (without application of the device). No differences in primary and secondary outcomes were found in the ITT and PP analysis. In the ITT analysis, 79 patients (75.2%) in the intervention group compared to 73 patients (70.2%) in the control group (p = 0.4) met the primary endpoint. In the PP analysis, the primary composite outcome was seen 53 patients (77.9%) in the intervention group compared to 73 patients (70.2%) in the control group (p = 0.27). For the AT analysis, 68 of the 105 patients (65%) remained in the intervention group after exclusion of 37 (35%) patients with failed application of the device. Consequently, 141 formed the control group. In the AT analysis, there was also no difference in the primary composite outcome between the two groups (53 patients (77.9%) in the intervention group compared to 99 patients (70.2%) in the control group). However, within the secondary outcomes, we found a significantly lower rate of mediolateral episiotomies in the intervention group (29% vs 45%, p = 0.034). No adverse outcomes for mother and child were seen. In one third of cases, the device was difficult to place correctly and/or to keep correctly in place. ConclusionThe perineal protection device was not able to reduce the primary composite outcome of the study in women giving birth by vacuum-assistance. Although this was not the primary end point, a lower rate of mediolateral episiotomies was observed, if the device had been 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. Video Abstract [Display omitted]