Effectiveness of Perineal Protection Devices in Reducing Birth-Related Perineal Trauma: A Systematic Review and Meta-Analysis of Randomized Controlled Trials and GRADE Assessment

Abstract

BACKGROUND: Perineal trauma during childbirth is a common complication with significant short- and long-term maternal consequences. Perineal protection devices (PPDs) have been developed as a potential preventive strategy, yet their clinical effectiveness remains under evaluation. AIM: To assess the effectiveness of perineal protection devices in reducing the incidence and severity of birth-related perineal trauma. METHODS: A systematic review and meta-analysis of randomized controlled trials (RCTs) was conducted. Eligible studies were identified from PubMed, Scopus, Web of Science, and Embase. Primary outcomes included rates of intact perineum, perineal tears (grade ≥ 2), labial tears, episiotomy, and Apgar scores. Secondary outcomes included adverse effects and feasibility. The Cochrane Risk of Bias tool 2 and GRADE assessment were used to evaluate study quality. RESULTS: Five RCTs involving 2331 participants were included. PPD use was associated with a significantly increased rate of intact perineum (RR 1.41; 95% CI 1.18-1.69; p < 0.001). No significant differences were found for grade 1 (RR 1.05; p = 0.48), grade 2 (RR 0.92; p = 0.32), or grade 3-4 perineal tears (RR 0.76; p = 0.26). Labial tears showed no significant reduction overall (RR 0.90; p = 0.64), but sensitivity analysis revealed a benefit after excluding one study (RR 0.72; p = 0.02). No significant differences were found in episiotomy rates (RR 0.96; p = 0.62) or Apgar scores < 7 at 5 min (RR 0.99; p = 0.93). CONCLUSION: PPDs appear safe and effective in increasing intact perineum rates without adverse neonatal outcomes. Further large-scale, standardized trials are needed to confirm their role in obstetric practice.