Int Urogynecol J. 2025 Nov 19. doi: 10.1007/s00192-025-06364-y. Online ahead of print.
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.
PMID:41258537 | DOI:10.1007/s00192-025-06364-y
