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Background <p>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.</p> Aim <p>To assess the effectiveness of perineal protection devices in reducing the incidence and severity of birth-related perineal trauma.</p> Methods <p>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.</p> Results <p>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; <i>p</i> &lt; 0.001). No significant differences were found for grade 1 (RR 1.05; <i>p</i> = 0.48), grade 2 (RR 0.92; <i>p</i> = 0.32), or grade 3–4 perineal tears (RR 0.76; <i>p</i> = 0.26). Labial tears showed no significant reduction overall (RR 0.90; <i>p</i> = 0.64), but sensitivity analysis revealed a benefit after excluding one study (RR 0.72; <i>p</i> = 0.02). No significant differences were found in episiotomy rates (RR 0.96; <i>p</i> = 0.62) or Apgar scores &lt; 7 at 5&#xa0;min (RR 0.99; <i>p</i> = 0.93).</p> Conclusion <p>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.</p> Graphical Abstract <p></p>

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

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年11月19日

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  • Salma Allam,
  • Omar Khalid Samir Abdelkader,
  • Rana Mansour,
  • Nour Elsayed,
  • Hind Elshiekh,
  • Joudi Tarabishi,
  • Sara Mohammad Hegazy,
  • Amr Arafa,
  • Ahmed Kertam

摘要

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.

Graphical Abstract