Evidence map›Paper›PMID 41258537›Full record

SynthesisInternational urogynecology journal2026

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

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

Abstract readSystematic ReviewMeta-Analysis
In one paragraph

Synthesis in International urogynecology journal, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Salma AllamFaculty of Medicine, Galala University, Galala City, Suez, Egypt. Salma.allam@gu.edu.eg.ORCID 0009-0005-2749-8982
Omar Khalid Samir AbdelkaderPort Said University Faculty of Medicine, Port Said, Egypt.ORCID 0009-0008-7255-5255
Rana MansourFaculty of Medicine, Galala University, Galala City, Suez, Egypt.ORCID 0009-0003-8820-5480
Nour ElsayedFaculty of Medicine, Galala University, Galala City, Suez, Egypt.ORCID 0009-0008-4698-9201
Hind ElshiekhFaculty of Medicine, Zagazig University, Zagazig, Egypt.ORCID 0009-0003-5567-6374
Joudi TarabishiDepartment of Obstetrics and Gynecology, University of Aleppo, Faculty of Medicine, Aleppo, Syria.ORCID 0000-0001-5325-482X
Sara Mohammad HegazyFaculty of Medicine, New Mansoura University, New Mansoura, Egypt.ORCID 0009-0008-2853-6874
Amr ArafaFaculty of Medicine, Alexandria University, Alexandria, Egypt.ORCID 0009-0008-5135-5166
Ahmed KertamTu Lab for Diagnostic Research, Yale School of Medicine, New Haven, CT, USA.ORCID 0000-0002-9038-7901

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPerineal 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.

aimTo assess the effectiveness of perineal protection devices in reducing the incidence and severity of birth-related perineal trauma.

methodsA 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.

resultsFive 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).

conclusionPPDs 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.

Indexed as

Delivery, ObstetricLacerationsObstetric Labor ComplicationsPerineumEpisiotomyFemaleHumansPregnancyRandomized Controlled Trials as TopicBirth injuryObstetric anal sphincter injuryPerineal protection devicePerineal traumaRandomized controlled trialsVaginal delivery

Identifiers

PMID41258537
PMCPMC12995966

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.