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Background: There is a growing body of evidence indicating that second-degree tears cause both short- and long-term consequences. Very few preventative measures have been found to reduce the incidence of these tears., Objective: This study aimed to investigate whether the use of a perineal protection device during vaginal birth reduces severe perineal tearing (grade ≥2 tear) in primiparous women compared with routine manual perineal support., Study Design: A single-center randomized controlled trial was conducted in Sweden from 2019 to 2021. Primiparous women at term were randomly allocated to the intervention group (n=43), where a perineal protection device was used, or to the routine care group (n=49). The primary outcome was grade of perineal tear. The secondary outcomes were vaginal and labial tearing. Continuous data were analyzed using the Student t test or Mann-Whitney U test. Dichotomous data were analyzed using the Pearson X 2 test, Fisher exact test, and ordinal logistic regression., Results: Women in the intervention group had a significantly lower risk of sustaining more extensive perineal tearing than those in the control group. The use of the perineal protection device decreased the risk of grade ≥2 tears in relation to grade 0 to 1 tears (odds ratio, 0.40; 95% confidence interval, 0.17-0.94). Ordinal logistic regression analyses revealed an odds ratio of 0.36 (95% confidence interval, 0.16-0.81) per incremetn of grade injury using the perineal protection device vs routine care (P=.013). The number needed to treat using the perineal protection device was 4.3 to avoid 1 grade ≥2 tear. Women in the treatment group showed less labial tearing (P=.016). No adverse effect was detected., Conclusion: The use of a perineal protection device reduced the risk of grade ≥2 perineal tearing by 60% and labial tearing. El resumen está disponible en Español al final del artículo., (Copyright © 2024 The Author(s). Published by Elsevier Inc. All rights reserved.)

Objective: To assess the effect of lateral episiotomy, compared with no episiotomy, on obstetric anal sphincter injury in nulliparous women requiring vacuum extraction., Design: A multicentre, open label, randomised controlled trial., Setting: Eight hospitals in Sweden, 2017-23., Participants: 717 nulliparous women with a single live fetus of 34 gestational weeks or more, requiring vacuum extraction were randomly assigned (1:1) to lateral episiotomy or no episiotomy using sealed opaque envelopes. Randomisation was stratified by study site., Intervention: A standardised lateral episiotomy was performed during the vacuum extraction, at crowning of the fetal head, starting 1-3 cm from the posterior fourchette, at a 60° (45-80°) angle from the midline, and 4 cm (3-5 cm) long. The comparison was no episiotomy unless considered indispensable., Main Outcome Measures: The primary outcome of the episiotomy in vacuum assisted delivery (EVA) trial was obstetric anal sphincter injury, clinically diagnosed by combined visual inspection and digital rectal and vaginal examination. The primary analysis used a modified intention-to-treat population that included all consenting women with attempted or successful vacuum extraction. As a result of an interim analysis at significance level P<0.01, the primary endpoint was tested at 4% significance level with accompanying 96% confidence interval (CI)., Results: From 1 July 2017 to 15 February 2023, 717 women were randomly assigned: 354 (49%) to lateral episiotomy and 363 (51%) to no episiotomy. Before vacuum extraction attempt, one woman withdrew consent and 14 had a spontaneous birth, leaving 702 for the primary analysis. In the intervention group, 21 (6%) of 344 women sustained obstetric anal sphincter injury, compared with 47 (13%) of 358 women in the comparison group (P=0.002). The risk difference was -7.0% (96% CI -11.7% to -2.5%). The risk ratio adjusted for site was 0.47 (96% CI 0.23 to 0.97) and unadjusted risk ratio was 0.46 (0.28 to 0.78). No significant differences were noted between groups in postpartum pain, blood loss, neonatal outcomes, or total adverse events, but the intervention group had more wound infections and dehiscence., Conclusions: Lateral episiotomy can be recommended for nulliparous women requiring vacuum extraction to significantly reduce the risk of obstetric anal sphincter injury., Trial Registration: ClinicalTrials.gov NCT02643108., Competing Interests: Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/disclosure-of-interest/ and declare: funding from the Swedish Research Council (2016-00526), the Stockholm Region (FoUI-960261/2021), and the Uppsala-Örebro Research Council (RFR-939428); no support from any organisation for the submitted work; no financial relationships with any organisations that might have an interest in the submitted work in the previous three years; and no other relationships or activities that could appear to have influenced the submitted work., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Purpose: The primary aim of this study was to observe the change in obstetric anal sphincter tear rates in instrumental deliveries during one decade. Secondly, the changes in non-instrumental deliveries were followed., Methods: Data from all deliveries at Hudiksvall Hospital, Sweden 2010-2011 and 2016-2017 were collected. The change of OASIS rate during instrumental deliveries was the most important. Statistical significances were calculated by using chi-square test, test for relative proportions, and Students t-test, where appropriate., Results: The total incidence of OASIS decreased significantly (from 2.54% to 0.73%, p  < .001). Even the OASIS rate in instrumental deliveries decreased substantially from 15.1% to 3.0% ( p  = .002) but the decrease was statistically insignificant in spontaneous deliveries (from 1.22% to 0.60%, p  = .065)., Conclusion: Based on the results of our study the manual protection of the perineum reduces the risk of OASIS in instrumental delivery significantly.