Trial reportBMJ (Clinical research ed.)2024
Lateral episiotomy or no episiotomy in vacuum assisted delivery in nulliparous women (EVA): multicentre, open label, randomised controlled trial.
Trial report in BMJ (Clinical research ed.), 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 18 papers.
What it found
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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.
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.
Randomized Controlled Clinical Trial of Lateral Episiotomy Versus no Episiotomy in Vacuum Assisted Delivery in Non-parous Women
Physiotherapeutic Protocol Compared to Usual Care in the Treatment of Postpartum Primiparas After Perineal Trauma: A Type 1 Hybrid Effectiveness-Implementation Randomized Controlled Trial With Economic Evaluation
Who cites it
18 citing papers in PubMed.
- Pelvic floor symptoms and quality of life 1 year postpartum in Swedish primiparous women-A follow-up of a randomized controlled trial.Acta obstetricia et gynecologica Scandinavica · 2026Trial
- Postpartum perineal pain and its association with sub-classified second-degree tears and perineal trauma-A follow-up of a randomized controlled trial.Acta obstetricia et gynecologica Scandinavica · 2024Trial
- Levator Ani Muscle Avulsion After Soft Cup Vacuum-Assisted Versus Spontaneous Vaginal Delivery: A 3D Transperineal Ultrasound Study.International urogynecology journal · 2026Article
- Prediction of Obstetric Anal Sphincter Injury in Nulliparous Women: Model Development and Temporal Validation.BJOG : an international journal of obstetrics and gynaecology · 2026Article
- Risk factors associated with deep perineal wound dehiscence after second-degree perineal tears or episiotomy.Acta obstetricia et gynecologica Scandinavica · 2026Article
- The pelvic floor dysfunction: Where obstetrics meets urogynecology.Acta obstetricia et gynecologica Scandinavica · 2026Article
- Impact of episiotomy on anal incontinence following second- to fourth-degree perineal tears-A cohort study.Acta obstetricia et gynecologica Scandinavica · 2026Article
- Episiotomy is associated with a reduced risk of obstetric anal sphincter injury in nulliparous vacuum-assisted deliveries, particularly in high-risk cases.Acta obstetricia et gynecologica Scandinavica · 2026Article
- The socioeconomic burden of pelvic floor disorders.Acta obstetricia et gynecologica Scandinavica · 2026Review
- Episiotomy in Operative Vaginal Delivery Reduces the Risk of Obstetric Anal Sphincter Injuries in Nulliparous Women: A Systematic Review and Meta-Analysis.Journal of clinical medicine · 2026Review
- The Association Between Episiotomy and Obstetrical Anal Sphincter Injuries Among Vacuum-Assisted Vaginal Deliveries: A Population-Based Retrospective Canadian Cohort Study.International urogynecology journal · 2026Article
- Episiotomy and Obstetric Anal Sphincter Injury in the Setting of Instrumental Vaginal Birth: A Retrospective Cohort Study.The Australian & New Zealand journal of obstetrics & gynaecology · 2026Article
- Prevalence and Predictors of Anal Sphincter Injuries in Primipara with Vacuum-Assisted Deliveries.International urogynecology journal · 2025Observational
- The PLUS study: efficacy of triclosan coated suture (VicrylPlusMaternal health, neonatology and perinatology · 2025Article
- Educational efficacy of the simulation-based episiotomy training: a multi-center observational study.BMC medical education · 2025Observational
- Mediolateral episiotomy and obstetric anal sphincter injuries in nullipara: a propensity score matching study.BMC pregnancy and childbirth · 2025Article
- Exuberant Granulation Complicating an Episiotomy Wound: Case Report on the Treatment Using Surgical Excision and Estrogen Vaginal Cream.International medical case reports journal · 2025Article
- Episiotomies and obstetric anal sphincter injuries following a restrictive episiotomy policy in France: An analysis of the 2010, 2016, and 2021 National Perinatal Surveys.PLoS medicine · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo assess the effect of lateral episiotomy, compared with no episiotomy, on obstetric anal sphincter injury in nulliparous women requiring vacuum extraction.
designA multicentre, open label, randomised controlled trial.
settingEight hospitals in Sweden, 2017-23.
participants717 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.
interventionA 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 measuresThe 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).
resultsFrom 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.
conclusionsLateral episiotomy can be recommended for nulliparous women requiring vacuum extraction to significantly reduce the risk of obstetric anal sphincter injury.
trial registrationClinicalTrials.gov NCT02643108.
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Registered trials
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.