Lateral episiotomy or no episiotomy in vacuum assisted delivery in nulliparous women (EVA) : multicentre, open label, randomised controlled trial

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Lateral episiotomy or no episiotomy in vacuum assisted delivery in nulliparous women (EVA) : multicentre, open label, randomised controlled trial

Bergendahl, Sandra (author): Karolinska Institutet,Karolinska Institute,Department of Clinical Sciences, Danderyd Hospital, Karolinska Institutet, Stockholm, Sweden,Danderyd Hosp, Karolinska Inst, Dept Clin Sci, Stockholm, Sweden.

Jonsson, Maria, 1966- (author): Uppsala universitet,Uppsala University,Department of Women's and Children's Health, Uppsala University, Uppsala, Sweden,Klinisk obstetrik

Hesselman, Susanne (author): Region Dalarna,Department of Women's and Children's Health, Centre for Clinical Research Dalarna, Falun, Sweden,Ctr Clin Res Dalarna, Dept Womens & Childrens Hlth, Falun, Sweden.

Ankarcrona, Victoria (author): Karolinska Institute,Department of Clinical Sciences, Danderyd Hospital, Karolinska Institutet, Stockholm, Sweden,Danderyd Hosp, Karolinska Inst, Dept Clin Sci, Stockholm, Sweden.

Leijonhufvud, Åsa (author): Lund University,Lunds universitet,Kliniska Vetenskaper, Helsingborg,Sektion II,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,Clinical Sciences, Helsingborg,Section II,Department of Clinical Sciences, Lund,Faculty of Medicine,Department of Clinical Science Helsingborg, Lund University, Helsingborg, Sweden,Lund Univ, Dept Clin Sci Helsingborg, Helsingborg, Sweden.

Wihlbäck, Anna-Carin (author): Umeå universitet,Umeå University,Obstetrik och gynekologi,Umeå Univ, Dept Clin Sci Obstet & Gynecol, Umeå, Sweden.

Wallström, Tove (author): Karolinska Institute,Department of Clinical Science and Education, South General Hospital, Karolinska Institutet, Stockholm, Sweden,Karolinska Inst, South Gen Hosp, Dept Clin Sci & Educ, Stockholm, Sweden.

Rydström, Emmie (author): Department of Obstetrics and Gynecology, Växjö Central Hospital, Växjö, Sweden,Växjö Cent Hosp, Dept Obstet & Gynecol, Växjö, Sweden.

Friberg, Hanna (author): Department of Obstetrics and Gynecology, Sahlgrenska University Hospital, Göteborg, Sweden,Sahlgrens Univ Hosp, Dept Obstet & Gynecol, Gothenburg, Sweden.

Kopp Kallner, Helena (author): Karolinska Institutet,Karolinska Institute,Department of Clinical Sciences, Danderyd Hospital, Karolinska Institutet, Stockholm, Sweden,Danderyd Hosp, Karolinska Inst, Dept Clin Sci, Stockholm, Sweden.

Brismar Wendel, Sophia (author): Karolinska Institutet,Karolinska Institute,Department of Clinical Sciences, Danderyd Hospital, Karolinska Institutet, Stockholm, Sweden,Danderyd Hosp, Karolinska Inst, Dept Clin Sci, Stockholm, Sweden.

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BMJ Publishing Group Ltd, 2024
2024
English.
In: BMJ (Clinical research ed.). - : BMJ Publishing Group Ltd. - 1756-1833. ; 385

Related links:: http://dx.doi.org/10... (free); show more...; https://doi.org/10.1...; https://umu.diva-por... (primary) (Raw object); https://uu.diva-port... (primary) (Raw object); https://lup.lub.lu.s...; https://doi.org/10.1...; http://kipublication...; https://urn.kb.se/re...; https://urn.kb.se/re...; http://kipublication...; show less...

Journal article (peer-reviewed)

Abstract Subject headings

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.

Subject headings

MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Reproduktionsmedicin och gynekologi (hsv//swe)
MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Obstetrics, Gynaecology and Reproductive Medicine (hsv//eng)

Keyword

Humans
Female
Episiotomy/methods
Pregnancy
Vacuum Extraction, Obstetrical/adverse effects
Adult
Anal Canal/injuries
Parity
Sweden
Obstetric Labor Complications/prevention & control
Lacerations/prevention & control
Young Adult

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art (subject category)
ref (subject category)

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By the university: Lund University; Karolinska Institutet; Umeå University; Uppsala University

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