Lateral episiotomy or no episiotomy in vacuum assisted delivery in nulliparous women (EVA) : multicentre, open label, randomised controlled trial
Bergendahl, Sandra ; Jonsson, Maria ; Hesselman, Susanne ; Ankarcrona, Victoria ; Leijonhufvud, Åsa LU
; Wihlbäck, Anna-Carin
; Wallström, Tove
; Rydström, Emmie
; Friberg, Hanna
and Kopp Kallner, Helena
, et al.
(2024)
In BMJ (Clinical research ed.)
385.
p.1-11
- Abstract
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°... (More)
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.
(Less)
- author
- Bergendahl, Sandra
; Jonsson, Maria
; Hesselman, Susanne
; Ankarcrona, Victoria
; Leijonhufvud, Åsa
LU
; Wihlbäck, Anna-Carin
; Wallström, Tove
; Rydström, Emmie
; Friberg, Hanna
and Kopp Kallner, Helena
, et al. (More)
- Bergendahl, Sandra
; Jonsson, Maria
; Hesselman, Susanne
; Ankarcrona, Victoria
; Leijonhufvud, Åsa
LU
; Wihlbäck, Anna-Carin
; Wallström, Tove
; Rydström, Emmie
; Friberg, Hanna
; Kopp Kallner, Helena
and Brismar Wendel, Sophia
(Less)
- organization
- publishing date
- 2024-06-17
- type
- Contribution to journal
- publication status
- published
- subject
- keywords
- 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
- in
- BMJ (Clinical research ed.)
- volume
- 385
- article number
- e079014
- pages
- 1 - 11
- publisher
- BMJ Publishing Group
- external identifiers
-
- scopus:85196484963
- pmid:38886011
- ISSN
- 1756-1833
- DOI
- 10.1136/bmj-2023-079014
- language
- English
- LU publication?
- yes
- additional info
- © 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.
- id
- e2ba3323-93cc-4d1b-88dd-daf33ed4f6c6
- date added to LUP
- 2024-08-22 22:11:17
- date last changed
- 2024-08-24 02:57:08
@article{e2ba3323-93cc-4d1b-88dd-daf33ed4f6c6,
abstract = {{<p>OBJECTIVE: To assess the effect of lateral episiotomy, compared with no episiotomy, on obstetric anal sphincter injury in nulliparous women requiring vacuum extraction.</p><p>DESIGN: A multicentre, open label, randomised controlled trial.</p><p>SETTING: Eight hospitals in Sweden, 2017-23.</p><p>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.</p><p>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.</p><p>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).</p><p>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.</p><p>CONCLUSIONS: Lateral episiotomy can be recommended for nulliparous women requiring vacuum extraction to significantly reduce the risk of obstetric anal sphincter injury.</p><p>TRIAL REGISTRATION: ClinicalTrials.gov NCT02643108.</p>}},
author = {{Bergendahl, Sandra and Jonsson, Maria and Hesselman, Susanne and Ankarcrona, Victoria and Leijonhufvud, Åsa and Wihlbäck, Anna-Carin and Wallström, Tove and Rydström, Emmie and Friberg, Hanna and Kopp Kallner, Helena and Brismar Wendel, Sophia}},
issn = {{1756-1833}},
keywords = {{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}},
language = {{eng}},
month = {{06}},
pages = {{1--11}},
publisher = {{BMJ Publishing Group}},
series = {{BMJ (Clinical research ed.)}},
title = {{Lateral episiotomy or no episiotomy in vacuum assisted delivery in nulliparous women (EVA) : multicentre, open label, randomised controlled trial}},
url = {{http://dx.doi.org/10.1136/bmj-2023-079014}},
doi = {{10.1136/bmj-2023-079014}},
volume = {{385}},
year = {{2024}},
}