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Minimizing tearing during vaginal delivery with a perineal protection device : a randomized controlled trial

André, Kristin LU ; Leijonhufvud, Åsa LU orcid ; Ignell, Claes LU orcid ; Källén, Karin LU and Stuart, Andrea LU (2024) In American Journal of Obstetrics & Gynecology MFM
Abstract
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

To investigate if the use of a perineal protection device during vaginal birth reduces severe perineal tearing (≥grade 2 tear) in primiparous women compared to routine manual perineal support.
Study design

A single center randomized controlled trial was performed in Sweden 2019-2021. Primiparous women at term were randomly allocated to the intervention group (n=43) where a perineal protection device was used, or to receive routine care (n=49). Main outcome measurement was grade of... (More)
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

To investigate if the use of a perineal protection device during vaginal birth reduces severe perineal tearing (≥grade 2 tear) in primiparous women compared to routine manual perineal support.
Study design

A single center randomized controlled trial was performed in Sweden 2019-2021. Primiparous women at term were randomly allocated to the intervention group (n=43) where a perineal protection device was used, or to receive routine care (n=49). Main outcome measurement was grade of perineal tear. Secondary outcomes were vaginal and labial tearing. Continuous data was analyzed with Student's T-test or Mann-Whitney U-test. Dichotomous data were analyzed with Pearson X2 test, Fisher's Exact test, and ordinal logistic regression.
Results

Women in the intervention group had a significantly lower risk of sustaining more extensive perineal tearing as compared to the control group. Use of the perineal protection device decreased risk of ≥grade 2 tears, in relation to grade 0-1 tears (OR 0.40 [95% CI 0.17–0.94]). Ordinal logistic regression analyses revealed an OR of 0.36 (0.16–0.81) for one-grade-injury increment, using the perineal protection device vs control group (p=0.013). Number needed to treat using the perineal protection device was 4.3 to avoid one ≥grade 2 tear. Women in the treatment group had less labial tearing (p=0.016). No adverse effects were detected.
Conclusions

Use of the perineal protection device reduced the risk of perineal tearing ≥grade 2 tear by 60% as well as labial tearing. (Less)
Please use this url to cite or link to this publication:
author
; ; ; and
organization
publishing date
type
Contribution to journal
publication status
in press
subject
keywords
birth injury, perineal protection device, perineal tear
in
American Journal of Obstetrics & Gynecology MFM
article number
101402
pages
28 pages
publisher
Elsevier
external identifiers
  • pmid:38880240
ISSN
2589-9333
DOI
10.1016/j.ajogmf.2024.101402
language
English
LU publication?
yes
id
36772dd2-70a3-4771-a9e5-ce1c48807414
alternative location
https://linkinghub.elsevier.com/retrieve/pii/S2589933324001289
date added to LUP
2024-06-18 15:08:22
date last changed
2024-06-19 03:00:05
@article{36772dd2-70a3-4771-a9e5-ce1c48807414,
  abstract     = {{Background<br/><br/>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.<br/>Objective<br/><br/>To investigate if the use of a perineal protection device during vaginal birth reduces severe perineal tearing (≥grade 2 tear) in primiparous women compared to routine manual perineal support.<br/>Study design<br/><br/>A single center randomized controlled trial was performed in Sweden 2019-2021. Primiparous women at term were randomly allocated to the intervention group (n=43) where a perineal protection device was used, or to receive routine care (n=49). Main outcome measurement was grade of perineal tear. Secondary outcomes were vaginal and labial tearing. Continuous data was analyzed with Student's T-test or Mann-Whitney U-test. Dichotomous data were analyzed with Pearson X2 test, Fisher's Exact test, and ordinal logistic regression.<br/>Results<br/><br/>Women in the intervention group had a significantly lower risk of sustaining more extensive perineal tearing as compared to the control group. Use of the perineal protection device decreased risk of ≥grade 2 tears, in relation to grade 0-1 tears (OR 0.40 [95% CI 0.17–0.94]). Ordinal logistic regression analyses revealed an OR of 0.36 (0.16–0.81) for one-grade-injury increment, using the perineal protection device vs control group (p=0.013). Number needed to treat using the perineal protection device was 4.3 to avoid one ≥grade 2 tear. Women in the treatment group had less labial tearing (p=0.016). No adverse effects were detected.<br/>Conclusions<br/><br/>Use of the perineal protection device reduced the risk of perineal tearing ≥grade 2 tear by 60% as well as labial tearing.}},
  author       = {{André, Kristin and Leijonhufvud, Åsa and Ignell, Claes and Källén, Karin and Stuart, Andrea}},
  issn         = {{2589-9333}},
  keywords     = {{birth injury; perineal protection device; perineal tear}},
  language     = {{eng}},
  month        = {{06}},
  publisher    = {{Elsevier}},
  series       = {{American Journal of Obstetrics & Gynecology MFM}},
  title        = {{Minimizing tearing during vaginal delivery with a perineal protection device : a randomized controlled trial}},
  url          = {{http://dx.doi.org/10.1016/j.ajogmf.2024.101402}},
  doi          = {{10.1016/j.ajogmf.2024.101402}},
  year         = {{2024}},
}