Minimizing tearing during vaginal delivery with a perineal protection device : a randomized controlled trial
(2024) In American Journal of Obstetrics & Gynecology MFM 6(9). p.1-9- 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:
https://lup.lub.lu.se/record/36772dd2-70a3-4771-a9e5-ce1c48807414
- author
- André, Kristin LU ; Leijonhufvud, Åsa LU ; Ignell, Claes LU ; Källén, Karin LU and Stuart, Andrea LU
- organization
- publishing date
- 2024
- type
- Contribution to journal
- publication status
- published
- subject
- keywords
- birth injury, perineal protection device, perineal tear
- in
- American Journal of Obstetrics & Gynecology MFM
- volume
- 6
- issue
- 9
- article number
- 101402
- pages
- 1 - 9
- 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
- date added to LUP
- 2024-06-18 15:08:22
- date last changed
- 2024-09-10 12:38:10
@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}}, number = {{9}}, pages = {{1--9}}, 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}}, volume = {{6}}, year = {{2024}}, }