Objective: To evaluate the impact of a care bundle (antenatal information to women, manual perineal protection and mediolateral episiotomy when indicated) on obstetric anal sphincter injury (OASI) rates.
Design: Multicentre stepped-wedge cluster design.
Setting: Sixteen maternity units located in four regions across England, Scotland and Wales.
Population: Women with singleton live births between October 2016 and March 2018.
Methods: Stepwise region by region roll-out every 3 months starting January 2017. The four maternity units in a region started at the same time. Multi-level logistic regression was used to estimate the impact of the care bundle, adjusting for time trend and case-mix factors (age, ethnicity, body mass index, parity, birthweight and mode of birth).
Main outcome measures: Obstetric anal sphincter injury in singleton live vaginal births.
Results: A total of 55 060 singleton live vaginal births were included (79% spontaneous and 21% operative). Median maternal age was 30 years (interquartile range 26-34 years) and 46% of women were primiparous. The OASI rate decreased from 3.3% before to 3.0% after care bundle implementation (adjusted odds ratio 0.80, 95% CI 0.65-0.98, P = 0.03). There was no evidence that the effect of the care bundle differed according to parity (P = 0.77) or mode of birth (P = 0.31). There were no significant changes in caesarean section (P = 0.19) or episiotomy rates (P = 0.16) during the study period.
Conclusions: The implementation of this care bundle reduced OASI rates without affecting caesarean section rates or episiotomy use. These findings demonstrate its potential for reducing perineal trauma during childbirth.
Tweetable abstract: OASI Care Bundle reduced severe perineal tear rates without affecting caesarean section rates or episiotomy use.
Keywords: Obstetric anal sphincter injury; perineal tear; quality improvement.
© 2020 The Authors. BJOG: An International Journal of Obstetrics and Gynaecology published by John Wiley & Sons Ltd on behalf of Royal College of Obstetricians and Gynaecologists.