A pre-post implementation study of a care bundle to reduce perineal trauma in unassisted births conducted by midwives

The perineal-bundle is a complex intervention widely implemented in Australian maternity care facilities.

Most bundle components have limited or conflicting evidence and the implementation required many midwives to change their usual practice for preventing perineal trauma.

To measure the effect of perineal bundle implementation on perineal injury for women having unassisted births with midwives.

A retrospective pre-post implementation study design to determine rates of second degree, severe perineal trauma, and episiotomy. Women who had an unassisted, singleton, cephalic vaginal birth at term between two time periods: January 2011 - November 2017 and August 2018 - August 2020 with a midwife or midwifery student accoucheur. We conducted logistic regression on the primary outcomes to control for confounding variables.

data from 20,155 births (pre-implementation) and 6273 (post-implementation) were analysed. After implementation, no significant difference in likelihood of severe perineal trauma was demonstrated (aOR 0.86, 95% CI 0.71-1.04, p = 0.124). Nulliparous women were more likely to receive an episiotomy (aOR 1.49 95% CI 1.31-1.70 p < 0.001) and multiparous women to suffer a second degree tear (aOR 1.18 95% CI 1.09-1.27 p < 0.001).

This study adds to the growing body of literature which suggests a number of bundle components are ineffective, and some potentially harmful. Why, and how, the bundle was introduced at scale without a research framework to test efficacy and safety is a key concern.

Suitably designed trials should be undertaken on all proposed individual or grouped perineal protection strategies prior to broad adoption.