PErineal Assessment and Repair Longitudinal Study (PEARLS): protocol for a matched pair cluster trial

PEARLS is a matched pair cluster trial, which is being conducted in maternity units across the UK. Units within a matched pair will be randomised to implement the study intervention either early or late in the study period. The intervention will include the cascading of a multi-professional training package to enhance midwifery and obstetric skills in the assessment, repair and postnatal management of perineal trauma. Women who have had an episiotomy or second degree perineal tear will be eligible for recruitment. Prior to developing the intervention and deciding on study outcomes, a Delphi survey and a consensus conference were held to identify what women, who previously suffered perineal trauma during childbirth, considered to be important outcomes for them. Findings from this preliminary work (which will be reported elsewhere) and other outcomes including women's experiences of perineal pain and pain on activity, breastfeeding uptake and duration and psychological well-being as assessed using the Edinburgh Postnatal Depression Scale (EPDS) will be assessed at 10 days and three months post-birth.Implementation of evidence-based perineal assessment and management practices, could lead to significantly improved physical and psychological health outcomes for women in the UK and world-wide.PEARLS is registered with the Current Controlled Trials Registry (no: ISRCTN28960026). NIHR UKCRN portfolio no: 4785.Persistent perineal pain is one of the most commonly experienced health problems associated with birth [1,2]. It is a symptom highly related to perineal trauma and can impact on a woman's physical and psychological well-being as well as her relationship with her baby and family. Around 85% of women who have a vaginal delivery will sustain perineal trauma, which occurs either spontaneously or as a consequence of an episiotomy, and three-quarters of women will require suturing to facilitate healing of the disrupted tissue [3]. Studies investigating maternal morbidity ha