Perineal Assessment and Repair Longitudinal Study (PEARLS): a matched-pair cluster randomized trial

Abstract

BackgroundPerineal trauma during childbirth affects millions of women worldwide every year. The aim of the Perineal Assessment and Repair Longitudinal Study (PEARLS) was to improve maternal clinical outcomes following childbirth through an enhanced cascaded multiprofessional training program to support implementation of evidence-based perineal management.MethodsThis was a pragmatic matched-pair cluster randomized controlled trial (RCT) that enrolled women (n = 3681) sustaining a second-degree perineal tear in one of 22 UK maternity units (clusters), organized in 11 matched pairs. Units in each matched pair were randomized to receive the training intervention either early (group A) or late (group B). Outcomes within each cluster were assessed prior to any training intervention (phase 1), and then after the training intervention was given to group A (phase 2) and group B (phase 3). Focusing on phase 2, the primary outcome was the percentage of women who had pain on sitting or walking at 10 to 12 days post-natal. Secondary outcomes included use of pain relief at 10 to 12 days post-natal, need for suture removal, uptake and duration of exclusive breastfeeding, and perineal wound infection. Practice-based measures included implementation of evidence into practice to promote effective clinical management of perineal trauma. Cluster-level paired t-tests were used to compare groups A and B.ResultsThere was no significant difference between the clusters in phase 2 of the study in the average percentage of women reporting perineal pain on sitting and walking at 10 to 12 days (mean difference 0.7%; 95% CI −10.1% to 11.4%; P = 0.89). The intervention significantly improved overall use of evidence-based practice in the clinical management of perineal trauma. Following the training intervention, group A clusters had a significant reduction in mean percentages of women reporting perineal wound infections and of women needing sutures removed.ConclusionPEARLS is the first RCT to assess the effects of a ‘training package on implementation of evidence-based perineal trauma management. The intervention did not significantly improve the primary outcome but did significantly improve evidence-based practice and some of the relevant secondary clinical outcomes for women.Trial registrationsISRCTN28960026NIHR UKCRN portfolio no: 4785.

Implementation methodology of practices based on scientific evidence for assistance in natural delivery: a pilot study

“…Therefore, the results showed that the educational intervention significantly improved the knowledge of professionals about the best perineal repair practices based on evidence, concluding that the permanent and standardized education is essential for the maintenance of improved care (13) . However, in the current study the results identified in the medical records showed that perineal lacerations and episiotomy rates increased by around four percentage points after the proposed intervention, but without a statistically significant difference.…”

A mixed methods study to explore women and clinician׳s response to pain associated with suturing second degree perineal tears and episiotomies [PRAISE]

“…This is despite the recognition that standards around perineal repair need to be improved nationally and internationally NICE, 2008;Kyei et al, 2012;Ismail et al, 2013). Variation in practice noted in this study appeared to be due to subjective, rule of thumb decisions made by clinicians.…”

“…The finding that women felt anxious about future functioning, healing or defecating was reflected by Way (2012) when women strived 'to be normal' (Way, 2012 p e712). Most recently, Bick (2014) identified that women who participated in the 'PEARLS' study (Ismail et al, 2013) felt the most important concern for them was around healing and future functioning.…”

“…This is a common event that affects women across a variety of international settings (Barreto-Scarabotto and Gonzalez-Riesco, 2008;Kettel et al, 2010;Ismail et al, 2013;Smith et al, 2013). Despite the frequency of the event there is a dearth of research which relates to women's experience of perineal suturing or the clinician's decision to suture.…”

Implementation of evidence into practice: complex, multi-faceted and multi-layered

“…As clinicians, we often assume we know what the primary study outcome should be -however, health service users are really the experts in knowing which outcomes have the highest priority, highlighting that when planning research we need to consider our audience. In our recent perineal repair trial (7) , as clinicians we assumed pain would be the most important outcome for women who had a second degree tear or an episiotomy. When we asked the women who had sustained these perineal outcomes what their priorities were, they were most concerned about perineal wound infection.…”