Christine Kettle

Continuous versus interrupted perineal repair with standard or rapidly absorbed sutures after spontaneous vaginal birth: a randomised controlled trial

BACKGROUND Trauma to the perineum is a serious and frequent problem after childbirth, with about 350000 women each year in the UK needing sutures for perineal injury after spontaneous vaginal delivery, and many millions more worldwide. We compared the continuous technique of perineal repair with the interrupted method, and the more rapidly absorbed polyglactin 910 suture material with the standard polyglactin 910 material. METHODS 1542 women who had a spontaneous vaginal delivery with a second-degree perineal tear or episiotomy were randomly allocated to either the continuous (n=771) or interrupted (771) suturing method, and to either the more rapidly absorbed polyglactin 910 suture material (772) or standard polyglactin 910 material (770). Primary outcomes were pain 10 days after delivery and superficial dyspareunia 3 months postpartum. Analysis was by intention to treat. FINDINGS At day 10, three women had dropped out of the study. Significantly fewer women reported pain at 10 days with the continuous technique than with the interrupted method (204/770 [26.5%] vs 338/769 [44.0%], odds ratio 0.47, 95% CI 0.38-0.58, p<0.0001). Occurrence of pain did not differ significantly between groups assigned the more rapidly absorbed material or standard material (256/769 [33.3%] vs 286/770 [37.1%], 0.84, 0.68-1.04, p=0.10). Women reported no difference in superficial dyspareunia at 3 months for the continuous vs the interrupted method (98/581 [16.9%] vs 102/593 [17.2%], 0.98, 0.72-1.33, p=0.88) or the more rapidly absorbed versus standard material (105/586 [17.9%] vs 95/588 [16.2%], 1.13, 0.84-1.54, p=0.42). Suture removal was done less with the more rapidly absorbed material than with standard suture material (22/769 [3%] vs 98/770 [13%], p<0.0001), and with the continuous versus interrupted method (24/770 [3%] vs 96/769 [12%], p<0.0001). INTERPRETATION A simple and widely practicable continuous repair technique can prevent one woman in six from having pain at 10 days. Also, the more rapidly absorbed polyglactin 910 material obviates need for suture removal up to 3 months postpartum for one in ten women sutured.

Repair Techniques for Obstetric Anal Sphincter Injuries: A Randomized Controlled Trial

OBJECTIVE: To compare one-year outcomes of primary overlap versus end-to-end repair of the external anal sphincter after acute obstetric anal sphincter injury. METHODS: Women who sustained third-degree (3b = greater than 50% external anal sphincter thickness, 3c = internal sphincter injury) or fourth-degree (including anorectal epithelium) perineal tears were randomly allocated to either immediate primary overlap or end-to-end repair. They were prospectively followed up for 12 months postrepair with serial questionnaires. The primary outcome was fecal incontinence at 12 months. Secondary outcomes were fecal urgency, flatus incontinence, perineal pain, dyspareunia, quality of life, and improvement of anal incontinence symptoms. RESULTS: Thirty-two women were randomized to each group. At 12 months, 24% (6/25) in the end-to-end and none in the overlap group reported fecal incontinence (P = .009, relative risk [RR] 0.07, 95% confidence interval [CI] 0.00–1.21, number needed to treat 4.2). Fecal urgency at 12 months was reported by 32% (8/25) in the end-to-end and 3.7% (1/27) in the overlap group (P = .02, RR 0.12, 95% CI 0.02–0.86, number needed to treat 3.6). There were no significant differences in dyspareunia and quality of life between the groups. At 12 months, 20% (5/25) reported perineal pain in the end-to-end and none in the overlap group (P = .04, RR 0.08, 95% CI 0.00–1.45, number needed to treat 5). During 12 months, 16% (4/25) in the end-to-end and none in the overlap group reported deterioration of defecatory symptoms (P = .01). CONCLUSION: Primary overlap repair of the external anal sphincter is associated with a significantly lower incidence of fecal incontinence, urgency, and perineal pain. When symptoms do develop, they appear to remain unchanged or deteriorate in the end-to-end group but improve in the overlap group. LEVEL OF EVIDENCE: I

How good are we at implementing evidence to support the management of birth related perineal trauma? A UK wide survey of midwifery practice

BackgroundThe accurate assessment and appropriate repair of birth related perineal trauma require high levels of skill and competency, with evidence based guideline recommendations available to inform UK midwifery practice. Implementation of guideline recommendations could reduce maternal morbidity associated with perineal trauma, which is commonly reported and persistent, with potential to deter women from a future vaginal birth. Despite evidence, limited attention is paid to this important aspect of midwifery practice. We wished to identify how midwives in the UK assessed and repaired perineal trauma and the extent to which practice reflected evidence based guidance. Findings would be used to inform the content of a large intervention study.MethodsA descriptive cross sectional study was completed. One thousand randomly selected midwives were accessed via the Royal College of Midwives (RCM) and sent a questionnaire. Study inclusion criteria included that the midwives were in clinical practice and undertook perineal assessment and management within their current role. Quantitative and qualitative data were collated. Associations between midwife characteristics and implementation of evidence based recommendations for perineal assessment and management were examined using chi-square tests of association.Results405 midwives (40.5%) returned a questionnaire, 338 (83.5%) of whom met inclusion criteria. The majority worked in a consultant led unit (235, 69.5%) and over a third had been qualified for 20 years or longer (129, 38.2%). Compliance with evidence was poor. Few (6%) midwives used evidence based suturing methods to repair all layers of perineal trauma and only 58 (17.3%) performed rectal examination as part of routine perineal trauma assessment. Over half (192, 58.0%) did not suture all second degree tears. Feeling confident to assess perineal trauma all of the time was only reported by 116 (34.3%) midwives, with even fewer (73, 21.6%) feeling confident to perform perineal repair all of the time. Two thirds of midwives (63.5%) felt confident to perform an episiotomy. Midwives qualified for 20 years or longer and those on more senior clinical grades were most likely to implement evidence based recommendations and feel confident about perineal management.ConclusionsThere are considerable gaps with implementation of evidence to support management of perineal trauma.

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

BackgroundThe Perineal Assessment and Repair Longitudinal Study (PEARLS) is a national clinical quality improvement initiative designed to improve the assessment and management of perineal trauma. Perineal trauma affects around 85% of women who have a vaginal birth in the UK each year and millions more world-wide. Continuous suturing techniques compared with traditional interrupted methods are more effective in reducing pain and postnatal morbidity, however they are not widely used by clinicians despite recommendations of evidence based national clinical guidelines. Perineal suturing skills and postnatal management of trauma remain highly variable within and between maternity units in the UK as well as worldwide. Implementation of a standardised training package to support effective perineal management practices could reduce perineal pain and other related postnatal morbidity for a substantial number of women.Methods/DesignPEARLS 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 womens 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.DiscussionImplementation 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.Trial registrationPEARLS is registered with the Current Controlled Trials Registry (no: ISRCTN28960026). NIHR UKCRN portfolio no: 4785.

Trends and risk factors for severe perineal trauma during childbirth in New South Wales between 2000 and 2008: a population-based data study

Objectives To determine trends and risk factors for severe perineal trauma between 2000 and 2008. Design This was a population-based data study. Setting New South Wales, Australia. Participants 510 006 women giving birth to a singleton baby during the period 2000–2008. Main outcome measures Rates of severe perineal trauma between 2000 and 2008 and associated demographic, fetal, antenatal, labour and delivery events and factors. Results There was an increase in the overall rate of severe perineal trauma from 2000 to 2008 from 1.4% to 1.9% (36% increase). Compared with women who were intact or had minor perineal trauma (first-degree tear, vaginal graze/tear), women who were primiparous (adjusted OR (AOR) 1.8 CI (1.65 to 1.95), were born in China or Vietnam (AOR 1.1 CI (1.09 to 1.23), gave birth in a private hospital (AOR 1.1 CI (1.03 to 1.20), had an instrumental birth (AOR 1.8 CI (1.65 to 1.95) and male baby (AOR 1.3 CI (1.27 to 1.34) all had a significantly higher risk of severe perineal trauma. Only giving birth to a male baby, adjusted for birth weight (AOR 1.5 CI (1.44 to 1.58), remained significant, when women with severe perineal trauma were compared with all other women not experiencing severe perineal trauma. This association increased over the study period. Conclusions To our knowledge, this is the first time that having a male baby has been found to exert such a strong independent risk for severe perineal trauma and the increasing significance of this in recent years needs further exploration.

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

AbstractBackgroundPerineal 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 registrationsISRCTN28960026 NIHR UKCRN portfolio no: 4785.

Diagnosis of Perineal Trauma

anal sphincter tear was considered to be a second degree tear. This may refl ect the teachings of Professor Ian Donald from Glasgow, who defi ned a third degree tear as one in which both the anal sphincter and anal mucosa were torn. In order to standardise the classifi cation of perineal trauma, Sultan proposed the classifi cation shown in Figure 2.1, which has been adopted by the RCOG and also internationally. The classifi cation is depicted in a schematic representation of the anal sphincter complex (Figure 2.2). The intact anal sphincter appears as a circular band of muscle (Figure 2.3a) that can be demonstrated by insertion of a fi nger in the anal canal (Figure 2.3b). Isolated tears of the anal epithelium (buttonhole) and vagina but without involvement of the anal sphincters are rare (Figure 2.4). In order to avoid confusion, such tears are not included in the above classifi cation. It is also possible to sustain a full-thickness third degree tear that only involves part of the length of the anal sphincter (Figure 2.5). In such circumstances or situations when the clinician is doubtful, the higher classifi cation should be selected. For example, if there is uncertainty between a 3a and 3b tear, the tear should be classifi ed as 3b. Some refer to fi rst and second degree tears as minor perineal trauma as opposed to major perineal trauma for third and fourth degree tears. However, as alluded to in Chapter 4, second degree tears can extend to become complex tears. 2.1 Prevalence

Perineal resuturing versus expectant management following vaginal delivery complicated by a dehisced wound (PREVIEW): protocol for a pilot and feasibility randomised controlled trial.

Background Each year, approximately 350 000 women in the UK experience perineal suturing following childbirth. For those women whose perineal wound dehisces, the management will vary according to individual practitioners preferences. For most women, the wound will be managed expectantly (healing by secondary intention), whereas others may be offered resuturing. However, there is limited scientific evidence and no clear guidelines to inform best practice. PREVIEW is a two-part study aiming to identify the best management strategy for dehisced perineal wounds, in terms of clinical effectiveness and womens preferences. Methods/design The main part of this study is a pilot and feasibility randomised controlled trial designed to provide preliminary evidence of the effectiveness of resuturing versus expectant management for dehisced perineal wounds following childbirth and to feed into the design and feasibility of a larger definitive trial. 144 participants will be randomly allocated to either intervention. The primary outcome is the proportion of women with a healed perineal wound at 6–8 weeks from the trial entry. Secondary outcomes include perineal pain, breast feeding rates, dyspareunia and womens satisfaction with the aesthetic results of the wound healing at 6 weeks, 3 months and 6 months post randomisation. Information will be collected using validated questionnaires. The second part of this study will be to conduct semistructured interviews with 12 study participants, aiming to capture information relating to their physical and psychological experiences following perineal wound dehiscence, assess the acceptability of the research plan and ensure that all outcomes relevant to women are included in the definitive trial. Dissemination The results of this study will inform a definitive randomised controlled trial that will provide conclusive evidence of what is the best management of perineal wound dehiscence. This will potentially lead to significant improvements in perineal care and will help to reduce the short- and long-term morbidity experienced by women. Clinical trials registration PREVIEW is registered with the International Standard Research for Clinical Trials (no: ISRCTN05754020) and adopted as a National Institute for Health Research (NIHR) Reproductive Health and Childbirth specialty group portfolio study UKCRN ID 9098.

“A patchwork of services” – caring for women who sustain severe perineal trauma in New South Wales – from the perspective of women and midwives

BackgroundCurrent research into severe perineal trauma (3rd and 4th degree) focuses upon identification of risk factors, preventative practices and methods of repair, with little focus on women’s experiences of, and interactions with, health professionals following severe perineal trauma (SPT). The aim of this study is to describe current health services provided to women in New South Wales (NSW) who have experienced SPT from the perspective of Clinical Midwifery Consultants (CMC) and women.MethodsThis study used a descriptive qualitative design and reports on the findings of a component of a larger mixed methods study. Data were collected through a semi-structured discussion group using a variety of non-directive, open-ended questions leading CMCs of NSW. A survey was distributed prior to the discussion group to collect further information and enable a more comprehensive understanding of services provided. Data from individual interviews with twelve women who had experienced SPT during vaginal birth is used to provide greater insight into their interactions with, and ease of access to, health service providers in NSW. An integrative approach was undertaken in reporting the findings which involved comparing and analysing findings from the three sets of data.ResultsOne overarching theme was identified: A Patchwork of Policy and Process which identified that current health services operate in a ‘patchwork’ manner when caring for women who sustain SPT. They are characterised by lack of consistency in practice and standardisation of care. Within the overarching theme, four subthemes were identified: Falling through the gaps; Qualifications, skills and attitudes of health professionals; Caring for women who have sustained SPT; and Gold standard care: how would it look?ConclusionThe findings from this study suggest that current health services in NSW represent a ‘patchwork’ of service provision for women who have sustained SPT. It appeared that women seek compassionate and supportive care based upon a clear exchange of information, and this should be considered when reflecting upon health service design. This study highlights the benefits of establishing multi-disciplinary collaborative specialist clinics to support women who experience SPT and associated morbidities, with the aim of providing comprehensive physiological and psychological support.

Dyspareunia following childbirth

While a temporary reduction in libido is acceptable following childbirth, women should not expect postpartum dyspareunia to occur. If these symptoms are left untreated a woman can become afraid of having intercourse and the problem can escalate, causing long‐term physical and psychological morbidity. This can lead to sexual disharmony and relationship breakdown. Early and sensitive management is crucial in the prevention of long‐term problems. In this article we present a multidisciplinary approach for managing women with dyspareunia following childbirth.