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

BMC Medicine

Debra Bick²  Peter W Thomas⁴  Sue Tohill⁶  Sue E Macdonald⁵  Christine Kettle³  Khaled M K Ismail¹ 

[1] Professor of Obstetrics and Gynaecology, School of Clinical and Experimental Medicine, College of Medical and Dental Sciences, University of Birmingham, Birmingham, West Midlands, B15 2TT, UK;Professor of Evidence Based Midwifery Practice, Kings College London, Florence Nightingale School of Nursing and Midwifery, 57 Waterloo Road, London SE1 8WA, UK;Professor of Women’s Health Staffordshire University, Blackheath Lane, Stafford, Staffordshire ST18 0AD, UK;Professor of Healthcare Statistics and Epidemiology, Bournemouth University, Clinical Research Unit, School of Health and Social Care, R506A Royal London House, Christchurch Road, Bournemouth, Dorset BH1 3LT, UK;Lead Midwife for Education, (until Dec 2012) College of Midwives, 15 Mansfield Street, London WIG 9NH, UK;Midwife, West Midlands (South) Comprehensive Local Research Network, University Hospitals Coventry and Warwickshire NHS Trust, University Hospital, Clifford Bridge Road, Coventry CV2 2DX, UK

关键词: Quality improvement;    Cluster RCT;    Trauma;    Perineum;    Childbirth;   

Others  :  855686
DOI  :  10.1186/1741-7015-11-209

 received in 2013-06-22, accepted in 2013-08-29,  发布年份 2013

【 摘 要 】

Background

Perineal 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.

Methods

This 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.

Results

There 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.

Conclusion

PEARLS 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 registrations

ISRCTN28960026

NIHR UKCRN portfolio no: 4785.

【 授权许可】

   
2013 Ismail et al.; licensee BioMed Central Ltd.

【 图 表 】

【 参考文献 】

• [1]McCandlish R, Bowler U, van Asten H, Berridge G, Winter C, Sames L, et al.: A randomised controlled trial of care of the perineum during second stage of normal labour. Brit J Obstet Gynaec 1998, 105:1262-1272.
• [2]Glazener CM: Sexual function after childbirth: women's experiences, persistent morbidity and lack of professional recognition. Brit J Obstet Gynaec 1997, 104:330-335.
• [3]Brown S, Lumley J: Maternal health after childbirth: results of an Australian population based survey. Brit J Obstet Gynaec 1998, 105:156-161.
• [4]East C, Webster J: Episiotomy at the Royal Women's Hospital, Brisbane: A comparison of practices in 1986 and 1992. Midwifery 1995, 11:195-200.
• [5]Kettle C, Hills RK, Ismail KM: Continuous versus interrupted sutures for repair of episiotomy or second degree tears. Cochrane Database Syst Rev 2007., 4CD000947
• [6]Kettle C, Hills RK, Jones P, Darby L, Gray R, Johanson R: Continuous versus interrupted perineal repair with standard or rapidly absorbed sutures after spontaneous vaginal birth: a randomised controlled trial. Lancet 2002, 359:2217-2223.
• [7]Kettle C, Dowswell T, Ismail KM: Continuous and interrupted suturing techniques for repair of episiotomy or second-degree tears. Cochrane Database Syst Rev 2012., 11CD000947
• [8]National Institute for Health and Clinical Excellence NICE clinical guideline 55: Intrapartum care: care of healthy women and their babies during childbirth. London, UK: National Institute for Health and Clinical Excellence; 2007.
• [9]Queensland Government Guideline QMaNC: Perineal care. State of Queensland: Queensland Government; 2010.
• [10]Bick DE, Ismail KM, Macdonald S, Thomas P, Tohill S, Kettle C: How good are we at implementing evidence to support the management of birth related perineal trauma? A UK wide survey of midwifery practice. BMC Pregnancy and Childbirth 2012, 12:57. BioMed Central Full Text
• [11]Bick DE, Kettle C, Macdonald S, Thomas PW, Hills RK, Ismail KM: PErineal Assessment and Repair Longitudinal Study (PEARLS): protocol for a matched pair cluster trial. BMC Pregnancy Childbirth 2010, 10:10. BioMed Central Full Text
• [12]Kettle C, Dowswell T, Ismail KMK: Absorbable suture materials for primary repair of episiotomy and second degree tears. Cochrane Database Syst Rev 2010., 6CD000006
• [13]Perkins E, et al.: "Women's views of important outcomes following perineal repair. " Proceedings of the International Conference of Obstetrics and Gynaecology, Montreal. BJOG 2008., 115(No. Suppl 1)
• [14]Bick D, MacArthur C, Winter H: Postnatal care. Evidence and Guidelines for Management. Second. ed. London: Churchill Livingstone; 2008.
• [15]Thompson SG, Pyke SD, Hardy RJ: The design and analysis of paired cluster randomized trials: an application of meta-analysis techniques. Stat Med 1997, 16:2063-2079.
• [16]Snap software. http://www.snapsurveys.com webcite
• [17]SPSS software. program
• [18]Donner A, Klar N: Design and analysis of cluster randomization trials in health research. 1st edition. London, UK: Arnold, Hodder Headline Group; 2000.
• [19]Hayes RJ, Moulton LH: Cluster Randomised Trials. New York: Chapman & Hall/CRC Press; 2009.
• [20]University of Bristol. MLwiN [program]. Version 2.1. version: Centre for Multilevel Modelling. UK: University of Bristol: ; 2009.
• [21]Institute of Medicine: Crossing the quality chasm: a new health system for the 21st century. Washington, DC: IOM; 2001.
• [22]Cantwell R, Clutton-Brock T, Cooper G, Dawson A, Drife J, Garrod D, et al.: Saving Mothers' Lives: Reviewing maternal deaths to make motherhood safer: 2006–2008. The Eighth Report of the Confidential Enquiries into Maternal Deaths in the United Kingdom. BJOG : an Int J Obstet Gynaecol 2011, 118:1-203.
• [23]Lau J, Antman EM, Jimenez-Silva J, Kupelnick B, Mosteller F, Chalmers TC: Cumulative meta-analysis of therapeutic trials for myocardial infarction. New England J Med 1992, 327:248-254.
• [24]Antman EM, Lau J, Kupelnick B, Mosteller F, Chalmers TC: A comparison of results of meta-analyses of randomized control trials and recommendations of clinical experts. Treatments for myocardial infarction. JAMA: J Am Med Assoc 1992, 268:240-248.
• [25]McGlynn EA, Asch SM, Adams J, Keesey J, Hicks J, DeCristofaro A, et al.: The quality of health care delivered to adults in the United States. New England J Med 2003, 348:2635-2645.
• [26]Campbell NC, Thain J, Deans HG, Ritchie LD, Rawles JM: Secondary prevention in coronary heart disease: baseline survey of provision in general practice. BMJ 1998, 316:1430-1434.
• [27]Bury TJ, Mead JM: Evidence based healthcare: a practical guide for therapists: Oxford. Boston: Butterworth-Heinemann; 1998.
• [28]Grimshaw JM, Eccles MP, Lavis JN, Hill SJ, Squires JE: Knowledge translation of research findings. Implementation Science: IS 2012, 7:50. BioMed Central Full Text