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会阴评估和修复纵向研究(PEARLS):一项配对病例对照群临床试验方案。

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

机构信息

King's College London, Florence Nightingale School of Nursing and Midwifery, James Clerk Maxwell Building, 57 Waterloo Road, London, UK.

出版信息

BMC Pregnancy Childbirth. 2010 Feb 25;10:10. doi: 10.1186/1471-2393-10-10.

Abstract

BACKGROUND

The 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/DESIGN: 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.

DISCUSSION

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.

TRIAL REGISTRATION

PEARLS is registered with the Current Controlled Trials Registry (no: ISRCTN28960026). NIHR UKCRN portfolio no: 4785.

摘要

背景

会阴评估和修复纵向研究(PEARLS)是一项全国性的临床质量改进计划,旨在改善会阴创伤的评估和管理。会阴创伤影响了英国每年约 85%的阴道分娩女性,以及全球更多的女性。与传统间断缝合方法相比,连续缝合技术在减轻疼痛和产后发病率方面更有效,然而,尽管有基于证据的国家临床指南的建议,它们并未被临床医生广泛使用。在英国以及全球范围内,各个产房之间的会阴缝合技术和创伤后的管理仍然存在很大差异。实施标准化培训包以支持有效的会阴管理实践,可以为大量女性减轻会阴疼痛和其他相关产后发病率。

方法/设计:PEARLS 是一项配对群组临床试验,正在英国各地的产房进行。配对中的单位将随机分配在研究期间早期或晚期实施研究干预。该干预措施包括将多专业培训包分层,以提高助产士和产科医生在会阴创伤的评估、修复和产后管理方面的技能。接受会阴切开术或二度会阴撕裂的女性将有资格参加招募。在制定干预措施并确定研究结果之前,进行了德尔菲调查和共识会议,以确定曾在分娩时遭受过会阴创伤的女性认为对她们重要的结果。这项初步工作(将在其他地方报告)的结果以及其他结果,包括女性会阴疼痛和活动时疼痛、母乳喂养率和持续时间以及使用爱丁堡产后抑郁量表(EPDS)评估的心理健康状况,将在产后 10 天和 3 个月进行评估。

讨论

实施基于证据的会阴评估和管理实践,可能会显著改善英国和全球女性的身心健康结果。

试验注册

PEARLS 在当前对照试验注册库(注册号:ISRCTN81756326)中注册。NIHR UKCRN 组合编号:4785。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d2e4/2836981/58b0b2342eda/1471-2393-10-10-1.jpg

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