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临床试验/NCT01278979
NCT01278979已完成不适用

Diagnosing Perineal Tears. Consistency in Midwifes Clinical Judgement When Assessing Perineal Tears Using Two Different Assessment Methods.

Ostfold Hospital Trust2 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2011年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
400
试验地点
2
主要终点
To investigate how different assessment methods affected the midwives´ clinical judgement between different midwife practitioners when they classify and evaluate perineal tears.

研究概览

简要总结

This study aims to compare different midwife practitioners assessments of perineal tears.

详细描述

Perineal injuries are one of the traumas most frequently suffered by women during delivery.Countries report wide variations in trauma rates, and within countries further variations exists among institutions and also among professional groups of caregivers.Visual and digital examination of the wound has been and is the most common way to assess and classify a perineal tear. However resent studies indicate that many tears diagnosed with this method are misclassified.The suggested reasons for this, apart from the fact that bleeding and tissue oedema make the diagnose difficult, is that many healthcare providers have too little training in perineal assessment and basic anatomy.

In this prospective randomised trial consenting women will be randomised in to the common visual and digital assessment of the perineal tear by to different midwives, blinded to each others assessment or visual and digital assessment and measuring of the tear with a small soft ruler, Peri-Rule also by two different midwives.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Spontaneous vaginal birth
  • Women over 18 years of age
  • Healthy Child
  • Written consent signed by participant
  • Spontaneous tear in perineum that involves the perineal skin

排除标准

  • Bleeding from tears that demand suturing immediately.
  • Bleeding that affected the general condition negatively
  • Complex tears that branched out in two or more different directions
  • Women delivered instrumentally forceps or ventouse
  • Women delivered with Cesarian section
  • Women who sustain episiotomy

结局指标

主要结局

To investigate how different assessment methods affected the midwives´ clinical judgement between different midwife practitioners when they classify and evaluate perineal tears.

时间窗: One and a half years

Assessment of perineal tears using different two different assessment methods

次要结局

  • Consistency between different midwife practitioners when the classify and evaluate perineal tears.(One and a half years)

研究者

发起方
Ostfold Hospital Trust
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ann Morris

authorized midwife and master student

Ostfold Hospital Trust

研究点 (2)

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