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临床试验/NCT02870712
NCT02870712已完成不适用

Randomized Controlled Trial of the Effectiveness of Perineal Pain and Security of the Suture Led by the Result of Hemostasis Versus Manual Compression Routine Suture Perineal Tears of First Degree During Childbirth, ImSOLENCE Study

Centre Hospitalier Universitaire de Besancon2 个研究点 分布在 1 个国家目标入组 112 人开始时间: 2017年3月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
112
试验地点
2
主要终点
Composite Outcome Measure for success defined by : - a negligible pain, - satisfactory healing, - no bleeding and infection of the perineum

研究概览

简要总结

During childbirth, the recommendations have evolved to a restriction of episiotomy. This reduction results in an increase of superficial vaginal and perineal tears. These lesions are usually routinely sutured which often causes the onset of discomfort and pain in the immediate postpartum period. Gordon showed, in 1998, improved comfort and pain when the skin was not sutured perineal tears during the second degree. Others have compared different techniques in the same indications (separated points running suture, biological adhesive) without demonstrated impact. These studies were not interested in isolated perineal tears or first degree or the application of a simple manual compression with or without a suture according to the result of hemostasis.

Our objective is to evaluate the possibility of not suture the perineum of the first degree. The use of suture only result of bleeding not yielding to manual compression.

Our approach is guided by the principles of "primum non nocere" and discerning about the dogmatic systematization.

研究设计

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

入排标准

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

入选标准

  • single Pregnancy
  • primiparae
  • delivery by spontaneous vaginal delivery
  • forward Delivery (≥ 37 weeks)
  • cephalic presentation
  • children living
  • perineal tear or isolated first-degree vaginal tear

排除标准

  • Known haemostatic anomaly
  • Premature birth (before 37)
  • caesarean
  • Instrumental delivery
  • Placenta and / or uterine revision
  • episiotomy
  • perineal tear ≥ 2nd degree

结局指标

主要结局

Composite Outcome Measure for success defined by : - a negligible pain, - satisfactory healing, - no bleeding and infection of the perineum

时间窗: ten day after childbirth

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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