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
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
- 是
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
