Comparison of the accuracy of Episcissor-60 with Mayo scissors in performing a mediolateral episiotomy- a randomized control trial for a duaration of 1 year in a tertiary care center.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 260
- 试验地点
- 1
- 主要终点
- to assess significance of the accurately angled of episiotomy with the use of Episcissor-60 in reduction in obstetric anal sphincter injuries
研究概览
简要总结
Episiotomy is the most commonly performed procedure, and an inaccurately performed episiotomy can risk in obstetric anal sphincter injuries and hold ground for medical negligence, there are various factors of episiotomy that govern the adequacy and accuracy of the episiotomy and reflect on the incidence of perineal tears. the angle recommeded is between 40-60 degrees. in this study we are comparing the angle of episiotomy between the regular Mayo scissor and the episcissor-60 which is a patented pre fixed scissor and its accuracy in prevention of obstetric tears and perianal injuries.
the secondary objective is to detect the rate of perineal injuries and infection rate and compare between the scissors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- Female
入选标准
- •Primigravida multigravida VBAC.
排除标准
- •previous obstetric phincter injury assisted vaginal delivery instrumental delivery.
结局指标
主要结局
to assess significance of the accurately angled of episiotomy with the use of Episcissor-60 in reduction in obstetric anal sphincter injuries
时间窗: the assessment is done immediately, after 24 hours
次要结局
- to assess accuracy of the angle of episiotomy incision with usage of fixed angle scissor(to assess clinical significance in reducing perineal infection)