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临床试验/NCT01930721
NCT01930721Unknown2 期

Comparison of Incision Angle of Mediolateral Episiotomy at 40 and 60 Degrees

Ain Shams Maternity Hospital1 个研究点 分布在 1 个国家目标入组 330 人开始时间: 2012年3月最近更新:
适应症

试验速览

阶段
2 期
入组人数
330
试验地点
1
主要终点
and fourth degree perineal tears.

研究概览

简要总结

The angle at which an episiotomy can be made is a continuous variable. If the investigators consider midline to be 0 degrees and a lateral episiotomy (never used today) to be 90 degrees, then it is theoretically possible to choose any angle from 0 to 90 degrees.

详细描述

Episiotomy is a surgical incision to the perineum in order to enlarge the vaginal orifice during the second stage of labor. Although seven types of episiotomy have been described in the literature , the most frequently performed types are the mediolateral and median episiotomies, with the former being the most common one. Despite being a common obstetric practice, the exact definition of a "mediolateral" episiotomy is often unclear. Several studies and reports, however, stated that a significant proportion of the so-claimed mediolateral episiotomy were not actually mediolateral. The current trial compares two angles of mediolateral episiotomy , regarding the risk of third- and fourth-degree perineal tearing, episiotomy-related pain and dyspareunia in primiparous women at a large tertiary maternity center, namely Ain Shams University Maternity Hospital, Cairo, Egypt.

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 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Primigravida with singleton pregnancy presenting by vertex.
  • Gestational age > 37 weeks
  • No instrumental delivery.
  • No fetal distress or any emergency

排除标准

  • Women had an episiotomy because of fetal distress and for technical reasons (emergency or episiotomy incised prior to the fetal head crowning the perineum.
  • Inability to understand the informed consent.

结局指标

主要结局

and fourth degree perineal tears.

时间窗: intraoperative

DESCRIBING THIRD AND FOURTH degree perieneal tears as regarding repair and post operative pain

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

malka amen

resident

Ain Shams Maternity Hospital

研究点 (1)

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