跳至主要内容
临床试验/NCT03611452
NCT03611452Unknown不适用

Simple Continuous, Subcuticular and Interrupted Skin Suturing of Episiotomy and 2nd-degree Perineal Tears : A Comparative Study

Assiut University0 个研究点目标入组 138 人开始时间: 2018年8月最近更新:
适应症

试验速览

阶段
不适用
入组人数
138
主要终点
the mean score of Perineal pain during vaginal suturing

研究概览

简要总结

Millions of women worldwide undergo perineal suturing after childbirth and the type of repair may have an impact on pain and healing.

The skin as a barrier between the internal structures and the external environment is exceptionally susceptible to injury, either through accidental injury or planned surgical incision. Today, as surgery increases in complexity, and the heightened public awareness of scar cosmesis and skin healing need to be optimized to ensure the overall success of the surgical procedure

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

性别
Female
接受健康志愿者

入选标准

  • Normal vaginal delivery.
  • At term (37 40 weeks ).
  • Live baby.
  • Vertex presentation

排除标准

  • Third and fourth degree perineal tear.
  • Instrumental vaginal delivery.
  • Previous perineal surgery.
  • Anaemia with hemoglobin level < 9 g/dl.
  • Diabetes mellitus.
  • Coagulation abnormalities.
  • Postpartum hemorrhage.
  • Delivery conducted outside Woman HealthHospital.
  • Breech delivery.
  • Body mass index >35 kg/m
  • Local infectious lesions.
  • Anal fissures or hemorrhoid.

结局指标

主要结局

the mean score of Perineal pain during vaginal suturing

时间窗: 10 minutes

assessment through visual analog scale score from 0 - 10 at every step of repair

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

Ahmed Mohamed Abbas

Principal investigator

Assiut University

相似试验