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临床试验/NCT06379048
NCT06379048已完成不适用

The Impact of Different Skin Suture Methods in Episiotomy Repair on Healing and Pain: A Randomized Clinical Trial

Başakşehir Çam & Sakura City Hospital2 个研究点 分布在 2 个国家目标入组 132 人开始时间: 2022年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
132
试验地点
2
主要终点
Healing by Redness, Edema, Ecchymosis and Discharge (REEDA) Score

研究概览

简要总结

Episiotomy is the intentional incision of the perineum during vaginal birth in order to accelerate the active phase of labor. This study aimed to compare various skin closure techniques in episiotomy repair.

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

  • Primiparous
  • Age between 18 to 45
  • Given birth in our labor ward

排除标准

  • Multiparous
  • having deep vaginal lacerations
  • having abnormalities in fetus
  • Rheumatologic diseases
  • Postpartum bleeding
  • Shoulder Dystocia
  • Operative Delivery
  • Using antithrombotic or anticoagulant medications

结局指标

主要结局

Healing by Redness, Edema, Ecchymosis and Discharge (REEDA) Score

时间窗: in postpartum day 15

Healing is assessed by Redness, Edema, Ecchymosis and Discharge (REEDA) Score REEDA Scale: Healed: 0; moderately healed: 1 to 5; mildly healed: 6 to 10; and not healed: 11 to 15

Pain by Visual Analog Scale (VAS)

时间窗: in postpartum day 15

Pain is assessed from 0 (none) to 10 (extreme) by Visual Analog Scale (VAS)

次要结局

未报告次要终点

研究者

发起方
Başakşehir Çam & Sakura City Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Emre Kar

Principal Investigator

Başakşehir Çam & Sakura City Hospital

研究点 (2)

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