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临床试验/NCT02615236
NCT02615236Unknown不适用

Prospective Evaluation of Perineal Ultrasound in Thr Delivery Room to Improve the Diagnosis of OASIS

Ain Shams University1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2016年6月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
300
试验地点
1
主要终点
anal incontinence

研究概览

简要总结

The aim of the study is to evaluate the role of routine perineal scan using 2D ultrasound immediatly after delivery to diagnose hidden perineal trauma that might affect patient's fecal continance

详细描述

In countries where there is high prevalence of doing episiotomy in primiparous women, the incidence of sustained obstetric anal sphincter injuries is increasing.

When the tear extend beyond the external anal sphincter its called 'OASIS' that might lead to either immediate of delayed anal incontinence. Anal incontinence is associated with significant medical, hygiene and social problems. Use of perineal ultrasound as a bedside test immediately after vaginal delivery could improve the diagnosis and determining the degree of these perineal traumas. This increased detection could lead to improved primary repair of the external and internal anal sphincter resulting in reduced rates of anal incontinence and improved quality of life for women

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
20 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • primiparous women immediately after vaginal delivery

排除标准

  • history of anal incontinence
  • previous anal sphincteric injuries
  • previous anal surgery

研究组 & 干预措施

PERINEAL ULTRASOUND

Experimental

Perineal ultrasound with a bedside scanner by inserting a the probe into the perineum and reviewed in real-time

干预措施: perineal ultrasound (Device)

Clinical diagnosis

Active Comparator

Diagnosis of OASIS will be clinically

干预措施: Clinical diagnosis (Procedure)

结局指标

主要结局

anal incontinence

时间窗: 3 months after delivery

patients will be reviewed for anal incontinence 3 months after delivery

次要结局

  • pain score(3 and 12 month after delivery)
  • questionnaire for effect on quality of life(3 and 12 month after delivery)

研究者

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

Ahmed Mohamed El Kotb Abdel Fattah

Dr. Ahmed Kotb

Ain Shams University

研究点 (1)

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