Prospective Evaluation of Perineal Ultrasound in Thr Delivery Room to Improve the Diagnosis of OASIS
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
- 是
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
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
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
Ahmed Mohamed El Kotb Abdel Fattah
Dr. Ahmed Kotb
Ain Shams University
