Use of 3D Ultrasound to Predict Anal Sphincter Defects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 250
- 主要终点
- Diagnostic test accuracy of 3D endovaginal (EVUS) and transperineal ultrasound (TPUS) for diagnosing Obstetric Anal Sphincter injurieS (OASIS)
研究概览
简要总结
Injury to the muscles of the back passage (anal canal) is a relatively common problem. This injury can result in problems with bowel control later in life and usually occurs during vaginal childbirth (commonly referred to as 3rd and 4th degree perineal tears). Currently women who have sustained injury to the muscles of the back passage undergo an ultrasound scan by inserting a probe 3 to 4 cms into the back passage. This helps to check if the muscle of the back passage has healed i.e is intact or has a defect. The investigators would like to establish whether a 3D ultrasound scan probe placed outside the vagina can identify the defects and hence avoid inserting the probe into the back passage. In addition to getting the above information using 3D ultrasound scan, the investigators would also like to identify injuries to the pelvic floor muscle (levator ani) in these patients. Which can be diagnosed using the 3D ultrasound probe placed outside the vagina (perineum). Women who sustain injury to this muscle are known to develop prolapse later on in life.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women who sustained an obstetric anal sphincter injury referred to the perineal clinic
排除标准
- 未提供
结局指标
主要结局
Diagnostic test accuracy of 3D endovaginal (EVUS) and transperineal ultrasound (TPUS) for diagnosing Obstetric Anal Sphincter injurieS (OASIS)
时间窗: 3 months Postpartum
To calculate the diagnostic test characteristics (e.g sensitivity, specificity, positive predictive value, negative predictive value and likelihood ratio) to enable comparison of three methods of ultrasound assessment of the anal sphincter following sphincter injury after vaginal delivery
次要结局
- Prevalence of Levator Ani Muscle Injury in women who sustained Obstetric Anal Sphincter Injury(3 months Postpartum)
研究者
Ranee Thakar
Consultant Obstetrician and Urogynaecologist
Croydon University Hospital
