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临床试验/NCT02655900
NCT02655900已完成不适用

Use of 3D Ultrasound to Predict Anal Sphincter Defects

Croydon University Hospital0 个研究点目标入组 250 人开始时间: 2013年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
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

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

发起方
Croydon University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ranee Thakar

Consultant Obstetrician and Urogynaecologist

Croydon University Hospital

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