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临床试验/NCT01310660
NCT01310660已完成不适用

Evaluation of Levator Injuries Using Transvaginal Endosonography

Croydon University Hospital1 个研究点 分布在 1 个国家目标入组 269 人开始时间: 2011年1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
269
试验地点
1
主要终点
The principal objective is to establish the incidence of levator muscle defects during pregnancy and after childbirth.

研究概览

简要总结

Prospective studies to date have identified that the levator ani muscle injuries occur in 14-19% of women after vaginal delivery.

In none of studies a vaginal examination was performed at the time of delivery. It has previously been shown that sonographic injuries of the anal sphincter that were believed to be occult were in fact clinically apparent but not recognised at the time of delivery. It is therefore important to correlate clinical findings to ultrasound images.

3D endovaginal endosonography has not previously been used to identify levator injuries. This should potentially provide a better view of the pelvic floor muscles.

The relationship between levator injury and symptoms of pelvic floor dysfunction has not been previously established using validated questionnaires. In this study, we include validated questionnaires to evaluate urinary incontinence, faecal incontinence and vaginal symptoms. As symptoms may become apparent only in the long term it is prudent that the women are followed up in the long term.

The principle objective is to establish the incidence of levator muscle defects during pregnancy and after childbirth. The levator muscle forms a major part of the pelvic floor and damage to this muscle can potentially cause urinary, bowel and sexual problems and pelvic organ prolapse.

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 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Pregnant women who have not delivered previously
  • Singleton pregnancy
  • Maternal age > 18 years and
  • No previous pregnancies >20 weeks of gestation
  • Ability to read and understand English.

排除标准

  • Pregnant women who have delivered previously
  • Multiple pregnancies

结局指标

主要结局

The principal objective is to establish the incidence of levator muscle defects during pregnancy and after childbirth.

时间窗: Antenatal, after delivery and postnatal

次要结局

未报告次要终点

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 Urogynaecologist

Croydon University Hospital

研究点 (1)

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