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临床试验/NCT05196620
NCT05196620尚未招募不适用

Prevalence of Anal Sphincter Defects After Childbirth in Primiparous Women

Universidad de Zaragoza1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
试验地点
1
主要终点
Integrity of anal sphincter

研究概览

简要总结

The incidence of obstetric sphincter tears has risen to 15-30% and the prevalence of anal incontinence (AI) symptoms after childbirth may be as high as 40%. The present study aims to evaluate the prevalence of anal sphincter defects after childbirth in primiparous women-

详细描述

The incidence of sphincter defect in women has raised in recently with current rates as high as 30% after vaginal deliveries. Fecal incontinence could be present at the time of the delivery but it is a real problem longtime after, in women older than 60 years.

It is of great importance not only an early detection but to indicates the best possible management as soon as posible.

The design is a prospective observational study including primiparous woman, without previous anal surgery.

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

  • Primiparous pregnant patients aged >18 y, evaluated during pregnancy and after childbirth, including both vaginal and cesarean deliveries.

排除标准

  • Non primiparous patients and patients with a history of anal surgery

结局指标

主要结局

Integrity of anal sphincter

时间窗: 4 months

No defect detected on EAUS

Defects on anal canal

时间窗: 4 months

Disruption of any of the anal canal sphincters

次要结局

  • QoL(4 months)

研究者

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

Jose-M Ramirez

Prof

Universidad de Zaragoza

研究点 (1)

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