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临床试验/NCT07336017
NCT07336017招募中不适用

Impact on Postpartum Anal Incontinence of an Educational Program for Delivery Room Staff on the Diagnosis and Repair of Obstetric Anal Sphincter Injuries

University Hospital, Strasbourg, France1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2025年6月17日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
1,000
试验地点
1
主要终点
St. Mark's score

研究概览

简要总结

Obstetric anal sphincter injuries are a source of significant short-term (pain, bleeding, infection, suture dehiscence), medium-term (anorectovaginal fistulas, sexual dysfunction), and long-term (anal incontinence in 30-60% of cases) morbidity. However, they are underdiagnosed and sometimes poorly repaired due to technical difficulties, the use of inappropriate surgical techniques, or a lack of awareness of their significant long-term morbidity. These diagnostic and therapeutic errors, however, significantly worsen the functional prognosis of patients. This study aims to evaluate the clinical impact of an educational program designed for continuing education in the diagnosis and repair of obstetric anal sphincter injuries for staff working in the delivery room.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

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

  • Adult women (≥18 years old)
  • who gave birth vaginally at Strasbourg University Hospital in the 3 months prior to and 3 months following the training of delivery room staff at both maternity wards
  • Singleton pregnancy
  • Live birth

排除标准

  • Multiple pregnancy
  • Fetal death in utero
  • Medical termination of pregnancy
  • Delivery by cesarean section.

结局指标

主要结局

St. Mark's score

时间窗: Up to 18 months

The St Mark's score is a tool for measuring the severity of fecal incontinence: The score is based on several criteria: Solid leakage: 2 points (1-3 times per month) Liquid leakage: 3 points (once a week) Gas: 1 point (less than once a week) Protection: 1 point (occasionally) Daily life: 2 points (moderate discomfort) Ability to control: 1 point The points for each criterion are added together: * Minimum score = 0 → no incontinence. * Maximum score = 24 → very severe incontinence

次要结局

未报告次要终点

研究者

发起方
University Hospital, Strasbourg, France
申办方类型
Other
责任方
Sponsor

研究点 (1)

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