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临床试验/NCT00506116
NCT00506116已完成3 期

Promoting Effective Recovery From Labor Urinary Incontinence: Prevention Reducing Birthing Risk

University of Michigan2 个研究点 分布在 1 个国家目标入组 140 人开始时间: 1996年7月最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
140
试验地点
2
主要终点
Leakage Index (

研究概览

简要总结

The purpose of this study is to determine whether pushing during labor that is controlled by the woman results in less birth-related injury and less postpartum urinary incontinence (UI).

详细描述

Birth related urinary incontinence (UI) is a predictor of UI in older women. Ways to protect the continence mechanism during delivery may diminish a woman's risk of UI later in life. We propose to study the functional anatomy of the pelvic floor as it relates to UI in women who are having their first baby. We hypothesize non-directed, spontaneous pushing is a protective strategy in decreasing the risk of immediate and long term UI. Longitudinal comparisons of pelvic floor characteristics will be taken at 35 week gestation and 6 weeks, 6 months, and 12 months postpartum. Study participants will be seen first at 20 weeks gestation for documentation of baseline levels of pelvic floor function, specifically voluntary and involuntary muscle strength, urinary continence status, and urethral support. They will be randomly assigned into non-directed, spontaneous (experimental) and directed, sustained pushing (control) groups. Alterations that may occur in urethral support before and after birth will be described through non-invasive urethral ultrasound.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Prevention
盲法
Single

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 giving birth for the first time who are:
  • Age 18 years or older
  • Less than 20 weeks gestation
  • Expected vaginal birth without use of epidural analgesia
  • Plan to reside in Southeast Michigan for one year following the birth of the infant.

排除标准

  • History of genito-urinary or neuro-muscular pathology
  • Previous pregnancy carried beyond 20 weeks gestation.

结局指标

主要结局

Leakage Index (

时间窗: 20 and 35 weeks gestation, and 6 weeks, 6 months, and 12 months postpartum

次要结局

  • Perineal status (Digital, speculum, chart review, ultrasound)(35 week gestation and 6 weeks, 6 months, and 12 months postpartum)
  • Pelvic Organ Prolapse Quantification System (POPQ)(35 weeks gestation and 6 weeks, 6 months, and 12 months postpartum)

研究者

申办方类型
Other

研究点 (2)

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