Assessment of Prevalence of Stress Urinary Incontinence During Pregnancy
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Prevalence of stress urinary incontinence during first trimester pregnancy
研究概览
简要总结
Stress urinary incontinence is the most common type of incontinence during pregnancy.our study aims at determining the prevalence in the first and third trimesters and the associated risk factors.
详细描述
The required sample size has been calculated using IBM© Sample Power© version 3 .The primary outcome measure is the prevalence of stress urinary incontinence (SUI) in the 1st and 3rd trimesters.
Accordingly, it is estimated that a sample of 240 patients in either study group would have a power of 80% (beta error, 0.2) to detect a statistically significant difference of 9% between the two groups as regards the incidence of SUI.
The incidence of SUI is assumed to equal 10% in the 1st trimester. The prevalence of SUI in the 3rd trimester is assumed to equal 10% under the null hypothesis and to equal 19% under the alternative hypothesis.
This calculation used a two-sided z test with a confidence level of 95% (alpha error, 0.05).
Data will be collected, tabulated, then analyzed using IBM© SPSS© Statistics version 22.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant women in first and third trimesters
排除标准
- •Communication problems.
- •Mental disturbances.
- •Previous surgery for incontinence or other pelvic procedures.
结局指标
主要结局
Prevalence of stress urinary incontinence during first trimester pregnancy
时间窗: 2 years
Determine the prevalence and associated risk factors in the first trimester
次要结局
- Prevalence of stress urinary incontinence during third trimester pregnancy(2 years)
研究者
Mohammed Nour Allah Abdel Monem
Resident of obstetrics&gynecology
Ain Shams Maternity Hospital