Assessment of Prevalence of Stress Urinary Incontinence During Pregnancy
NCT ID: NCT03117504
Last Updated: 2017-04-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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SUSPENDED
500 participants
OBSERVATIONAL
2016-01-05
2017-07-20
Brief Summary
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Detailed Description
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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.
Normally distributed numerical data will be presented as mean and SD, and skewed data as median and inter-quartile range.
Qualitative data will be presented as number and percentage.Comparison of normally distributed numerical data will be done using the unpaired Student t test. Skewed data will be compared using the Mann-Whitney U test.
Categorical data will be compared using the chi-squared test, or Fisher's exact test when appropriate.
A two-sided p-value \<0.05 will be considered statistically significant .
Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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First trimester
women during first trimester(less than 14 weeks of pregnancy) will complete self-reported questionnaires and undergo clinical examination to confirm the stress incontinence.
questionnaire
a questionnaire is given to each woman to determine the urinary incontinence and it's impact on quality of life.
Third trimester
women during third trimester(more than 28 weeks of pregnancy) will complete self-reported questionnaires and undergo clinical examination to confirm the stress incontinence.
questionnaire
a questionnaire is given to each woman to determine the urinary incontinence and it's impact on quality of life.
Interventions
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questionnaire
a questionnaire is given to each woman to determine the urinary incontinence and it's impact on quality of life.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Mental disturbances.
* Previous surgery for incontinence or other pelvic procedures.
FEMALE
Yes
Sponsors
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Ain Shams Maternity Hospital
OTHER
Responsible Party
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Mohammed Nour Allah Abdel Monem
Resident of obstetrics&gynecology
Principal Investigators
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Hazem M Sammour, MD
Role: STUDY_CHAIR
Ain Shams Maternity Hospital
Locations
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Ain Shams Faculty of Medicine
Cairo Governorate, Cairo Governorate, Egypt
Countries
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Other Identifiers
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MNAAMonem
Identifier Type: -
Identifier Source: org_study_id
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