Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2026-03-10 @ 11:33 PM
Study NCT ID:
NCT03117504
Status:
SUSPENDED
Last Update Posted:
2017-04-18
First Post:
2017-03-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Prevalence of Stress Urinary Incontinence During Pregnancy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014550', 'term': 'Urinary Incontinence, Stress'}], 'ancestors': [{'id': 'D014549', 'term': 'Urinary Incontinence'}, {'id': 'D014555', 'term': 'Urination Disorders'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'lack of funding', 'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2016-01-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2017-07-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-04-17', 'studyFirstSubmitDate': '2017-03-21', 'studyFirstSubmitQcDate': '2017-04-17', 'lastUpdatePostDateStruct': {'date': '2017-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-05-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of stress urinary incontinence during first trimester pregnancy', 'timeFrame': '2 years', 'description': 'Determine the prevalence and associated risk factors in the first trimester'}], 'secondaryOutcomes': [{'measure': 'Prevalence of stress urinary incontinence during third trimester pregnancy', 'timeFrame': '2 years', 'description': 'Determine the prevalence and associated risk factors in the third trimester'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Stress urinary incontinence', 'SUI'], 'conditions': ['Stress Urinary Incontinence']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nAccordingly, 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.\n\nThe 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.\n\nThis calculation used a two-sided z test with a confidence level of 95% (alpha error, 0.05).\n\nData will be collected, tabulated, then analyzed using IBM© SPSS© Statistics version 22.\n\nNormally distributed numerical data will be presented as mean and SD, and skewed data as median and inter-quartile range.\n\nQualitative 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.\n\nCategorical data will be compared using the chi-squared test, or Fisher's exact test when appropriate.\n\nA two-sided p-value \\<0.05 will be considered statistically significant ."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'A cross-sectional study of two groups of women will be conducted. Each group consists of 250 patients with a total number of 500 patients\n\n* group 1 : women during first trimester(less than 14 weeks of pregnancy).\n* group 2: women during third trimester (more than 28 weeks of pregnancy).', 'genderDescription': 'Pregnant women', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant women in first and third trimesters\n\nExclusion Criteria:\n\n* Communication problems.\n* Mental disturbances.\n* Previous surgery for incontinence or other pelvic procedures.'}, 'identificationModule': {'nctId': 'NCT03117504', 'briefTitle': 'Assessment of Prevalence of Stress Urinary Incontinence During Pregnancy', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams Maternity Hospital'}, 'officialTitle': 'Assessment of Prevalence of Stress Urinary Incontinence During Pregnancy', 'orgStudyIdInfo': {'id': 'MNAAMonem'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'First trimester', 'description': 'women during first trimester(less than 14 weeks of pregnancy) will complete self-reported questionnaires and undergo clinical examination to confirm the stress incontinence.', 'interventionNames': ['Other: questionnaire']}, {'label': 'Third trimester', 'description': 'women during third trimester(more than 28 weeks of pregnancy) will complete self-reported questionnaires and undergo clinical examination to confirm the stress incontinence.', 'interventionNames': ['Other: questionnaire']}], 'interventions': [{'name': 'questionnaire', 'type': 'OTHER', 'description': "a questionnaire is given to each woman to determine the urinary incontinence and it's impact on quality of life.", 'armGroupLabels': ['First trimester', 'Third trimester']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1156', 'city': 'Cairo Governorate', 'state': 'Cairo Governorate', 'country': 'Egypt', 'facility': 'Ain Shams Faculty of Medicine'}], 'overallOfficials': [{'name': 'Hazem M Sammour, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Ain Shams Maternity Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams Maternity Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident of obstetrics&gynecology', 'investigatorFullName': 'Mohammed Nour Allah Abdel Monem', 'investigatorAffiliation': 'Ain Shams Maternity Hospital'}}}}