Ignite Creation Date:
2025-12-24 @ 7:59 PM
Ignite Modification Date:
2026-01-02 @ 3:04 PM
Study NCT ID:
NCT03126604
Status:
UNKNOWN
Last Update Posted:
2017-04-24
First Post:
2017-04-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pelvic Floor Function After Vaginal and Cesarean Delivery Among Egyptian Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059952', 'term': 'Pelvic Floor Disorders'}], 'ancestors': [{'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2018-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-04-20', 'studyFirstSubmitDate': '2017-04-20', 'studyFirstSubmitQcDate': '2017-04-20', 'lastUpdatePostDateStruct': {'date': '2017-04-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'urinary incontinence', 'timeFrame': '6 months after delivery', 'description': 'evaluation using the International Consultation on Incontinence Questionnaire Short Form'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pelvic Floor Disorders']}, 'descriptionModule': {'briefSummary': 'A cross sectional study for assessment of pelvic floor functions after 6 months to 4 years after normal vaginal delivery or Cesarean section', 'detailedDescription': 'A cross sectional study for assessment of pelvic floor functions after 6 months to 4 years after normal vaginal delivery or Cesarean section Four separate entities were evaluated using internationally recognized and validated questionnaires:\n\n1. Pelvic organ prolapse evaluated using the Pelvic Organ Prolapse Distress Inventory\n2. Urinary functions were evaluated using the International Consultation on Incontinence Questionnaire Short Form\n3. Fecal incontinence was evaluated using Wexner Fecal Incontinence Score\n4. Sexual functions were evaluated using female sexual function index'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'women who delivered vaginally or Cesarean for the first time within 6 months to 5 years before evaluation', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* primiparity,\n* singleton pregnancy\n* cephalic presentation\n* term delivery (38-42 weeks).\n\nExclusion Criteria:\n\n* Women with operative vaginal delivery (vacuum extraction or forceps delivery)\n* women who had another delivery between the time of first one and time of evaluation\n* women with neurological diseases\n* women with vascular diseases and Diabetes Mellitus'}, 'identificationModule': {'nctId': 'NCT03126604', 'briefTitle': 'Pelvic Floor Function After Vaginal and Cesarean Delivery Among Egyptian Women', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Evaluation of Pelvic Floor Function After Vaginal and Cesarean Delivery Among Egyptian Women', 'orgStudyIdInfo': {'id': '5'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'vaginal delivery', 'description': 'Women underwent non complicated non instumental normal vaginal delivery', 'interventionNames': ['Diagnostic Test: female sexual function index']}, {'label': 'Cesarean section', 'description': 'Women underwent elective Cesarean section', 'interventionNames': ['Diagnostic Test: female sexual function index']}], 'interventions': [{'name': 'female sexual function index', 'type': 'DIAGNOSTIC_TEST', 'description': 'evaluation of sexual functions questionnaire about Desire, Arousal, Orgasm,pain , lubrications, satisfactions', 'armGroupLabels': ['Cesarean section', 'vaginal delivery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12151', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Kasr Alainy medical school', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Ahmed Maged, MD', 'role': 'CONTACT', 'email': 'prof.ahmedmaged@gmail.com', 'phone': '01005227404'}], 'overallOfficials': [{'name': 'Ahmed Maged, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kasr Alainy medical school'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Ahmed Maged', 'investigatorAffiliation': 'Cairo University'}}}}