Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 10:39 PM
Study NCT ID:
NCT02661867
Status:
COMPLETED
Last Update Posted:
2016-01-25
First Post:
2016-01-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pelvic Floor Function Evaluation of Singleton Primiparae After Vaginal Delivery and Cesarean Section
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059952', 'term': 'Pelvic Floor Disorders'}, {'id': 'D056887', 'term': 'Pelvic Organ Prolapse'}, {'id': 'D014549', 'term': 'Urinary Incontinence'}, {'id': 'D005242', 'term': 'Fecal Incontinence'}], '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'}, {'id': 'D011391', 'term': 'Prolapse'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014555', 'term': 'Urination Disorders'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D036801', 'term': 'Parturition'}], 'ancestors': [{'id': 'D011247', 'term': 'Pregnancy'}, {'id': 'D012098', 'term': 'Reproduction'}, {'id': 'D055703', 'term': 'Reproductive Physiological Phenomena'}, {'id': 'D012101', 'term': 'Reproductive and Urinary Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 865}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-22', 'studyFirstSubmitDate': '2016-01-16', 'studyFirstSubmitQcDate': '2016-01-22', 'lastUpdatePostDateStruct': {'date': '2016-01-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-01-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pelvic organ prolapse symptoms score', 'timeFrame': 'seven years after delivery', 'description': 'calculated from validated questionnaire International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF)'}], 'secondaryOutcomes': [{'measure': 'Urinary incontinence symptoms score', 'timeFrame': 'seven years after delivery', 'description': 'calculated from validated questionnaire Pelvic Organ Prolapse Distress Inventory (POPDI-6)'}, {'measure': 'Fecal incontinence symptoms score', 'timeFrame': 'seven years after delivery', 'description': 'calculated from validated questionnaire Wexner Fecal Incontinence Score (WS)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Childbirth', 'Pelvic organ prolapse', 'Urinary incontinence', 'Fecal incontinence'], 'conditions': ['Pelvic Floor Disorders']}, 'referencesModule': {'references': [{'pmid': '22907482', 'type': 'BACKGROUND', 'citation': 'Memon H, Handa VL. Pelvic floor disorders following vaginal or cesarean delivery. Curr Opin Obstet Gynecol. 2012 Oct;24(5):349-54. doi: 10.1097/GCO.0b013e328357628b.'}, {'pmid': '28171703', 'type': 'DERIVED', 'citation': 'Huser M, Janku P, Hudecek R, Zbozinkova Z, Bursa M, Unzeitig V, Ventruba P. Pelvic floor dysfunction after vaginal and cesarean delivery among singleton primiparas. Int J Gynaecol Obstet. 2017 May;137(2):170-173. doi: 10.1002/ijgo.12116. Epub 2017 Mar 1.'}]}, 'descriptionModule': {'briefSummary': 'Objective of this longitudinal observational cohort study was to analyze incidence of pelvic floor dysfunction (PFD) symptoms, including pelvic organ prolapse (POP), urinary incontinence (UI), and fecal incontinence (FI), seven to twelve years after delivery, in two groups of singleton primiparae after vaginal delivery (VD) and cesarean section (CS).', 'detailedDescription': 'Pelvic floor disorders (PFD) usually refers to three definable groups of symptoms that include pelvic organ prolapse (POP), urinary incontinence (UI), and fecal incontinence (FI). The prevalence of these conditions increases with age, but in general, PFD affect 20-50 % of women throughout their lives. Thus, PFD are common and have significant societal impact. Another important PFD risk factor is childbearing. Specifically, these disorders are more common among multiparas. Vaginal delivery (VD) has been considered the main contributing factor because of pelvic floor muscle, fascia, and nerves damage.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Primiparae delivered vaginally (VD group) or by cesarean section (CS group) during the years 2002-2007 in university-based large perinatology center', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* singleton pregnancy\n* cephalic presentation\n* delivery in term (gestational week 38-42)\n* no other childbirth during study period\n\nExclusion Criteria:\n\n\\- operative vaginal delivery (vacuum extraction or forceps delivery)'}, 'identificationModule': {'nctId': 'NCT02661867', 'briefTitle': 'Pelvic Floor Function Evaluation of Singleton Primiparae After Vaginal Delivery and Cesarean Section', 'organization': {'class': 'OTHER', 'fullName': 'Brno University Hospital'}, 'officialTitle': 'Pelvic Floor Function Evaluation of Singleton Primiparae After Vaginal Delivery and Cesarean Section: Seven to Twelve-Year Long Observational Cohort Study', 'orgStudyIdInfo': {'id': 'Plure'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'VD', 'description': 'Vaginal delivery group - women who gave birth of offspring through the vagina without the use of special instruments such as forceps or a vacuum extractor (instrumental vaginal delivery)', 'interventionNames': ['Behavioral: delivery']}, {'label': 'CS', 'description': "Cesarean section group - women delivered by surgical procedure in which one or more incisions are made through a mother's abdomen and uterus to deliver a baby. Cesarean section is performed when a vaginal delivery would put the baby's or mother's life or health at risk.", 'interventionNames': ['Behavioral: delivery']}], 'interventions': [{'name': 'delivery', 'type': 'BEHAVIORAL', 'description': 'delivery either vaginal or by cesarean section', 'armGroupLabels': ['CS', 'VD']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Brno University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'doctor', 'investigatorFullName': 'Martin Huser', 'investigatorAffiliation': 'Brno University Hospital'}}}}