Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2026-02-27 @ 1:07 AM
Study NCT ID:
NCT01766193
Status:
COMPLETED
Last Update Posted:
2017-02-17
First Post:
2013-01-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Delivery Method and Risk for Urogenital Prolapse 15-20 Years Later
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014596', 'term': 'Uterine Prolapse'}, {'id': 'D014549', 'term': 'Urinary Incontinence'}, {'id': 'D005242', 'term': 'Fecal Incontinence'}], 'ancestors': [{'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D056887', 'term': 'Pelvic Organ Prolapse'}, {'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': 'D052801', 'term': 'Male Urogenital 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': 'D014620', 'term': 'Vacuum Extraction, Obstetrical'}, {'id': 'D002585', 'term': 'Cesarean Section'}], 'ancestors': [{'id': 'D005113', 'term': 'Extraction, Obstetrical'}, {'id': 'D036861', 'term': 'Delivery, Obstetric'}, {'id': 'D013513', 'term': 'Obstetric Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1641}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-16', 'studyFirstSubmitDate': '2013-01-07', 'studyFirstSubmitQcDate': '2013-01-09', 'lastUpdatePostDateStruct': {'date': '2017-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-01-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'symptoms of urogenital prolapse', 'timeFrame': '15-20 years after first delivery'}, {'measure': 'surgery for urogenital prolapse', 'timeFrame': '15-20 years after first delivery'}], 'secondaryOutcomes': [{'measure': 'damage to pelvic floor musculature', 'timeFrame': '15-20 years after first delivery'}, {'measure': 'urinary incontinence', 'timeFrame': '15-20 years after first delivery'}, {'measure': 'anal incontinence', 'timeFrame': '15-20 years after first delivery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Delivery, obstetric', 'Obstetric Surgical Procedures', 'Vacuum Extraction, Obstetrical', 'Cesarean Section', 'Obstetrical Forceps', 'Epidemiology', 'Norway'], 'conditions': ['Uterine Prolapse', 'Urinary Incontinence', 'Fecal Incontinence']}, 'referencesModule': {'references': [{'pmid': '25683873', 'type': 'RESULT', 'citation': 'Volloyhaug I, Morkved S, Salvesen O, Salvesen K. Pelvic organ prolapse and incontinence 15-23 years after first delivery: a cross-sectional study. BJOG. 2015 Jun;122(7):964-71. doi: 10.1111/1471-0528.13322. Epub 2015 Feb 16.'}, {'pmid': '25920322', 'type': 'RESULT', 'citation': 'Volloyhaug I, Morkved S, Salvesen O, Salvesen KA. Forceps delivery is associated with increased risk of pelvic organ prolapse and muscle trauma: a cross-sectional study 16-24 years after first delivery. Ultrasound Obstet Gynecol. 2015 Oct;46(4):487-95. doi: 10.1002/uog.14891. Epub 2015 Aug 25.'}, {'pmid': '26198007', 'type': 'RESULT', 'citation': 'Volloyhaug I, Morkved S, Salvesen KA. Association between pelvic floor muscle trauma and pelvic organ prolapse 20 years after delivery. Int Urogynecol J. 2016 Jan;27(1):39-45. doi: 10.1007/s00192-015-2784-8. Epub 2015 Jul 22.'}, {'pmid': '26300128', 'type': 'RESULT', 'citation': 'Volloyhaug I, Morkved S, Salvesen O, Salvesen KA. Assessment of pelvic floor muscle contraction with palpation, perineometry and transperineal ultrasound: a cross-sectional study. Ultrasound Obstet Gynecol. 2016 Jun;47(6):768-73. doi: 10.1002/uog.15731. Epub 2016 May 2.'}]}, 'descriptionModule': {'briefSummary': 'The lifetime risk for a woman to undergo surgery for either vaginal prolapse or urinary incontinence is high. Previous studies have shown that pregnancy and childbirth are risk factors for developing prolapse. There is a lack of studies that follow women several years after delivery aiming to find whether symptoms of prolapse are linked to delivery method, ie vacuum, forceps, normal vaginal delivery and cesarean section. The investigators plan this study is to get more knowledge about pathology of prolapse and incontinence, to enable development of preventive strategies for these conditions.\n\nAim of the study is to determine whether the prevalence of symptoms and performed surgery for urogenital prolapse differs among women delivered by vacuum, forceps, normal vaginal delivery and cesarean section 15-20 years after their first delivery.\n\nThe investigators identify women that delivered their first child at St. Olavs Hospital, Trondheim, Norway between 1990-1997. Questionnaires will be sent to 2500 women (PFIQ-7, PFDI-20, PISQ-12), 600 of whom will get a clinical examination, where pelvic floor musculature is examined by palpation and 4D ultrasound, and a POP-Q quantification of prolapse performed.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women who delivered their first child at St. Olavs Hospital, Trondheim (Norway) between 1990-1997', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* first delivery in time period 1990-1997\n* vaginal birth, spontaneous, forceps or vacuum extraction, or cesarean section\n* residency in Klæbu, Malvik, Melhus, Midtre Gauldal, Rissa, Selbu, Trondheim, Tydal, Åfjord at the time of first delivery\n\nExclusion Criteria:\n\n* stillbirth\n* breech birth\n* congenital Abnormalities\n* residency outside the 9 selected communities\n* forceps delivery following previous vacuum extraction delivery or spontaneous vaginal birth\n* vacuum extraction delivery following previous forceps delivery or spontaneous vaginal birth\n* Vaginal birth following previous cesarean section'}, 'identificationModule': {'nctId': 'NCT01766193', 'acronym': 'uropro', 'briefTitle': 'Delivery Method and Risk for Urogenital Prolapse 15-20 Years Later', 'organization': {'class': 'OTHER', 'fullName': 'Norwegian University of Science and Technology'}, 'officialTitle': 'Delivery Method and Risk for Urogenital Prolapse 15-20 Years Later', 'orgStudyIdInfo': {'id': '2012/666'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'vaginal birth', 'description': 'women whose first child was born by spontaneous vaginal delivery', 'interventionNames': ['Procedure: vaginal delivery']}, {'label': 'cesarean section', 'description': 'women whose first child was born by cesarean section', 'interventionNames': ['Procedure: cesarean section']}, {'label': 'forceps', 'description': 'women whose first child was born by forceps extraction', 'interventionNames': ['Procedure: forceps extraction']}, {'label': 'vacuum', 'description': 'women whose first child was born by vacuum extraction', 'interventionNames': ['Procedure: vacuum extraction']}], 'interventions': [{'name': 'vaginal delivery', 'type': 'PROCEDURE', 'armGroupLabels': ['vaginal birth']}, {'name': 'forceps extraction', 'type': 'PROCEDURE', 'description': 'vaginal delivery by forceps extraction', 'armGroupLabels': ['forceps']}, {'name': 'vacuum extraction', 'type': 'PROCEDURE', 'description': 'vaginal delivery by vacuum extraction', 'armGroupLabels': ['vacuum']}, {'name': 'cesarean section', 'type': 'PROCEDURE', 'armGroupLabels': ['cesarean section']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Trondheim', 'country': 'Norway', 'facility': 'St Olavs Hospital Trondheim University Hospital', 'geoPoint': {'lat': 63.43049, 'lon': 10.39506}}], 'overallOfficials': [{'name': 'Kjell Å Salvesen, prof MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Norwegian University of Science and Technology'}, {'name': 'Siv Mørkved, PhD prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'St. Olavs Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Norwegian University of Science and Technology', 'class': 'OTHER'}, 'collaborators': [{'name': 'St. Olavs Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}