Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2025-12-26 @ 3:03 AM
Study NCT ID:
NCT05196620
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-12-04
First Post:
2021-12-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prevalence of Anal Sphincter Defects After Childbirth
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005242', 'term': 'Fecal Incontinence'}], 'ancestors': [{'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-01', 'studyFirstSubmitDate': '2021-12-29', 'studyFirstSubmitQcDate': '2022-01-13', 'lastUpdatePostDateStruct': {'date': '2023-12-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Integrity of anal sphincter', 'timeFrame': '4 months', 'description': 'No defect detected on EAUS'}, {'measure': 'Defects on anal canal', 'timeFrame': '4 months', 'description': 'Disruption of any of the anal canal sphincters'}], 'secondaryOutcomes': [{'measure': 'QoL', 'timeFrame': '4 months', 'description': 'According to a dedicated questionnaire'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Anal Ultrasound', 'Fecal Incontinence', 'Childbirth'], 'conditions': ['Fecal Incontinence', 'Childbirth Problems']}, 'referencesModule': {'references': [{'pmid': '31325659', 'type': 'BACKGROUND', 'citation': 'Tejedor P, Plaza J, Bodega-Quiroga I, Ortega-Lopez M, Garcia-Olmo D, Pastor C. The Role of Three-Dimensional Endoanal Ultrasound on Diagnosis and Classification of Sphincter Defects After Childbirth. J Surg Res. 2019 Dec;244:382-388. doi: 10.1016/j.jss.2019.06.080. Epub 2019 Jul 17.'}, {'pmid': '16260538', 'type': 'BACKGROUND', 'citation': 'Sultan AH, Thakar R. Diagnosis of anal sphincter tears to prevent fecal incontinence: a randomized controlled trial. Obstet Gynecol. 2005 Nov;106(5 Pt 1):1108-9; author reply 1109. doi: 10.1097/01.AOG.0000186051.88740.7f. No abstract available.'}, {'pmid': '27272501', 'type': 'BACKGROUND', 'citation': 'Johannessen HH, Wibe A, Stordahl A, Sandvik L, Morkved S. Do pelvic floor muscle exercises reduce postpartum anal incontinence? A randomised controlled trial. BJOG. 2017 Mar;124(4):686-694. doi: 10.1111/1471-0528.14145. Epub 2016 Jun 7.'}, {'pmid': '15981061', 'type': 'BACKGROUND', 'citation': 'Damon H, Bretones S, Henry L, Mellier G, Mion F. Long-term consequences of first vaginal delivery-induced anal sphincter defect. Dis Colon Rectum. 2005 Sep;48(9):1772-6. doi: 10.1007/s10350-005-0075-z.'}, {'pmid': '26637088', 'type': 'BACKGROUND', 'citation': 'Harvey MA, Pierce M, Alter JE, Chou Q, Diamond P, Epp A, Geoffrion R, Harvey MA, Larochelle A, Maslow K, Neustaedter G, Pascali D, Pierce M, Schulz J, Wilkie D, Sultan A, Thakar R; Society of Obstetricians and Gynaecologists of Canada. Obstetrical Anal Sphincter Injuries (OASIS): Prevention, Recognition, and Repair. J Obstet Gynaecol Can. 2015 Dec;37(12):1131-48. doi: 10.1016/s1701-2163(16)30081-0.'}, {'pmid': '28685224', 'type': 'BACKGROUND', 'citation': 'Thomas GP, Gould LE, Casunuran F, Kumar DA. A retrospective review of 1495 patients with obstetric anal sphincter injuries referred for assessment of function and endoanal ultrasonography. Int J Colorectal Dis. 2017 Sep;32(9):1321-1325. doi: 10.1007/s00384-017-2851-3. Epub 2017 Jul 7.'}]}, 'descriptionModule': {'briefSummary': 'The incidence of obstetric sphincter tears has risen to 15-30% and the prevalence of anal incontinence (AI) symptoms after childbirth may be as high as 40%. The present study aims to evaluate the prevalence of anal sphincter defects after childbirth in primiparous women-', 'detailedDescription': 'The incidence of sphincter defect in women has raised in recently with current rates as high as 30% after vaginal deliveries. Fecal incontinence could be present at the time of the delivery but it is a real problem longtime after, in women older than 60 years.\n\nIt is of great importance not only an early detection but to indicates the best possible management as soon as posible.\n\nThe design is a prospective observational study including primiparous woman, without previous anal surgery.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Primaparous pregnat', 'genderDescription': 'It is a study about childbirth problems.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Primiparous pregnant patients aged \\>18 y, evaluated during pregnancy and after childbirth, including both vaginal and cesarean deliveries.\n\nExclusion Criteria:\n\n* Non primiparous patients and patients with a history of anal surgery'}, 'identificationModule': {'nctId': 'NCT05196620', 'acronym': 'PRADA', 'briefTitle': 'Prevalence of Anal Sphincter Defects After Childbirth', 'organization': {'class': 'OTHER', 'fullName': 'Universidad de Zaragoza'}, 'officialTitle': 'Prevalence of Anal Sphincter Defects After Childbirth in Primiparous Women', 'orgStudyIdInfo': {'id': 'UZaragoza-3'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'EAUS', 'description': 'Patients with EAUS pre and postpartum', 'interventionNames': ['Other: Endoanal Ultrasound (EAUS)']}], 'interventions': [{'name': 'Endoanal Ultrasound (EAUS)', 'type': 'OTHER', 'description': 'Endoanal Ultrasound pre- and postpartum', 'armGroupLabels': ['EAUS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50009', 'city': 'Zaragoza', 'country': 'Spain', 'facility': 'Hospital Clinico Lozano Blesa', 'geoPoint': {'lat': 41.65606, 'lon': -0.87734}}], 'centralContacts': [{'name': 'Jose-M Ramirez, Prof', 'role': 'CONTACT', 'email': 'jramirez@unizar.es', 'phone': '+34639776364'}], 'overallOfficials': [{'name': 'Jose-M Ramirez, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidad de Zaragoza'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad de Zaragoza', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hospital Clínico Universitario Lozano Blesa', 'class': 'OTHER'}, {'name': 'Instituto de Investigación Sanitaria Aragón', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof', 'investigatorFullName': 'Jose-M Ramirez', 'investigatorAffiliation': 'Universidad de Zaragoza'}}}}