Ignite Creation Date:
2025-12-24 @ 1:20 PM
Ignite Modification Date:
2025-12-31 @ 6:24 PM
Study NCT ID:
NCT01320995
Status:
TERMINATED
Last Update Posted:
2015-03-25
First Post:
2011-03-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Perineal Echography in the Delivery Room for the Detection of Anal Lesions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004688', 'term': 'Encopresis'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D019960', 'term': 'Elimination Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 111}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-24', 'studyFirstSubmitDate': '2011-03-22', 'studyFirstSubmitQcDate': '2011-03-22', 'lastUpdatePostDateStruct': {'date': '2015-03-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-03-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Presence/absence of anal incontinence', 'timeFrame': '3 months', 'description': 'Anal incontinence is defined as a Wexner score \\> 4'}], 'secondaryOutcomes': [{'measure': 'Wexner anal incontinence score', 'timeFrame': '3 months'}, {'measure': 'Visual Analog Scale for discomfort during perineal ultrasound', 'timeFrame': '2 hours', 'description': 'Ranges from 0.0 to 10.0'}, {'measure': 'Kappa coefficient for second reading of ultrasounds', 'timeFrame': '30 days', 'description': 'A second reading of each ultrasound is obtained within 30 days. The Kappa coefficient of concordance will be calculated between the two readings.'}, {'measure': 'Presence/absence of a sphincter tear', 'timeFrame': '2 hours', 'description': 'Presence/absence of a sphincter tear immediately after delivery.'}, {'measure': 'Patient requires anal sutures (yes/no)', 'timeFrame': '2 hours', 'description': 'Patient requires anal sutures after delivery?'}, {'measure': 'Presence/absence of suture infection', 'timeFrame': '3 months', 'description': 'Has an infection ocurred between delivery and the follow up visit at 3 months post partum?'}, {'measure': 'Questionnaire PFIQ', 'timeFrame': '3 months'}, {'measure': 'Questionnaire PFDI', 'timeFrame': '3 months'}, {'measure': 'Questionnaire SF36', 'timeFrame': '3 months'}, {'measure': 'Questionnaire Euroqol', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Second degree vaginal tear', 'Perineal ultrasound', 'Anal incontinence'], 'conditions': ['Parturition']}, 'descriptionModule': {'briefSummary': 'The main objective of this study is to compare the rate of anal incontinence (measured by the Wexner score, qualitative and quantitative (\\> 4)) at 3 months post partum among primiparas with vaginal tears ≥ 2nd degree who receive a sphincter injury screening at delivery by conducting a sphincter ultrasound in the delivery room versus a similar group of women who do not benefit from screening.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The patient must have given his/her informed and signed consent\n* The patient must be insured or beneficiary of a health insurance plan\n* The patient is available for 3 months of follow up\n* The patient is delivering her first child; vaginal delivery\n* The patient has a minimum stage 2 perineal lesion\n* The patient accepts perineal echography\n\nExclusion Criteria:\n\n* The patient is under judicial protection, under tutorship or curatorship\n* The patient refuses to sign the consent\n* It is impossible to correctly inform the patient\n* Cesarien section\n* No perineal lesion (intact perineum)\n* Emergency situation which hinders screening for anal lesions under good medical conditions\n* Previous vaginal delivery'}, 'identificationModule': {'nctId': 'NCT01320995', 'acronym': 'OASIS 1', 'briefTitle': 'Perineal Echography in the Delivery Room for the Detection of Anal Lesions', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nīmes'}, 'officialTitle': 'Perineal Echography in the Delivery Room for the Detection of Anal Lesions Among Primiparous Mothers: a Randomized Study', 'orgStudyIdInfo': {'id': 'AOI/2010/VL-02'}, 'secondaryIdInfos': [{'id': '2011-A00050-41', 'type': 'OTHER', 'domain': 'RCB number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental arm', 'description': 'In this arm, perineal ultrasound is used directly after delivery in order to hypothetically better detect anal lesions.', 'interventionNames': ['Procedure: Perineal ultrasound']}, {'type': 'NO_INTERVENTION', 'label': 'Standard arm', 'description': 'No perineal ultrasound immediately after delivery.'}], 'interventions': [{'name': 'Perineal ultrasound', 'type': 'PROCEDURE', 'description': 'Perineal ultrasound is performed after delivery in order to better detect sphincter lesions.', 'armGroupLabels': ['Experimental arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30029', 'city': 'Nîmes', 'state': 'Gard', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire de Nîmes', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}, {'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'CHU de Montpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}], 'overallOfficials': [{'name': 'Vincent Letouzey, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hospitalier Universitaire de Nîmes'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nīmes', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}