Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2025-12-30 @ 2:00 AM
Study NCT ID:
NCT01533467
Status:
COMPLETED
Last Update Posted:
2012-02-15
First Post:
2012-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Device Designed to Protect the Perineum During Labor
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-02', 'completionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-02-12', 'studyFirstSubmitDate': '2012-02-06', 'studyFirstSubmitQcDate': '2012-02-12', 'lastUpdatePostDateStruct': {'date': '2012-02-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-02-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Grade I and II rupture during delivery', 'timeFrame': 'time at the delivery department (up to 12 months)', 'description': 'Number and extension of perineal tears during delivery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Delivery rupture', 'perineal protection device', 'reduce perineal tears'], 'conditions': ['Perineal Tear']}, 'referencesModule': {'references': [{'pmid': '25126978', 'type': 'DERIVED', 'citation': 'Lavesson T, Griph ID, Skarvad A, Karlsson AS, Nilsson HB, Steinvall M, Haadem K. A perineal protection device designed to protect the perineum during labor: a multicenter randomized controlled trial. Eur J Obstet Gynecol Reprod Biol. 2014 Oct;181:10-4. doi: 10.1016/j.ejogrb.2014.07.006. Epub 2014 Jul 30.'}]}, 'descriptionModule': {'briefSummary': 'Objective:\n\nTo investigate the protective effects of a newly invented device for reducing tears in the perineum during vaginal childbirth.\n\nDesign:\n\nA multicenter randomized control trial performed at three hospitals in Sweden, in Helsingborg, Lund and Malmö. Participants recruited are women with vaginal delivery (N=1200), cephalic presentation. They will be randomized to an intervention group, with a perineal protection device, and a control group deliver as normal.\n\nMain outcome measures:\n\nThe effect on the frequency and extension of perineal ruptures grade I, II and anal sphincter rupture are measured.', 'detailedDescription': 'Perineal rupture shall be measured with a ruler. Anal sphincter ruptures be examined by physicians. Drawing be made of the tears by the midwife.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Vaginal delivery\n\nExclusion Criteria:\n\n* Age below 18 years and no understanding of written and oral information.'}, 'identificationModule': {'nctId': 'NCT01533467', 'briefTitle': 'A Device Designed to Protect the Perineum During Labor', 'organization': {'class': 'OTHER', 'fullName': 'Helsingborgs Hospital'}, 'officialTitle': 'Study of Perineal Protection Device', 'orgStudyIdInfo': {'id': 'KH-HBG-12'}, 'secondaryIdInfos': [{'id': '148/2008', 'type': 'OTHER_GRANT', 'domain': 'Thelma Zoegas and Stig och Ragna Gortons Foundation'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Perineal device used', 'description': 'Use of the perineal device during delivery', 'interventionNames': ['Device: Perineal protection device']}, {'type': 'NO_INTERVENTION', 'label': 'No intervention', 'description': 'Controls, delivered as normal'}], 'interventions': [{'name': 'Perineal protection device', 'type': 'DEVICE', 'otherNames': ['Manufacturer; Calle Gejde AB, 234 21 Lomma, Sweden'], 'description': 'Use of the device during delivery and inspection afterwards to see the tears.', 'armGroupLabels': ['Perineal device used']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25187', 'city': 'Helsingborg', 'state': 'Helsingborg', 'country': 'Sweden', 'facility': 'Knut Haadem', 'geoPoint': {'lat': 56.04673, 'lon': 12.69437}}], 'overallOfficials': [{'name': 'Knut Haadem, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dept Obstet & Gynecol, Helsingborg Hospital, Helsingborg, Sweden'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Helsingborgs Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Lund University Hospital', 'class': 'OTHER'}, {'name': 'Skane University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Knut Haadem', 'investigatorAffiliation': 'Helsingborgs Hospital'}}}}