Ignite Creation Date:
2025-12-25 @ 3:31 AM
Ignite Modification Date:
2026-03-03 @ 4:07 AM
Study NCT ID:
NCT02144805
Status:
COMPLETED
Last Update Posted:
2015-05-06
First Post:
2014-05-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Closure of Uterine Incision by Single or Double Layer Technique
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D013537', 'term': 'Sutures'}], 'ancestors': [{'id': 'D053831', 'term': 'Surgical Fixation Devices'}, {'id': 'D013523', 'term': 'Surgical Equipment'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 77}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-05', 'studyFirstSubmitDate': '2014-05-20', 'studyFirstSubmitQcDate': '2014-05-21', 'lastUpdatePostDateStruct': {'date': '2015-05-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-05-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Myometrial thickness', 'timeFrame': '5 months', 'description': 'Thickness of the remaining myometrium corresponding to the former cesarean uterine incision measured by ultra sound'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Pregnancy']}, 'descriptionModule': {'briefSummary': 'The study compares short-term and long-term effects on myometrial thickness in women sutured by single- or double-layer technique by closure of cesarean uterine incision. The study is a randomized clinically controlled study.', 'detailedDescription': 'Objective: To compare short-term and long-term effects on myometrial thickness in women sutured by single- or double-layer technique by closure of cesarean uterine incision. The study is a randomized clinically controlled study.\n\nDesign:Follow-up by ultra sound of a randomised controlled trial. Surgical technique was blinded for the investigator.\n\nSetting: An obstetric department in a tertiary referral hospital, 2008-2013. Participants: Healthy nulliparous scheduled for elective caesarean section randomly assigned to closure of the uterine incision by single- or double layer techniques.\n\nIntervention: A modified version of the Misgav-Ladach surgical technique was used. The women were examined by abdominal ultra sound before discharge from the maternity ward, and by vaginal ultra sound and hysterosonography minimum five month post partum.\n\nMain outcome measure: Thickness of the remaining myometrium corresponding to the former cesarean uterine incision measured by ultra sound.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women submitted to cesarean sectio\n\nExclusion Criteria:\n\n* Exclusion criteria were: Former uterine operations such as myomectomy or surgery resulting in entering the cavity, fibroids located in the cervix or the cervicalcorporal border, inflammatory bowel disease, SLE, rheumatoid arthritis, IDDM, re-operations after inclusion or the cesarean section and more than three additional single sutures for hemostasis.'}, 'identificationModule': {'nctId': 'NCT02144805', 'briefTitle': 'Closure of Uterine Incision by Single or Double Layer Technique', 'organization': {'class': 'OTHER', 'fullName': 'Zealand University Hospital'}, 'officialTitle': 'Evaluation of Single Versus Double-layer Technique by Closure of Cesarean Uterine Incision. A Randomized Controlled Study', 'orgStudyIdInfo': {'id': 'SJ-29'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Suturing in a single layer', 'description': 'The technique used for single layer to close the uterine incision following cesarean sectio', 'interventionNames': ['Procedure: Suturing in a single layer']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Suturing in two layer', 'description': 'The technique used for two layer technie to close the uterine incision following cesarean sectio', 'interventionNames': ['Procedure: Suturing in two layer']}], 'interventions': [{'name': 'Suturing in a single layer', 'type': 'PROCEDURE', 'description': 'The procedure define the use of one single suture for closure of the uterine incision following cesarean section.', 'armGroupLabels': ['Suturing in a single layer']}, {'name': 'Suturing in two layer', 'type': 'PROCEDURE', 'description': 'The procedure define the use of two sutures for closing the uterine incision following cesarean section', 'armGroupLabels': ['Suturing in two layer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4000', 'city': 'Roskilde', 'state': 'Roskilde', 'country': 'Denmark', 'facility': 'Department of Obstetrics and Gynecology', 'geoPoint': {'lat': 55.64152, 'lon': 12.08035}}], 'overallOfficials': [{'name': 'Gitte Bennich, consultant', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Zealand University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zealand University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Region Zealand', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}