Ignite Creation Date:
2025-12-24 @ 2:59 PM
Ignite Modification Date:
2025-12-26 @ 1:25 AM
Study NCT ID:
NCT01860859
Status:
COMPLETED
Last Update Posted:
2015-05-18
First Post:
2013-05-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Suture of UTerus and Ultrasound Repair Evaluation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 81}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-14', 'studyFirstSubmitDate': '2013-05-09', 'studyFirstSubmitQcDate': '2013-05-21', 'lastUpdatePostDateStruct': {'date': '2015-05-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-05-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean myometrium thickness', 'timeFrame': '6 months after intervention', 'description': 'Using transvaginal ultrasound the residual myometrium thickness at the site of the uterine scar will be measure.'}], 'secondaryOutcomes': [{'measure': 'Estimated blood loss', 'timeFrame': 'Same day of intervention: day 1'}, {'measure': 'Operative time', 'timeFrame': 'Same day of intervention: day 1'}, {'measure': 'Mean number of haemostatic sutures', 'timeFrame': 'Same day of intervention: day 1'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['cesarean', 'ultrasound', 'hysterotomy', 'uterus', 'suture'], 'conditions': ['Uterine Scar Defect']}, 'referencesModule': {'references': [{'pmid': '22399223', 'type': 'BACKGROUND', 'citation': 'Roberge S, Boutin A, Chaillet N, Moore L, Jastrow N, Demers S, Bujold E. Systematic review of cesarean scar assessment in the nonpregnant state: imaging techniques and uterine scar defect. Am J Perinatol. 2012 Jun;29(6):465-71. doi: 10.1055/s-0032-1304829. Epub 2012 Mar 7.'}, {'pmid': '21794864', 'type': 'BACKGROUND', 'citation': 'Roberge S, Chaillet N, Boutin A, Moore L, Jastrow N, Brassard N, Gauthier RJ, Hudic I, Shipp TD, Weimar CH, Fatusic Z, Demers S, Bujold E. Single- versus double-layer closure of the hysterotomy incision during cesarean delivery and risk of uterine rupture. Int J Gynaecol Obstet. 2011 Oct;115(1):5-10. doi: 10.1016/j.ijgo.2011.04.013. Epub 2011 Jul 26.'}]}, 'descriptionModule': {'briefSummary': 'This study compares three techniques of uterine closure on myometrium thickness evaluated by ultrasound six months after the primary cesarean. The three techniques include: 1) locked single layer closure; 2) double layer closure with a first continuous locked suture and a second imbricating continuous suture; 3) double layer closure with a first continuous unlocked suture of the deep portion of the myometrium avoiding the inclusion of the decidua and a second unlocked continuous suture that approximate the upper portion of the myometrium. The primary outcome is the mean myometrium thickness at the site of the uterine scar evaluated by transvaginal ultrasound at six months after cesarean.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Planned cesarean\n* Primary cesarean\n* ≥ 38 gestational weeks\n\nExclusion Criteria:\n\n* Previous cesarean\n* Women \\< 18 years old\n* Multiple gestation\n* Mullerian anomalies\n* Active labor\n* Diabetes\n* BMI \\>35 kg/m2\n* Placenta praevia\n* Chronic systemic disease'}, 'identificationModule': {'nctId': 'NCT01860859', 'acronym': 'SUTURE', 'briefTitle': 'Suture of UTerus and Ultrasound Repair Evaluation', 'organization': {'class': 'OTHER', 'fullName': 'CHU de Quebec-Universite Laval'}, 'officialTitle': 'Randomized Controlled Trial Comparing Three Techniques of Uterine Closure on the Myometrium Thickness Evaluated With Ultrasound Six Months After a Primary Cesarean', 'orgStudyIdInfo': {'id': 'C12-03-204'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Unlocked double layer', 'description': 'Double layer closure with a first continuous unlocked suture of the deep portion of the myometrium avoiding the inclusion of the decidua and a second unlocked continuous suture that approximate the upper portion of the myometrium.', 'interventionNames': ['Procedure: Closure of the hysterotomy at the time of primary cesarean']}, {'type': 'OTHER', 'label': 'Locked single layer closure', 'description': 'As reported in Williams Obstetrics textbook', 'interventionNames': ['Procedure: Closure of the hysterotomy at the time of primary cesarean']}, {'type': 'OTHER', 'label': 'Locked double layer', 'description': 'Double layer closure with a first continuous locked suture and a second imbricating continuous suture.', 'interventionNames': ['Procedure: Closure of the hysterotomy at the time of primary cesarean']}], 'interventions': [{'name': 'Closure of the hysterotomy at the time of primary cesarean', 'type': 'PROCEDURE', 'armGroupLabels': ['Locked double layer', 'Locked single layer closure', 'Unlocked double layer']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'G1V 4G2', 'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'facility': 'CHU de Québec', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CHU de Quebec-Universite Laval', 'class': 'OTHER'}, 'collaborators': [{'name': 'Laval University', 'class': 'OTHER'}, {'name': 'Université de Montréal', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, MSc', 'investigatorFullName': 'Emmanuel Bujold', 'investigatorAffiliation': 'CHU de Quebec-Universite Laval'}}}}