Ignite Creation Date:
2025-12-25 @ 1:28 AM
Ignite Modification Date:
2025-12-27 @ 10:56 PM
Study NCT ID:
NCT05750394
Status:
UNKNOWN
Last Update Posted:
2023-03-02
First Post:
2023-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cesarean 123 Trial: Randomized Trial Comparing Single, Double and Triple Layer Uterine Closures During Cesarean Delivery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C112829', 'term': 'Endomet'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Radiologist blinded to closure method'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-07', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-28', 'studyFirstSubmitDate': '2023-02-20', 'studyFirstSubmitQcDate': '2023-02-20', 'lastUpdatePostDateStruct': {'date': '2023-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Myometrial thickness', 'timeFrame': '4 months', 'description': 'Residual myometrial thickness at the scar site assessed by MRI performed'}], 'secondaryOutcomes': [{'measure': 'Niche', 'timeFrame': '4 months', 'description': 'Myometrial niche formation assessed by MRI performed'}, {'measure': 'Scar ratio', 'timeFrame': '4 month', 'description': 'Scar healing ratio (HR) difference as defined by HR= residual myometrial thickness/total myometrial thickness by MRI'}, {'measure': 'Blood loss', 'timeFrame': '1 day', 'description': 'Post-operative change in hemoglobin'}, {'measure': 'Time for closure', 'timeFrame': 'Immediate', 'description': 'Time required for hysterotomy closure'}, {'measure': 'Extra sutures', 'timeFrame': 'Immediate', 'description': 'The number of extra sutures required to achieve surgeon-acceptable hemostasis'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Cesarean', 'Myometrium', 'scar thickness', 'niche'], 'conditions': ['Pregnancy Related']}, 'referencesModule': {'references': [{'pmid': '26522861', 'type': 'RESULT', 'citation': 'Roberge S, Demers S, Girard M, Vikhareva O, Markey S, Chaillet N, Moore L, Paris G, Bujold E. Impact of uterine closure on residual myometrial thickness after cesarean: a randomized controlled trial. Am J Obstet Gynecol. 2016 Apr;214(4):507.e1-507.e6. doi: 10.1016/j.ajog.2015.10.916. Epub 2015 Nov 11.'}, {'pmid': '34146146', 'type': 'RESULT', 'citation': 'Alessandri F, Evangelisti G, Centurioni MG, Gustavino C, Ferrero S, Barra F. Fishbone double-layer barbed suture in cesarean section: a help in preventing long-term obstetric sequelae? Arch Gynecol Obstet. 2021 Sep;304(3):573-576. doi: 10.1007/s00404-021-06121-8.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to compare post-operative uterine scar thickness in people who have had the uterus closed during cesarean sections by one of three different methods. The main questions it aims to answer are:\n\n* Residual myometrial thickness at the scar site assessed by MRI performed 4 months after the procedure\n* Myometrial niche formation assessed by MRI performed 4 months after the procedure\n* Scar healing ratio (HR) difference as defined by HR= residual myometrial thickness/total myometrial thickness\n* Post-operative change in hemoglobin\n* Time required for hysterotomy closure\n* The number of extra sutures required to achieve surgeon-acceptable hemostasis\n\nParticipants undergoing scheduled cesarean sections will be randomized to one of three different uterine closure methods. The methods are:\n\n1. Single layer closure using the following technique: Closure of the myometrium and serosa with one barbed suture using a running unlocked technique. The endometrium should be excluded.\n2. Double layer closure using the following technique: Closure of the full thickness of the myometrium with one smooth suture using a running locked technique. The endometrium should be excluded. Followed by imbrication of the second layer with one smooth suture using a running unlocked technique.\n3. Triple layer closure of Endometrium, Myometrium and Serosa (EMS) using one of the the following two techniques: Closure of the endometrium and 2-4 mm of internal myometrium with one barbed suture using a running unlocked technique followed by closure of the remaining myometrium and serosa with one barbed suture using a running unlocked technique. Or, Closure of the endometrium and 2-4 mm of internal myometrium with one barbed suture on using a running unlocked technique followed by closure of the remaining myometrium with one barbed suture a running unlocked technique followed by closure of the serosa with one barbed suture using a running unlocked technique.\n\nFour months after the surgery, participants will have a MRI of the pelvis to assess the scar on the uterus.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Pregnant people having cesarean delivery', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years or older\n* Singleton gestation\n* Nonurgent primary or secondary cesarean delivery at greater than 35w6d\n* Body Mass Index (BMI) \\<35 kg/m\\^2\n\nExclusion Criteria:\n\n* More than 1 prior cesarean delivery\n* Multiple gestation\n* Known coagulation disorder or current use of anti-coagulants\n* Mullerian anomalies\n* Placenta previa'}, 'identificationModule': {'nctId': 'NCT05750394', 'acronym': 'C123T', 'briefTitle': 'Cesarean 123 Trial: Randomized Trial Comparing Single, Double and Triple Layer Uterine Closures During Cesarean Delivery', 'organization': {'class': 'OTHER', 'fullName': "Brigham and Women's Hospital"}, 'officialTitle': 'Cesarean 123 Trial: Prospective Randomized Trial Comparing Single, Double and Triple Layer Uterine Closures During Cesarean Delivery', 'orgStudyIdInfo': {'id': '2023P000041'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Single Layer Closure', 'description': 'Single layer closure using the following technique:\n\na. Closure of the myometrium and serosa with one (1) 0 V-Loc 90 suture on a GS-24 needle using an unlocked technique. The endometrium should be excluded.', 'interventionNames': ['Procedure: Uterine layers closed', 'Device: Suture Type', 'Procedure: Endometrium']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Double Layer Closure', 'description': 'Double layer closure using the following technique:\n\n1. Closure of the full thickness of the myometrium with one (1) Monocryl suture on a CT needle using a running locked technique. The endometrium should be excluded.\n2. Imbrication of the first layer with one (1) Monocryl suture on a CT needle using a running un-locked technique', 'interventionNames': ['Procedure: Uterine layers closed', 'Device: Suture Type', 'Procedure: Endometrium']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Triple Layer Closure', 'description': 'Triple layer closure of Endometrium, Myometrium and Serosa (EMS) using one of the the following two techniques:\n\n1. Closure of the endometrium and 2-4 mm of internal myometrium with one (1) 2-0 V-Loc 90 suture on a GS-21 needle using an unlocked technique\n2. Closure of the remaining myometrium and serosa with one (1) 0 V-Loc 90 suture on a GS-24 needle using an unlocked technique\n\nor\n\n1. Closure of the endometrium and 2-4 mm of internal myometrium with one (1) 2-0 V-Loc 90 suture on a GS-21 needle using an unlocked technique\n2. Closure of the remaining myometrium with one (1) 0 V-Loc 90 suture on a GS-24 needle using an unlocked technique\n3. Closure of the serosa with one (1) 2-0 V-Loc 90 suture on a GS-21 needle using an unlocked technique', 'interventionNames': ['Procedure: Uterine layers closed', 'Device: Suture Type', 'Procedure: Endometrium']}], 'interventions': [{'name': 'Uterine layers closed', 'type': 'PROCEDURE', 'description': 'Uterus closed with 1, 2 or 3 layers', 'armGroupLabels': ['Double Layer Closure', 'Single Layer Closure', 'Triple Layer Closure']}, {'name': 'Suture Type', 'type': 'DEVICE', 'description': 'Barbed or smooth', 'armGroupLabels': ['Double Layer Closure', 'Single Layer Closure', 'Triple Layer Closure']}, {'name': 'Endometrium', 'type': 'PROCEDURE', 'description': 'Included or excluded', 'armGroupLabels': ['Double Layer Closure', 'Single Layer Closure', 'Triple Layer Closure']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'James A. Greenberg, MD', 'role': 'CONTACT', 'email': 'jagreenberg@bwh.harvard.edu', 'phone': '7819101968'}, {'name': 'Pamela A. Richtmyer', 'role': 'CONTACT', 'email': 'prichtmyer@mgh.harvard.edu', 'phone': '857-282-5170'}], 'overallOfficials': [{'name': 'James A. Greenberg, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Brigham and Women's Hospital"}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': '1 year after completion', 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Brigham and Women's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Vice Chair OB/GYN', 'investigatorFullName': 'James Greenberg, MD', 'investigatorAffiliation': "Brigham and Women's Hospital"}}}}