Ignite Creation Date:
2025-12-24 @ 1:35 PM
Ignite Modification Date:
2026-01-02 @ 1:09 PM
Study NCT ID:
NCT02410395
Status:
UNKNOWN
Last Update Posted:
2018-05-15
First Post:
2015-04-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
NIche Development With Closure of Cesarean Uterotomy by Modified or Conventional Two-layer Technique
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D003226', 'term': 'Congresses as Topic'}], 'ancestors': [{'id': 'D009938', 'term': 'Organizations'}, {'id': 'D004472', 'term': 'Health Care Economics and Organizations'}]}}, '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': 230}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2015-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2023-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-05-09', 'studyFirstSubmitDate': '2015-04-01', 'studyFirstSubmitQcDate': '2015-04-06', 'lastUpdatePostDateStruct': {'date': '2018-05-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-04-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-05-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Presence of a cesarean scar niche more than 2 mm deep.', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Residual myometrial thickness of the cesarean scar (RMT)', 'timeFrame': '6 months'}, {'measure': 'Cesarean scar niche depth, width, length, myometrium adjacent to the scar', 'timeFrame': '6 months'}, {'measure': 'Post-menstrual spotting', 'timeFrame': '15 months'}, {'measure': 'Incidence of cesarean scar pregnancy or spontaneous abortions', 'timeFrame': '72 months'}, {'measure': 'Adverse pregnancy outcomes in the following pregnancy', 'timeFrame': '72 months', 'description': 'Composite of placenta previa, placenta accreta or percreta, uterine rupture or dehiscence'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cesarean Scar Niche']}, 'descriptionModule': {'briefSummary': 'The aim of this trial was to compare two different uterotomy surgical techniques on the occurrence of a uterine niche and the risk of a number of short- and long-term gynecological complications associated with the presence and size of the niche.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Singleton pregnant\n* Intended elective cesarean section\n\nExclusion Criteria:\n\n* Cervical dilatation of more than 4 cm\n* Previous cesarean section'}, 'identificationModule': {'nctId': 'NCT02410395', 'acronym': 'NICUM', 'briefTitle': 'NIche Development With Closure of Cesarean Uterotomy by Modified or Conventional Two-layer Technique', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'NIche Development With Closure of Cesarean Uterotomy by Modified or Conventional Two-layer Technique (NICUM Study)', 'orgStudyIdInfo': {'id': 'AUH060804'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional technique', 'description': 'Closure of the uterotomy with a conventional two-layer technique', 'interventionNames': ['Procedure: Conventional']}, {'type': 'EXPERIMENTAL', 'label': 'Modified technique', 'description': 'Closure of the uterotomy with a modified two-layer technique', 'interventionNames': ['Procedure: Modified']}], 'interventions': [{'name': 'Conventional', 'type': 'PROCEDURE', 'description': 'Two-layer technique with the first layer performed as an un-locked, continuous suture without inclusion of the endometrium and the second layer performed as an un-locked, continuous suture with the stitches placed superficially, horizontally along the first layer.', 'armGroupLabels': ['Conventional technique']}, {'name': 'Modified', 'type': 'PROCEDURE', 'description': 'The modified mattress suture is performed as a single-suture, double-layer technique with limited inclusion of the myometrium and broad inclusion of the serosal surface and myometrium, interchangeably', 'armGroupLabels': ['Modified technique']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8930', 'city': 'Randers', 'country': 'Denmark', 'facility': 'Dep. Obstetrics and Gynecology, Regional Hospital of Randers', 'geoPoint': {'lat': 56.4607, 'lon': 10.03639}}], 'overallOfficials': [{'name': 'Niels Uldbjerg, MD, DMSc', 'role': 'STUDY_CHAIR', 'affiliation': 'Aarhus University Hospital'}, {'name': 'Lone Hvidman, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Aarhus University Hospital'}, {'name': 'Axel Forman, MD, DMSc', 'role': 'STUDY_CHAIR', 'affiliation': 'Aarhus University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'collaborators': [{'name': 'Randers Regional Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}