[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100539771":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":25,"centralContacts":30,"locations":36,"responsibleParty":58,"collaborators":24,"id":60,"slug":24,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":63,"acronym":24,"eligibilityCriteria":64,"healthyVolunteers":61,"sex":65,"minAge":66,"maxAge":24,"enrollmentInfo":67,"targetDuration":24,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":24,"overallStatus":39,"whyStopped":24,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Single-layer","EXPERIMENTAL","Patients who are randomized in this arm undergo a single layer-hysterotomy closure",[13],"Procedure: Hysterotomy closure",{"label":15,"type":10,"description":16,"interventionNames":17},"Double-layer","Patients who are randomized in this arm undergo a double layer-hysterotomy closure",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"PROCEDURE","Hysterotomy closure","Hysterotomy closure is done in either one of two ways. Single layer closure consists in a single layer, unlocked suture. Double layer closure consists in a double layer, unlocked suture.",[15,9],null,[26],{"name":27,"affiliation":28,"role":29},"Giuseppe Perugino, MD","Ospedale Policlinico Maggiore Ca' Granda Milano","PRINCIPAL_INVESTIGATOR",[31],{"name":27,"role":32,"phone":33,"phoneExt":34,"email":35},"CONTACT","3383030553","+39","giuseppe.perugino@policlinico.mi.it",[37],{"facility":38,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Fondazione Cà Granda IRCCS Ospedale Maggiore Policlinico di Milano","RECRUITING","Milan","Mi","20122","Italy","IT",{"type":46,"coordinates":47},"Point",[48,49],9.18951,45.46427,{"lat":49,"lon":48},[52,53,56],{"name":27,"role":32,"phone":33,"phoneExt":24,"email":35},{"name":54,"role":55,"phone":24,"phoneExt":24,"email":24},"Floriana Carbone, MD","SUB_INVESTIGATOR",{"name":57,"role":55,"phone":24,"phoneExt":24,"email":24},"Ottavio Cassardo, MD",{"type":59,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100539771",false,"NCT06308172","Impact of Single- Versus Double-layer Hysterotomy Closure on Cesarean Niche Development: a Randomized Controlled Trial","Inclusion Criteria:\n\n* nulliparous\n* singleton\n* age 18-45\n* spontaneous pregnancy or autologous assisted fertilization\n* gestational age 38-40 weeks\n* elective C-section\n* informed consent\n\nExclusion Criteria:\n\n* coagulopathy\n* autoimmune diseases\n* gestational diabetes\n* anticoagulant therapy\n* immunosuppressive therapy\n* endometriosis\n* uterine fibromatosis\n* spontaneous labour\n* connective tissue diseases","FEMALE","18 Years",{"count":68,"type":69},150,"ESTIMATED","INTERVENTIONAL",[72],"NA","The objective of this randomized monocentric study is to assess potential variations in the incidence and severity of isthmocele morbidity among women undergoing cesarean section with either single or double-layer closure of the hysterotomy. Our primary outcome aims to investigate whether there is a reduction in the median duration of intermenstrual spotting in patients belonging to the two respective closure groups",[75,76,77,78,79],"Cesarean Section; Dehiscence","Uterine Bleeding","Uterus; Scar","Uterus Abnormal","Cesarean Section Complications","2024-03-06",{"date":82,"type":83},"2024-03-13","ACTUAL",{"date":85,"type":83},"2021-12-01",{"date":87,"type":69},"2026-12-01",{"name":5,"class":6},1]