[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100569246":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":52,"collaborators":26,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":64,"sex":65,"minAge":66,"maxAge":26,"enrollmentInfo":67,"targetDuration":26,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":83,"overallStatus":40,"whyStopped":26,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Hospital Clinic of Barcelona","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Study Group: Uterine repair with barbed suture","EXPERIMENTAL","Uterine closure following cesarean section is carried out using an unlocked single-layer barbed suture with an endometrium-free technique.",[13],"Device: Barbed suture",{"label":15,"type":16,"description":17,"interventionNames":18},"Control Group: Uterine repair with conventional smooth suture","ACTIVE_COMPARATOR","Uterine repair following cesarean section is performed using a conventional smooth polyglactin suture with a continuous single-layer, endometrium-free technique, in accordance with the standard procedure at our center.",[19],"Device: Conventional smooth suture",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Barbed suture","Size 0 barbed absorbable monofilament suture with unidirectional spikes that includes a loop in one of its ends, not requiring knots.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Conventional smooth suture","Size 1 smooth multifilament absorbable polyglactin suture.",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Cristina Mula","CONTACT","+34 635486919","mula@clinic.cat",[38],{"facility":39,"status":40,"city":41,"state":26,"zip":26,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Hospital Clínic de Barcelona","RECRUITING","Barcelona","Spain","ES",{"type":45,"coordinates":46},"Point",[47,48],2.15899,41.38879,{"lat":48,"lon":47},[51],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},{"type":53,"investigatorFullName":54,"investigatorTitle":55,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Cristina Mula Navarro","SPECIALIST IN OBSTETRIC AND GYNECOLOGY, MD","100569246","clinical-impact-of-uterine-repair-during-cesarean-section-with-barbed-suture-on-the-incidence-of-isthmocele-100569246",false,"NCT06691750","Clinical Impact of Uterine Repair During Cesarean Section with Barbed Suture on the Incidence of Isthmocele","Clinical Impact of Uterine Repair During Cesarean Section with Barbed Suture on the Incidence of Isthmocele and Its Ultrasound and Molecular Characteristics: a Randomized Controlled Trial","CESARIS","Inclusion Criteria:\n\n* Pregnant women who deliver at Hospital Clinic of Barcelona by a planned, intrapartum or urgent cesarean section, irrespective of their pregnancy risk.\n* Had accepted to participate in the study during the third trimester of gestation.\n* Patients who accept a 6-month follow-up visit.\n* Minimal maternal age of 18 years old.\n\nExclusion Criteria:\n\n* Patients who end up delivering in another center.\n* Patients who deliver by vaginal route.\n* Patients diagnosed with isthmocele prior to the current pregnancy.\n* Need for histerectomy in the following 6 months after delivery.\n* Patients with known allergies to any of the components of the barbed suture.",true,"FEMALE","18 Years",{"count":68,"type":69},364,"ESTIMATED","INTERVENTIONAL",[72],"NA","Pregnant women, irrespective of their pregnancy risk, who undergo a cesarean section for any reason will be randomized to one of two suturing techniques: conventional suture or barbed suture for uterine repair after the cesarean section. Following surgery, these patients will be followed up for clinical outcomes, ultrasound evaluation of the uterine scar, and study of the hypoxic-inflammatory environment of the uterine cavity.",[75,76,77,78,79,80,81,82],"Isthmocele","Cesarean Scar Defect","Pelvic Pain","Spotting","Infertility","Uterine Niche","Uterine Abnormal Bleeding","Niche",[75,84,85,23,86],"Uterine niche","Cesarean scar defect","Cesarean section","2025-03-10",{"date":89,"type":90},"2025-03-13","ACTUAL",{"date":92,"type":90},"2024-11-22",{"date":94,"type":69},"2028-05",{"name":5,"class":6},1]