[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"niche\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:niche":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,41,76],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100566523","hysteroscopic-intrauterine-suturing-100566523",false,"NCT06656286","Hysteroscopic Intrauterine Suturing","Hysteroscopic Intrauterine Suturing by Using X-Tack - Pilot Study","Inclusion Criteria:\n\n* Benign indication for hysterectomy\n\nExclusion Criteria:\n\n* Evidence or suspicious for malignancy","FEMALE","18 Years",{"count":19,"type":20},2,"ESTIMATED","INTERVENTIONAL",[23],"NA","Clinical trial The aim of the study is to evaluate the safety and feasibility of intrauterine suturing with Apollos X-tack, inserted into the uterus by hysteroscope.\n\nPrimary outcome:\n\nIntrauterine suture will sustain the procedure - when the uterus will be opened the suture will be observed.\n\nSecondary outcome:\n\nProcedure complications. Study Design Interventional pilot Study\n\nStudy group:\n\nWomen undergoing laparoscopic hysterectomy.",[26,27],"Niche","Uterine Disease","NOT_YET_RECRUITING","2025-03-12",{"date":31,"type":32},"2025-03-13","ACTUAL",{"date":34,"type":20},"2025-04-25",{"date":36,"type":20},"2026-07-02",{"name":38,"class":39},"HaEmek Medical Center, Israel","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":49,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":21,"phases":52,"briefSummary":53,"conditions":54,"keywords":62,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":40},"100569246","clinical-impact-of-uterine-repair-during-cesarean-section-with-barbed-suture-on-the-incidence-of-isthmocele-100569246","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,{"count":51,"type":20},364,[23],"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.",[55,56,57,58,59,60,61,26],"Isthmocele","Cesarean Scar Defect","Pelvic Pain","Spotting","Infertility","Uterine Niche","Uterine Abnormal Bleeding",[55,63,64,65,66],"Uterine niche","Cesarean scar defect","Barbed suture","Cesarean section","RECRUITING","2025-03-10",{"date":31,"type":32},{"date":71,"type":32},"2024-11-22",{"date":73,"type":20},"2028-05",{"name":75,"class":39},"Hospital Clinic of Barcelona",{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":49,"sex":16,"minAge":17,"maxAge":83,"enrollmentInfo":84,"targetDuration":4,"studyType":21,"phases":86,"briefSummary":87,"conditions":88,"keywords":89,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":40},"100463290","niche-in-cesarean-scar-trial-nicest-100463290","NCT05312775","Niche In CEsarean Scar Trial (NICEST)","Single Versus Double-layer Closure of The Cesarean Scar In Niche Development: A Randomized Clinical Trial","Inclusion Criteria:\n\n* Pregnant women who undergo a primary CD (planned or unplanned)\n* Age ≥ 18 years.\n* Gestational age ≥ 37 0\u002F7 weeks\n\nExclusion Criteria:\n\n* Previous major uterine surgery (e.g. laparoscopic or laparotomic fibroid resection, septum resection).\n* Women with abnormal menstrual bleeding (e.g. cervical dysplasia, communicating hydrosalpinx, uterine anomaly or endocrine disorders disturbing ovulation, drugs, polyps, fibroids, etc.).\n* Women with dysmenorrhea, dyspareunia, suprapubic pain.\n* Abnormal placenta: Placenta privia, Placenta percreta… in the current pregnancy.","60 Years",{"count":85,"type":20},938,[23],"Rationale: Cesarean delivery (CD) rates are increasing rapidly worldwide. The consequences of cesarean section not only affect the next pregnancies such as uterine rupture or malplacentation but also cause many gynecological complications or infertility due to the formation of cesarean scar defect (CSD) or Niche. One of the major factors for Niche formation is the techniques of hysterotomy closure at the time of cesarean delivery. Most common hysterotomy closures include single and double layers closure. However, there is limited literature to prove which technique decreases niche creation and associated gynecological complications.\n\nObjective: To compare the effect of uterine closure techniques during CD on the formation of Niche evaluated on transvaginal ultrasound and gynecological complications.\n\nStudy design: a double-blinded, single-center, randomized clinical trial. Setting: Hanoi Obstetrics \\& Gynecology Hospital (HOGH), Viet Nam. Study population: All women at gestational age ≥ 37 0\u002F7 weeks who undergo a primary CD (planned or unplanned).\n\nIntervention: After informed consent, women will be randomized to either unlocked single layer closure or unlocked double-layer closures of cesarean uterine scar in a 1:1 ratio Primary outcome: The proportion of Niche over time (at 6, 12, 18, 24 months after CD) in the two groups.\n\nPower calculation: A sample size of 389 women is needed for each group. Nature and extent of the burden and risks associated with participation, benefit, and group relatedness: Both uterine closure methods followed by the Vietnam Ministry of Health (VN-MOH), transvaginal ultrasound is also not harmful. It is believed that there are no potential increased risks to patients taking part in this trial because of the standard care and management they receive.",[26],[90,91,92],"single-layer uterine closure","double-layer uterine closure","niche","2024-02-28",{"date":95,"type":32},"2024-03-01",{"date":97,"type":32},"2022-05-01",{"date":99,"type":20},"2026-10",{"name":101,"class":39},"Nguyen Thi Thu Ha"]