[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100594452":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":35,"locations":44,"responsibleParty":66,"collaborators":70,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":74,"sex":80,"minAge":81,"maxAge":19,"enrollmentInfo":82,"targetDuration":19,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":97,"overallStatus":47,"whyStopped":19,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"fullName":5,"class":6},"University of Zurich","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"U-CaVIT","EXPERIMENTAL","Prophylactic treatment with Rüsch® Balloon Catheter Ch. 24",[13,14],"Device: Rüsch® Balloon Catheter Ch. 24","Other: Ultrasonography",{"label":16,"type":17,"description":18,"interventionNames":19},"Control","NO_INTERVENTION","Women in the control group will be treated according to the standard of care procedure.",null,[21,26],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":19},"DEVICE","Rüsch® Balloon Catheter Ch. 24","After cesarean delivery, patients in the intervention group receive the following intervention: The Rüsch® Balloon Catheter Ch. 24 will be inserted directly into the uterus before uterotomy closure.\n\nAfter insertion of the catheter, the catheter balloon is filled up to 80 ml of 0.9% saline solution and connected to the vacuum device whereby an intrauterine vacuum of -60 to a maximum of -70 kPa is applied once the uterotomy is closed. Once the catheter has been positioned, it is left in place for one hour as a prophylactic measure while a vacuum is applied.\n\nThe device will be removed by draining the liquid in the balloon, after 1 hour of vacuum-induced tamponade. The final decision for removal of the catheter in this study is made by the senior physician responsible for the woman.",[9],{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":19},"Ultrasonography","The position of the balloon catheter as well as the condition of the uterine cavity are assessed immediately postoperatively using ultrasonography.",[9],[31],{"name":32,"affiliation":33,"role":34},"Christian Prof. Dr. med. Christian Haslinger, MD","University Hospital Zürich, Switzerland","PRINCIPAL_INVESTIGATOR",[36,41],{"name":37,"role":38,"phone":39,"phoneExt":19,"email":40},"Christian Prof. Dr. med. Haslinger, MD","CONTACT","+41 43 253 75 75","Christian.haslinger@usz.ch",{"name":42,"role":38,"phone":19,"phoneExt":19,"email":43},"Janine Dünner, MSc","janine.duenner@usz.ch",[45],{"facility":46,"status":47,"city":48,"state":19,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"University Hospital Zurich","RECRUITING","Zurich","8091","Switzerland","CH",{"type":53,"coordinates":54},"Point",[55,56],8.55,47.36667,{"lat":56,"lon":55},[59,63,65],{"name":60,"role":38,"phone":61,"phoneExt":19,"email":62},"Christian Prof. Dr. Haslinger, MD","+41 44 255 46 13","christian.haslinger@usz.ch",{"name":42,"role":38,"phone":64,"phoneExt":19,"email":43},"+41 44 2555220",{"name":60,"role":34,"phone":19,"phoneExt":19,"email":19},{"type":67,"investigatorFullName":68,"investigatorTitle":69,"investigatorAffiliation":5,"oldNameTitle":19,"oldOrganization":19},"SPONSOR_INVESTIGATOR","Christian Haslinger","Prof. Dr. med.",[71],{"name":5,"class":6},"100594452","u-cavit-versus-standard-of-care-for-prevention-of-atonic-postpartum-hemorrhage-after-cesarean-section-in-high-risk-women-100594452",false,"NCT07019623","U-CaVIT Versus Standard of Care for Prevention of Atonic Postpartum Hemorrhage After Cesarean Section in High-risk Women.","Uro-catheter Vacuum-induced Uterine Tamponade (U-CaVIT) Versus Standard of Care for Prevention of Atonic Postpartum Hemorrhage After Cesarean Section in High-risk Women: a Monocentric Randomized-controlled Pilot Study.","UCaVIT Pilot","Inclusion Criteria:\n\n* Signed informed consent\n* Maternal age ≥18 years\n* Gestational age ≥30+0 weeks of pregnancy at day of delivery\n* Vital pregnancy\n* Delivery mode: planned cesarean delivery\n* High-risk patient for PPH specified by the presence of at least one of the following characteristics: Previous PPH, obesity (BMI ≥30 kg\u002Fm2), high parity (patient who has had ≥4 previous births (live or stillborn) at ≥20 weeks of gestation), very advanced maternal age ≥45 years, multiple gestation, polyhydramnios (defined as amniotic fluid index \\> 25 cm or deepest amniotic fluid pocket \\> 8 cm) at admission to delivery, suspected fetal macrosomia (estimated fetal weight ≥ 4500g)\n\nExclusion Criteria:\n\n* Insufficient language skills in German or English to understand and sign informed consent\n* Participation in another interventional study\n* Emergency cesarean section (incl. patients undergoing cesarean after failed vaginal delivery)\n* Subjects who change their delivery plan from vaginal to cesarean section in the course of hospitalization\n* Women with regular and painful contractions and women who do not have time for sufficient consideration\n* Clinical situations in which vacuum-induced uterine tamponade is unlikely to be effective or is contraindicated:\n\n  * Uterine or vaginal anomalies (genital tract congenital anomalies)\n  * Cesarean section due to placenta previa or suspected placenta accreta spectrum\n  * Suspected uterine rupture\n  * Injuries of the cervix or vagina\n  * Submucous or intramural uterine fibroids which are buldging into the uterine cavity\n  * Deep endometriosis \\[16, 17\\]\n* Planned atony-prophylaxis with oxytocin due to contraindication for carbetocin\n* Previous MMC-repair (myelomeningocele-repair)\n* Clinical diagnosis of chorioamnionitis, sepsis\n* Known allergy to silicone\n* Known and proven diagnosis of bleeding disorder or thrombophilia\n* Known thrombocytopenia during second half of pregnancy with thrombocytes \\\u003C 100 G\u002FL\n* Known anemia during second half of pregnancy with Hb\\\u003C80","FEMALE","18 Years",{"count":83,"type":84},70,"ESTIMATED","INTERVENTIONAL",[87],"NA","This pilot study aims to assess performance, safety and feasibility of U-CaVIT method (Uro-Catheter Vacuum Induced Tamponade), using the Rüsch® Brillant Silicone Balloon Catheter, an urological catheter, for the prevention of atonic PPH in high-risk women undergoing cesarean delivery.\n\nThe U-CaVIT method has been implemented at the Department of Obstetrics at university hospital of Zurich (USZ) due to temporary supply issues with the Bakri® Balloon Catheter. The Rüsch® Balloon Catheter is used in case of uterine atony when standard first-line uterotonic treatments have failed or in some cases as add-on therapy in non-atonic PPH. In the meantime, the use of U-CaVIT has become standard practice at the USZ for the treatment of atonic PPH, appearing to be user-friendly, clinically effective according to treating physicians, well tolerated by the treated women and cost-saving compared to the previously used Bakri® Balloon.",[90,91,92,93,94,95,96],"Postpartum Hemorrhage (Primary)","Hemorrhage","Postpartum Complication","Delivery ,Complications,Maternal","Pregnancy Complications","Cesarean Delivery","Balloon",[98,99,100,101,102,103,104,105],"Postpartum Hemorrhage","Delivery complications","high risk patients","Pregnancy","Balloon Catheter","Tamponade","prophylactic","Vacuum-induced tamponade","2026-04-17",{"date":108,"type":109},"2026-04-22","ACTUAL",{"date":111,"type":109},"2025-05-28",{"date":113,"type":84},"2026-11",{"name":68,"class":6},1]