[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Christian Haslinger\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":84},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,48],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":32,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100553123","phase-4-swift---swiss-factor-xiii-trial-in-pph-100553123",false,"NCT06481995","SWIFT - SWIss Factor XIII Trial in PPH","Early Factor XIII Replacement in Postpartum Hemorrhage: Multi-center, Randomized, Controlled, Investigator-initiated Trial","SWIFT","Inclusion Criteria:\n\n* planned vaginal delivery\n* singleton vital pregnancy\n* gestational age at delivery \\>= 30+0 weeks\n* maternal weight at admission for delivery \\\u003C100 kg\n\nExclusion Criteria:\n\n* Antithrombotic therapy in pregnancy (therapeutic dosage) until admission for delivery (LMWH, UFH)\n* diagnosis of preeclampsia (ISSHP classification , eclampsia or HELLP syndrome),\n* known history of deep vein thrombosis or pulmonary embolism,\n* known 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 g\u002FL,\n* known sickle cell disease,\n* known malignant tumor(s),\n* participation in another study with investigational drug within the 30 days preceding and during the present study,\n* inability to follow the procedures of the study, e.g. due to language problems,\n* known or suspected non-compliance, drug or alcohol abuse.\n\nExclusion criteria prior randomization\n\n* Maternal fever ≥39.0°C\n* unplanned cesarean delivery is performed,\n* Measured Blood Loss remains \\\u003C 700 mL after administration of 1g tranexamic acid .\n* Postpartum hemorrhage due to occult bleeding (intra-abdominal, retroperitoneal, parametric),","FEMALE","18 Years",{"count":20,"type":21},988,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","The goal of this trial is to determine if postpartum blood loss can be reduced by replenishing coagulation factor XIII (FXIII) at an early stage of postpartum hemorrhage (PPH).\n\nSummary of current body of evidence:\n\n* Morbidity and mortality due to PPH is rising.\n* Current guidelines focus on replenishment of fibrinogen as an initial step in the treatment of PPH-related coagulopathy, despite non-conclusive evidence in all prospective trials.\n* Trials from other specialties demonstrate a significant impact of FXIII on perioperative bleeding complications; a previous study at the University Hospital Zurich showed that pre-partum factor XIII activity had a strong association to postpartum blood loss.\n\nTherefore, this nationwide, multi-center, randomized, controlled trial in multiple perinatal centers across Switzerland will be conducted. The goal is to determine if postpartum blood loss and PPH-related complications can be reduced by replenishing FXIII.\n\nAll participating women receive, according to the national guideline, 1g tranexamic acid (TXA) i.v. in case of PPH (measured blood loss \\[MBL\\] ≥ 500 mL) during the pre-study phase. Randomization takes place if bleeding continues and exceeds 700mL. The intervention group then receives FXIII (Fibrogammin®) according to approved dosage in addition to obstetric standard of care treatment for causes of PPH; the control group receives only standard of care treatment.",[27,28,29,30,31],"Postpartum Hemorrhage","Coagulation Disorder","Coagulation Factor Deficiency","Hemorrhage","Postpartum Complication",[33,34],"Postpartum hemorrhage","coagulation factor XIII","RECRUITING","2026-04-21",{"date":38,"type":39},"2026-04-27","ACTUAL",{"date":41,"type":39},"2024-07-09",{"date":43,"type":21},"2028-12-31",{"name":45,"class":46},"Christian Haslinger","OTHER",9,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":60,"conditions":61,"keywords":67,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},"100594452","u-cavit-versus-standard-of-care-for-prevention-of-atonic-postpartum-hemorrhage-after-cesarean-section-in-high-risk-women-100594452","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",{"count":57,"type":21},70,[59],"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.",[62,30,31,63,64,65,66],"Postpartum Hemorrhage (Primary)","Delivery ,Complications,Maternal","Pregnancy Complications","Cesarean Delivery","Balloon",[27,68,69,70,71,72,73,74],"Delivery complications","high risk patients","Pregnancy","Balloon Catheter","Tamponade","prophylactic","Vacuum-induced tamponade","2026-04-17",{"date":77,"type":39},"2026-04-22",{"date":79,"type":39},"2025-05-28",{"date":81,"type":21},"2026-11",{"name":45,"class":46},1,""]