[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100571509":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":20,"locations":11,"responsibleParty":30,"collaborators":35,"id":37,"slug":38,"hasResults":39,"nctId":40,"briefTitle":41,"officialTitle":42,"acronym":11,"eligibilityCriteria":43,"healthyVolunteers":39,"sex":44,"minAge":45,"maxAge":46,"enrollmentInfo":47,"targetDuration":11,"studyType":50,"phases":51,"briefSummary":53,"conditions":54,"keywords":56,"overallStatus":64,"whyStopped":11,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":11},{"fullName":5,"class":6},"Nazarbayev University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention group (cesarean section + REBOA)","EXPERIMENTAL",null,[13],"Device: REBOA",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"DEVICE","REBOA","endovascular balloon occlusion of the aorta",[9],[21,26],{"name":22,"role":23,"phone":24,"phoneExt":11,"email":25},"Gauri Bapayeva, MD, PhD","CONTACT","+77017462800","gauri.bapayeva@gmail.com",{"name":27,"role":23,"phone":28,"phoneExt":11,"email":29},"Milan M Terzic, MD, PhD","+381642802888","milan.terzic@nu.edu.kz",{"type":31,"investigatorFullName":32,"investigatorTitle":33,"investigatorAffiliation":34,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Gauri Bapayeva","Professor","University Medical Center, Kazakhstan",[36],{"name":34,"class":6},"100571509","effectiveness-of-reboa-in-reducing-blood-loss-during-cesarean-section-in-patients-with-pas-100571509",false,"NCT06721182","Effectiveness of REBOA in Reducing Blood Loss During Cesarean Section in Patients with PAS","Effectiveness of Endovascular Balloon Occlusion of the Aorta in Reducing Blood Loss During Cesarean Section in Patients with Placenta Accreta Spectrum Disorders in Tertiary Care Center in Kazakhstan: a Randomized Controlled Trial","Inclusion Criteria: (1) singleton pregnancy at 34 weeks of gestation or more, (2) age 18 to 45 years, (3) confirmed diagnosis of placenta accreta spectrum, (4) indication for elective cesarean section, (5) consent for aortic balloon occlusion during cesarean section -\n\nExclusion Criteria:(1) pregnant patients at the gestational age ˂ 34 weeks of gelation, (2) multiple pregnancy, (3) need for emergency caesarean section, (4) coagulopathy (known coagulopathy, women with abnormal baseline activated partial thromboplastin time (aPTT), prothrombin time (PT), international normalization ratio (INR) before surgery)\n\n\\-","FEMALE","18 Years","45 Years",{"count":48,"type":49},100,"ESTIMATED","INTERVENTIONAL",[52],"NA","Obstetric hemorrhage is one of the leading causes of maternal mortality and morbidity worldwide. The major risk factors for obstetric hemorrhage include placenta previa and placenta accreta spectrum (PAS) disorders. The frequency of PAS disorders is increasing worldwide and is accompanied by intraoperative massive bleeding with hemorrhagic shock and increasing rates of cesarean hysterectomy. To decrease risks of bleeding, various approached of endovascular balloon occlusion are tested during the recent decade. This study aims to evaluate the effectiveness of resuscitative endovascular balloon occlusion of the aorta (REBOA) in reducing blood loss and preserving the reproductive organs during cesarean section. This will be a prospective randomized controlled trial involving 100 patients in tertiary care obstetric center in Kazakhstan. The study population will consist of pregnant women who will be admitted to the University Medical Center for cesarean section due to placenta previa complicated by PAS disorders. Study subjects will be randomly divided in intervention and control groups. The results will be analyzed through the measurement of primary (blood loss during cesarean section) and secondary outcomes \\[occurrence of hysterectomy during cesarean section, blood transfusion volume, duration of surgery, balloon application time, stay in intensive care unit (ICU), neonatal outcomes, complications, and total days of postsurgical hospital stay\\]. Use of REBOA is expected to minimize intraoperative blood loss during cesarean section, decrease the need for transfusion of blood components, reduce the time of surgical intervention, and decrease the rate of maternal complications and reduce the rate of cesarean hysterectomy.",[55],"Placenta Accreta Spectrum",[17,57,58,59,60,61,62,63],"obstetric hemorrhage","cesarean hysterectomy","placenta accreta spectrum","clinical outcome","cesarean section","endovascular balloon occlusion","abnormally invasive placenta","NOT_YET_RECRUITING","2024-12-03",{"date":67,"type":68},"2024-12-06","ACTUAL",{"date":70,"type":49},"2024-12-20",{"date":72,"type":49},"2026-12-01",{"name":5,"class":6}]