[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100589588":3},{"organization":4,"outcomesModule":7,"designInfo":29,"detailedDescription":38,"studyPopulation":28,"armGroups":39,"interventions":52,"overallOfficials":66,"centralContacts":71,"locations":82,"responsibleParty":101,"collaborators":28,"id":105,"slug":28,"hasResults":106,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":28,"eligibilityCriteria":110,"healthyVolunteers":111,"sex":112,"minAge":113,"maxAge":114,"enrollmentInfo":115,"targetDuration":28,"studyType":118,"phases":119,"briefSummary":121,"conditions":122,"keywords":124,"overallStatus":85,"whyStopped":28,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":138},{"fullName":5,"class":6},"Yuzuncu Yil University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":28},[9,13],{"measure":10,"description":11,"timeFrame":12},"Uterine tonus","The effect of carbetocin on uterine tone will be evaluated by the surgical team using a numerical scoring scale between 0-10. A score of 0 will indicate atony, and a score of 10 will indicate full contraction.","For 30 minutes after carbetocin administration.",{"measure":14,"description":15,"timeFrame":12},"Additional uterotonic drug requirement","If the uterine tone is 7 or below, the surgical team will perform uterine massage, and in patients who do not see a sufficient increase in uterine tone, an additional uterotonic, 0.2 mg methylergonavine (Methyl ampoule 0.2 mg\u002Fml) will be administered IM by the anesthesia team and recorded.",[17,21,25],{"measure":18,"description":19,"timeFrame":20},"Intraoperative bleeding","Total intraoperative bleeding was recorded by calculating and estimating the aspirator volume, pad-sponge-compress count and surgical area.","from drug administration to the end of surgery.",{"measure":22,"description":23,"timeFrame":24},"Mean Blood Pressure","Mean blood pressure will be measured every 5 minutes intraoperatively using a noninvasive method.","Intraoperatively every 5 minutes",{"measure":26,"description":27,"timeFrame":24},"Heart Rate","Heart rate will be measured every 5 minutes intraoperatively using a noninvasive method.",null,{"allocation":30,"interventionModel":31,"interventionModelDescription":32,"primaryPurpose":33,"observationalModel":28,"timePerspective":28,"maskingInfo":34},"RANDOMIZED","PARALLEL","In 80 pregnant patients scheduled for elective cesarean section, patients will be randomly assigned to receive 5 IU oxytocin or 100 μg carbetocin IV bolus intraoperatively after the birth of the baby.","SUPPORTIVE_CARE",{"masking":35,"maskingDescription":28,"whoMasked":36},"SINGLE",[37],"PARTICIPANT","The study will have a double-blind design and will be conducted after obtaining an approval from the local ethics committee. The study will include 80 patients planned for elective caesarean section surgeries , aged 18-40 years with an ASA score of I-II. The patients will be randomized by sealed tender and will be divided into 2 groups with 40 patients each.\n\nAll cases will receive routine preparation for general anesthesia. All patients placed on the operating room will receive two large-bore vascular access. For anesthesia induction 2 mg\u002Fkg propofol and 0.5 mg\u002Fkg rocuronium will be used. Anesthesia will be maintained with 60% air, 40% oxygen and 2 MAC sevoflurane.Demographic data of the patients (age, height, weight), ASA score and surgical time will be recorded. During the operation, hemodynamic parameters will be recorded just before the drugs are given and at the 1st, 5th, 10th, 15th, 20th, 25th and 30th minutes after the drug is given. In addition, intraoperative blood loss and the need for additional uterotonics throughout the surgery will be recorded. All data will be recorded and statistical analysis will be made.",[40,46],{"label":41,"type":42,"description":43,"interventionNames":44},"Oxytocin (Group-O)","ACTIVE_COMPARATOR","Group-O: Oxytocin group (n:40). In cesarean surgery, 5 IU of oxytocin will be administered after the baby delivered.",[45],"Procedure: Group-O",{"label":47,"type":48,"description":49,"interventionNames":50},"Carbetocin (Group-C)","EXPERIMENTAL","Group-C: Carbetocin group (n:40). In cesarean surgery, 100 μg carbetocin IV bolus will be administered after the baby delivered.",[51],"Procedure: Group-C",[53,60],{"type":54,"name":55,"description":56,"armGroupLabels":57,"otherNames":58},"PROCEDURE","Group-C","100 iu carbetosin administered to carbetocin group",[47],[59],"Group Carbetosin",{"type":54,"name":61,"description":62,"armGroupLabels":63,"otherNames":64},"Group-O","In cesarean surgery, 5 IU of oxytocin will be administered after the baby delivered.",[41],[65],"Group Oxytocine",[67],{"name":68,"affiliation":69,"role":70},"Şükran ŞS Sevimli, Assoc.Prof","Van Yüzüncü Yıl University Van\u002FTurkey","STUDY_DIRECTOR",[72,78],{"name":73,"role":74,"phone":75,"phoneExt":76,"email":77},"Nurettin NK Kurt, assoc.Prof.","CONTACT","+90 4322150473","6080","dr.nurettinkurt@gmail.com",{"name":79,"role":74,"phone":80,"phoneExt":76,"email":81},"Baran BT Türeli, MD","+90 05393133865","barantureli@gmail.com",[83],{"facility":84,"status":85,"city":86,"state":87,"zip":88,"country":89,"countryCode":28,"cosmosGeoPoint":90,"geoPoint":95,"contacts":96},"Van Yuzuncu Yil University","RECRUITING","Van","Tuşba","65100","Turkey (Türkiye)",{"type":91,"coordinates":92},"Point",[93,94],43.38323,38.49457,{"lat":94,"lon":93},[97],{"name":98,"role":74,"phone":99,"phoneExt":28,"email":100},"Şükran ŞS Sevimli, MD","+90 5445262921","sevimli@hotmail.com",{"type":102,"investigatorFullName":103,"investigatorTitle":104,"investigatorAffiliation":5,"oldNameTitle":28,"oldOrganization":28},"PRINCIPAL_INVESTIGATOR","Nurettin KURT","Assistant Professor","100589588",false,"NCT06956365","To Compare the Effects of Oxytocin and Carbetocin on Intraoperative Hemodynamic Changes in Cesarean Section Surgeries.","Van Yuzuncu Yil University Faculty of Medicine Ethics Committee","Inclusion Criteria:\n\n* Patients scheduled for caesarean sections\n* Between 18-40 years\n* ASA I-II group\n* Those who will undergo general anesthesia\n* Those between 35-40 weeks of pregnancy\n* 1st and 2nd caesarean sections\n\nExclusion Criteria:\n\n* Those who prefer spinal or epidural anesthesia\n* Those who are outside the age range of 18-40\n* Those who are ASA III and above\n* Those with HT, DM, cardiac and respiratory diseases\n* Preeclampsia, eclampsia, HELLP\n* Those with a history of drug use that affects the cardiovascular system\n* Placenta Previa, Placenta Acreta, Placenta Acreta",true,"FEMALE","18 Years","40 Years",{"count":116,"type":117},80,"ESTIMATED","INTERVENTIONAL",[120],"NA","To compare the effects of oxytocin and carbetocin, used as uterotonics in elective caesarean section surgeries, in terms of intraoperative hemodynamic changes.",[123],"Cesarean Section",[125,126,127,128,18],"Cesarean section","Oxytocin","Carbetocin","Uterotonic","2025-04-24",{"date":131,"type":132},"2025-05-04","ACTUAL",{"date":134,"type":132},"2024-05-14",{"date":136,"type":117},"2025-07-30",{"name":5,"class":6},1]