[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100620104":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":26,"responsibleParty":37,"collaborators":26,"id":41,"slug":42,"hasResults":43,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":26,"eligibilityCriteria":47,"healthyVolunteers":43,"sex":48,"minAge":49,"maxAge":26,"enrollmentInfo":50,"targetDuration":26,"studyType":53,"phases":54,"briefSummary":56,"conditions":57,"keywords":60,"overallStatus":62,"whyStopped":26,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":26},{"fullName":5,"class":6},"Western Galilee Hospital-Nahariya","OTHER_GOV",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Carbetocin arm","EXPERIMENTAL","Participants in this arm will receive intravenous carbetocin (100 micrograms) immediately after placental delivery for the prevention of postpartum hemorrhage following vaginal delivery. Carbetocin will be administered as part of active management of the third stage of labor in women at increased risk for postpartum hemorrhage.",[13],"Drug: Carbetocin 100 Microgram\u002FmL Solution for Injection",{"label":15,"type":16,"description":17,"interventionNames":18},"Misoprostol arm","ACTIVE_COMPARATOR","Participants in this arm will receive rectal misoprostol (1000 micrograms) immediately after placental delivery, in addition to intravenous oxytocin, for the prevention of postpartum hemorrhage following vaginal delivery. This regimen represents an accepted uterotonic prophylaxis strategy for women at increased risk for postpartum hemorrhage.",[19],"Drug: Misoprostol",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Carbetocin 100 Microgram\u002FmL Solution for Injection","Participants randomized to this intervention will receive intravenous carbetocin 100 micrograms administered immediately after placental delivery as prophylaxis for postpartum hemorrhage following vaginal delivery. Carbetocin is a long-acting synthetic analogue of oxytocin and is used as part of active management of the third stage of labor in women at increased risk for postpartum hemorrhage.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Misoprostol","Participants randomized to this intervention will receive rectal misoprostol 1000 micrograms immediately after placental delivery for the prevention of postpartum hemorrhage following vaginal delivery. In accordance with standard practice, intravenous oxytocin 10 units will also be administered as part of active management of the third stage of labor in women at increased risk for postpartum hemorrhage.",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Nadir Ganem, Dr.","CONTACT","04-910-7107","nadirg@gmc.gov.il",{"type":38,"investigatorFullName":39,"investigatorTitle":40,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Dr Raneen Abu Shqara","Dr.","100620104","carbetocin-vs-misoprostol-for-postpartum-hemorrhage-prevention-100620104",false,"NCT07353281","Carbetocin vs Misoprostol for Postpartum Hemorrhage Prevention","Carbetocin Versus Misoprostol for the Prevention of Postpartum Hemorrhage After Vaginal Delivery in Women With Risk Factors: A Prospective Randomized Study","Inclusion Criteria\n\n* Women aged 18 years or older\n* Singleton pregnancy\n* Gestational age 37-42 weeks\n* Cephalic presentation\n* Vaginal delivery\n* Presence of one or more risk factors for postpartum hemorrhage, including:\n* Grand multiparity (≥5 previous deliveries)\n* History of postpartum hemorrhage\n* History of manual removal of placenta\n* Estimated fetal weight ≥4,000 grams\n* Polyhydramnios\n* Chorioamnionitis\n* Prolonged oxytocin use during labor (third augmentation cycle or more)\n* Eligible for prophylactic uterotonic therapy after delivery\n* Provided written informed consent\n\nExclusion Criteria\n\n* Multiple gestation\n* Known major fetal anomalies\n* Intrauterine fetal demise (IUFD)\n* Contraindication to vaginal delivery\n* Known hypersensitivity to carbetocin, misoprostol, or oxytocin\n* Known coagulation disorders requiring alternative management\n* Planned cesarean delivery\n* Participation in another interventional study that may affect postpartum bleeding outcomes","FEMALE","18 Years",{"count":51,"type":52},146,"ESTIMATED","INTERVENTIONAL",[55],"NA","Postpartum hemorrhage (PPH) is a leading cause of maternal morbidity and mortality worldwide, particularly among women with known risk factors. Uterotonic agents are routinely administered after vaginal delivery to prevent excessive bleeding. Carbetocin, a long-acting oxytocin analogue, and misoprostol are both used for this purpose, but comparative data in high-risk vaginal deliveries remain limited.\n\nThis prospective randomized study aims to compare the effectiveness and safety of intravenous carbetocin versus rectal misoprostol for the prevention of postpartum hemorrhage in women with risk factors undergoing vaginal delivery at Galilee Medical Center. The primary outcome is the incidence of postpartum hemorrhage. Secondary outcomes include the need for additional uterotonic agents or surgical interventions, changes in hemoglobin levels, blood transfusion requirements, and maternal adverse effects.",[58,59],"Postpartum Complication","Postpartum Hemorrhage",[61],"Postpartum hemorrhage, Carbetocin, Misoprostol, Vaginal delivery, Uterotonic agents, High-risk pregnancy","NOT_YET_RECRUITING","2026-01-13",{"date":65,"type":66},"2026-01-20","ACTUAL",{"date":68,"type":52},"2026-01-31",{"date":70,"type":52},"2028-01-01",{"name":5,"class":6}]