[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100655991":3},{"organization":4,"outcomesModule":7,"designInfo":33,"detailedDescription":39,"studyPopulation":32,"armGroups":40,"interventions":53,"overallOfficials":66,"centralContacts":77,"locations":86,"responsibleParty":103,"collaborators":32,"id":106,"slug":107,"hasResults":108,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":32,"eligibilityCriteria":112,"healthyVolunteers":108,"sex":113,"minAge":114,"maxAge":115,"enrollmentInfo":116,"targetDuration":32,"studyType":119,"phases":120,"briefSummary":122,"conditions":123,"keywords":127,"overallStatus":89,"whyStopped":32,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":143},{"fullName":5,"class":6},"Wolfson Medical Center","OTHER_GOV",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":32},[9],{"measure":10,"description":11,"timeFrame":12},"Endogenous Thrombin Potential (ETP)","Between-group comparison of ETP to assess similarity of anticoagulant effect; lower ETP indicates greater anticoagulation.","Postoperative day 2: immediately before the study drug dose (trough) and approximately 3 hours after the study drug dose (peak), during the index hospitalization",[14,16,18,21,24,28],{"measure":15,"description":15,"timeFrame":12},"Thrombin Generation - Lag Time (minutes)",{"measure":17,"description":17,"timeFrame":12},"Thrombin Generation - Peak Thrombin (nM)",{"measure":19,"description":19,"timeFrame":20},"Anti-Xa activity (IU\u002FmL) - Enoxaparin arm","Postoperative day 2: immediately before the enoxaparin dose (trough) and approximately 3 hours after the enoxaparin dose (peak), during the index hospitalization",{"measure":22,"description":22,"timeFrame":23},"Plasma Rivaroxaban Concentration (ng\u002FmL) - Rivaroxaban arm","Postoperative day 2: immediately before the rivaroxaban dose (trough) and approximately 3 hours after the rivaroxaban dose (peak), during the index hospitalization",{"measure":25,"description":26,"timeFrame":27},"Treatment Satisfaction (ACTS Questionnaire total and subscales)","The Anti-Clot Treatment Scale (validated patient-reported measure; higher scores reflect greater satisfaction)","Postoperative day 2, prior to hospital discharge",{"measure":29,"description":30,"timeFrame":31},"Adverse Events (bleeding and VTE)","Clinically evident bleeding, confirmed VTE events, allergic reactions, or other AEs possibly related to study drugs, collected during hospitalization and via phone at \\~2 days post-discharge and 6 weeks.","From randomization through 6 weeks postpartum, including assessment during the index hospitalization, approximately 2 days after discharge, and at 6 weeks postpartum",null,{"allocation":34,"interventionModel":35,"interventionModelDescription":32,"primaryPurpose":36,"observationalModel":32,"timePerspective":32,"maskingInfo":37},"RANDOMIZED","PARALLEL","PREVENTION",{"masking":38,"maskingDescription":32,"whoMasked":32},"NONE","Randomized (1:1), open-label, parallel-group, single-center study at Wolfson Medical Center. Eligible participants (Hebrew-speaking, age 18-50, elective cesarean, and meeting local VTE prophylaxis criteria) are randomized to rivaroxaban 10 mg PO once daily or enoxaparin 40 mg SC once daily from the day of surgery until discharge (first dose ≥12 h after cesarean and ≥6 h after spinal anesthesia). On POD2 two blood draws are performed: trough pre-dose and peak \\~3 h after dosing. Tests: PT, aPTT, anti-Xa with appropriate calibrators, thrombin generation (endogenous thrombin potential \\[ETP\\], lag time, peak thrombin). ACTS (Anti-Clot Treatment Scale (ACTS) satisfaction questionnaire) is administered before discharge. Safety follow-up calls 2 days after discharge and 6 weeks postpartum for bleeding, VTE, allergic reactions or other AEs.",[41,47],{"label":42,"type":43,"description":44,"interventionNames":45},"Rivaroxaban","EXPERIMENTAL","Participants receive rivaroxaban 10 mg orally (PO) once daily, starting ≥12 hours after cesarean delivery and ≥6 hours after spinal anesthesia, and continuing once daily during the index hospitalization until discharge. Standard postpartum care is provided to all participants.",[46],"Drug: Rivaroxaban",{"label":48,"type":49,"description":50,"interventionNames":51},"Enoxaparin","ACTIVE_COMPARATOR","Participants receive enoxaparin 40 mg subcutaneously (SC) once daily, starting ≥12 hours after cesarean delivery and ≥6 hours after spinal anesthesia, and continuing once daily during the index hospitalization until discharge. Standard postpartum care is provided to all participants",[52],"Drug: Enoxaparin 40 mg",[54,60],{"type":55,"name":42,"description":56,"armGroupLabels":57,"otherNames":58},"DRUG","10 mg PO once daily from ≥12 h post-C-section until discharge",[42],[59],"Xarelto",{"type":55,"name":61,"description":62,"armGroupLabels":63,"otherNames":64},"Enoxaparin 40 mg","40 mg SC once daily from ≥12 h post-C-section until discharge",[48],[65],"Clexane",[67,70,73,75],{"name":68,"affiliation":5,"role":69},"Amihai Rottenstreich, MD","PRINCIPAL_INVESTIGATOR",{"name":71,"affiliation":5,"role":72},"Ilia Kleiner, MD","STUDY_DIRECTOR",{"name":74,"affiliation":5,"role":72},"Noa Gonen, MD",{"name":76,"affiliation":5,"role":72},"Hagit Eisenberg, MD",[78,83],{"name":79,"role":80,"phone":81,"phoneExt":32,"email":82},"Or Marom, MD","CONTACT","+972-52-554-0490","orr.marom@gmail.com",{"name":76,"role":80,"phone":84,"phoneExt":32,"email":85},"+972-52-3397843","hagiteisen@yahoo.com",[87],{"facility":88,"status":89,"city":90,"state":32,"zip":91,"country":92,"countryCode":93,"cosmosGeoPoint":94,"geoPoint":99,"contacts":100},"Edith Wolfson Medical Center","RECRUITING","Holon","6997107","Israel","IL",{"type":95,"coordinates":96},"Point",[97,98],34.77918,32.01034,{"lat":98,"lon":97},[101],{"name":76,"role":80,"phone":102,"phoneExt":32,"email":85},"+972523397843",{"type":69,"investigatorFullName":104,"investigatorTitle":105,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"Hagit Eisenberg","Obstetrics and Gynecology Resident Physician","100655991","rivaroxaban-vs-enoxaparin-after-cesarean-section-laboratory-thromboprophylaxis-outcomes-100655991",false,"NCT07820670","Rivaroxaban vs Enoxaparin After Cesarean Section: Laboratory Thromboprophylaxis Outcomes","The Laboratory Effect of Rivaroxaban Compared to Enoxaparin as Prophylactic Anticoagulant Therapy After Cesarean Section: A Randomized Open-Label Trial","Inclusion Criteria:\n\n* Hebrew-speaking women\n* age 18-50\n* Elective cesarean at Wolfson\n* Indicated for in-hospital thromboprophylaxis per local protocol (need ≥2 risk factors among: cesarean delivery; age \\>35; BMI \\>30; parity ≥3; labor duration ≥12 h; postpartum hemorrhage or blood transfusion; reduced mobility)\n\nExclusion Criteria:\n\n* Known thrombophilia\n* Prior arterial\u002Fvenous thrombosis\n* Creatinine clearance \\\u003C29 mL\u002Fmin\n* Abnormal liver enzymes\u002Fbilirubin or liver disease\n* Coagulation disorders\n* Platelets \\\u003C75,000\u002Fmm³\n* Interacting drugs affecting DOAC metabolism (e.g., strong CYP3A4\u002FP-gp modulators; azoles; protease inhibitors; rifampicin; phenytoin; carbamazepine; phenobarbital; St. John's wort; dronedarone)\n* Active bleeding or contraindication to anticoagulation\n* Peptic disease\u002FGI bleeding history\n* Hemoptysis risk\u002Fhistory\n* Preeclampsia\n* Active infection\n* Significant lower-limb varicosities\n* Need for prophylaxis beyond discharge (≥3 risk factors)\n* Maternal weight \\\u003C50 kg or \\>100 kg","FEMALE","18 Years","50 Years",{"count":117,"type":118},62,"ESTIMATED","INTERVENTIONAL",[121],"NA","Pregnancy and the postpartum period increase venous thromboembolism (VTE) risk. After cesarean section, low-molecular-weight heparin (LMWH; enoxaparin) is commonly used for short-term thromboprophylaxis, but it requires daily subcutaneous injections and can cause adverse effects. Direct oral anticoagulants (DOACs) such as rivaroxaban offer convenient once-daily oral dosing. In women who meet institutional criteria for short-term postpartum thromboprophylaxis until hospital discharge, we will compare the laboratory anticoagulant effect of rivaroxaban versus enoxaparin using thrombin generation parameters.\n\nThis randomized, open-label trial will enroll women undergoing elective cesarean section who are indicated for in-hospital prophylaxis. Blood will be drawn on postoperative day 2 at trough (pre-dose) and peak (\\~3 hours post-dose) to measure thrombin generation, anti-Xa activity and drug levels, and participants will complete the Anti-Clot Treatment Scale (ACTS) satisfaction questionnaire. Safety follow-up will occur by telephone at 2 days post-discharge and at 6 weeks postpartum.",[124,125,126],"Postpartum Period","Cesarean Section Surgery","VTE (Venous Thromboembolism)",[42,48,128,129,130,131,132,133],"LMWH","DOAC","Thromboprophylaxis","Thrombin Generation","Endogenous Thrombin Potential","Post-cesarean","2026-09-09",{"date":136,"type":137},"2026-09-15","ACTUAL",{"date":139,"type":137},"2025-12-01",{"date":141,"type":118},"2027-12",{"name":5,"class":6},1]