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Rivaroxaban vs Enoxaparin After Cesarean Section: Laboratory Thromboprophylaxis Outcomes

RecruitingNAAges 18 Years - 50 YearsFemaleWolfson Medical Center
NCT07820670 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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. This 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 dru

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📋 Eligibility rules (as published)
Inclusion Criteria: * Hebrew-speaking women * age 18-50 * Elective cesarean at Wolfson * 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) Exclusion Criteria: * Known thrombophilia * Prior arterial/venous thrombosis * Creatinine clearance \<29 mL/min * Abnormal liver enzymes/bilirubin or liver disease * Coagulation disorders * Platelets \<75,000/mm³ * Interacting drugs affecting DOAC metabolism (e.g., strong CYP3A4/P-gp modulators; azoles; protease inhibitors; rifampicin; phenytoin; carbamazepine; phenobarbital; St. John's wort; dronedarone) * Active bleeding or contraindication to anticoagulation * Peptic disease/GI bleeding history * Hemoptysis risk/history * Preeclampsia * Active infection * Significant lower-limb varicosities * Need for prophylaxis beyond discharge (≥3 risk factors) * Maternal weight \<50 kg or \>100 kg
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What it tests

  • Rivaroxaban
  • Enoxaparin 40 mg
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Where

1 site
Edith Wolfson Medical Center
Holon, Israel
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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