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Rivaroxaban vs Enoxaparin After Cesarean Section: Laboratory Thromboprophylaxis Outcomes

Sponsor: Wolfson Medical Center • ClinicalTrials.gov ID: NCT07820670

Registry updated: 2026-09-15

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Description

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 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.

Interventions

Rivaroxaban (Drug)
10 mg PO once daily from ≥12 h post-C-section until discharge
Enoxaparin 40 mg (Drug)
40 mg SC once daily from ≥12 h post-C-section until discharge

Eligibility criteria

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

Conditions

Postpartum Period Cesarean Section Surgery VTE (Venous Thromboembolism)

Locations

Edith Wolfson Medical Center — Holon, Israel

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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