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Rivaroxaban vs Enoxaparin After Cesarean Section: Laboratory Thromboprophylaxis Outcomes

StatusRecruiting
PhaseNot applicable
Started
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Record History

  1. Minor Study First Submitted
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.
Trial Details
NCT Number NCT07820670
Lead Sponsor Wolfson Medical Center
Conditions
(from sponsor)
Postpartum Period, Cesarean Section Surgery, VTE (Venous Thromboembolism)
Related terms Venous Thromboembolism
Enrollment 62 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov