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Rivaroxaban vs Enoxaparin After Cesarean Section: Laboratory Thromboprophylaxis Outcomes
Sponsor: Wolfson Medical Center
Summary
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.
Official title: The Laboratory Effect of Rivaroxaban Compared to Enoxaparin as Prophylactic Anticoagulant Therapy After Cesarean Section: A Randomized Open-Label Trial
Key Details
Gender
FEMALE
Age Range
18 Years - 50 Years
Study Type
INTERVENTIONAL
Enrollment
62
Start Date
2025-12-01
Completion Date
2027-12
Last Updated
2026-09-15
Healthy Volunteers
No
Interventions
Rivaroxaban
10 mg PO once daily from ≥12 h post-C-section until discharge
Enoxaparin 40 mg
40 mg SC once daily from ≥12 h post-C-section until discharge
Locations (1)
Edith Wolfson Medical Center
Holon, Israel