Rivaroxaban vs Enoxaparin After Cesarean Section: Laboratory Thromboprophylaxis Outcomes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorWolfson Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
Known thrombophilia
Prior arterial/venous thrombosis
Creatinine clearance <29 mL/min
Abnormal liver enzymes/bilirubin or liver disease
Trial design
Design model
Parallel
Treatments tested in this trial
Rivaroxaban
Drug10 mg PO once daily from ≥12 h post-C-section until discharge
Enoxaparin 40 mg
Drug40 mg SC once daily from ≥12 h post-C-section until discharge
Treatment groups
62 Participants
are divided into 2 treatment groupsGroup A: RivaroxabanExperimental treatment 1 intervention
Group B: EnoxaparinActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Endogenous Thrombin Potential (ETP)
Between-group comparison of ETP to assess similarity of anticoagulant effect; lower ETP indicates greater anticoagulation.
Time frame
Postoperative day 2: immediately before the study drug dose (trough) and approximately 3 hours after the study drug dose (peak), during the index hospitalizationSecondary outcomes
1
Thrombin Generation - Lag Time (minutes)
Thrombin Generation - Lag Time (minutes)
Time frame
Postoperative day 2: immediately before the study drug dose (trough) and approximately 3 hours after the study drug dose (peak), during the index hospitalization2
Thrombin Generation - Peak Thrombin (nM)
Thrombin Generation - Peak Thrombin (nM)
Time frame
Postoperative day 2: immediately before the study drug dose (trough) and approximately 3 hours after the study drug dose (peak), during the index hospitalization3
Anti-Xa activity (IU/mL) - Enoxaparin arm
Anti-Xa activity (IU/mL) - Enoxaparin arm
Time frame
Postoperative day 2: immediately before the enoxaparin dose (trough) and approximately 3 hours after the enoxaparin dose (peak), during the index hospitalization4
Plasma Rivaroxaban Concentration (ng/mL) - Rivaroxaban arm
Plasma Rivaroxaban Concentration (ng/mL) - Rivaroxaban arm
Time frame
Postoperative day 2: immediately before the rivaroxaban dose (trough) and approximately 3 hours after the rivaroxaban dose (peak), during the index hospitalizationSponsors and contacts
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Source ClinicalTrials.gov