Rivaroxaban vs Enoxaparin After Cesarean Section: Thromboprophylaxis Lab Outcomes
Official title: The Laboratory Effect of Rivaroxaban Compared to Enoxaparin as Prophylactic Anticoagulant Therapy After Cesarean Section: A Randomized Open-Label Trial
Run by Wolfson Medical Center · NCT07820670 · Data updated 2026-11-12
This study tests whether rivaroxaban taken by mouth once daily after cesarean section provides a similar lab profile for blood clot prevention as enoxaparin given as a daily shot in eligible postpartum women.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 50 Years |
| Sex | Women only |
| Enrollment | 62 (estimated) |
| Sponsor | Wolfson Medical Center Government |
| Locations | 1 site (Holon) |
| Status | Recruiting |
| Started | December 1, 2025 |
| Main results expected | June 2027 |
| Study ends | December 2027 |
| Registry record updated | September 15, 2026 |
| Trial ID | NCT07820670 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Hebrew-speaking women aged 18–50 undergoing elective cesarean delivery who require in-hospital postpartum thromboprophylaxis per local protocol.
✕Probably not a fit
Women outside the local eligibility criteria, those with contraindications to anticoagulation, or those not meeting the VTE risk-factor thresholds may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized, open-label trial compares rivaroxaban 10 mg daily to enoxaparin 40 mg daily for short-term postpartum thromboprophylaxis after elective cesarean delivery. The study measures laboratory markers of anticoagulation, including thrombin generation, anti-Xa activity, and drug levels, on postoperative day 2. Participants complete a satisfaction questionnaire and are followed for bleeding and other adverse events up to six weeks postpartum. The trial is conducted at a single center (Wolfson Medical Center) with Hebrew-speaking women aged 18–50 who meet local VTE prophylaxis criteria. Safety monitoring includes post-discharge follow-up calls and assessment of VTE, bleeding, and allergic reactions.
Why it matters
Potential benefit: If rivaroxaban shows comparable lab anticoagulation and safety, it could offer a convenient oral alternative to injections for postpartum thromboprophylaxis.
How similar studies have gone: Prior research supports DOACs in other settings, but this specific postpartum thromboprophylaxis comparison is novel in this center.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Edith Wolfson Medical Center
Holon, Israel Recruiting
Study contacts
- Principal investigator: Amihai Rottenstreich, MD — Wolfson Medical Center
- Study coordinator: Or Marom, MD
- Email: orr.marom@gmail.com
- Phone: +972-52-554-0490
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.