Postpartum PeriodNCT07820670
Rivaroxaban vs Enoxaparin After Cesarean Section: Laboratory Thromboprophylaxis Outcomes
A study testing Rivaroxaban and Enoxaparin 40 mg in people with Postpartum Period and Cesarean Section Surgery, run by Wolfson Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Postpartum Period, Cesarean Section Surgery, VTE (Venous Thromboembolism)
- What is being tested?
- Rivaroxaban and Enoxaparin 40 mg
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Dec 2025to Dec 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- Known thrombophilia
- Prior arterial/venous thrombosis
- Creatinine clearance <29 mL/min
- Abnormal liver enzymes/bilirubin or liver disease
- Coagulation disorders
- Platelets <75,000/mm³
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site, 1 recruiting
- Recruiting
Edith Wolfson Medical Center
Holon, 6997107
Hagit Eisenberg, MD, +972523397843, hagiteisen@yahoo.com
About this study
Official title: The Laboratory Effect of Rivaroxaban Compared to Enoxaparin as Prophylactic Anticoagulant Therapy After Cesarean Section: A Randomized Open-Label 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.
Read the detailed description
Randomized (1:1), open-label, parallel-group, single-center study at Wolfson Medical Center. Eligible participants (Hebrew-speaking, age 18-50, elective cesarean, and meeting local VTE prophylaxis criteria) are randomized to rivaroxaban 10 mg PO once daily or enoxaparin 40 mg SC once daily from the day of surgery until discharge (first dose ≥12 h after cesarean and ≥6 h after spinal anesthesia). On POD2 two blood draws are performed: trough pre-dose and peak ~3 h after dosing. Tests: PT, aPTT, anti-Xa with appropriate calibrators, thrombin generation (endogenous thrombin potential [ETP], lag time, peak thrombin). ACTS (Anti-Clot Treatment Scale (ACTS) satisfaction questionnaire) is administered before discharge. Safety follow-up calls 2 days after discharge and 6 weeks postpartum for bleeding, VTE, allergic reactions or other AEs.
- Being tested
- Rivaroxaban, Enoxaparin 40 mg
- Keywords
- Rivaroxaban, Enoxaparin, LMWH, DOAC, Thromboprophylaxis, Thrombin Generation, Endogenous Thrombin Potential, Post-cesarean
- Medical subject headings
- Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RivaroxabanDrug
Also called Xarelto
10 mg PO once daily from ≥12 h post-C-section until discharge
Enoxaparin 40 mgDrug
Also called Clexane
40 mg SC once daily from ≥12 h post-C-section until discharge
| Study group | Role | What they receive |
|---|---|---|
| Rivaroxaban | Experimental | Participants receive rivaroxaban 10 mg orally (PO) once daily, starting ≥12 hours after cesarean delivery and ≥6 hours after spinal anesthesia, and continuing once daily during the index hospitalization until discharge. Standard postpartum care is provided to all participants. Receives: Drug: Rivaroxaban |
| Enoxaparin | Active comparator | Participants receive enoxaparin 40 mg subcutaneously (SC) once daily, starting ≥12 hours after cesarean delivery and ≥6 hours after spinal anesthesia, and continuing once daily during the index hospitalization until discharge. Standard postpartum care is provided to all participants Receives: Drug: Enoxaparin 40 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endogenous Thrombin Potential (ETP)
Between-group comparison of ETP to assess similarity of anticoagulant effect; lower ETP indicates greater anticoagulation.
Measured: Postoperative day 2: immediately before the study drug dose (trough) and approximately 3 hours after the study drug dose (peak), during the index hospitalization
Secondary outcomes (6)
Thrombin Generation - Lag Time (minutes)
Thrombin Generation - Lag Time (minutes)
Measured: Postoperative day 2: immediately before the study drug dose (trough) and approximately 3 hours after the study drug dose (peak), during the index hospitalization
Thrombin Generation - Peak Thrombin (nM)
Thrombin Generation - Peak Thrombin (nM)
Measured: Postoperative day 2: immediately before the study drug dose (trough) and approximately 3 hours after the study drug dose (peak), during the index hospitalization
Anti-Xa activity (IU/mL) - Enoxaparin arm
Anti-Xa activity (IU/mL) - Enoxaparin arm
Measured: Postoperative day 2: immediately before the enoxaparin dose (trough) and approximately 3 hours after the enoxaparin dose (peak), during the index hospitalization
Plasma Rivaroxaban Concentration (ng/mL) - Rivaroxaban arm
Plasma Rivaroxaban Concentration (ng/mL) - Rivaroxaban arm
Measured: Postoperative day 2: immediately before the rivaroxaban dose (trough) and approximately 3 hours after the rivaroxaban dose (peak), during the index hospitalization
Treatment Satisfaction (ACTS Questionnaire total and subscales)
The Anti-Clot Treatment Scale (validated patient-reported measure; higher scores reflect greater satisfaction)
Measured: Postoperative day 2, prior to hospital discharge
Adverse Events (bleeding and VTE)
Clinically evident bleeding, confirmed VTE events, allergic reactions, or other AEs possibly related to study drugs, collected during hospitalization and via phone at ~2 days post-discharge and 6 weeks.
Measured: From randomization through 6 weeks postpartum, including assessment during the index hospitalization, approximately 2 days after discharge, and at 6 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2026
- Study start1 Dec 2025
- Primary completionJun 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Postpartum PeriodStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wolfson Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Hagit Eisenberg, Wolfson Medical Center
- Investigators
- Amihai Rottenstreich, MD, Principal investigator, Wolfson Medical CenterIlia Kleiner, MD, Study director, Wolfson Medical CenterNoa Gonen, MD, Study director, Wolfson Medical CenterHagit Eisenberg, MD, Study director, Wolfson Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07820670
- Sponsor's protocol ID
- 0085-25-WOMC
- Status last verified
- Sep 2026
- First submitted
- 1 Sep 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) underlying the main results will be shared, including: demographics and baseline characteristics; operative/anesthesia details relevant to timing; thrombin-generation parameters (ETP, lag time, peak thrombin); anti-Xa activity (enoxaparin arm); plasma rivaroxaban levels (rivaroxaban arm); ACTS questionnaire scores; adverse events (bleeding/VTE) and follow-up outcomes through 6 weeks postpartum. A data dictionary/codebook will accompany the dataset. Free-text notes and direct identifiers (names, full dates, contact details, MRNs) will not be shared.
Publications
Cano SJ, Lamping DL, Bamber L, Smith S. The Anti-Clot Treatment Scale (ACTS) in clinical trials: cross-cultural validation in venous thromboembolism patients. Health Qual Life Outcomes. 2012 Sep 26;10:120. doi: 10.1186/1477-7525-10-120.
PubMed 23013426Cohen H, Dore CJ, Clawson S, Hunt BJ, Isenberg D, Khamashta M, Muirhead N; RAPS Trial Protocol Collaborators. Rivaroxaban in antiphospholipid syndrome (RAPS) protocol: a prospective, randomized controlled phase II/III clinical trial of rivaroxaban versus warfarin in patients with thrombotic antiphospholipid syndrome, with or without SLE. Lupus. 2015 Sep;24(10):1087-94. doi: 10.1177/0961203315581207. Epub 2015 May 4.
PubMed 25940537Eerenberg ES, Kamphuisen PW, Sijpkens MK, Meijers JC, Buller HR, Levi M. Reversal of rivaroxaban and dabigatran by prothrombin complex concentrate: a randomized, placebo-controlled, crossover study in healthy subjects. Circulation. 2011 Oct 4;124(14):1573-9. doi: 10.1161/CIRCULATIONAHA.111.029017. Epub 2011 Sep 6.
PubMed 21900088Guyatt GH, Akl EA, Crowther M, Gutterman DD, Schuunemann HJ; American College of Chest Physicians Antithrombotic Therapy and Prevention of Thrombosis Panel. Executive summary: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012 Feb;141(2 Suppl):7S-47S. doi: 10.1378/chest.1412S3. No abstract available.
PubMed 22315257Chan NC, Eikelboom JW, Weitz JI. Evolving Treatments for Arterial and Venous Thrombosis: Role of the Direct Oral Anticoagulants. Circ Res. 2016 Apr 29;118(9):1409-24. doi: 10.1161/CIRCRESAHA.116.306925.
PubMed 27126650Greer IA, Nelson-Piercy C. Low-molecular-weight heparins for thromboprophylaxis and treatment of venous thromboembolism in pregnancy: a systematic review of safety and efficacy. Blood. 2005 Jul 15;106(2):401-7. doi: 10.1182/blood-2005-02-0626. Epub 2005 Apr 5.
PubMed 15811953Stein PD, Hull RD, Kayali F, Olson RE, Alshab AK, Meyers FA, Ghali WA, Silbergleit A, Gibson P. Venous thromboembolism in pregnancy: 21-year trends. Am J Med. 2004 Jul 15;117(2):121-5. doi: 10.1016/j.amjmed.2004.02.021. No abstract available.
PubMed 15234649