Apixaban Versus Enoxaparin for Postpartum Venous Thromboembolism Prophylaxis

Apixaban Versus Enoxaparin for Thromboprophylaxis After Delivery

The purpose of this study is to compare the use of oral apixaban to subcutaneous enoxaparin for venous thromboembolism (VTE) prophylaxis in postpartum women at high risk for VTE. The primary goal is to evaluate medication adherence rates and patient satisfaction with the treatment.

Study Overview

• Status: Not yet recruiting
• Conditions: Postpartum; DVT Prophylaxis
• Intervention / Treatment: Drug: Apixaban; Drug: Enoxaparin

Detailed Description

Venous thromboembolism (VTE) is a leading cause of pregnancy-related morbidity and mortality. Current guidelines recommend pharmacologic thromboprophylaxis with low-molecular-weight heparin (LMWH), such as enoxaparin, for postpartum women with increased risk factors. However, common patient complaints related to enoxaparin include injection site reaction, pain, bruising, bleeding, nausea, vomiting, and cost. Oral anticoagulation therapy, such as apixaban (an oral factor Xa inhibitor), could obviate many of these negative effects.This single-center, prospective, open-blinded randomized controlled trial aims to investigate the use of apixaban versus enoxaparin for VTE prophylaxis in the postpartum period. Eligible postpartum women (after vaginal or cesarean delivery) with high risk for VTE will be randomized in a 1:1 ratio.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nira Gridish; Phone Number: +972503027855; Email: n_gridish@rambam.health.gov.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age ≥ 18 years.
• After Vaginal or C/S delivery.
• Need prophylactic treatment in a preventive dose.
• Presence of one or more high risk factors: Active infection, IBD, Heart disease, Type 1 diabetes with nephropathy, IV drug user, Surgical operation in Postpartum period, Emergency cesarean section.

OR presence of 2 low risk factors: Age > 35, post-partum hemorrhage > 1000 ml, Cesarean section, Hysterectomy, BMI > 30, Multiparity- Third birth or more, Active Smoking, Obstetric complications in current pregnancy (including preeclampsia, preterm birth before 37 weeks, active infection including chorioamnionitis, prolonged labor over 24 hours), Twin birth, Immobility, Large varicose veins, Stillbirth

Exclusion Criteria:

• Breast feeding.
• Predispose to hypercoagulability
• Familial history of VTE.
• Antiphospholipid syndrome (APS).
• Prior VTE.
• Anticoagulant treatment before or during pregnancy.
• BMI > 40
• History of severe renal or hepatic disease.
• Use of selective serotonin reuptake inhibitors or serotonin-norepinephrine reuptake inhibitors.
• Known diagnosis of bleeding dyscrasia (eg, von Willebrand disease).
• Spinal/epidural hematoma or spinal puncture.
• Active pathological bleeding or high risk of bleeding.
• Hemoglobin > 9 mg/dl before the delivery.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Apixaban; Apixaban. 2.5 mg administered orally twice a day	Drug: Apixaban; Apixaban. 2.5 mg administered orally twice a day; Other Names: eliquis
Active Comparator: Enoxaparin; Enoxaparin. 40 mg (or 60 mg for weight > 91 kg) administered subcutaneously once a day	Drug: Enoxaparin; Enoxaparin 40 mg (or 60 mg for weight > 91 kg) administered subcutaneously once a day; Other Names: clexane

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
General Treatment Convenience Assessed by a Study-Specific Patient Satisfaction Questionnaire	Patient-reported treatment convenience assessed using a study-specific questionnaire. The primary measurement is an 11-point general convenience Visual Analog Scale (VAS) where patients rate the overall convenience of their assigned post-partum anticoagulant treatment (oral vs. subcutaneous) from 0 ("Not convenient at all") to 10 ("Very convenient"). Higher scores indicate a higher level of treatment convenience. The outcome also incorporates a categorical question evaluating whether the treatment was easy to take/receive (categorized as: Agree, Neutral, Disagree).	up to 6 weeks postpartum
Medication Adherence Rate Assessed by Patient Self-Report	Adherence to the prescribed thromboprophylaxis regimen, assessed via patient self-report within the study questionnaire. Adherence is evaluated through targeted categorical questions regarding compliance: (1) whether the patient faced difficulties remembering to take the medication, and (2) whether any dose was missed during the hospitalization period. Responses are categorized as "Agree," "Neutral," or "Disagree." The outcome will be reported as the percentage of patients who demonstrated adherence (i.e., no missed doses and no memory difficulties) versus non-adherent patients	Up to 6 weeks postpartum
Treatment-Related Pain Intensity Assessed by a Visual Analog Scale (VAS)	Intensity of pain specifically associated with the administration of the assigned anticoagulant therapy. This is evaluated using an 11-point Visual Analog Scale (VAS) embedded in the questionnaire. Patients who report experiencing treatment-related pain rate its intensity on a scale ranging from 0 ("No pain at all") to 10 ("Unbearable pain"). Lower scores indicate lower pain levels and better treatment tolerance.	Up to 6 weeks postpartum
Patient Treatment Preference and Recommendation Assessed by Self-Report	Patient preference for future short-term preventative treatment options based on their experience during the clinical trial. Patients select their preferred route of administration from three options: Oral tablets, Subcutaneous injections, or No preference. Additionally, the assessment includes a categorical question on whether the patient would recommend their assigned treatment to another person (Categorized as: Agree, Disagree, Do not know). Results will be presented as the proportion (%) of patients in each preference and recommendation category.	Up to 6 weeks postpartum

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Venous Thromboembolism (VTE)	Occurrence of VTE event	up to 6 weeks postpartum
Incidence of major bleeding and bleeding events	Major bleeding and bleeding events defined according to the International Society on Thrombosis and Hemostasis (ISTH) criteria.	up to 6 weeks postpartum
Decrease in hemoglobin values	Comparison of the decrease in hemoglobin levels between the apixaban and enoxaparin study groups. The baseline value is defined as the hemoglobin level measured via complete blood count (CBC) upon the patient's admission to the labor and delivery unit. The final value is the hemoglobin level measured on the day of her clinical discharge from the postpartum ward. The decrease will be calculated for each participant by subtracting the discharge value from the baseline value.	From baseline (admission to labor and delivery unit) up to the day of postpartum discharge (typically 2 to 5 days)
Incidence of adverse events	Patient-reported side effects assessed via a participant questionnaire.	up to 6 weeks postpartum
ACTS Burden Score	Treatment burden associated with assigned anticoagulant therapy, assessed using the ACTS Burden subscale. The subscale contains 5 items with a total score ranging from 5 to 25. Lower scores indicate lower perceived treatment burden and greater treatment satisfaction.	Up to 6 weeks postpartum
ACTS Benefit Score	Perceived benefit of assigned anticoagulant therapy, assessed using the Anti-Clot Treatment Scale (ACTS) Benefit subscale. The ACTS Benefit subscale consists of 3 items evaluating patient perception of treatment effectiveness and reassurance. Total scores range from 3 to 15. Higher scores indicate greater perceived treatment benefit.	Up to 6 weeks postpartum
Treatment Convenience Score	Participant-reported convenience of assigned anticoagulant therapy, assessed using a Visual Analog Scale (VAS). Scores range from 0 to 10, where 0 represents "not convenient at all" and 10 represents "extremely convenient." Higher scores indicate greater treatment convenience.	Up to 6 weeks postpartum

Collaborators and Investigators

• Sponsor: Ron Beloosesky MD

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: March 22, 2026
• First Submitted That Met QC Criteria: July 20, 2026
• First Posted (Actual): July 21, 2026

Study Record Updates

• Last Update Posted (Actual): July 21, 2026
• Last Update Submitted That Met QC Criteria: July 20, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: postpartum; enoxaparin; apixaban; vte prophylaxis
• Additional Relevant MeSH Terms: Carbohydrates; Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Enoxaparin; apixaban
• Other Study ID Numbers: 0495-24RMB

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No