Apixaban Versus Enoxaparin for Postpartum Venous Thromboembolism Prophylaxis

NCT07716332 | Not Yet Recruiting

• 1 other identifier: 0495-24RMB
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Postpartum; DVT Prophylaxis

Keywords

apixaban; enoxaparin; vte prophylaxis; postpartum

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (7)

• Incidence of Venous Thromboembolism (VTE)

  up to 6 weeks postpartum

• Incidence of major bleeding and bleeding events

  up to 6 weeks postpartum

• Decrease in hemoglobin values

  From baseline (admission to labor and delivery unit) up to the day of postpartum discharge (typically 2 to 5 days)

• Incidence of adverse events

  up to 6 weeks postpartum

• ACTS Burden Score

  Up to 6 weeks postpartum

Study Arms (2)

Apixaban

EXPERIMENTAL

Apixaban. 2.5 mg administered orally twice a day

Drug: Apixaban

Enoxaparin

ACTIVE COMPARATOR

Enoxaparin. 40 mg (or 60 mg for weight \> 91 kg) administered subcutaneously once a day

Drug: Enoxaparin

Interventions

Apixaban DRUG

Apixaban. 2.5 mg administered orally twice a day

Also known as: eliquis

Apixaban

Enoxaparin DRUG

Enoxaparin 40 mg (or 60 mg for weight \> 91 kg) administered subcutaneously once a day

Also known as: clexane

Enoxaparin

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ron Beloosesky MD: lead

MeSH Terms

Interventions

apixaban; Enoxaparin

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Central Study Contacts

Nira Gridish

CONTACT

+972503027855; n_gridish@rambam.health.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of the Gynecology and Obstetric Ultrasonography Unit.

Study Record Dates

• First Submitted: March 22, 2026
• First Posted: July 21, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: July 21, 2026

Record last verified: 2026-07