About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Breast feeding.
Predispose to hypercoagulability
Familial history of VTE.
Antiphospholipid syndrome (APS).
Trial design
Parallel
Treatments tested in this trial
Apixaban
DrugApixaban. 2.5 mg administered orally twice a day
Enoxaparin
DrugEnoxaparin 40 mg (or 60 mg for weight \> 91 kg) administered subcutaneously once a day
Treatment groups
Trial outcomes
Primary outcomes
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).
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
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.
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.
Secondary outcomes
Incidence of Venous Thromboembolism (VTE)
Occurrence of VTE event
Incidence of major bleeding and bleeding events
Major bleeding and bleeding events defined according to the International Society on Thrombosis and Hemostasis (ISTH) criteria.
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.
Incidence of adverse events
Patient-reported side effects assessed via a participant questionnaire.
Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Ron Beloosesky MD
Lead sponsor
Rambam Health Care Campus
Sponsor institution
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