Apixaban Versus Enoxaparin for Postpartum Venous Thromboembolism Prophylaxis

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).

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

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 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.

Occurrence of VTE event

Major bleeding and bleeding events defined according to the International Society on Thrombosis and Hemostasis (ISTH) criteria.

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.

Patient-reported side effects assessed via a participant questionnaire.

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.

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.

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.