DVT Prophylaxis, Postpartum
Conditions
Keywords
apixaban, enoxaparin, vte prophylaxis, postpartum
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.
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.
Interventions
DRUGApixaban
Apixaban. 2.5 mg administered orally twice a day
DRUGEnoxaparin
Enoxaparin 40 mg (or 60 mg for weight \> 91 kg) administered subcutaneously once a day
Sponsors
Ron Beloosesky MD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| General Treatment Convenience Assessed by a Study-Specific Patient Satisfaction Questionnaire | up to 6 weeks postpartum | 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 | Up to 6 weeks postpartum | 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) | Up to 6 weeks postpartum | 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 | Up to 6 weeks postpartum | 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
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Venous Thromboembolism (VTE) | up to 6 weeks postpartum | Occurrence of VTE event |
| Incidence of major bleeding and bleeding events | up to 6 weeks postpartum | Major bleeding and bleeding events defined according to the International Society on Thrombosis and Hemostasis (ISTH) criteria. |
| Decrease in hemoglobin values | From baseline (admission to labor and delivery unit) up to the day of postpartum discharge (typically 2 to 5 days) | 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 | up to 6 weeks postpartum | Patient-reported side effects assessed via a participant questionnaire. |
| ACTS Burden Score | Up to 6 weeks postpartum | 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. |
| ACTS Benefit Score | Up to 6 weeks postpartum | 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. |
| Treatment Convenience Score | Up to 6 weeks postpartum | 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. |
Contacts
CONTACTNira Gridish
Outcome results
None listed