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Not Yet Recruiting NCT07716332

Apixaban Versus Enoxaparin for Postpartum Venous Thromboembolism Prophylaxis

Conditions: Postpartum, DVT Prophylaxis

Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 150
Sponsor: Ron Beloosesky MD

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.

Eligibility Criteria

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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07716332). StuddyBuddy aggregates publicly available trial information.