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Not yet recruiting NCT07716332

Apixaban Versus Enoxaparin for Postpartum Venous Thromboembolism Prophylaxis

No phase Interventional Postpartum DVT Prophylaxis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Apixaban, Enoxaparin.
Who it may be relevant to
Registry conditions: Postpartum, DVT Prophylaxis. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Apixaban Versus Enoxaparin for Thromboprophylaxis After Delivery

Overview

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

  • Drug Apixaban
    Apixaban. 2.5 mg administered orally twice a day
  • Drug Enoxaparin
    Enoxaparin 40 mg (or 60 mg for weight \> 91 kg) administered subcutaneously once a day

Primary outcome measures

  • General Treatment Convenience Assessed by a Study-Specific Patient Satisfaction Questionnaire [Time frame: up to 6 weeks postpartum]
  • Medication Adherence Rate Assessed by Patient Self-Report [Time frame: Up to 6 weeks postpartum]
  • Treatment-Related Pain Intensity Assessed by a Visual Analog Scale (VAS) [Time frame: Up to 6 weeks postpartum]
  • Patient Treatment Preference and Recommendation Assessed by Self-Report [Time frame: Up to 6 weeks postpartum]
Secondary outcome measures (7)
  • Incidence of Venous Thromboembolism (VTE) [Time frame: up to 6 weeks postpartum]
  • Incidence of major bleeding and bleeding events [Time frame: up to 6 weeks postpartum]
  • Decrease in hemoglobin values [Time frame: From baseline (admission to labor and delivery unit) up to the day of postpartum discharge (typically 2 to 5 days)]
  • Incidence of adverse events [Time frame: up to 6 weeks postpartum]
  • ACTS Burden Score [Time frame: Up to 6 weeks postpartum]
  • ACTS Benefit Score [Time frame: Up to 6 weeks postpartum]
  • Treatment Convenience Score [Time frame: Up to 6 weeks postpartum]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07716332 · 0495-24RMB

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗