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Apixaban Versus Enoxaparin for Postpartum Venous Thromboembolism Prophylaxis

20 juillet 2026 mis à jour par: Ron Beloosesky MD

Apixaban Versus Enoxaparin for Thromboprophylaxis After Delivery

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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

150

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: La prévention
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Apixaban
Apixaban. 2.5 mg administered orally twice a day
Médicament: Apixaban
Apixaban. 2.5 mg administered orally twice a day
Autres noms:
  • éliquis
Comparateur actif: Enoxaparin
Enoxaparin. 40 mg (or 60 mg for weight > 91 kg) administered subcutaneously once a day
Médicament: Enoxaparin
Enoxaparin 40 mg (or 60 mg for weight > 91 kg) administered subcutaneously once a day
Autres noms:
  • clexane

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
General Treatment Convenience Assessed by a Study-Specific Patient Satisfaction Questionnaire
Délai: 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).
up to 6 weeks postpartum
Medication Adherence Rate Assessed by Patient Self-Report
Délai: 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
Up to 6 weeks postpartum
Treatment-Related Pain Intensity Assessed by a Visual Analog Scale (VAS)
Délai: 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.
Up to 6 weeks postpartum
Patient Treatment Preference and Recommendation Assessed by Self-Report
Délai: 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.
Up to 6 weeks postpartum

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Incidence of Venous Thromboembolism (VTE)
Délai: up to 6 weeks postpartum
Occurrence of VTE event
up to 6 weeks postpartum
Incidence of major bleeding and bleeding events
Délai: up to 6 weeks postpartum
Major bleeding and bleeding events defined according to the International Society on Thrombosis and Hemostasis (ISTH) criteria.
up to 6 weeks postpartum
Decrease in hemoglobin values
Délai: 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.
From baseline (admission to labor and delivery unit) up to the day of postpartum discharge (typically 2 to 5 days)
Incidence of adverse events
Délai: up to 6 weeks postpartum
Patient-reported side effects assessed via a participant questionnaire.
up to 6 weeks postpartum
ACTS Burden Score
Délai: 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.
Up to 6 weeks postpartum
ACTS Benefit Score
Délai: 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.
Up to 6 weeks postpartum
Treatment Convenience Score
Délai: 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.
Up to 6 weeks postpartum

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Ron Beloosesky MD

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 juillet 2026

Achèvement primaire (Estimé)

1 avril 2027

Achèvement de l'étude (Estimé)

1 avril 2027

Dates d'inscription aux études

Première soumission

22 mars 2026

Première soumission répondant aux critères de contrôle qualité

20 juillet 2026

Première publication (Réel)

21 juillet 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

21 juillet 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

20 juillet 2026

Dernière vérification

1 juillet 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 0495-24RMB

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

produit fabriqué et exporté des États-Unis.

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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