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Apixaban Versus Enoxaparin for Postpartum Venous Thromboembolism Prophylaxis

20 juli 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

150

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Apixaban
Apixaban. 2.5 mg administered orally twice a day
Geneesmiddel: Apixaban
Apixaban. 2.5 mg administered orally twice a day
Andere namen:
  • eliquis
Actieve vergelijker: Enoxaparin
Enoxaparin. 40 mg (or 60 mg for weight > 91 kg) administered subcutaneously once a day
Geneesmiddel: Enoxaparin
Enoxaparin 40 mg (or 60 mg for weight > 91 kg) administered subcutaneously once a day
Andere namen:
  • clexaan

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
General Treatment Convenience Assessed by a Study-Specific Patient Satisfaction Questionnaire
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Incidence of Venous Thromboembolism (VTE)
Tijdsspanne: up to 6 weeks postpartum
Occurrence of VTE event
up to 6 weeks postpartum
Incidence of major bleeding and bleeding events
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: up to 6 weeks postpartum
Patient-reported side effects assessed via a participant questionnaire.
up to 6 weeks postpartum
ACTS Burden Score
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Ron Beloosesky MD

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 juli 2026

Primaire voltooiing (Geschat)

1 april 2027

Studie voltooiing (Geschat)

1 april 2027

Studieregistratiedata

Eerst ingediend

22 maart 2026

Eerst ingediend dat voldeed aan de QC-criteria

20 juli 2026

Eerst geplaatst (Werkelijk)

21 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

21 juli 2026

Laatste update ingediend die voldeed aan QC-criteria

20 juli 2026

Laatst geverifieerd

1 juli 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 0495-24RMB

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

product vervaardigd in en geëxporteerd uit de V.S.

Nee

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