Low Molecular Weight hEparin vs. Aspirin Post-partum

Last updated: February 26, 2025
Sponsor: Mount Sinai Hospital, Canada
Overall Status: Completed

Phase

N/A

Condition

Venous Thrombosis

Thromboembolism

Venous Thromboembolism

Treatment

Low molecular weight heparin and low-dose aspirin

Prophylactic low molecular weight heparin

Clinical Study ID

NCT05058924
20-0275A
  • Ages > 18
  • Female

Study Summary

This is single centre pilot, randomized controlled trial assessing postpartum prophylactic anticoagulation with 3 weeks of LMWH followed by 3 weeks of Aspirin compared to standard of care of prophylactic LMWH for 6 weeks at moderate to high risk of developing VTE.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Personal history of unprovoked VTE prior to pregnancy or hormone associated VTE andnot prescribed therapeutic anticoagulation or

  2. Family history (1st degree relative) of VTE and antithrombin deficiency, protein Cor protein S deficiency or

  3. Combined thrombophilia or homozygous for the factor V Leiden mutation or prothrombingene mutation, and family history of VTE (1st degree relative) and

  4. > 18 years of age.

Exclusion

Exclusion Criteria:

  1. Pre-existing indication for therapeutic LMWH

  2. Contraindication to ASA:

  3. Known ASA allergy

  4. Documented history of gastrointestinal ulcer

  5. Known platelet count < 50x10^9/L at any time during the current pregnancy orpostpartum

  6. Contraindication to LMWH, e.g. known allergy

  7. Active bleeding at any site, excluding physiological vaginal bleeding

  8. Patients with bleeding disorders

  9. Known severe hypertension (SBP >200mm/hg and/or DBP >120mm/hg) during the currentpregnancy or postpartum

Study Design

Total Participants: 30
Treatment Group(s): 2
Primary Treatment: Low molecular weight heparin and low-dose aspirin
Phase:
Study Start date:
August 29, 2021
Estimated Completion Date:
March 01, 2024

Study Description

A single centre pilot, randomized controlled trial assessing postpartum prophylactic anticoagulation with 3 weeks of LMWH followed by 3 weeks of Aspirin compared to standard of care of prophylactic LMWH for 6 weeks for women at moderate to high risk of developing VTE to determine feasibility of conducting a large non inferiority trial using the same regimens.

Connect with a study center

  • Mount Sinai Hospital

    Toronto, Ontario M5G 1Z5
    Canada

    Site Not Available

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