The PARTUM Trial: Postpartum Aspirin to Reduce Thromboembolism Undue Morbidity

Sponsor
University of Calgary
Study ID
NCT06494878
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Aspirin
  • Low Molecular Weight Heparin
  • Postpartum Period
  • Venous Thromboembolism

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Aspirin — DRUG
    75-100 mg taken once daily by mouth.
  • Low-molecular-weight heparin — DRUG
    Low-molecular-weight heparin injections daily as prescribed by the treating physician.

Study Details

The goal of the PARTUM trial is to determine if taking low-dose aspirin daily for 6 weeks after delivery is similar (non-inferior) to usual care low-molecular-weight heparin injections to prevent venous thromboembolism (VTE: blood clots in the legs or lungs) for postpartum individuals with VTE risk factors.

Key Dates

First listed
Jul 10, 2024
Start date
Apr 30, 2025
Status verified
Feb 2025
Primary completion
Aug 31, 2030
Completion
Dec 31, 2030

Study Design

Enrollment
8,805 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Aspirin
    Low-dose aspirin (75-100 mg) once daily for 6 weeks.
  • Active Comparator: Low-molecular-weight heparin
    Site-specific low-molecular-weight heparin regimen as prescribed by the treating physician.

Primary Outcome Measure

Symptomatic VTE [ Time Frame: 6 weeks ]

Central Contacts

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