The PARTUM Trial: Postpartum Aspirin to Reduce Thromboembolism Undue Morbidity (NCT06494878) | Clinical Trial Compass
Not Yet RecruitingPhase 3
The PARTUM Trial: Postpartum Aspirin to Reduce Thromboembolism Undue Morbidity
Canada8,805 participantsStarted 2025-04
Plain-language summary
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.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion criteria
✓. Known inherited thrombophilia diagnosed prior to enrolment, regardless of family history of VTE:
✓. Antepartum immobilization for ≥7 days. Immobilization is defined as bed rest with 90% of waking hours spent in bed at any time during the antepartum period AND/OR
✓. Pre-pregnancy BMI ≥30 kg/m²
✓. Smoking in the current pregnancy or within 3 months prior to pregnancy
✓. Previous clinical history of superficial vein thrombosis
✓. Preeclampsia
✓. Current pregnancy ending in stillbirth (pregnancy loss \>20 weeks gestation)
✓. Unplanned cesarean delivery (unplanned = not a scheduled cesarean delivery)
Exclusion criteria
✕. More than 48 hours since delivery at the time of randomization
✕. Received more than 1 dose of LMWH since delivery
✕. Need for postpartum LMWH prophylaxis or systemic anticoagulation as judged by their physician and/or local investigator. May include but is not limited to:
✕. Documented history of provoked or unprovoked VTE
✕. Known high-risk inherited thrombophilia i) Antithrombin deficiency, or ii) Homozygous factor V Leiden, or iii) Homozygous prothrombin gene mutation, or iv) More than 1 thrombophilia: any combination of 2 or more: factor V Leiden, prothrombin gene mutation, protein C deficiency, protein S deficiency
✕. Need for postpartum ASA as judged by their physician and/or local investigator. May include but is not limited to: