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.
The PARTUM trial design is a Prospective Randomized Open Blinded End-point (PROBE) non-inferiority trial. Participants with risk factors for venous thromboembolism (VTE) as defined by the inclusion criteria will be identified during pregnancy, labor and delivery, and up to 48 hours after delivery. Eligible and consenting participants will be randomly assigned to one of two study arms: Low-dose aspirin (75-100mg according to country availability) daily for 42 days post-randomization, or a usual care site-specific low-molecular-weight-heparin (LMWH) regimen with the dose and duration of LMWH determined by the participant's healthcare provider. Follow-up will occur at 6 weeks and 90 days post-randomization.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
8,805
75-100 mg taken once daily by mouth.
Low-molecular-weight heparin injections daily as prescribed by the treating physician.
Foothills Medical Centre
Calgary, Alberta, Canada
The Ottawa Hospital - General Campus
Ottawa, Ontario, Canada
Mount Sinai Hospital
Toronto, Ontario, Canada
Symptomatic VTE
Proximal lower or upper extremity DVT, PE involving segmental or higher arteries or multiple subsegmental arteries, and unusual site \[non-limb\] venous thromboembolism
Time frame: 6 weeks
Late symptomatic VTE
Proximal lower or upper extremity DVT, PE involving segmental or higher arteries or multiple subsegmental arteries, and unusual site \[non-limb\] venous thromboembolism
Time frame: 90 days
Superficial vein thrombosis
A non-compressible vein segment on ultrasound that involves the superficial veins in the lower or upper extremity
Time frame: At 6 weeks and at 90 days
Distal deep vein thrombosis
A non-compressible vein segment on ultrasound involving the deep veins that is distal to the popliteal vein in the lower extremity, or distal to the axillary vein in the upper extremity
Time frame: At 6 weeks and at 90 days
Single subsegmental pulmonary embolism (SSPE)
Intraluminal filling defect that involves one subsegmental artery only
Time frame: At 6 weeks and at 90 days
Major bleeding
Based on the ISTH definition
Time frame: At 6 weeks and at 90 days
Clinically relevant non-major bleeding
Based on the ISTH definition
Time frame: At 6 weeks and at 90 days
Wound hematoma requiring intervention
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Requiring intervention such as hematoma evacuation or wound packing
Time frame: At 6 weeks and at 90 days
Symptomatic arterial thromboembolism
Ischemic stroke/transient ischemic attack, myocardial infarction, or peripheral arterial embolism
Time frame: At 6 weeks and at 90 days
Postpartum preeclampsia
New preeclampsia presenting in the postpartum period
Time frame: At 6 weeks and at 90 days
Heparin-induced thrombocytopenia
According to a priori categories of definite or possible HIT.
Time frame: At 6 weeks and at 90 days
All-cause mortality
Time frame: At 6 weeks and at 90 days