NCT06494878

The PARTUM Trial: Postpartum Aspirin to Reduce Thromboembolism Undue Morbidity

The PARTUM (Postpartum Aspirin to Reduce Thromboembolism Undue Morbidity) Trial

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 8,805 (estimated)
• Sponsor: University of Calgary · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

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

Interventions

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

Timeline

• Start date: 2025-04-01
• Primary completion: 2030-08-01
• Completion: 2030-12-01
• First posted: 2024-07-10
• Last updated: 2025-03-03

Locations

3 sites across 1 country: Canada