The PARTUM Trial: Postpartum Aspirin to Reduce Thromboembolism Undue Morbidity

What this study is about

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 join (things the study team will check)

✅ You may be able to join if…

• ONE (or more) First Order Criterion: i. Heterozygous factor V Leiden, or ii. Heterozygous prothrombin gene variant, or iii. Protein C deficiency, or iv. Protein S deficiency, and/or TWO (or more) Second Order 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)
• Small-for-gestational-age infant at time of delivery (<3rd percentile adjusted for gestational age and sex)
• Peripartum or postpartum infection (symptoms/signs of infection and documented fever and laboratory evidence of infection with positive blood cultures or an elevated white blood cell count based on local laboratory cutoffs)
• Postpartum hemorrhage (≥1000 mL of blood loss, regardless of delivery mode)

🚫 You may not be able to join if…

• 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
  • Mechanical heart valve(s)
  • Known antiphospholipid syndrome (APS)
  • 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:
  • Documented history of myocardial infarction
  • Documented history of ischemic stroke or transient ischemic attack (TIA)
• Active bleeding, excluding normal vaginal bleeding, at the time of randomization
• Known medical condition as judged by their physician and/or local investigator to be a contraindication to ASA or LMWH including known ASA or LMWH allergy
• <18 years of age
• Unable or declined consent

Where this trial is running

• Foothills Medical Centre, Calgary, Alberta, Canada
• The Ottawa Hospital - General Campus, Ottawa, Ontario, Canada
• Mount Sinai Hospital, Toronto, Ontario, Canada

Who to contact

Leslie Skeith, MD · 403-944-5246 · laskeith@ucalgary.ca

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT06494878.