Status:
NOT_YET_RECRUITING
The PARTUM Trial: Postpartum Aspirin to Reduce Thromboembolism Undue Morbidity
Lead Sponsor:
University of Calgary
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Conditions:
Venous Thromboembolism
Postpartum Period
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief 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 veno...
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 cr...
Eligibility Criteria
Inclusion
- ONE (or more) First Order Criterion:
- Known inherited thrombophilia diagnosed prior to enrolment, regardless of family history of VTE:
- i. Heterozygous factor V Leiden, or ii. Heterozygous prothrombin gene variant, or iii. Protein C deficiency, or iv. Protein S deficiency, and/or
- 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
- TWO (or more) Second Order Criteria:
- 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)
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2030
Estimated Enrollment :
8805 Patients enrolled
Trial Details
Trial ID
NCT06494878
Start Date
April 1 2025
End Date
December 1 2030
Last Update
March 3 2025
Active Locations (3)
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1
Foothills Medical Centre
Calgary, Alberta, Canada, T2N 2T9
2
The Ottawa Hospital - General Campus
Ottawa, Ontario, Canada, K1H 8L6
3
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 1Z5