The PARTUM Trial: Postpartum Aspirin to Reduce Thromboembolism Undue Morbidity

Recruiting now · Phase 3

Conditions studied: Venous Thromboembolism, Postpartum Period, Aspirin, Low Molecular Weight Heparin

In brief

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.

Key facts

Study ID

NCT06494878

Run by

University of Calgary

People needed

8805

Starts

2026-06-04

Expected to finish

2030-12-01

Last updated by the study team

2026-07-27

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify 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 it is running

• Foothills Medical Centre — Calgary, Alberta, Canada (enrolling)
• The Ottawa Hospital - General Campus — Ottawa, Ontario, Canada
• Hvidovre Hospital — Hvidovre, Capital Region, Denmark
• CHU de Nancy — Nancy, France
• APHP - Hôpital Port Royal — Paris, France
• CHU de Saint-Etienne — Saint-Etienne, France
• CHU de Toulouse — Toulouse, France
• Rotunda Hospital, RCSI Department of Obstetrics and Gynaecology — Dublin, Ireland
• UCD Centre for Human Reproduction, The Coombe Hospital — Dublin, Ireland
• Amsterdam UMC — Amsterdam, Netherlands
• Association Hospitalière De Bruxelles Et De Schaerbeek - Centre Hospitalier Universitaire Brugmann — Brussels, Belgium
• Medical University of Warsaw — Warsaw, Poland

Full record on ClinicalTrials.gov

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