ClinicalTrials.gg
RecruitingNCT06494878Updated Jul 27, 2026

The PARTUM Trial: Postpartum Aspirin to Reduce Thromboembolism Undue Morbidity

A Phase 3 interventional study of Aspirin and Low-molecular-weight heparin in Venous Thromboembolism, Postpartum Period and Aspirin, sponsored by University of Calgary. Recruiting at 12 sites in 7 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-27.

Sponsored by University of Calgary · Phase 3, Interventional, and Prevention

From the registry’s dates

  • Started Jun 2026; still recruiting 5 months later.
Phase
Phase 3
Study type
Interventional
Enrollment
8,805
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

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

Keywords

  • deep vein thrombosis
  • pulmonary embolism
  • postpartum
  • pregnancy
  • thrombophilia
  • cesarean delivery
  • preeclampsia
  • small-for-gestational age infant
  • postpartum hemorrhage
  • postpartum infection
03

In context

Venous Thromboembolism

712 studies on the registry are indexed under Venous Thromboembolism; 146 are open to participants now.

This study's planned enrollment of 8,805 is above the median of 240 across 401 interventional studies indexed under Venous Thromboembolism.

Browse Venous Thromboembolism studies →

Lead sponsor

University of Calgary is the lead sponsor of 703 studies on the registry; 196 are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 2 (20%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • ONE (or more) First Order Criterion:

    1. 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

    2. 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:

  1. Pre-pregnancy ≥30 kg/m²
  2. Smoking in the current pregnancy or within 3 months prior to pregnancy
  3. Previous clinical history of superficial vein thrombosis
  4. Preeclampsia
  5. Current pregnancy ending in stillbirth (pregnancy loss >20 weeks gestation)
  6. Unplanned cesarean delivery (unplanned = not a scheduled cesarean delivery)
  7. Small-for-gestational-age infant at time of delivery (\<3rd percentile adjusted for gestational age and sex)
  8. 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)
  9. Postpartum hemorrhage (≥1000 mL of blood loss, regardless of delivery mode)

Exclusion criteria

Exclusion Criteria:

  1. More than 48 hours since delivery at the time of randomization
  2. Received more than 1 dose of LMWH since delivery
  3. Need for postpartum LMWH prophylaxis or systemic anticoagulation as judged by their physician and/or local investigator. May include but is not limited to:

    1. Documented history of provoked or unprovoked VTE
    2. Mechanical heart valve(s)
    3. Known antiphospholipid syndrome (APS)
    4. 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
  4. Need for postpartum ASA as judged by their physician and/or local investigator. May include but is not limited to:

    1. Documented history of myocardial infarction
    2. Documented history of ischemic stroke or (TIA)
  5. Active bleeding, excluding normal vaginal bleeding, at the time of randomization
  6. Known medical condition as judged by their physician and/or local investigator to be a to ASA or LMWH including known ASA or LMWH allergy
  7. \<18 years of age
  8. Unable or declined consent
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
8,805 participants (estimated)

Study arms

  • Experimental
    Aspirin

    Low-dose aspirin (75-100 mg) once daily for 6 weeks.

    Drug: Aspirin

  • Active comparator
    Low-molecular-weight heparin

    Site-specific low-molecular-weight heparin regimen as prescribed by the treating physician.

    Drug: Low-molecular-weight heparin

Interventions

  • 75-100 mg taken once daily by mouth.

  • Low-molecular-weight heparin injections daily as prescribed by the treating physician.

    Also known as: Dalteparin, Enoxaparin, Nadroparin, Tinzaparin

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. Single subsegmental pulmonary embolism (SSPE)

    Intraluminal filling defect that involves one subsegmental artery only

    Time frame: At 6 weeks and at 90 days

  5. Major bleeding

    Based on the ISTH definition

    Time frame: At 6 weeks and at 90 days

  6. Clinically relevant non-major bleeding

    Based on the ISTH definition

    Time frame: At 6 weeks and at 90 days

  7. Wound hematoma requiring intervention

    Requiring intervention such as hematoma evacuation or wound packing

    Time frame: At 6 weeks and at 90 days

  8. Symptomatic arterial thromboembolism

    Ischemic stroke/transient ischemic attack, myocardial infarction, or peripheral arterial embolism

    Time frame: At 6 weeks and at 90 days

  9. Postpartum preeclampsia

    New preeclampsia presenting in the postpartum period

    Time frame: At 6 weeks and at 90 days

  10. Heparin-induced thrombocytopenia

    According to a priori categories of definite or possible HIT.

    Time frame: At 6 weeks and at 90 days

  11. All-cause mortality

    Time frame: At 6 weeks and at 90 days

07

Study locations

1 of 12 sites recruiting
08

References and documents

Individual participant data

Plan to share: Yes — Data will be shared upon request.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2026 (actual). Primary completion is estimated for Sep 2030, 51 months after the start.

Of 47 phase 3 interventional studies under Venous Thromboembolism, half reached primary completion within 41 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 60. This study's planned 51 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 12, 2024
First posted
Jul 10, 2024
StartActual
Jun 4, 2026
Primary completionEst.
Sep 2030
CompletionEst.
Dec 2030
Last update
Jul 27, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06494878
Collaborators
Canadian Institutes of Health Research (CIHR), European Clinical Research Infrastructure Network
Responsible party
Sponsor
First posted
Jul 10, 2024
Start date
Jun 4, 2026
Primary completion
Sep 2030 (estimated)
Completion
Dec 2030 (estimated)
Last update
Jul 27, 2026

Study contacts

Leslie Skeith, MD
Contact
laskeith@ucalgary.ca
403-944-5246
Jill Baxter, BSc
Contact
jbaxter@ucalgary.ca
403-220-7103
Leslie Skeith, MD
principal investigator · University of Calgary
Marc Rodger, MD
principal investigator · McGill University Health Centre/Research Institute of the McGill University Health Centre

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Aspirin

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