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The PARTUM Trial: Postpartum Aspirin to Reduce Thromboembolism Undue Morbidity

ConditionsVenous ThromboembolismPostpartum PeriodAspirinLow Molecular Weight Heparin
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of Calgary

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

More than 48 hours since delivery at the time of randomization

Received more than 1 dose of LMWH since delivery

Documented history of provoked or unprovoked VTE

Mechanical heart valve(s)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Aspirin

    Drug

    75-100 mg taken once daily by mouth.

  • Low-molecular-weight heparin

    Drug

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

Treatment groups

8,805 Participants
are divided into 2 treatment groups
Group A: AspirinExperimental treatment 1 intervention
Group B: Low-molecular-weight heparinActive comparator 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Calgary

Lead sponsor

Canadian Institutes of Health Research (CIHR)

Collaborator

European Clinical Research Infrastructure Network

Collaborator

Source ClinicalTrials.gov
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