Comparing Aspirin with Low-molecular-weight heparin for venous thromboembolism
Official title: The PARTUM Trial: Postpartum Aspirin to Reduce Thromboembolism Undue Morbidity
The PARTUM (Postpartum Aspirin to Reduce Thromboembolism Undue Morbidity) Trial
- Phase 3
- 2 groups
- Sites in Calgary and Ottawa
- Recruiting
Interventions
- Medication
Aspirin
75-100 mg taken once daily by mouth.
- Medication
Low-molecular-weight heparin
Low-molecular-weight heparin injections daily as prescribed by the treating physician.
Canadian Sites (2)
1 of 2 recruiting
- Recruiting
Foothills Medical Centre
Calgary, Alberta
- Not yet recruiting
The Ottawa Hospital - General Campus
Ottawa, Ontario
Eligibility Criteria
See who this study is looking for28 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +ONE (or more) First Order Criterion:
- +Known inherited thrombophilia diagnosed prior to enrolmentEnrolmentThe number of participants a study plans to include, or has included.Read more →, 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:
- +Previous clinical history of superficial vein thrombosis
- +Preeclampsia
- +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)
- +Pre-pregnancy BMI ≥30 kg/m²
- +Current pregnancy ending in stillbirth (pregnancy loss \>20 weeks gestation)
- +Smoking in the current pregnancy or within 3 months prior to pregnancy
Exclusion
- −Known medical condition as judged by their physician and/or local investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → to be a contraindication to ASA or LMWH including known ASA or LMWH allergy
- −More than 48 hours since delivery at the time of randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →
- −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
- −\<18 years of age
- −Unable or declined consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a way to prevent a condition from developing.
Phase 3Phase 3A large study comparing a treatment against the current standard.Read more → — a large study comparing this against the current standard, usually across many hospitals.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A receives Aspirin.
Registry label: A: Aspirin
Group B, the comparison group, receives Low-molecular-weight heparin.
Registry label: B: Low-molecular-weight heparin
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment, so the two can be compared.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study lists female participants only.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 8,805 people.
The study is currently expected to finish around December 2030.
The main measurement is taken over: 6 weeks.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Symptomatic VTE — measured over 6 weeks.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06494878 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About AspirinDrug
75-100 mg taken once daily by mouth.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About Low-molecular-weight heparinDrug
Low-molecular-weight heparin injections daily as prescribed by the treating physician.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It lists female participants only.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: 6 weeks.
The study as a whole is currently expected to finish around 2030-12.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 8,805 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 2 locations, including: Calgary, Alberta, Canada; Ottawa, Ontario, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
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.
Think this trial might be right for you?
Complete a quick intake form and we will match you with this and other relevant trials based on your medical profile.
See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.