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New treatment option for Venous Thromboembolism
Official title The PARTUM Trial: Postpartum Aspirin to Reduce Thromboembolism Undue Morbidity
ClinicalTrials.gov ID: NCT06494878
What this study is testing
What is Aspirin?
Aspirin is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for venous thromboembolism.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join 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...
- 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...
- Pre-pregnancy BMI ≥30 kg/m²
- Smoking in the current pregnancy or within 3 months prior to pregnancy
You likely can't join 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...
- Documented history of provoked or unprovoked VTE
- Mechanical heart valve(s)
- Known antiphospholipid syndrome (APS)
See the full eligibility criteria
- 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...
- 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...
- Postpartum hemorrhage (≥1000 mL of blood loss, regardless of delivery mode)
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Brussels, Belgium
- Calgary, Alberta, Canada
- Ottawa, Ontario, Canada
- Hvidovre, Capital Region, Denmark
- Nancy, France
- Paris, France
- Saint-Etienne, France
- Toulouse, France
- Dublin, Ireland
- Amsterdam, Netherlands
- Warsaw, Poland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Brussels, Belgium; Calgary, Alberta, Canada; Ottawa, Ontario, Canada; Hvidovre, Capital Region, Denmark; Nancy, France; Paris, France and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.