Recruiting
Phase 3
The PARTUM Trial: Postpartum Aspirin to Reduce Thromboembolism Undue Morbidity
Condition(s) studied
Venous ThromboembolismPostpartum PeriodAspirinLow Molecular Weight Heparin
Investigational drug(s) / intervention(s)
Aspirin: 75-100 mg taken once daily by mouth.
Low-molecular-weight heparin: Low-molecular-weight heparin injections daily as prescribed by the treating physician.
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.
Eligibility
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 BMI ≥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:
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 transient ischemic attack (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 contraindication to ASA or LMWH including known ASA or LMWH allergy
7. \<18 years of age
8. Unable or declined consent
Primary outcome measure(s)
- Symptomatic VTE — 6 weeks
Proximal lower or upper extremity DVT, PE involving segmental or higher arteries or multiple subsegmental arteries, and unusual site \[non-limb\] venous thromboembolism
Trial sites (12)
| Facility | City | Region | Status |
| Association Hospitalière De Bruxelles Et De Schaerbeek - Centre Hospitalier Universitaire Brugmann |
Brussels |
Belgium |
Not Yet Recruiting |
| Foothills Medical Centre |
Calgary |
Alberta |
Recruiting |
| The Ottawa Hospital - General Campus |
Ottawa |
Ontario |
Not Yet Recruiting |
| Hvidovre Hospital |
Hvidovre |
Capital Region |
Not Yet Recruiting |
| CHU de Nancy |
Nancy |
France |
Not Yet Recruiting |
| APHP - Hôpital Port Royal |
Paris |
France |
Not Yet Recruiting |
| CHU de Saint-Etienne |
Saint-Etienne |
France |
Not Yet Recruiting |
| CHU de Toulouse |
Toulouse |
France |
Not Yet Recruiting |
| Rotunda Hospital, RCSI Department of Obstetrics and Gynaecology |
Dublin |
Ireland |
Not Yet Recruiting |
| UCD Centre for Human Reproduction, The Coombe Hospital |
Dublin |
Ireland |
Not Yet Recruiting |
| Amsterdam UMC |
Amsterdam |
Netherlands |
Not Yet Recruiting |
| Medical University of Warsaw |
Warsaw |
Poland |
Not Yet Recruiting |
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