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Recruiting
NCT06494878
The PARTUM Trial: Postpartum Aspirin to Reduce Thromboembolism Undue Morbidity
Conditions: Venous Thromboembolism, Postpartum Period, Aspirin, Low Molecular Weight Heparin
Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 8805
Sponsor: University of Calgary
Location: Association Hospitalière De Bruxelles Et De Schaerbeek - Centre Hospitalier Universitaire Brugmann Brussels
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 Criteria
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 (\
Source: ClinicalTrials.gov (NCT06494878). StuddyBuddy aggregates publicly available trial information.