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| Name | Class |
|---|---|
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
| Canadian Venous Thromboembolism Clinical Trials and Outcomes Research (CanVECTOR) Network | NETWORK |
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The pilot PARTUM trial is a randomized, multicenter, placebo-controlled trial. Women who are at modest risk of VTE (as defined by the inclusion criteria) will be identified during pregnancy, labor and delivery and up to 48 hours postpartum. Eligible and consenting participants will be randomly assigned to one of two study arms: aspirin 81 mg daily or placebo daily for 6 weeks.
The purpose of the pilot PARTUM trial is to determine whether it is feasible to conduct a larger randomized controlled trial to determine whether low-dose aspirin is efficacious and safe at preventing postpartum venous thromboembolism (VTE) in women at increased risk of VTE, compared to placebo.
Given the large sample size needed to adequately power a large multicenter trial that assesses the efficacy of aspirin 81 mg versus placebo, the investigators first need to determine if it is possible to recruit enough women. If the pilot trial is successful and there are no major changes to the study design, then the secondary clinical outcomes collected in the pilot trial will be used in the analysis of the full multicenter trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aspirin | Active Comparator | Aspirin 81 mg daily for six weeks post-randomization (postpartum) |
|
| Placebo | Placebo Comparator | Placebo daily for six weeks post-randomization (postpartum) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aspirin 81 mg | Drug | Aspirin 81 mg p.o. daily |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment Rate | Mean recruitment rate per center per month | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Consent Rate | Proportion of eligible subjects who provide consent | 6 months |
| Withdrawals/Loss to Follow-up | Proportion of withdrawals/loss to follow-up among participants |
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Inclusion Criteria: Study inclusion criteria includes one (or more) first order criterion or two (or more) second order criteria. A patient is still eligible if they have multiple criteria met, at the discretion of the local investigator.
ONE (or more) First Order Criteria:
Known inherited thrombophilia diagnosed prior to enrolment:
i) Heterozygous factor V Leiden, OR ii) Heterozygous prothrombin gene variant, OR iii) Protein C deficiency, OR iv) Protein S deficiency
Immobilization (90% of waking hours spent in bed) for ≥7 days anytime during the antepartum period
TWO (or more) Second Order Criteria:
Exclusion Criteria:
More than 48 hours since delivery
Received more than 2 doses of low-molecular-weight heparin (LMWH) since delivery
Need for postpartum LMWH prophylaxis or systemic anticoagulation as judged by the local investigator. May include but is not limited to:
Need for postpartum aspirin as judged by the local investigator. May include but is not limited to:
Contraindication to aspirin including:
<18 years of age
Unable or refused consent
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| Name | Affiliation | Role |
|---|---|---|
| Leslie Skeith, MD | University of Calgary | Principal Investigator |
| Marc Rodger, MD | McGill University Health Centre/Research Institute of the McGill University Health Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Foothills Medical Centre | Calgary | Alberta | T2N 2T9 | Canada | ||
| British Columbia Women's Hospital & Health Centre |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39827892 | Derived | Skeith L, Malinowski AK, El-Chaar D, Chan WS, Donnelly J, Chauleur C, Ganzevoort W, Wood S, Dubois S, McCarthy C, Buchmuller A, Wiegers H, Gibson PS, Ni Ainle F, Middeldorp S, Duffett L, Bates SM, Garven A, Baxter J, Lethebe BC, Rodger MA; Pilot PARTUM Group. Low-dose aspirin versus placebo in postpartum venous thromboembolism: a multi-national, pilot, randomised, placebo-controlled trial. Lancet Haematol. 2025 Feb;12(2):e109-e119. doi: 10.1016/S2352-3026(24)00338-7. Epub 2025 Jan 16. | |
| 39238110 |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Dec 8, 2025 | |
| Reset | Dec 23, 2025 | |
| Release | Feb 18, 2026 | |
| Reset | Mar 10, 2026 | |
| Release | Apr 27, 2026 | |
| Reset | May 19, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 8, 2025 | Dec 23, 2025 | |||
| Feb 18, 2026 |
| ID | Term |
|---|---|
| D054556 | Venous Thromboembolism |
| D020246 | Venous Thrombosis |
| D011655 | Pulmonary Embolism |
| D019851 | Thrombophilia |
| D011225 | Pre-Eclampsia |
| D006473 | Postpartum Hemorrhage |
| ID | Term |
|---|---|
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
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| Placebo | Drug | Placebo p.o. daily |
|
| 9 months |
| Study Drug Compliance | Level of compliance with study drug through participant recall and medication diary | 6 months |
| Time Required to Obtain Site Institutional Approvals | Proportion of sites requiring >18 months to obtain all required approvals/contracts from time of delivery of all study documents. | 24 months |
| VTE Event Rate | A more precise estimate of the VTE event rate | 6 months |
| Bleeding Event Rate | A more precise estimate of the major and clinically relevant non-major bleeding event rate | 6 months |
| Vancouver |
| British Columbia |
| V6H 3N1 |
| Canada |
| The Ottawa Hospital - General Campus | Ottawa | Ontario | K1H 8L6 | Canada |
| Mount Sinai Hospital | Toronto | Ontario | M5G 1Z5 | Canada |
| Centre Hospitalier Universitaire de Saint-Etienne | Saint-Étienne-de-Montluc | Pays de la Loire Region | 42270 | France |
| Rotunda Hospital | Dublin | D01 P5W9 | Ireland |
| The Amsterdam Medical Centre | Amsterdam | North Holland | 1105 | Netherlands |
| Derived |
| Blondon M, Claver M, Celetta E, Righini M, de Tejada BM. Preventing Postpartum Venous Thromboembolism With Low-Molecular-Weight Heparin: The PP-HEP Pilot Randomised Controlled Trial. BJOG. 2025 Jan;132(1):35-43. doi: 10.1111/1471-0528.17943. Epub 2024 Sep 5. |
| 33779986 | Derived | Middleton P, Shepherd E, Gomersall JC. Venous thromboembolism prophylaxis for women at risk during pregnancy and the early postnatal period. Cochrane Database Syst Rev. 2021 Mar 29;3(3):CD001689. doi: 10.1002/14651858.CD001689.pub4. |
| Mar 10, 2026 |
| Apr 27, 2026 | May 19, 2026 |
| D013927 |
| Thrombosis |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004617 | Embolism |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D046110 | Hypertension, Pregnancy-Induced |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007744 | Obstetric Labor Complications |
| D011644 | Puerperal Disorders |
| D014592 | Uterine Hemorrhage |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |