drugset / Trial / NCT04153760
Pilot PARTUM Trial: Postpartum Aspirin to Reduce Thromboembolism Undue Morbidity
Phase 0
Completed
257 enrolled
University of Calgary
Canadian Institutes of Health Research (CIHR) · collabCanadian Venous Thromboembolism Clinical Trials and Outcomes Research (CanVECTOR) Network · collab
RandomizedParallel-groupQuadruple-blindPrevention
Summary
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.
Timeline
- Start
- 2020-10-07
- Primary completion
- 2023-09-05
- Completion
- 2023-09-05
Publications
- 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.
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Aspirin | Small molecule | 81 mg | Oral |