Postpartum venous thromboembolism (VTE: deep vein thrombosis [DVT] or PE) carries significant morbidity, and PE is a leading cause of maternal mortality. Conversely, bleeding is a major cause of severe maternal morbidity. Postpartum VTE prevention strategies frequently include low-molecular-weight heparin (LMWH) injections despite little evidence. LMWH prophylaxis is overused in many countries and imposes cost, pain, and bleeding risk. There remains a critical and well-defined knowledge gap regarding the optimal prophylaxis strategy
to prevent postpartum VTE.
The PARTUM trial will close this gap and is a non-inferiority randomized trial of 8,805 participants in 10 countries to assess if 6 weeks (wks) of low-dose aspirin (ASA) is non-inferior to usual care LMWH regimens to prevent VTE in postpartum patients at risk of VTE. We request funds to recruit 1,850 patients in 3 European countries. The primary outcome is symptomatic VTE up to 6 wks postpartum. Secondary outcomes include late VTE up to 90 days, superficial vein thrombosis, major bleeding, clinically relevant non-major bleeding, wound hematoma, heparin-induced thrombocytopenia, arterial thromboembolism, preeclampsia, and mortality. Eligible patients will be allocated via web randomization to ASA 75-100 mg daily for 6 wks or a site-specific usual care LMWH regimen. Inclusion criteria: 1 inherited thrombophilia or antepartum immobilization and/or combination of 2 or more moderate VTE risk factors. Followup is by electronic questionnaire at 6 weeks and 90 days (phone call if concerns), and medical record review. The symptomatic VTE rate at 6 wks and secondary outcome analyses will be compared between trial arms using a Fisher’s test of proportions, with 95% confidence intervals. If ASA is non-inferior to LMWH in preventing VTE and has a better safety profile, this well accepted, simple, inexpensive intervention could be used in routine practice to improve outcomes and reduce health inequity globally.
