Prevention of Postpartum Venous Thromboembolism in Women at Intermediate Risk

Venous thromboembolism (VTE) is currently the second cause of death in women of reproductive age worldwide. The incidence of VTE during pregnancy is 1.2 to 1.4/1000 women, half of VTE occurring during postpartum and as PE in majority of cases, accounting for 8.8% of maternal deaths. Majority of postpartum VTE occurs in women with one or more moderate risk factors (obesity, caesarean section, postpartum hemorrhage). For these women at intermediate risk, the efficacy and safety of thromboprophylaxis have not been assessed yet during postpartum and international guidelines for pharmacological thromboprophylaxis, based on data extrapolated from other populations, observational studies and small clinical trials are inconsistent across countries. We designed an open-label, randomized, controlled trial, aiming to demonstrate the superiority of a pharmacological thromboprophylaxis strategy with LMWH (LMWH type chosen according to physician / patient's preference) during 6 weeks after delivery (the 6-weeks follow-up visit being matched with usual care) in women at intermediate risk, over no pharmacological thromboprophylaxis.

NCT Number	NCT06845423
Lead Sponsor	University Hospital, Brest
Conditions	Venous Thromboembolism (VTE), Post Partum Women
Enrollment	2,400 participants
Start Date	2025-05-16
Primary Completion	2028-05-16 (estimated)
Study Completion	2028-08-16 (estimated)
Updated on ClinicalTrials.gov	2026-06-10