Evaluating Short-term Low-dose Low-molecular-weight Heparin to Prevent Blood Clots After Delivery in a Randomized Phase 3 Trial

What this Trial Is About

Researchers are evaluating the use of a short-term, low-dose low-molecular-weight heparin LMWH treatment to prevent venous thromboembolism VTE in women after delivery. This phase 3 randomized trial aims to determine if LMWH given in the postpartum period affects the risk of blood clots within 90 days after delivery, as well as its impact on bleeding and wound complications compared to no treatment. Participants will be randomly assigned to receive either low-dose LMWH for 7 to 10 days after delivery or no treatment. The LMWH options include enoxaparin, nadroparin, dalteparin, or tinzaparin at specified doses taken once daily. The study uses a parallel design with single masking and follows participants for 90 days post-delivery to assess outcomes. During the study, participants will be monitored for venous thrombotic events, bleeding, wound healing issues, infections, and other complications. Assessments include imaging for VTE surveillance, quality of life evaluations at 14 days, and tracking of hospital stay duration and serious adverse events. Follow-up continues for 90 days after randomization to gather comprehensive safety and effectiveness data.

Short-term Low-dose Low-molecular-weight Heparin to Prevent Postpartum Thrombosis