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Recruiting Phase 3 NCT07140211

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

Trial Parameters

Condition Venous Thromboembolism (VTE)
Sponsor Marc Blondon
Study Type INTERVENTIONAL
Phase Phase 3
Enrollment 9,200
Sex FEMALE
Min Age 18 Years
Max Age N/A
Start Date 2025-10-15
Completion 2030-08
Interventions
Low-dose low-molecular-weight heparin

Brief Summary

The goal of this clinical trial is to evaluate the risk-benefit of a short-term treatment with a low-dose low-molecular-weight heparin (LMWH), in the postpartum period (after delivery). The main questions it aims to answer are: * compared to no treatment, does short-term postpartum LMWH modify the risk of venous thromboembolism within 90 days of delivery? * compared to no treatment, does short-term postpartum LMWH modify the risks of bleeding and wound complications? Participants will take low-dose LMWH for 7-10 days or no treatment, and will be followed for 90 days post-delivery.

Eligibility Criteria

Inclusion Criteria: postpartum women after delivery AND ≥1 major risk factor / ≥2 minor risk factors: * Major risk factors: Emergency cesarean section ; Pre-pregnancy BMI ≥35kg/m2 ; Known low-risk thrombophilia (heterozygous factor V Leiden; heterozygous G20210 prothrombin mutation) ; Pre-eclampsia ; Pre-term delivery ; Peripartum systemic infection ; Intra-uterine growth restriction ; Pregnancy loss * Minor risk factors: Age ≥35 years ; Pre-pregnancy BMI 30.0-34.9kg/m2 ; Current smoking ; Elective cesarean section ; Postpartum hemorrhage ; Antenatal immobility Exclusion Criteria: * ≥2 doses of postpartum LMWH * Any indication for therapeutic anticoagulation * A high-risk of postpartum VTE * An increased bleeding risk * A contra-indication to heparin

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