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
| Condition(s) | Venous Thromboembolism (VTE), Post Partum Women |
|---|---|
| Status | Recruiting |
| Phase | Phase 4 |
| Study type | Interventional |
| Summary | 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 |
| Who can participate | Inclusion Criteria: * Women at intermediate risk of VTE during post-partum= with a 3% or more risk of VTE based on a validated prediction model\* or International guidelines (ACCP 2012). * Age over 18 years * Delivery between 6 hours and \< 36 hours * Written informed consent * Definition: Intermediate risk is defined as ≥ 3%, based on risk prediction model developed by Sultan et al taking in account: smoking, varicose veins, obesity, comorbidities, diabetes, pre-eclampsia, post-partum hemorrhage, postpartum infection, emergency or elective section or following ACCP guidelines: one major risk factor or two minor risk factors. Exclusion Criteria: * Previous personal history of VTE * LMWH started during antenatal period * Need for anticoagulation at curative dose * Contraindication to LMWH ( |
| Ages | 18 Years |
| Sex | Female |
| Lead sponsor | University Hospital, Brest |
| Locations | Amiens, France; Bordeaux, France; Brest, France; Clamart, France; Clermont-Ferrand, France; La Roche-sur-Yon, France (+12 more sites) |
| Start date | 2025-05-16 |
| NCT ID | NCT06845423 |
| Official listing | https://clinicaltrials.gov/study/NCT06845423 |