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Prevention of Postpartum Venous Thromboembolism in Women at Intermediate Risk

RecruitingPhase 4Ages 18 Years - anyFemaleUniversity Hospital, Brest
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In plain words

What the trial is, and whether it could suit you

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 wit

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📋 Eligibility rules (as published)
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 (previous heparin induced thrombopenia, hemostatic impairment, known severe renal insufficiency) * Women who received more than two doses of LMWH since delivery * Unable or refusal to give informed consent * Aspirin at a daily dose 100 mg or dual antiplatelet therapy * Previous inclusion in Mum-VTE study * Concomitant participation in another therapeutic study
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What it tests

  • Low molecular weight heparin
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Where

18 sites
CHU d'Amiens Picardie
Amiens, France
CHU de Bordeaux, Groupe Pellegrin, Centre Aliénor d'Aquitaine
Bordeaux, France
CHU de Brest
Brest, France
Hôpital Béclère, AP-HP
Clamart, France
CHU de Clermont Ferrand Site Estaing
Clermont-Ferrand, France
CH départemental de Vendée
La Roche-sur-Yon, France
Hôpital Bicêtre, AP-HP
Le Kremlin-Bicêtre, France
Hôpital Nord Marseille, AP-HM
Marseille, France

…and 10 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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