Prevention of Postpartum Venous Thromboembolism in Women at Intermediate Risk

Официальное название

Prevention of Postpartum Venous Thromboembolism in Women at Intermediate Risk. An Open-label, Randomized, Controlled Trial Comparing Two Strategies With or Without Pharmacological Thromboprophylaxis

Обзор

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.

Вмешательства

• Препарат Low molecular weight heparin
  Pharmacological thromboprophylaxis using LMWH at preventive dosage. The choice of subcutaneous LMWH depends on the practice of each center: * Enoxaparine 4000 UI (weight \> 90 kg 6000 UI) * Tinzaparine 3500 UI (weight \> 90 kg 4500 UI) * Dalteparine 5000 UI (weight \> 90 kg 7500 UI) * Nadroparine 2850 UI (weight \> 90 kg 3800 UI).

Первичные конечные точки

• Symptomatic VTE (DVT or non-fatal or fatal PE) [Срок оценки: 6 weeks]

Вторичные конечные точки (12)

• Symptomatic VTE (DVT or non-fatal or fatal PE) [Срок оценки: 3 months]
• Major bleeding (as defined by the criteria of the International Society of Thrombosis and Haemostasis) [Срок оценки: 6 weeks]
• Major bleeding (as defined by the criteria of the International Society of Thrombosis and Haemostasis) [Срок оценки: 3 months]
• Clinically relevant non-major bleeding [Срок оценки: 6 weeks]
• Clinically relevant non-major bleeding [Срок оценки: 3 months]
• Net Clinical benefit [Срок оценки: 6 weeks]
• Net Clinical benefit [Срок оценки: 3 months]
• Number of Thrombocytopenia [Срок оценки: 6 weeks]
• Mortality [Срок оценки: 6 weeks]
• Mortality [Срок оценки: 3 months]
• VTE suspicion [Срок оценки: 6 weeks]
• VTE suspicion [Срок оценки: 3 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

Франция · 18 центров

• CHU d'Amiens Picardie — Amiens
• CHU de Bordeaux, Groupe Pellegrin, Centre Aliénor d'Aquitaine — Bordeaux
• CHU de Brest — Brest
• Hôpital Béclère, AP-HP — Clamart
• CHU de Clermont Ferrand Site Estaing — Clermont-Ferrand
• CH départemental de Vendée — La Roche-sur-Yon
• Hôpital Bicêtre, AP-HP — Le Kremlin-Bicêtre
• Hôpital Nord Marseille, AP-HM — Marseille
• … и ещё 10 центров

Идентификаторы

NCT: NCT06845423 · 29BRC22.0254

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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