RecruitingPhase 4NCT06845423

Prevention of Postpartum Venous Thromboembolism in Women at Intermediate Risk

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


Sponsor

University Hospital, Brest

Enrollment

2,400 participants

Start Date

May 16, 2025

Study Type

INTERVENTIONAL

Conditions

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 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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Low molecular weight heparin for people with post-partum women and venous thromboembolism (vte). The study is currently recruiting participants at 18 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLow 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).


Locations(18)

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

Centre Hospitalier des Pays de Morlaix

Morlaix, France

CHRU de Nancy

Nancy, France

CHU de Nantes

Nantes, France

Hôpital Lariboisière, AP-HP

Paris, France

Groupe Hospitalier Paris Saint Joseph

Paris, France

CH de Pau

Pau, France

Centre Hospitalier de Périgueux

Périgueux, France

Centre Hospitalier de Cornouaille Quimper Concarneau

Quimper, France

CHU de Rennes

Rennes, France

CHU de St Etienne - Hôpital Nord

Saint-Priest-en-Jarez, France

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NCT06845423


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