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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
2,400
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).
CHU d'Amiens Picardie
Amiens, France
NOT_YET_RECRUITINGCHU de Bordeaux, Groupe Pellegrin, Centre Aliénor d'Aquitaine
Bordeaux, France
NOT_YET_RECRUITINGCHU de Brest
Brest, France
RECRUITINGHôpital Béclère, AP-HP
Clamart, France
NOT_YET_RECRUITINGCHU de Clermont Ferrand Site Estaing
Clermont-Ferrand, France
NOT_YET_RECRUITINGCH départemental de Vendée
La Roche-sur-Yon, France
NOT_YET_RECRUITINGHôpital Bicêtre, AP-HP
Le Kremlin-Bicêtre, France
NOT_YET_RECRUITINGHôpital Nord Marseille, AP-HM
Marseille, France
NOT_YET_RECRUITINGCentre Hospitalier des Pays de Morlaix
Morlaix, France
NOT_YET_RECRUITINGCHRU de Nancy
Nancy, France
NOT_YET_RECRUITING...and 8 more locations
Symptomatic VTE (DVT or non-fatal or fatal PE)
Blindly adjudicated objectively confirmed symptomatic VTE (DVT or non-fatal or fatal PE) ) during the first 6-week postpartum period
Time frame: 6 weeks
Symptomatic VTE (DVT or non-fatal or fatal PE)
blindly adjudicated objectively confirmed symptomatic VTE (DVT or non-fatal or fatal PE) during 3-month follow-up period after delivery (entire study period).
Time frame: 3 months
Major bleeding (as defined by the criteria of the International Society of Thrombosis and Haemostasis)
Blindly adjudicated major bleeding (as defined by the criteria of the International Society of Thrombosis and Haemostasis) during 6-week study treatment period
Time frame: 6 weeks
Major bleeding (as defined by the criteria of the International Society of Thrombosis and Haemostasis)
Blindly adjudicated major bleeding (as defined by the criteria of the International Society of Thrombosis and Haemostasis) during 3-month follow-up after delivery.
Time frame: 3 months
Clinically relevant non-major bleeding
Blindly adjudicated clinically relevant non-major bleeding during 6-week study treatment period
Time frame: 6 weeks
Clinically relevant non-major bleeding
Blindly adjudicated clinically relevant non-major bleeding during 3-month follow-up after delivery.
Time frame: 3 months
Net Clinical benefit
The net clinical benefit of study treatment (composite of symptomatic VTE and major or clinically relevant non major bleeding) during 6-week postpartum period
Time frame: 6 weeks
Net Clinical benefit
The net clinical benefit of study treatment (composite of symptomatic VTE and major or clinically relevant non major bleeding) during 3-month follow-up after delivery
Time frame: 3 months
Number of Thrombocytopenia
Cases of heparin induced thrombocytopenia associated with LMWH during 6-week study treatment period.
Time frame: 6 weeks
Mortality
Blindly adjudicated mortality of all causes during 6-week study treatment period
Time frame: 6 weeks
Mortality
Blindly adjudicated mortality of all causes during 3-month follow-up period after delivery.
Time frame: 3 months
VTE suspicion
Number of VTE suspicion in interventional and control arm during 6-week study treatment period
Time frame: 6 weeks
VTE suspicion
Number of VTE suspicion in interventional and control arm during 3-month follow-up period after delivery.
Time frame: 3 months
Treatment compliance
Treatment compliance during 6-week study treatment period based on Girerd questionnaire
Time frame: 6 weeks
Objectively confirmed symptomatic VTE (DVT or non-fatal or fatal PE)
\- Blindly adjudicated objectively confirmed symptomatic VTE (DVT or non-fatal or fatal PE) during the first 6-week postpartum period (i.e., study treatment period) in clinically relevant prespecified subgroups (caesarean section, obesity, age 35 y, smoker during pregnancy, pre-term birth \< 37, pre-eclampsia, postpartum infection, postpartum hemorrhage, VTE family history).
Time frame: 6 weeks
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