A Phase 4 interventional study of Low molecular weight heparin in Venous Thromboembolism (VTE) and Post Partum Women, sponsored by University Hospital, Brest. Recruiting at 18 sites in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-10.
Sponsored by University Hospital, Brest · Phase 4, Interventional, and Prevention
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.
694 studies on the registry are indexed under Venous Thromboembolism; 152 are open to participants now.
This study's planned enrollment of 2,400 is above the median of 259 across 382 interventional studies indexed under Venous Thromboembolism.
Browse Venous Thromboembolism studies →University Hospital, Brest is the lead sponsor of 594 studies on the registry; 135 are open to participants now.
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Written informed consent
Exclusion Criteria:
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). All patients can have compression stockings
Drug: Low molecular weight heparin
No pharmacological thromboprophylaxis. All patients can have compression stockings.
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).
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
Plan to share: Yes — All collected data that underlie results in a publication
Supporting information: Study protocol
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University Hospital, Brest