Prevention of Postpartum Venous Thromboembolism in Women at Intermediate Risk

Phase 4

Recruiting

• Conditions: Venous Thromboembolism (VTE); Post Partum Women
• Interventions: Drug: Low molecular weight heparin

• Registration Number: NCT06845423
• Lead Sponsor: University Hospital, Brest

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-02-20
• Study First Submitted QC: 2025-02-24
• Study First Posted: 2025-02-25
• Status Verified: 2025-05
• Study Start: 2025-05-16
• Last Update Submitted: 2025-05-16
• Last Update Posted: 2025-05-18
• Primary Completion: 2028-05-16
• Study Completion: 2028-08-16

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 2400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Group	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). All patients can have compression stockings

Primary Outcome Measures

Name	Time	Method
Symptomatic VTE (DVT or non-fatal or fatal PE)	6 weeks	Blindly adjudicated objectively confirmed symptomatic VTE (DVT or non-fatal or fatal PE) ) during the first 6-week postpartum period

Secondary Outcome Measures

Name	Time	Method
Mortality	3 months	Blindly adjudicated mortality of all causes during 3-month follow-up period after delivery.
Objectively confirmed symptomatic VTE (DVT or non-fatal or fatal PE)	6 weeks	- 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).
Symptomatic VTE (DVT or non-fatal or fatal PE)	3 months	blindly adjudicated objectively confirmed symptomatic VTE (DVT or non-fatal or fatal PE) during 3-month follow-up period after delivery (entire study period).
Major bleeding (as defined by the criteria of the International Society of Thrombosis and Haemostasis)	3 months	Blindly adjudicated major bleeding (as defined by the criteria of the International Society of Thrombosis and Haemostasis) during 3-month follow-up after delivery.
Net Clinical benefit	3 months	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
Clinically relevant non-major bleeding	3 months	Blindly adjudicated clinically relevant non-major bleeding during 3-month follow-up after delivery.
Number of Thrombocytopenia	6 weeks	Cases of heparin induced thrombocytopenia associated with LMWH during 6-week study treatment period.
VTE suspicion	3 months	Number of VTE suspicion in interventional and control arm during 3-month follow-up period after delivery.
Treatment compliance	6 weeks	Treatment compliance during 6-week study treatment period based on Girerd questionnaire

Trial Locations

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 Bicetre, 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; 🇫🇷 Perigueux, France

Centre Hospitalier de Cornouaille Quimper Concarneau; 🇫🇷 Quimper, France

CHU de Rennes; 🇫🇷 Rennes, France

CHU de St Etienne - Hôpital Nord; 🇫🇷 St PRIEST EN JAREZ, France