Prevention of Postpartum Venous Thromboembolism in Women at Intermediate Risk

NCT06845423 | Recruiting Phase 4 DMC

• 1 other identifier: 29BRC22.0254
• Study Type: interventional
• Target: 2,400
• Locations: 1 country
• Sites: 18

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.

Conditions

Venous Thromboembolism (VTE); Post Partum Women

Outcome Measures

Primary Outcomes (1)

• 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

  6 weeks

Secondary Outcomes (14)

• Symptomatic VTE (DVT or non-fatal or fatal PE)

  3 months

• Major bleeding (as defined by the criteria of the International Society of Thrombosis and Haemostasis)

  6 weeks

• Major bleeding (as defined by the criteria of the International Society of Thrombosis and Haemostasis)

  3 months

• Clinically relevant non-major bleeding

  6 weeks

• Clinically relevant non-major bleeding

  3 months

Study Arms (2)

Experimental Group

EXPERIMENTAL

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

Control group

NO INTERVENTION

No pharmacological thromboprophylaxis. All patients can have compression stockings.

Interventions

Low molecular weight heparin DRUG

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).

Experimental Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• Concomitant participation in another therapeutic study

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (18)

CHU d'Amiens Picardie

Amiens, 80054, France

NOT YET RECRUITING

CHU de Bordeaux, Groupe Pellegrin, Centre Aliénor d'Aquitaine

Bordeaux, 33000, France

NOT YET RECRUITING

CHU de Brest

Brest, 29200, France

RECRUITING

Hôpital Béclère, AP-HP

Clamart, 92140, France

NOT YET RECRUITING

CHU de Clermont Ferrand Site Estaing

Clermont-Ferrand, 63000, France

NOT YET RECRUITING

CH départemental de Vendée

La Roche-sur-Yon, 85000, France

NOT YET RECRUITING

Hôpital Bicêtre, AP-HP

Le Kremlin-Bicêtre, 94720, France

NOT YET RECRUITING

Hôpital Nord Marseille, AP-HM

Marseille, 13015, France

NOT YET RECRUITING

Centre Hospitalier des Pays de Morlaix

Morlaix, 29600, France

NOT YET RECRUITING

CHRU de Nancy

Nancy, 54000, France

NOT YET RECRUITING

CHU de Nantes

Nantes, 44000, France

NOT YET RECRUITING

Hôpital Lariboisière, AP-HP

Paris, 75010, France

NOT YET RECRUITING

Groupe Hospitalier Paris Saint Joseph

Paris, 75014, France

NOT YET RECRUITING

CH de Pau

Pau, 64000, France

NOT YET RECRUITING

Centre Hospitalier de Périgueux

Périgueux, 24019, France

NOT YET RECRUITING

Centre Hospitalier de Cornouaille Quimper Concarneau

Quimper, 29000, France

NOT YET RECRUITING

CHU de Rennes

Rennes, 35203, France

NOT YET RECRUITING

CHU de St Etienne - Hôpital Nord

Saint-Priest-en-Jarez, 42270, France

NOT YET RECRUITING

MeSH Terms

Conditions

Venous Thromboembolism

Interventions

Heparin, Low-Molecular-Weight

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Emmanuelle LE MOIGNE, MD, PhD

  CHU de Brest

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emmanuelle LE MOIGNE, MD, PhD

CONTACT

0298347344; emmanuelle.lemoigne@chu-brest.fr

Sarah ROBIN, MD

CONTACT

sarah.robin@chu-brest.fr

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: All critical events (VTE, bleeding and mortality) will be validated by a central, independent clinical events committee (ICEC) which will adjudicate outcomes blinded for treatment allocation (PROBE study).
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a multicenter PROBE study (prospective randomized open with blinded evaluation of the endpoints by an independent adjudication committee) with two parallel groups

Study Record Dates

• First Submitted: February 20, 2025
• First Posted: February 25, 2025
• Study Start: May 16, 2025
• Primary Completion (Estimated): May 16, 2028
• Study Completion (Estimated): August 16, 2028
• Last Updated: May 18, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available beginning five years and ending fifteen years following the final study report completion
• Access Criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.

Locations

FR (18)