Prevention of Postpartum Venous Thromboembolism in Women at Intermediate Risk

Last updated: May 16, 2025
Sponsor: University Hospital, Brest
Overall Status: Active - Recruiting

Phase

4

Condition

Thromboembolism

Venous Thrombosis

Venous Thromboembolism

Treatment

Low molecular weight heparin

Clinical Study ID

NCT06845423
29BRC22.0254
  • Ages > 18
  • Female

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Women at intermediate risk of VTE during post-partum= with a 3% or more risk of VTEbased 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 predictionmodel 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 ACCPguidelines: one major risk factor or two minor risk factors.

Exclusion

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, hemostaticimpairment, 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

Total Participants: 2400
Treatment Group(s): 1
Primary Treatment: Low molecular weight heparin
Phase: 4
Study Start date:
May 16, 2025
Estimated Completion Date:
August 16, 2028

Connect with a study center

  • CHU d'Amiens Picardie

    Amiens, 80054
    France

    Site Not Available

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

    Bordeaux, 33000
    France

    Site Not Available

  • CHU de Brest

    Brest, 29200
    France

    Active - Recruiting

  • Hôpital Béclère, AP-HP

    Clamart, 92140
    France

    Site Not Available

  • CHU de Clermont Ferrand Site Estaing

    Clermont - Ferrand, 63000
    France

    Site Not Available

  • CH départemental de Vendée

    La Roche Sur Yon, 85000
    France

    Site Not Available

  • Hôpital Bicêtre, AP-HP

    Le Kremlin Bicetre, 94720
    France

    Site Not Available

  • Hôpital Nord Marseille, AP-HM

    Marseille, 13015
    France

    Site Not Available

  • Centre Hospitalier des Pays de Morlaix

    Morlaix, 29600
    France

    Site Not Available

  • CHRU de Nancy

    Nancy, 54000
    France

    Site Not Available

  • CHU de Nantes

    Nantes, 44000
    France

    Site Not Available

  • CH de Pau

    PAU, 64000
    France

    Site Not Available

  • Groupe Hospitalier Paris Saint Joseph

    Paris, 75014
    France

    Site Not Available

  • Hôpital Lariboisière, AP-HP

    Paris, 75010
    France

    Site Not Available

  • Centre Hospitalier de Périgueux

    Perigueux, 24019
    France

    Site Not Available

  • Centre Hospitalier de Cornouaille Quimper Concarneau

    Quimper, 29000
    France

    Site Not Available

  • CHU de Rennes

    Rennes, 35203
    France

    Site Not Available

  • CHU de St Etienne - Hôpital Nord

    St PRIEST EN JAREZ, 42270
    France

    Site Not Available

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