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NCT Number: NCT06845423

Prevention of Postpartum Venous Thromboembolism in Women at Intermediate Risk

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.

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Key information

Conditions

Venous Thromboembolism (VTE) Cardiovascular Diseases Embolism and Thrombosis Post Partum Women Thromboembolism Vascular Diseases Venous Thromboembolism

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

CHU d'Amiens Picardie, Amiens, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Primary outcomes

  1. Symptomatic VTE (DVT or non-fatal or fatal PE)

    Time frame: 6 weeks

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

Secondary outcomes

  1. Symptomatic VTE (DVT or non-fatal or fatal PE)

    Time frame: 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).

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

    Time frame: 6 weeks

    Blindly adjudicated major bleeding (as defined by the criteria of the International Society of Thrombosis and Haemostasis) during 6-week study treatment period

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

    Time frame: 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.

  4. Clinically relevant non-major bleeding

    Time frame: 6 weeks

    Blindly adjudicated clinically relevant non-major bleeding during 6-week study treatment period

  5. Clinically relevant non-major bleeding

    Time frame: 3 months

    Blindly adjudicated clinically relevant non-major bleeding during 3-month follow-up after delivery.

  6. Net Clinical benefit

    Time frame: 6 weeks

    The net clinical benefit of study treatment (composite of symptomatic VTE and major or clinically relevant non major bleeding) during 6-week postpartum period

  7. Net Clinical benefit

    Time frame: 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

  8. Number of Thrombocytopenia

    Time frame: 6 weeks

    Cases of heparin induced thrombocytopenia associated with LMWH during 6-week study treatment period.

  9. Mortality

    Time frame: 6 weeks

    Blindly adjudicated mortality of all causes during 6-week study treatment period

  10. Mortality

    Time frame: 3 months

    Blindly adjudicated mortality of all causes during 3-month follow-up period after delivery.

  11. VTE suspicion

    Time frame: 6 weeks

    Number of VTE suspicion in interventional and control arm during 6-week study treatment period

  12. VTE suspicion

    Time frame: 3 months

    Number of VTE suspicion in interventional and control arm during 3-month follow-up period after delivery.

  13. Treatment compliance

    Time frame: 6 weeks

    Treatment compliance during 6-week study treatment period based on Girerd questionnaire

  14. Objectively confirmed symptomatic VTE (DVT or non-fatal or fatal PE)

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Emmanuelle LE MOIGNE, MD, PhD

CONTACT

[email protected]

0298347344 ext. +33

Sarah ROBIN, MD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Official study title

Prevention of Postpartum Venous Thromboembolism in Women at Intermediate Risk. An Open-label, Randomized, Controlled Trial Comparing Two Strategies With or Without Pharmacological Thromboprophylaxis

Acronym: MUM-VTE

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Feb 25, 2025
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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