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Venous Thromboembolism (VTE)Phase 4MUM-VTENCT06845423

Prevention of Postpartum Venous Thromboembolism in Women at Intermediate Risk

A Phase 4 study testing Low molecular weight heparin in people with Venous Thromboembolism (VTE) and Post Partum Women, run by University Hospital, Brest at 18 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Low molecular weight heparin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,400 participants
Where
18 sitesFrance
Study dates
16 May 2025to 16 Aug 2028
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 9Show fewer
  • Aspirin at a daily dose 100 mg or dual antiplatelet therapy
  • Previous inclusion in Mum-VTE study
  • Concomitant participation in another therapeutic study

Trial locations and contacts

18 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Emmanuelle LE MOIGNE, MD, PhD contact

0298347344 ext. +33

emmanuelle.lemoigne@chu-brest.fr

Sarah ROBIN, MD contact

sarah.robin@chu-brest.fr

18 sites in 1 country

France18 sites, 18 recruiting

  • CHU d'Amiens Picardie

    Amiens, 80054

    Marie-Antoinette SEVESTRE, MD, PhD, 03 22 08 73 06 ext. +33, sevestre.marie-antoinette@chu-amiens.fr

    Not yet recruiting

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

    Bordeaux, 33000

    Loïc SENTHILES, MD,PhD, 05 56 79 56 03 ext. +33, loic.sentilhes@chu-bordeaux.fr

    Not yet recruiting

  • CHU de Brest

    Brest, 29200

    Karine MORCEL, Md, PhD, 02 98 23 85 52 ext. +33, karine.morcel@chu-brest.fr

    Recruiting

  • Hôpital Béclère, AP-HP

    Clamart, 92140

    VIVANTI Alexandre, MD,PhD, 01 45 37 44 41 ext. +33, alexandre.vivanti@aphp.fr

    Not yet recruiting

  • CHU de Clermont Ferrand Site Estaing

    Clermont-Ferrand, 63000

    Denis GALLOT, MD, PhD, 04 73 75 01 60 ext. +33, dgallot@chu-clermontferrand.fr

    Not yet recruiting

  • CH départemental de Vendée

    La Roche-sur-Yon, 85000

    NORCA Johanne, MD, 02 81 44 65 72 ext. +33, johanne.norca@ght85.fr

    Not yet recruiting

  • Hôpital Bicêtre, AP-HP

    Le Kremlin-Bicêtre, 94720

    Dominique LUTON, MD,PhD, 01 45 21 77 64 ext. +33, dominique.luton@aphp.fr

    Not yet recruiting

  • Hôpital Nord Marseille, AP-HM

    Marseille, 13015

    BLANC Julie, MD, PhD, 04 91 96 53 82 ext. +33, JulieVirginie.BLANC@ap-hm.fr

    Not yet recruiting

  • Centre Hospitalier des Pays de Morlaix

    Morlaix, 29600

    Jean-Benoît BREST, MD, 02 98 62 64 33 ext. +33, jbbrest@ch-morlaix.fr

    Not yet recruiting

  • CHRU de Nancy

    Nancy, 54000

    Catherine ZUILY-LAMY, MD, 03 83 34 44 00 ext. +33, C.ZUILY-LAMY@chru-nancy.fr

    Not yet recruiting

  • CHU de Nantes

    Nantes, 44000

    Norbert WINER, MD, PhD, 02 40 08 31 90 ext. +33, norbert.winer@chu-nantes.fr

    Not yet recruiting

  • Hôpital Lariboisière, AP-HP

    Paris, 75010

    Maxime DELRUE, MD, 01 49 95 64 11 ext. +33, maxime.delrue@aphp.fr

    Not yet recruiting

  • Groupe Hospitalier Paris Saint Joseph

    Paris, 75014

    Elie AZRIA, MD, PhD, 01 44 12 81 04 ext. +33, eazria@ghpsj.fr

    Not yet recruiting

  • CH de Pau

    Pau, 64000

    Caroline BOHEC, MD, 05 59 92 50 04 ext. +33, caroline.bohec@ch-pau.fr

    Recruiting

  • Centre Hospitalier de Périgueux

    Périgueux, 24019

    May-Lise BOUVET, MD, 05 53 45 25 25 ext. +33, may-lise.bouvet@ch-perigueux.fr

    Not yet recruiting

  • Centre Hospitalier de Cornouaille Quimper Concarneau

    Quimper, 29000

    Camille SAUVEE, MD, 02 90 26 45 27 ext. +33, c.sauvee@ch-cornouaille.fr

    Not yet recruiting

  • CHU de Rennes

    Rennes, 35203

    Patricia BRANCHU, MD, PhD, 02 99 26 67 80 ext. +33, patricia.branchu@chu-rennes.fr

    Not yet recruiting

  • CHU de St Etienne - Hôpital Nord

    Saint-Priest-en-Jarez, 42270

    CHAULEUR Céline, MD, PhD, 04 77 82 86 11 ext. +33, celine.chauleur@chu-st-etienne.fr

    Not yet recruiting

Other trials in France

About this study

Official 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

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.

Being tested
Low molecular weight heparin
Medical subject headings
Venous Thromboembolism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Low molecular weight heparinDrug

    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).
Study groups in NCT06845423
Study groupRoleWhat they receive
Experimental GroupExperimentalPharmacological 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
Receives: Drug: Low molecular weight heparin
Control groupNo interventionNo pharmacological thromboprophylaxis. All patients can have compression stockings.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 6 weeks

Secondary outcomes (14)

  1. 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).

    Measured: 3 months

  2. 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

    Measured: 6 weeks

  3. 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.

    Measured: 3 months

  4. Clinically relevant non-major bleeding

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

    Measured: 6 weeks

  5. Clinically relevant non-major bleeding

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

    Measured: 3 months

  6. 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

    Measured: 6 weeks

  7. 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

    Measured: 3 months

  8. Number of Thrombocytopenia

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

    Measured: 6 weeks

  9. Mortality

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

    Measured: 6 weeks

  10. Mortality

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

    Measured: 3 months

  11. VTE suspicion

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

    Measured: 6 weeks

  12. VTE suspicion

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

    Measured: 3 months

  13. Treatment compliance

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

    Measured: 6 weeks

  14. 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).

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Feb 2025
  2. Study start16 May 2025
  3. Primary completion16 May 2028 (estimated)
  4. Study completion16 Aug 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is a multicenter PROBE study (prospective randomized open with blinded evaluation of the endpoints by an independent adjudication committee) with two parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
2,400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06845423
Sponsor's protocol ID
29BRC22.0254
Acronym
MUM-VTE
Status last verified
Jun 2026
First submitted
20 Feb 2025
Last updated
10 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All collected data that underlie results in a publication

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Low molecular weight heparin in people with Venous Thromboembolism (VTE) and Post Partum Women, run by University Hospital, Brest at 18 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Emmanuelle LE MOIGNE, MD, PhD (0298347344 ext. +33, emmanuelle.lemoigne@chu-brest.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Symptomatic VTE (DVT or non-fatal or fatal PE) (time frame: 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06845423.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.

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