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Taking peoplePhase 4

Blood thinner injections after childbirth to prevent blood clots in women at intermediate risk

Tests low molecular weight heparin against no medicine for preventing blood clots after delivery.

Key facts

Who runs it
University Hospital, Brest
Where
France18 sites in 1 countryChoose a country to see its sites
Trial code
Registry title
Prevention of Postpartum Venous Thromboembolism in Women at Intermediate Risk
Status
Recruiting
Phase
Phase 4
People taking part
2,400 people, planned
Started
16 May 2025
Expected to end
16 Aug 2028
Type of study
Interventional, 2 groupsOne group gets no study treatment, for comparison.
Treatments tested
  • Low molecular weight heparin
Record updated
10 June 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for women who gave birth recently and have an intermediate risk of blood clots in the veins (VTE) after birth. It compares blood-thinner shots (LMWH) for 6 weeks with no blood-thinner medicine.

Age
Over 18 years
Sex
Women only
Disease stage
Gave birth between 6 hours and < 36 hours ago. Intermediate risk of VTE after birth, meaning a risk of 3% or more. This is based on a prediction model or ACCP 2012 guidelines (one major or two minor risk factors).
Earlier treatment
Cannot have started LMWH during pregnancy. Cannot have had more than two doses of LMWH since giving birth.

Main reasons for not taking part

  • Earlier blood clot in a vein (VTE)
  • Needing blood thinners at full treatment dose
  • Cannot take LMWH, for example after heparin-induced low platelets, a bleeding disorder or known severe kidney failure
  • Taking aspirin at 100 mg a day or two antiplatelet medicines
  • Taking part in another treatment study, or joined the Mum-VTE study before

The registry criteria, word for word

Show all 13 criteriaShow less

Who can take part

  • 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 take part

  • Previous personal history of VTE
  • Contraindication to LMWH (previous heparin induced thrombopenia, hemostatic impairment, known severe renal insufficiency)
  • Women who received more than two doses of LMWH since delivery
  • Aspirin at a daily dose 100 mg or dual antiplatelet therapy
  • Previous inclusion in Mum-VTE study
  • Concomitant participation in another therapeutic study
  • LMWH started during antenatal period
  • Need for anticoagulation at curative dose
  • Unable or refusal to give informed consent

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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 full original descriptionShow less

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.

The 2 groups in the trial

  • Experimental GroupTreatment being tested

    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

    Treatment: Low molecular weight heparin

  • Control groupNo study treatment, for comparison

    No pharmacological thromboprophylaxis. All patients can have compression stockings.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

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Data and sources

Registry record
Listed on ClinicalTrials.gov.
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
Plain-language title
Blood thinner injections after childbirth to prevent blood clots in women at intermediate riskGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 15 November 2026.
Record updated
10 June 2026