Preventing blood clots in postpartum women at intermediate risk

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

This study is testing if giving a blood thinner to women at risk of blood clots after giving birth can help prevent those clots during the first six weeks postpartum.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 2400 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: University Hospital, Brest (other)
• Locations: 18 sites (Amiens and 17 other locations)
• Trial ID: NCT06845423 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of low molecular weight heparin (LMWH) as a thromboprophylaxis strategy for women at intermediate risk of venous thromboembolism (VTE) during the postpartum period. The study will involve an open-label, randomized, controlled design, where eligible participants will receive LMWH for six weeks following delivery. The focus is on women who have a 3% or greater risk of VTE based on validated prediction models and international guidelines. The trial seeks to provide clearer guidelines for pharmacological thromboprophylaxis in this population, which has been inconsistently addressed in current literature.

Who should consider this trial

Good fit: Ideal candidates for this study are postpartum women over 18 years old who are at intermediate risk of VTE with a 3% or greater risk based on validated prediction models.

Not a fit: Patients with a previous history of VTE or those requiring anticoagulation at curative doses will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could significantly reduce the incidence of postpartum VTE and related maternal mortality.

How similar studies have performed: While there is limited data on the specific use of LMWH for this population, similar studies have shown promise in thromboprophylaxis for high-risk patients, indicating potential for success.

Eligibility criteria

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

Where this trial is running

Amiens and 17 other locations

• CHU d'Amiens Picardie — Amiens, France (NOT_YET_RECRUITING)
• CHU de Bordeaux, Groupe Pellegrin, Centre Aliénor d'Aquitaine — Bordeaux, France (NOT_YET_RECRUITING)
• CHU de Brest — Brest, France (RECRUITING)
• Hôpital Béclère, AP-HP — Clamart, France (NOT_YET_RECRUITING)
• CHU de Clermont Ferrand Site Estaing — Clermont-Ferrand, France (NOT_YET_RECRUITING)
• CH départemental de Vendée — La Roche-sur-Yon, France (NOT_YET_RECRUITING)
• Hôpital Bicêtre, AP-HP — Le Kremlin-Bicêtre, France (NOT_YET_RECRUITING)
• Hôpital Nord Marseille, AP-HM — Marseille, France (NOT_YET_RECRUITING)
• Centre Hospitalier des Pays de Morlaix — Morlaix, France (NOT_YET_RECRUITING)
• CHRU de Nancy — Nancy, France (NOT_YET_RECRUITING)
• CHU de Nantes — Nantes, France (NOT_YET_RECRUITING)
• Hôpital Lariboisière, AP-HP — Paris, France (NOT_YET_RECRUITING)
• Groupe Hospitalier Paris Saint Joseph — Paris, France (NOT_YET_RECRUITING)
• CH de Pau — Pau, France (NOT_YET_RECRUITING)
• Centre Hospitalier de Périgueux — Périgueux, France (NOT_YET_RECRUITING)
• Centre Hospitalier de Cornouaille Quimper Concarneau — Quimper, France (NOT_YET_RECRUITING)
• CHU de Rennes — Rennes, France (NOT_YET_RECRUITING)
• CHU de St Etienne - Hôpital Nord — Saint-Priest-en-Jarez, France (NOT_YET_RECRUITING)

Study contacts

• Principal investigator: Emmanuelle LE MOIGNE, MD, PhD — CHU de Brest
• Study coordinator: Emmanuelle LE MOIGNE, MD, PhD

Conditions: Venous Thromboembolism, Post Partum Women