Preventing blood clots in postpartum women at intermediate risk

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• CHU de Brest
  Brest, France Recruiting
• CH de Pau
  Pau, France Recruiting
• CHU d'Amiens Picardie
  Amiens, France Not yet recruiting
• CHU de Bordeaux, Groupe Pellegrin, Centre Aliénor d'Aquitaine
  Bordeaux, France Not yet recruiting
• Hôpital Béclère, AP-HP
  Clamart, France Not yet recruiting
• CHU de Clermont Ferrand Site Estaing
  Clermont-Ferrand, France Not yet recruiting

Study contacts

• Principal investigator: Emmanuelle LE MOIGNE, MD, PhD — CHU de Brest
• Study coordinator: Emmanuelle LE MOIGNE, MD, PhD
• Email: emmanuelle.lemoigne@chu-brest.fr
• Phone: 0298347344

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.