Actively Recruiting
Prevention of Postpartum Venous Thromboembolism in Women at Intermediate Risk
Led by University Hospital, Brest · Updated on 2025-05-18
2400
Participants Needed
18
Research Sites
169 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Prevention of Postpartum Venous Thromboembolism in Women at Intermediate Risk
Who Can Participate
Eligibility Criteria
You may qualify if you...
-
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.
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 18 locations
1
CHU d'Amiens Picardie
Amiens, France, 80054
Not Yet Recruiting
2
CHU de Bordeaux, Groupe Pellegrin, Centre Aliénor d'Aquitaine
Bordeaux, France, 33000
Not Yet Recruiting
3
CHU de Brest
Brest, France, 29200
Actively Recruiting
4
Hôpital Béclère, AP-HP
Clamart, France, 92140
Not Yet Recruiting
5
CHU de Clermont Ferrand Site Estaing
Clermont-Ferrand, France, 63000
Not Yet Recruiting
6
CH départemental de Vendée
La Roche-sur-Yon, France, 85000
Not Yet Recruiting
7
Hôpital Bicêtre, AP-HP
Le Kremlin-Bicêtre, France, 94720
Not Yet Recruiting
8
Hôpital Nord Marseille, AP-HM
Marseille, France, 13015
Not Yet Recruiting
9
Centre Hospitalier des Pays de Morlaix
Morlaix, France, 29600
Not Yet Recruiting
10
CHRU de Nancy
Nancy, France, 54000
Not Yet Recruiting
11
CHU de Nantes
Nantes, France, 44000
Not Yet Recruiting
12
Hôpital Lariboisière, AP-HP
Paris, France, 75010
Not Yet Recruiting
13
Groupe Hospitalier Paris Saint Joseph
Paris, France, 75014
Not Yet Recruiting
14
CH de Pau
Pau, France, 64000
Not Yet Recruiting
15
Centre Hospitalier de Périgueux
Périgueux, France, 24019
Not Yet Recruiting
16
Centre Hospitalier de Cornouaille Quimper Concarneau
Quimper, France, 29000
Not Yet Recruiting
17
CHU de Rennes
Rennes, France, 35203
Not Yet Recruiting
18
CHU de St Etienne - Hôpital Nord
Saint-Priest-en-Jarez, France, 42270
Not Yet Recruiting
Research Team
E
Emmanuelle LE MOIGNE, MD, PhD
CONTACT
S
Sarah ROBIN, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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