Actively Recruiting
Prevention of Postpartum Venous Thromboembolism in Women at Intermediate Risk An Open-label, Randomized, Controlled Trial Comparing Pharmacological Thromboprophylaxis With or Without Low Molecular Weight Heparin
Led by University Hospital, Brest · Updated on 2025-05-18
2400
Participants Needed
18
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Venous thromboembolism (VTE) is a serious cause of death among women of reproductive age, especially during pregnancy and postpartum. This trial is focused on women at intermediate risk for postpartum VTE, a group for whom the effectiveness and safety of preventive blood thinning medication have not been well studied. The trial aims to compare the use of low molecular weight heparin (LMWH) for six weeks after delivery to no medication, to see which approach better prevents VTE during this critical period. Participants will be randomly assigned to one of two groups: one receiving pharmacological thromboprophylaxis with LMWH at preventive doses chosen according to the center's practice, including enoxaparin, tinzaparin, dalteparin, or nadroparin; the other group will not receive pharmacological thromboprophylaxis. All participants may use compression stockings. The treatment period lasts six weeks after delivery, matching usual postpartum care. During the study, women will be monitored for symptomatic VTE events such as deep vein thrombosis or pulmonary embolism over six weeks, along with bleeding events and overall safety outcomes. Researchers will also track treatment compliance and mortality. Follow-up includes assessments at six weeks and three months postpartum to evaluate both benefits and risks of the thromboprophylaxis strategy. The total participation duration is at least three months after delivery.
CONDITIONS
Brief 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 venous thromboembolism during postpartum with a 3% or higher risk based on a validated prediction model or international guidelines
- Age 18 years or older
- Delivery occurred between 6 hours and less than 36 hours prior
- Provided written informed consent
- Intermediate risk defined as at least 3% risk based on factors including smoking, varicose veins, obesity, comorbidities, diabetes, pre-eclampsia, postpartum hemorrhage, postpartum infection, emergency or elective cesarean section, or following ACCP guidelines with one major or two minor risk factors
You will not qualify if you...
- Previous personal history of venous thromboembolism
- Use of low molecular weight heparin started during pregnancy
- Need for anticoagulation at full therapeutic dose
- Contraindications to low molecular weight heparin such as previous heparin-induced thrombopenia, bleeding problems, or severe kidney failure
- More than two doses of low molecular weight heparin received since delivery
- Unable or unwilling to give informed consent
- Use of aspirin at 100 mg daily or dual antiplatelet therapy
- Previous participation in the Mum-VTE study
- Participation in another therapeutic clinical trial at the same time
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 weeks postpartum
Participants receive pharmacological thromboprophylaxis using low molecular weight heparin at preventive dosage or no pharmacological thromboprophylaxis. All participants may use compression stockings.
Visits as needed during the 6 weeks postpartum period
Duration - Up to 3 months postpartum
Participants are monitored for symptomatic venous thromboembolism and bleeding events up to 3 months postpartum.
Follow-up visits or contacts up to 3 months postpartum
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
S
Sarah ROBIN, MD
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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