Clinical trial NCT06845423: Prevention of Postpartum Venous Thromboembolism in Women at Intermediate Risk
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Venous Thromboembolism (VTE)
Post Partum Women
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2025-02-25
Enrollment: 2400
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a multicenter PROBE study (prospective randomized open with blinded evaluation of the endpoints by an independent adjudication committee) with two parallel groups
Primary purpose: PREVENTION

Brief summary: 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.


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

Primary outcomes:
measure: Symptomatic VTE (DVT or non-fatal or fatal PE)
timeFrame: 6 weeks
Secondary outcomes:
measure: Symptomatic VTE (DVT or non-fatal or fatal PE)
timeFrame: 3 months
measure: Major bleeding (as defined by the criteria of the International Society of Thrombosis and Haemostasis)
timeFrame: 6 weeks
measure: Major bleeding (as defined by the criteria of the International Society of Thrombosis and Haemostasis)
timeFrame: 3 months
measure: Clinically relevant non-major bleeding
timeFrame: 6 weeks
measure: Clinically relevant non-major bleeding
timeFrame: 3 months
measure: Net Clinical benefit
timeFrame: 6 weeks
measure: Net Clinical benefit
timeFrame: 3 months
measure: Number of Thrombocytopenia
timeFrame: 6 weeks
measure: Mortality
timeFrame: 6 weeks
measure: Mortality
timeFrame: 3 months
measure: VTE suspicion
timeFrame: 6 weeks
measure: VTE suspicion
timeFrame: 3 months
measure: Treatment compliance
timeFrame: 6 weeks
measure: Objectively confirmed symptomatic VTE (DVT or non-fatal or fatal PE)
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU d'Amiens Picardie
city: Bordeaux
country: France
facility: CHU de Bordeaux, Groupe Pellegrin, Centre Aliénor d'Aquitaine
city: Brest
country: France
facility: CHU de Brest
city: Clamart
country: France
facility: Hôpital Béclère, AP-HP
city: Clermont - Ferrand
country: France
facility: CHU de Clermont Ferrand Site Estaing
city: La Roche Sur Yon
country: France
facility: CH départemental de Vendée
city: Le Kremlin Bicetre
country: France
facility: Hôpital Bicêtre, AP-HP
city: Marseille
country: France
facility: Hôpital Nord Marseille, AP-HM
city: Morlaix
country: France
facility: Centre Hospitalier des Pays de Morlaix
city: Nancy
country: France
facility: CHRU de Nancy
city: Nantes
country: France
facility: CHU de Nantes
city: Paris
country: France
facility: Hôpital Lariboisière, AP-HP
city: Paris
country: France
facility: Groupe Hospitalier Paris Saint Joseph
city: PAU
country: France
facility: CH de Pau
city: Perigueux
country: France
facility: Centre Hospitalier de Périgueux
city: Quimper
country: France
facility: Centre Hospitalier de Cornouaille Quimper Concarneau
city: Rennes
country: France
facility: CHU de Rennes
city: St PRIEST EN JAREZ
country: France
facility: CHU de St Etienne - Hôpital Nord
Study officials:
affiliation: CHU de Brest
name: Emmanuelle LE MOIGNE, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: