Prevention of Postpartum Venous Thromboembolism in Women at Intermediate Risk
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity Hospital, Brest
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Low molecular weight heparin
DrugPharmacological thromboprophylaxis using LMWH at preventive dosage. The choice of subcutaneous LMWH depends on the practice of each center: * Enoxaparine 4000 UI (weight \> 90 kg 6000 UI) * Tinzaparine 3500 UI (weight \> 90 kg 4500 UI) * Dalteparine 5000 UI (weight \> 90 kg 7500 UI) * Nadroparine 2850 UI (weight \> 90 kg 3800 UI).
Treatment groups
2,400 Participants
are divided into 2 treatment groupsGroup A: Experimental GroupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Symptomatic VTE (DVT or non-fatal or fatal PE)
Blindly adjudicated objectively confirmed symptomatic VTE (DVT or non-fatal or fatal PE) ) during the first 6-week postpartum period
Time frame
6 weeksSecondary outcomes
1
Symptomatic VTE (DVT or non-fatal or fatal PE)
blindly adjudicated objectively confirmed symptomatic VTE (DVT or non-fatal or fatal PE) during 3-month follow-up period after delivery (entire study period).
Time frame
3 months2
Major bleeding (as defined by the criteria of the International Society of Thrombosis and Haemostasis)
Blindly adjudicated major bleeding (as defined by the criteria of the International Society of Thrombosis and Haemostasis) during 6-week study treatment period
Time frame
6 weeks3
Major bleeding (as defined by the criteria of the International Society of Thrombosis and Haemostasis)
Blindly adjudicated major bleeding (as defined by the criteria of the International Society of Thrombosis and Haemostasis) during 3-month follow-up after delivery.
Time frame
3 months4
Clinically relevant non-major bleeding
Blindly adjudicated clinically relevant non-major bleeding during 6-week study treatment period
Time frame
6 weeksSponsors and contacts
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Source ClinicalTrials.gov