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
Qualifiers
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
Treatments tested in this trial
- Low molecular weight heparin