Prevention of Postpartum Venous Thromboembolism in Women at Intermediate Risk
Recruiting
Phase 4
Interventional Study
Venous Thromboembolism (VTE)
Post Partum Women
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Female
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 2,400 (estimated)
- Sponsor
- University Hospital, Brest · Other
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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, post…
Trial Locations
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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: Inter…
Contacts