Short-term Low-dose Low-molecular-weight Heparin to Prevent Postpartum Thrombosis
Recruiting
Phase 3
Interventional Study
Venous Thromboembolism (VTE)
Postpartum
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
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 3
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 9,200 (estimated)
- Sponsor
- Marc Blondon · Other
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About This Trial
The goal of this clinical trial is to evaluate the risk-benefit of a short-term treatment with a low-dose low-molecular-weight heparin (LMWH), in the postpartum period (after delivery). The main questions it aims to answer are:
* compared to no treatment, does short-term postpartum LMWH modify the risk of venous thromboembolism within 90 days of delivery?
* compared to no treatment, does short-te…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: postpartum women after delivery AND ≥1 major risk factor / ≥2 minor risk factors:
* Major risk factors: Emergency cesarean section ; Pre-pregnancy BMI ≥35kg/m2 ; Known low-risk thrombophilia (heterozygous factor V Leiden; heterozygous G20210 prothrombin mutation) ; Pre-eclampsia…
Contacts