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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low-molecular-weight heparin | Experimental |
| |
| No treatment | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low-dose low-molecular-weight heparin | Drug | Low-molecular-weight heparin given for 7-10 days after delivery:
|
| Measure | Description | Time Frame |
|---|---|---|
| Venous thrombotic outcomes | Centrally-adjudicated, objectively-diagnosed, symptomatic venous thromboembolism (deep vein thrombosis / pulmonary embolism) | Within 90 days post-randomization |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality | Within 90 days post-randomization | |
| Bleeding | Obstetrical and non-obstetrical major and clinically-relevant non-major bleeding | Within 90 days post-randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Main safety composite outcome | Composite outcome of centrally-adjudicated obstetrical major bleeding, non-obstetrical major bleeding and/or major surgical site / perineal wound complication | Within 90 days post-randomization |
Inclusion Criteria: postpartum women after delivery AND ≥1 major risk factor / ≥2 minor risk factors:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marc Blondon | Contact | (+41).22.372.92.92 | marc.blondon@hug.ch |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Geneva University Hospitals | Recruiting | Geneva | Switzerland |
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| ID | Term |
|---|---|
| D054556 | Venous Thromboembolism |
| ID | Term |
|---|---|
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D006495 | Heparin, Low-Molecular-Weight |
| ID | Term |
|---|---|
| D006493 | Heparin |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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| Heparin-induced thrombocytopenia | Within 90 days post-randomization |
| Surgical site / perineal complications, and endometritis | Within 90 days post-randomization |
| Septic pelvic thrombosis | Within 90 days post-randomization |
| Superficial vein thrombosis | Within 90 days post-randomization |
| Stroke and cerebral vein thrombosis | Within 90 days post-randomization |
| Persistent lochia | At 42 day post-randomization |
| Maternal quality of life | Measured by the PROMIS global short form (PROMIS-10) questionnaire | At 14 days post-randomization |
| Maternity clot risk | Within 90 days post-randomization |
| VTE surveillance (imaging) | Within 90 days post-randomization |
| Duration of hospital stay | Within 90 days post-randomization |
| Serious adverse events | Within 90 days post-randomization |