Postpartum, Venous Thromboembolism (VTE)
Conditions
Brief summary
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-term postpartum LMWH modify the risks of bleeding and wound complications? Participants will take low-dose LMWH for 7-10 days or no treatment, and will be followed for 90 days post-delivery.
Interventions
DRUGLow-dose low-molecular-weight heparin
Low-molecular-weight heparin given for 7-10 days after delivery: * enoxaparin 4000-6000IU o.d. * nadroparin 3800-5700IU o.d. * dalteparin 5000-7500IU o.d. * tinzaparin 4500-7000IU o.d.
Sponsors
Marc Blondon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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 ; Pre-term delivery ; Peripartum systemic infection ; Intra-uterine growth restriction ; Pregnancy loss * Minor risk factors: Age ≥35 years ; Pre-pregnancy BMI 30.0-34.9kg/m2 ; Current smoking ; Elective cesarean section ; Postpartum hemorrhage ; Antenatal immobility
Exclusion criteria
* ≥2 doses of postpartum LMWH * Any indication for therapeutic anticoagulation * A high-risk of postpartum VTE * An increased bleeding risk * A contra-indication to heparin
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Venous thrombotic outcomes | Within 90 days post-randomization | Centrally-adjudicated, objectively-diagnosed, symptomatic venous thromboembolism (deep vein thrombosis / pulmonary embolism) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All-cause mortality | Within 90 days post-randomization | — |
| Bleeding | Within 90 days post-randomization | Obstetrical and non-obstetrical major and clinically-relevant non-major bleeding |
| 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 | At 14 days post-randomization | Measured by the PROMIS global short form (PROMIS-10) questionnaire |
| 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 | — |
Countries
Switzerland
Contacts
CONTACTMarc Blondon
Outcome results
None listed