Venous Thromboembolism
Conditions
Brief summary
In previous attemps to answer the question of risk-benefit of postpartum thromboprophylaxis, researchers were faced with low recruitement rates. The goal of this pilot feasibility randomized controlled trial of postpartum pharmacological thromboprophylaxis is to examine the feasibility (recruitement rate) and participation rate at the Geneva University Hospitals
Interventions
DRUGEnoxaparin
Prophylactic dose of enoxaparin once daily for 10 days after delivery.
Sponsors
University Hospital, Geneva
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
adult women within 48h of delivery, with: * ≥2 of the following risk factors Age ≥35 years Pre-pregnancy BMI 30.0-34.9kg/m2 Current smoking Elective cesarean section Postpartum hemorrhage Antenatal immobility * and/or ≥1 of the following 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 (\<37th week of gestation) Peripartum systemic infection (defined as fever with use of antibiotics) Intra-uterine growth restriction (birth weight \<5th percentile)
Exclusion criteria
* any indication for therapeutic anticoagulation * a high-risk of postpartum venous thromboembolism (personal history, high-risk thrombophilia) * an increased bleeding risk * a contra-indication to the use of heparin
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitement rate | 6 months | Number of study inclusion per month |
| Study participation | Within 48 hours after delivery | Proportion of eligible women who are presented the study and who accept to participate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Surgical site complication | Within 90 day of delivery | Cesarean section site complication |
| Heparin-induced thrombocytopenia | Within 90 day of delivery | — |
| Venous thromboembolism | Within 90 day after delivery | Pulmonary embolism and deep vein thrombosis |
| All-cause mortality | Within 90 day of delivery | — |
| Satisfaction with study intervention | After completion of the 10 days of study drug | Satisfaction based on TSQMII questionnaire |
| Septic pelvic thrombophlebitis | Within 90 day of delivery | — |
| Bleeding | Within 90 day after delivery | Major and clinically relevant non-major bleeding |
Countries
Switzerland
Outcome results
None listed