Postpartum Heparin Against Venous Thromboembolism: a Pilot Randomized Controlled Trial

Study Overview
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Brief Summary
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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

Official Title
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Postpartum Heparin Against Venous Thromboembolism: a Pilot Randomized Controlled Trial

Conditions
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Venous Thromboembolism

Intervention / Treatment
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* Drug: Enoxaparin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Enoxaparin<br>Enoxaparin 20-60mg o.d., according to bodyweight, for 10 days postpartum. | Drug: Enoxaparin<br>* Prophylactic dose of enoxaparin once daily for 10 days after delivery.<br>|
| No Intervention: No treatment<br>No treatment. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitement rate | Number of study inclusion per month | 6 months | 
| Study participation | Proportion of eligible women who are presented the study and who accept to participate | Within 48 hours after delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Venous thromboembolism | Pulmonary embolism and deep vein thrombosis | Within 90 day after delivery | 
| Bleeding | Major and clinically relevant non-major bleeding | Within 90 day after delivery | 
| Surgical site complication | Cesarean section site complication | Within 90 day of delivery | 
| Heparin-induced thrombocytopenia |  | Within 90 day of delivery | 
| Septic pelvic thrombophlebitis |  | Within 90 day of delivery | 
| All-cause mortality |  | Within 90 day of delivery | 
| Satisfaction with study intervention | Satisfaction based on TSQMII questionnaire | After completion of the 10 days of study drug |