Postpartum Heparin Against Venous Thromboembolism: a Pilot Randomized Controlled Trial

Phase 3

Completed

• Conditions: Venous Thromboembolism
• Interventions: Drug: Enoxaparin

• Registration Number: NCT05878899
• Lead Sponsor: University Hospital, Geneva

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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-03
• Study First Submitted: 2023-03-06
• Primary Completion: 2023-03-13
• Study Completion: 2023-03-13
• Status Verified: 2023-05
• Study First Submitted QC: 2023-05-24
• Last Update Submitted: 2023-05-24
• Study First Posted: 2023-05-26
• Last Update Posted: 2023-05-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 77

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Enoxaparin	Enoxaparin	Enoxaparin 20-60mg o.d., according to bodyweight, for 10 days postpartum.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (1)

Geneva University Hospitals; 🇨🇭 Geneve, Switzerland