drugset / Trial / NCT04447378

Safety of Fondaparinux as Post Partum Thromboprophylaxis

NCT04447378

Phase 4 Completed 60 enrolled National University of Malaysia
NaSingle-groupOpen-labelPrevention

Summary

Venous thromboembolism (VTE) remains as one of leading causes of maternal morbidity and mortality, with postpartum period carries the greatest risk. Perinatal thromboprophylaxis is often administered based on risk-factor assessment. Low molecular weight heparin has a proven safety profile in obstetrics population, however its porcine derived content may lead to reduced uptake amongst certain religious groups. The investigators aimed to evaluate the safety of fondaparinux as an alternative postpartum thromboprophylaxis. The investigators planned a prospective, single arm, open label study. Women who fulfilled the criteria for post natal thromboprophylaxis based on the 2015 RCOG guidelines were recruited. Each patient would receive subcutaneous injection of Fondaparinux, 2.5mg daily for 10 days. The investigators would conduct a telephone interview on day 10 post delivery and six week outpatient review in clinic.

Timeline

Start
2017-09-01
Primary completion
2018-06-01
Completion
2018-06-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Fondaparinux Other / unclassified 2.5 mg Subcutaneous