NCT04447378

Safety of Fondaparinux as Post Partum Thromboprophylaxis

Safety of Fondaparinux as Postpartum Venous Thromboembolism Prophylaxis

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: National University of Malaysia · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

All women were taught the injection technique and counselled regarding the symptoms of bleeding and VTE, prior to discharge. All patients were also advised to wear compression stockings and ensure adequate hydration at home The primary outcome measure was occurrence of pulmonary embolism or deep vein thrombosis suggestive by clinical symptoms and assessment. Secondary outcome measures were allergic reaction and bleeding tendency such as secondary post-partum haemorrhage, spinal site bleeding and wound haematoma. Allergic reaction and bleeding tendency in neonates were also recorded.

Conditions

• Thromboembolism in the Puerperium

Interventions

Type	Name	Description
DRUG	Fondaparinux 2.5Mg/0.5Ml Inj Syr	post natal thromboprophylaxis

Timeline

• Start date: 2017-09-01
• Primary completion: 2018-06-01
• Completion: 2018-06-01
• First posted: 2020-06-25
• Last updated: 2020-06-26

Locations

1 site across 1 country: Malaysia