Safety of Fondaparinux as Post Partum Thromboprophylaxis

Phase 4

Completed

• Conditions: Thromboembolism in the Puerperium
• Interventions: Drug: Fondaparinux 2.5Mg/0.5Ml Inj Syr

• Registration Number: NCT04447378
• Lead Sponsor: National University of Malaysia

Brief 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.

Study Timeline

• Study Start: 2017-09-01
• Primary Completion: 2018-06-01
• Study Completion: 2018-06-01
• Status Verified: 2020-06
• Study First Submitted: 2020-06-22
• Study First Submitted QC: 2020-06-22
• Last Update Submitted: 2020-06-24
• Study First Posted: 2020-06-25
• Last Update Posted: 2020-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

• Malaysian
• Age 18 and above
• Scores asintermediate risk on 2015 Royal College of Obstetricians & Gynaecologists (RCOG) VTE risk assessment

Exclusion Criteria

1. Hypersensitivity to fondaparinux
2. Patients with bleeding disorders - haemophilia , thrombocytopenia, von Willebrand's disease.
3. Weight < 50 kg
4. Patients with primary postpartum haemorrhage
5. Patients who already on anti - coagulants
6. Medical co morbidities - Systemic lupus erythematosus, heart failure, nephrotic syndrome, type 1 diabetes mellitus with nephropathy, sickle cell disease, current intravenous drug user
7. Uncontrolled hypertension ( blood pressure > 200 mmHg systolic or > 120 mmHg diastolic )

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Fondaparinux	Fondaparinux 2.5Mg/0.5Ml Inj Syr	Subcutaneous injection of fondaparinux 2.5 mg once daily would be given over 10 days for post partum thromboprophylaxis

Primary Outcome Measures

Name	Time	Method
Venous thromboembolism (VTE)	Within six weeks of delivery	VTE occurence of either deep vein thrombosis or pulmonary embolism

Secondary Outcome Measures

Name	Time	Method
Major Bleeding requiring hospitalisation	within six weeks of delivery	Secondary post partum haemorrhage or spinal site bleeding
Minor bleeding	within six weeks of delivery	Wound site bleeding, skin bruising
Allergic reaction	within 24 hours from last injection	Any allergy symptoms following injection of fondaparinux
Neonatal bleeding tendency	within six weeks of delivery	Any bruising of bleeding tendency in neonates

Trial Locations

Locations (1)

Department of Obstetrics & Gynaecology, Universiti Kebangsaan Medical Centre; 🇲🇾 Cheras, Kuala Lumpur, Malaysia