Safety of Fondaparinux as Post Partum Thromboprophylaxis

Thromboembolism in the Puerperium Clinical Trial

Official title:

Safety of Fondaparinux as Postpartum Venous Thromboembolism Prophylaxis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04447378
• Other study ID #: JEP -2017-543
• Status: Completed
• Phase: Phase 4
• Start date: September 1, 2017
• Est. completion date: June 1, 2018

Study information

• Verified date: June 2020
• Source: National University of Malaysia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 1, 2018
• Est. primary completion date: June 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 )

Related Conditions & MeSH terms

• Thromboembolism
• Thromboembolism in the Puerperium

Intervention

Drug:
• Fondaparinux 2.5Mg/0.5Ml Inj Syr
post natal thromboprophylaxis

Locations

Country	Name	City	State
Malaysia	Department of Obstetrics & Gynaecology, Universiti Kebangsaan Medical Centre	Cheras	Kuala Lumpur

Sponsors (1)

Lead Sponsor	Collaborator
National University of Malaysia

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Venous thromboembolism (VTE)	VTE occurence of either deep vein thrombosis or pulmonary embolism	Within six weeks of delivery
Secondary	Major Bleeding requiring hospitalisation	Secondary post partum haemorrhage or spinal site bleeding	within six weeks of delivery
Secondary	Minor bleeding	Wound site bleeding, skin bruising	within six weeks of delivery
Secondary	Allergic reaction	Any allergy symptoms following injection of fondaparinux	within 24 hours from last injection
Secondary	Neonatal bleeding tendency	Any bruising of bleeding tendency in neonates	within six weeks of delivery