Safety of Fondaparinux as Post Partum Thromboprophylaxis

Safety of Fondaparinux as Postpartum Venous Thromboembolism Prophylaxis

Sponsors

Lead Sponsor: National University of Malaysia

Source 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.

Overall Status Completed
Start Date September 1, 2017
Completion Date June 1, 2018
Primary Completion Date June 1, 2018
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
Venous thromboembolism (VTE) Within six weeks of delivery
Secondary Outcome
Measure Time Frame
Major Bleeding requiring hospitalisation within six weeks of delivery
Minor bleeding within six weeks of delivery
Allergic reaction within 24 hours from last injection
Neonatal bleeding tendency within six weeks of delivery
Enrollment 60
Condition
Intervention

Intervention Type: Drug

Intervention Name: Fondaparinux 2.5Mg/0.5Ml Inj Syr

Description: post natal thromboprophylaxis

Arm Group Label: Fondaparinux

Other Name: N/A; single arm study

Eligibility

Criteria:

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 )

Gender: Female

Gender Based: Yes

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Nor Azlin Mohamed Ismail, MBCHB, MMED Principal Investigator Faculty of Medicine, National University of Malaysia
Location
Facility: Department of Obstetrics & Gynaecology, Universiti Kebangsaan Medical Centre
Location Countries

Malaysia

Verification Date

June 2020

Responsible Party

Type: Principal Investigator

Investigator Affiliation: National University of Malaysia

Investigator Full Name: Aida Hani Mohd Kalok

Investigator Title: Lecturer & Clinical Specialist

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: Fondaparinux

Type: Experimental

Description: Subcutaneous injection of fondaparinux 2.5 mg once daily would be given over 10 days for post partum thromboprophylaxis

Patient Data No
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Prevention

Masking: None (Open Label)

Source: ClinicalTrials.gov