Thromboembolism in the Puerperium
Conditions
Keywords
pregnancy, thromboembolism, prophylaxis
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.
Interventions
DRUGFondaparinux 2.5Mg/0.5Ml Inj Syr
post natal thromboprophylaxis
Sponsors
National University of Malaysia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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 )
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Venous thromboembolism (VTE) | Within six weeks of delivery | VTE occurence of either deep vein thrombosis or pulmonary embolism |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Malaysia
Outcome results
None listed