Clinical trial NCT04447378: Safety of Fondaparinux as Post Partum Thromboprophylaxis
Official title: Safety of Fondaparinux as Postpartum Venous Thromboembolism Prophylaxis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Thromboembolism in the Puerperium
Keywords: pregnancy
thromboembolism
prophylaxis
Lead sponsor: National University of Malaysia
Sponsor class: OTHER
First posted: 2020-06-25
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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 )

Primary outcomes:
measure: Venous thromboembolism (VTE)
timeFrame: Within six weeks of delivery
Secondary outcomes:
measure: Major Bleeding requiring hospitalisation
timeFrame: within six weeks of delivery
measure: Minor bleeding
timeFrame: within six weeks of delivery
measure: Allergic reaction
timeFrame: within 24 hours from last injection
measure: Neonatal bleeding tendency
timeFrame: within six weeks of delivery
Other outcomes:
Locations:
city: Cheras
country: Malaysia
facility: Department of Obstetrics & Gynaecology, Universiti Kebangsaan Medical Centre
state: Kuala Lumpur
Study officials:
affiliation: Faculty of Medicine, National University of Malaysia
name: Nor Azlin Mohamed Ismail, MBCHB, MMED
role: PRINCIPAL_INVESTIGATOR
References: