Safety of Fondaparinux as Post Partum Thromboprophylaxis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-01

Study Completion Date

2018-06-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Thromboembolism in the Puerperium

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Fondaparinux

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

Group Type EXPERIMENTAL

Fondaparinux 2.5Mg/0.5Ml Inj Syr

Intervention Type DRUG

post natal thromboprophylaxis

Interventions

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Fondaparinux 2.5Mg/0.5Ml Inj Syr

post natal thromboprophylaxis

Intervention Type DRUG

Other Intervention Names

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N/A; single arm study

Eligibility Criteria

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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 )

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes