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Completed

NCT Number: NCT04447378

Safety of Fondaparinux as Post Partum Thromboprophylaxis

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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Key information

Conditions

Thromboembolism in the Puerperium Cardiovascular Diseases Embolism and Thrombosis Thromboembolism Vascular Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Department of Obstetrics & Gynaecology, Universiti Kebangsaan Medical Centre

Cheras, Kuala Lumpur, 56000, Malaysia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Malaysian
  • Age 18 and above
  • Scores asintermediate risk on 2015 Royal College of Obstetricians & Gynaecologists (RCOG) VTE risk assessment

Exclusion criteria

  • Hypersensitivity to fondaparinux
  • Patients with bleeding disorders - haemophilia , thrombocytopenia, von Willebrand's disease.
  • Weight < 50 kg
  • Patients with primary postpartum haemorrhage
  • Patients who already on anti - coagulants
  • Medical co morbidities - Systemic lupus erythematosus, heart failure, nephrotic syndrome, type 1 diabetes mellitus with nephropathy, sickle cell disease, current intravenous drug user
  • Uncontrolled hypertension ( blood pressure > 200 mmHg systolic or > 120 mmHg diastolic )

Treatment and study plan

Fondaparinux 2.5Mg/0.5Ml Inj Syr

Drug

post natal thromboprophylaxis

Other names: N/A; single arm study

Primary outcomes

  1. Venous thromboembolism (VTE)

    Time frame: Within six weeks of delivery

    VTE occurence of either deep vein thrombosis or pulmonary embolism

Secondary outcomes

  1. Major Bleeding requiring hospitalisation

    Time frame: within six weeks of delivery

    Secondary post partum haemorrhage or spinal site bleeding

  2. Minor bleeding

    Time frame: within six weeks of delivery

    Wound site bleeding, skin bruising

  3. Allergic reaction

    Time frame: within 24 hours from last injection

    Any allergy symptoms following injection of fondaparinux

  4. Neonatal bleeding tendency

    Time frame: within six weeks of delivery

    Any bruising of bleeding tendency in neonates

Sponsors and collaborators

Lead sponsor

National University of Malaysia

Other

Registry information

Official study title

Safety of Fondaparinux as Postpartum Venous Thromboembolism Prophylaxis

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jun 25, 2020
Registry last updated
Jun 26, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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