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Safety of Fondaparinux as Post Partum Thromboprophylaxis

Primary Purpose

Thromboembolism in the Puerperium

Status
Completed
Phase
Phase 4
Locations
Malaysia
Study Type
Interventional
Intervention
Fondaparinux 2.5Mg/0.5Ml Inj Syr
Sponsored by
National University of Malaysia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Thromboembolism in the Puerperium focused on measuring pregnancy, thromboembolism, prophylaxis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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 )

Sites / Locations

  • Department of Obstetrics & Gynaecology, Universiti Kebangsaan Medical Centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Fondaparinux

Arm Description

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

Outcomes

Primary Outcome Measures

Venous thromboembolism (VTE)
VTE occurence of either deep vein thrombosis or pulmonary embolism

Secondary Outcome Measures

Major Bleeding requiring hospitalisation
Secondary post partum haemorrhage or spinal site bleeding
Minor bleeding
Wound site bleeding, skin bruising
Allergic reaction
Any allergy symptoms following injection of fondaparinux
Neonatal bleeding tendency
Any bruising of bleeding tendency in neonates

Full Information

First Posted
June 22, 2020
Last Updated
June 24, 2020
Sponsor
National University of Malaysia
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1. Study Identification

Unique Protocol Identification Number
NCT04447378
Brief Title
Safety of Fondaparinux as Post Partum Thromboprophylaxis
Official Title
Safety of Fondaparinux as Postpartum Venous Thromboembolism Prophylaxis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
June 1, 2018 (Actual)
Study Completion Date
June 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National University of Malaysia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thromboembolism in the Puerperium
Keywords
pregnancy, thromboembolism, prophylaxis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fondaparinux
Arm Type
Experimental
Arm Description
Subcutaneous injection of fondaparinux 2.5 mg once daily would be given over 10 days for post partum thromboprophylaxis
Intervention Type
Drug
Intervention Name(s)
Fondaparinux 2.5Mg/0.5Ml Inj Syr
Other Intervention Name(s)
N/A; single arm study
Intervention Description
post natal thromboprophylaxis
Primary Outcome Measure Information:
Title
Venous thromboembolism (VTE)
Description
VTE occurence of either deep vein thrombosis or pulmonary embolism
Time Frame
Within six weeks of delivery
Secondary Outcome Measure Information:
Title
Major Bleeding requiring hospitalisation
Description
Secondary post partum haemorrhage or spinal site bleeding
Time Frame
within six weeks of delivery
Title
Minor bleeding
Description
Wound site bleeding, skin bruising
Time Frame
within six weeks of delivery
Title
Allergic reaction
Description
Any allergy symptoms following injection of fondaparinux
Time Frame
within 24 hours from last injection
Title
Neonatal bleeding tendency
Description
Any bruising of bleeding tendency in neonates
Time Frame
within six weeks of delivery

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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: 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 )
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nor Azlin Mohamed Ismail, MBCHB, MMED
Organizational Affiliation
Faculty of Medicine, National University of Malaysia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Obstetrics & Gynaecology, Universiti Kebangsaan Medical Centre
City
Cheras
State/Province
Kuala Lumpur
ZIP/Postal Code
56000
Country
Malaysia

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
IPD is available upon request

Learn more about this trial

Safety of Fondaparinux as Post Partum Thromboprophylaxis

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