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Safety of Fondaparinux as Post Partum Thromboprophylaxis

Sponsor
National University of Malaysia (Other)
Overall Status
Completed
CT.gov ID
NCT04447378
Collaborator
(none)
60
Enrollment
1
Location
1
Arm
9
Actual Duration (Months)
6.7
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Fondaparinux 2.5Mg/0.5Ml Inj Syr
 Phase 4

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Safety of Fondaparinux as Postpartum Venous Thromboembolism Prophylaxis
Actual Study Start Date :
Sep 1, 2017
Actual Primary Completion Date :
Jun 1, 2018
Actual Study Completion Date :
Jun 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Fondaparinux

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

Drug: Fondaparinux 2.5Mg/0.5Ml Inj Syr
post natal thromboprophylaxis
Other Names:
  • N/A; single arm study

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Venous thromboembolism (VTE) [Within six weeks of delivery]

      VTE occurence of either deep vein thrombosis or pulmonary embolism

    Secondary Outcome Measures

    1. Major Bleeding requiring hospitalisation [within six weeks of delivery]

      Secondary post partum haemorrhage or spinal site bleeding

    2. Minor bleeding [within six weeks of delivery]

      Wound site bleeding, skin bruising

    3. Allergic reaction [within 24 hours from last injection]

      Any allergy symptoms following injection of fondaparinux

    4. Neonatal bleeding tendency [within six weeks of delivery]

      Any bruising of bleeding tendency in neonates

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts 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 )

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Obstetrics & Gynaecology, Universiti Kebangsaan Medical Centre Cheras Kuala Lumpur Malaysia 56000

    Sponsors and Collaborators

    • National University of Malaysia

    Investigators

    • Principal Investigator: Nor Azlin Mohamed Ismail, MBCHB, MMED, Faculty of Medicine, National University of Malaysia

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Aida Hani Mohd Kalok, Lecturer & Clinical Specialist, National University of Malaysia
    ClinicalTrials.gov Identifier:
    NCT04447378
    Other Study ID Numbers:
    • JEP -2017-543
    First Posted:
    Jun 25, 2020
    Last Update Posted:
    Jun 26, 2020
    Last Verified:
    Jun 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Keywords provided by Aida Hani Mohd Kalok, Lecturer & Clinical Specialist, National University of Malaysia
    pregnancy
    thromboembolism
    prophylaxis
    Additional relevant MeSH terms:
    Thromboembolism
    PENTA
    Fondaparinux

    Study Results

    No Results Posted as of Jun 26, 2020