<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04447378</url>
  </required_header>
  <id_info>
    <org_study_id>JEP -2017-543</org_study_id>
    <nct_id>NCT04447378</nct_id>
  </id_info>
  <brief_title>Safety of Fondaparinux as Post Partum Thromboprophylaxis</brief_title>
  <official_title>Safety of Fondaparinux as Postpartum Venous Thromboembolism Prophylaxis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National University of Malaysia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National University of Malaysia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Venous thromboembolism (VTE) remains as one of leading causes of maternal morbidity and&#xD;
      mortality, with postpartum period carries the greatest risk. Perinatal thromboprophylaxis is&#xD;
      often administered based on risk-factor assessment. Low molecular weight heparin has a proven&#xD;
      safety profile in obstetrics population, however its porcine derived content may lead to&#xD;
      reduced uptake amongst certain religious groups. The investigators aimed to evaluate the&#xD;
      safety of fondaparinux as an alternative postpartum thromboprophylaxis.&#xD;
&#xD;
      The investigators planned a prospective, single arm, open label study. Women who fulfilled&#xD;
      the criteria for post natal thromboprophylaxis based on the 2015 RCOG guidelines were&#xD;
      recruited. Each patient would receive subcutaneous injection of Fondaparinux, 2.5mg daily for&#xD;
      10 days. The investigators would conduct a telephone interview on day 10 post delivery and&#xD;
      six week outpatient review in clinic.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All women were taught the injection technique and counselled regarding the symptoms of&#xD;
      bleeding and VTE, prior to discharge. All patients were also advised to wear compression&#xD;
      stockings and ensure adequate hydration at home&#xD;
&#xD;
      The primary outcome measure was occurrence of pulmonary embolism or deep vein thrombosis&#xD;
      suggestive by clinical symptoms and assessment. Secondary outcome measures were allergic&#xD;
      reaction and bleeding tendency such as secondary post-partum haemorrhage, spinal site&#xD;
      bleeding and wound haematoma. Allergic reaction and bleeding tendency in neonates were also&#xD;
      recorded.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2017</start_date>
  <completion_date type="Actual">June 1, 2018</completion_date>
  <primary_completion_date type="Actual">June 1, 2018</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Venous thromboembolism (VTE)</measure>
    <time_frame>Within six weeks of delivery</time_frame>
    <description>VTE occurence of either deep vein thrombosis or pulmonary embolism</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Major Bleeding requiring hospitalisation</measure>
    <time_frame>within six weeks of delivery</time_frame>
    <description>Secondary post partum haemorrhage or spinal site bleeding</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Minor bleeding</measure>
    <time_frame>within six weeks of delivery</time_frame>
    <description>Wound site bleeding, skin bruising</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Allergic reaction</measure>
    <time_frame>within 24 hours from last injection</time_frame>
    <description>Any allergy symptoms following injection of fondaparinux</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neonatal bleeding tendency</measure>
    <time_frame>within six weeks of delivery</time_frame>
    <description>Any bruising of bleeding tendency in neonates</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Thromboembolism in the Puerperium</condition>
  <arm_group>
    <arm_group_label>Fondaparinux</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subcutaneous injection of fondaparinux 2.5 mg once daily would be given over 10 days for post partum thromboprophylaxis</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fondaparinux 2.5Mg/0.5Ml Inj Syr</intervention_name>
    <description>post natal thromboprophylaxis</description>
    <arm_group_label>Fondaparinux</arm_group_label>
    <other_name>N/A; single arm study</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Malaysian&#xD;
&#xD;
          -  Age 18 and above&#xD;
&#xD;
          -  Scores asintermediate risk on 2015 Royal College of Obstetricians &amp; Gynaecologists&#xD;
             (RCOG) VTE risk assessment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Hypersensitivity to fondaparinux&#xD;
&#xD;
          2. Patients with bleeding disorders - haemophilia , thrombocytopenia, von Willebrand's&#xD;
             disease.&#xD;
&#xD;
          3. Weight &lt; 50 kg&#xD;
&#xD;
          4. Patients with primary postpartum haemorrhage&#xD;
&#xD;
          5. Patients who already on anti - coagulants&#xD;
&#xD;
          6. Medical co morbidities - Systemic lupus erythematosus, heart failure, nephrotic&#xD;
             syndrome, type 1 diabetes mellitus with nephropathy, sickle cell disease, current&#xD;
             intravenous drug user&#xD;
&#xD;
          7. Uncontrolled hypertension ( blood pressure &gt; 200 mmHg systolic or &gt; 120 mmHg diastolic&#xD;
             )&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nor Azlin Mohamed Ismail, MBCHB, MMED</last_name>
    <role>Principal Investigator</role>
    <affiliation>Faculty of Medicine, National University of Malaysia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Obstetrics &amp; Gynaecology, Universiti Kebangsaan Medical Centre</name>
      <address>
        <city>Cheras</city>
        <state>Kuala Lumpur</state>
        <zip>56000</zip>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Malaysia</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 22, 2020</study_first_submitted>
  <study_first_submitted_qc>June 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 25, 2020</study_first_posted>
  <last_update_submitted>June 24, 2020</last_update_submitted>
  <last_update_submitted_qc>June 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 26, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>National University of Malaysia</investigator_affiliation>
    <investigator_full_name>Aida Hani Mohd Kalok</investigator_full_name>
    <investigator_title>Lecturer &amp; Clinical Specialist</investigator_title>
  </responsible_party>
  <keyword>pregnancy</keyword>
  <keyword>thromboembolism</keyword>
  <keyword>prophylaxis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thromboembolism</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>PENTA</mesh_term>
    <mesh_term>Fondaparinux</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>IPD is available upon request</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04447378
org study id: JEP -2017-543
nct id: NCT04447378
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
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.
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Venous thromboembolism (VTE)
time frame: Within six weeks of delivery
description: VTE occurence of either deep vein thrombosis or pulmonary embolism
measure: Major Bleeding requiring hospitalisation
time frame: within six weeks of delivery
description: Secondary post partum haemorrhage or spinal site bleeding
measure: Minor bleeding
time frame: within six weeks of delivery
description: Wound site bleeding, skin bruising
measure: Allergic reaction
time frame: within 24 hours from last injection
description: Any allergy symptoms following injection of fondaparinux
measure: Neonatal bleeding tendency
time frame: within six weeks of delivery
description: Any bruising of bleeding tendency in neonates
arm group label: Fondaparinux
arm group type: Experimental
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: Fondaparinux 2.5Mg/0.5Ml Inj Syr
description: post natal thromboprophylaxis
arm group label: Fondaparinux
other name: N/A; single arm study
criteria: 
gender: Female
gender based: Yes
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Nor Azlin Mohamed Ismail, MBCHB, MMED
role: Principal Investigator
affiliation: Faculty of Medicine, National University of Malaysia
facility: 
country: Malaysia
responsible party type: Principal Investigator
investigator affiliation: National University of Malaysia
investigator full name: Aida Hani Mohd Kalok
investigator title: Lecturer & Clinical Specialist
mesh term: Thromboembolism
mesh term: PENTA
mesh term: Fondaparinux
sharing ipd: No
ipd description: IPD is available upon request