<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/NCT04505514</url>
  </required_header>
  <id_info>
    <org_study_id>2020121-8204</org_study_id>
    <nct_id>NCT04505514</nct_id>
  </id_info>
  <brief_title>Single Dose Intravenous Iron Isomaltoside in Combination With Oral Iron vs Oral Iron Monotherapy in Patients With Anemia After Postpartum Haemorrhage</brief_title>
  <acronym>IVIronPPH</acronym>
  <official_title>Single Dose Intravenous Iron Isomaltoside in Combination With Oral Iron vs Oral Iron Monotherapy in Patients With Anemia After Postpartum Haemorrhage: A Single-blinded, Randomised Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Malaya</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Malaya</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigator's study is going to compare effectiveness of single dose intravenous iron in&#xD;
      combination with oral iron versus oral iron monotherapy in correcting haemoglobin deficit,&#xD;
      replenishing iron stores and improving clinical symptoms in women with post-partum anaemia&#xD;
      after postpartum hemorrhage without increasing the rate of adverse outcomes.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 1, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">October 31, 2022</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Hemoglobin concentration (g/dL)</measure>
    <time_frame>Six weeks after intervention</time_frame>
    <description>To evaluate the increase in hemoglobin level</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Serum iron concentration</measure>
    <time_frame>Six weeks after intervention</time_frame>
    <description>To evaluate the increase in serum iron concentration (µmol/L)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Serum ferritin concentration</measure>
    <time_frame>six weeks after intervention</time_frame>
    <description>serum ferritin levels (µg/L)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>General fatigue score</measure>
    <time_frame>Six weeks after intervention</time_frame>
    <description>Using the Multidimensional Fatigue Inventory (MFI) which will be answered by the participants, scores will be taken ranging from lowest 4, till the highest of 20. A higher score will indicate higher levels of fatigue.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants that had adverse effects to intravenous iron</measure>
    <time_frame>Up to six weeks after intervention</time_frame>
    <description>Any adverse effects experienced by the participant arising from the administration of intravenous iron isomaltoside will be documented and managed as per protocol.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood transfusion requirement</measure>
    <time_frame>Up to six weeks after intervention</time_frame>
    <description>Number of blood transfusions required after intervention</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Post Partum Hemorrhage</condition>
  <condition>Anemia</condition>
  <arm_group>
    <arm_group_label>Intravenous Iron Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Oral Iron Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Iron Isomaltoside 1000</intervention_name>
    <description>single dose of 1000 mg iron isomaltoside diluted in 100 ml of 0.9% sodium chloride, infused intravenously over ≥ 20 minutes.&#xD;
- infusion set will be covered for blinding</description>
    <arm_group_label>Intravenous Iron Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>100 ml of 0.9% sodium chloride, infused intravenously over ≥ 20 minutes.&#xD;
- infusion set will be covered for blinding</description>
    <arm_group_label>Oral Iron Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Iberet-Folic-500</intervention_name>
    <description>once a day dose, to start 5 days after the intervention</description>
    <arm_group_label>Intravenous Iron Group</arm_group_label>
    <arm_group_label>Oral Iron Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  women who underwent spontaneous vaginal delivery with Post partum hemorrhage (PPH) ≥&#xD;
             500ml OR women who underwent lower segment caesarean section with PPH ≥ 1000 ml&#xD;
&#xD;
          -  post PPH haemoglobin level ≤ 10.0 g/dl measured within 48hrs after delivery and&#xD;
             stabilisation &amp; resuscitation.&#xD;
&#xD;
          -  ≥ 18 years of age&#xD;
&#xD;
          -  Proficient in Malaysian language or English language&#xD;
&#xD;
          -  Willingness to consent for blood taking and attending follow-up at 2 weeks and 6 weeks&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  refused consent to participate in trial&#xD;
&#xD;
          -  history of hemolytic anemia, Thalassemia , and sickle cell anemia&#xD;
&#xD;
          -  women with signs of sepsis (clinical or laboratory evidence-intrapartum fever &gt;38.5&#xD;
             degrees with abnormal vital signs, positive blood culture)&#xD;
&#xD;
          -  clinical or laboratory evidence of hepatic or renal, cardiovascular and hemolytic&#xD;
             abnormalities&#xD;
&#xD;
          -  history of active severe acid peptic disorder, esophagitis or hiatus hernia and&#xD;
             malabsorption syndrome.&#xD;
&#xD;
          -  Severe symptoms of anemia including dyspnoea at rest, angina pectoris, syncope or&#xD;
             transient ischemic attacks.&#xD;
&#xD;
          -  history of severe asthma, eczema or other atopic allergy&#xD;
&#xD;
          -  known allergy to iron&#xD;
&#xD;
          -  patients with known immune or inflammatory conditions (e.g. systemic lupus&#xD;
             erythematosus, rheumatoid arthritis).&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Carolyn Yim Chue Wai, MBBS</last_name>
    <phone>+603-79493133</phone>
    <email>drcarolyim@um.edu.my</email>
  </overall_contact>
  <location>
    <facility>
      <name>University of Malaya Medical Centre</name>
      <address>
        <city>Petaling Jaya</city>
        <state>Wilayah Persekutuan Kuala Lumpur</state>
        <zip>59100</zip>
        <country>Malaysia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Carolyn Yim Chue Wai, MBBS</last_name>
      <phone>+603-79493133</phone>
      <email>drcarolyim@um.edu.my</email>
    </contact>
  </location>
  <location_countries>
    <country>Malaysia</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>July 23, 2020</study_first_submitted>
  <study_first_submitted_qc>August 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2020</study_first_posted>
  <last_update_submitted>August 11, 2020</last_update_submitted>
  <last_update_submitted_qc>August 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 12, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Malaya</investigator_affiliation>
    <investigator_full_name>Dr Carolyn Yim Chue Wai</investigator_full_name>
    <investigator_title>Consultant Anaesthesiologist</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Postpartum Hemorrhage</mesh_term>
    <mesh_term>Anemia</mesh_term>
    <mesh_term>Hemorrhage</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Iron isomaltoside 1000</mesh_term>
  </intervention_browse>
  <!-- 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/NCT04505514
org study id: 2020121-8204
nct id: NCT04505514
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The investigator's study is going to compare effectiveness of single dose intravenous iron in
      combination with oral iron versus oral iron monotherapy in correcting haemoglobin deficit,
      replenishing iron stores and improving clinical symptoms in women with post-partum anaemia
      after postpartum hemorrhage without increasing the rate of adverse outcomes.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Hemoglobin concentration (g/dL)
time frame: Six weeks after intervention
description: To evaluate the increase in hemoglobin level
measure: Serum iron concentration
time frame: Six weeks after intervention
description: To evaluate the increase in serum iron concentration (µmol/L)
measure: Serum ferritin concentration
time frame: six weeks after intervention
description: serum ferritin levels (µg/L)
measure: General fatigue score
time frame: Six weeks after intervention
description: Using the Multidimensional Fatigue Inventory (MFI) which will be answered by the participants, scores will be taken ranging from lowest 4, till the highest of 20. A higher score will indicate higher levels of fatigue.
measure: Number of participants that had adverse effects to intravenous iron
time frame: Up to six weeks after intervention
description: Any adverse effects experienced by the participant arising from the administration of intravenous iron isomaltoside will be documented and managed as per protocol.
measure: Blood transfusion requirement
time frame: Up to six weeks after intervention
description: Number of blood transfusions required after intervention
arm group label: Intravenous Iron Group
arm group type: Experimental
arm group label: Oral Iron Group
arm group type: Active Comparator
intervention type: Drug
intervention name: Iron Isomaltoside 1000
description: single dose of 1000 mg iron isomaltoside diluted in 100 ml of 0.9% sodium chloride, infused intravenously over ≥ 20 minutes.
- infusion set will be covered for blinding
arm group label: Intravenous Iron Group
intervention type: Drug
intervention name: Placebo
description: 100 ml of 0.9% sodium chloride, infused intravenously over ≥ 20 minutes.
- infusion set will be covered for blinding
arm group label: Oral Iron Group
intervention type: Drug
intervention name: Iberet-Folic-500
description: once a day dose, to start 5 days after the intervention
arm group label: Intravenous Iron Group
arm group label: Oral Iron Group
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
last name: Carolyn Yim Chue Wai, MBBS
phone: +603-79493133
email: drcarolyim@um.edu.my
facility: 
status: Recruiting
contact: 
country: Malaysia
responsible party type: Principal Investigator
investigator affiliation: University of Malaya
investigator full name: Dr Carolyn Yim Chue Wai
investigator title: Consultant Anaesthesiologist
mesh term: Postpartum Hemorrhage
mesh term: Anemia
mesh term: Hemorrhage
mesh term: Iron isomaltoside 1000