Back to resultsSingle Dose Intravenous Iron Isomaltoside in Combination With Oral Iron vs Oral Iron Monotherapy in Patients With Anemia After Postpartum Haemorrhage (IVIronPPH)
Primary Purpose
Post Partum Hemorrhage, Anemia
Status
Unknown status
Phase
Phase 4
Locations
Malaysia
Study Type
Interventional
Intervention
Iron Isomaltoside 1000
Placebo
Iberet-Folic-500
Sponsored by
About this trial
This is an interventional treatment trial for Post Partum Hemorrhage
Eligibility Criteria
Inclusion Criteria:
- women who underwent spontaneous vaginal delivery with Post partum hemorrhage (PPH) ≥ 500ml OR women who underwent lower segment caesarean section with PPH ≥ 1000 ml
- post PPH haemoglobin level ≤ 10.0 g/dl measured within 48hrs after delivery and stabilisation & resuscitation.
- ≥ 18 years of age
- Proficient in Malaysian language or English language
- Willingness to consent for blood taking and attending follow-up at 2 weeks and 6 weeks
Exclusion Criteria:
- refused consent to participate in trial
- history of hemolytic anemia, Thalassemia , and sickle cell anemia
- women with signs of sepsis (clinical or laboratory evidence-intrapartum fever >38.5 degrees with abnormal vital signs, positive blood culture)
- clinical or laboratory evidence of hepatic or renal, cardiovascular and hemolytic abnormalities
- history of active severe acid peptic disorder, esophagitis or hiatus hernia and malabsorption syndrome.
- Severe symptoms of anemia including dyspnoea at rest, angina pectoris, syncope or transient ischemic attacks.
- history of severe asthma, eczema or other atopic allergy
- known allergy to iron
- patients with known immune or inflammatory conditions (e.g. systemic lupus erythematosus, rheumatoid arthritis).
Sites / Locations
- University of Malaya Medical CentreRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intravenous Iron Group
Oral Iron Group
Arm Description
Outcomes
Primary Outcome Measures
Hemoglobin concentration (g/dL)
To evaluate the increase in hemoglobin level
Serum iron concentration
To evaluate the increase in serum iron concentration (µmol/L)
Serum ferritin concentration
serum ferritin levels (µg/L)
Secondary Outcome Measures
General fatigue score
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.
Number of participants that had adverse effects to intravenous iron
Any adverse effects experienced by the participant arising from the administration of intravenous iron isomaltoside will be documented and managed as per protocol.
Blood transfusion requirement
Number of blood transfusions required after intervention
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04505514
Brief Title
Single Dose Intravenous Iron Isomaltoside in Combination With Oral Iron vs Oral Iron Monotherapy in Patients With Anemia After Postpartum Haemorrhage
Acronym
IVIronPPH
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2020 (Actual)
Primary Completion Date
October 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Malaya
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Partum Hemorrhage, Anemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intravenous Iron Group
Arm Type
Experimental
Arm Title
Oral Iron Group
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Iron Isomaltoside 1000
Intervention 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
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
100 ml of 0.9% sodium chloride, infused intravenously over ≥ 20 minutes.
- infusion set will be covered for blinding
Intervention Type
Drug
Intervention Name(s)
Iberet-Folic-500
Intervention Description
once a day dose, to start 5 days after the intervention
Primary Outcome Measure Information:
Title
Hemoglobin concentration (g/dL)
Description
To evaluate the increase in hemoglobin level
Time Frame
Six weeks after intervention
Title
Serum iron concentration
Description
To evaluate the increase in serum iron concentration (µmol/L)
Time Frame
Six weeks after intervention
Title
Serum ferritin concentration
Description
serum ferritin levels (µg/L)
Time Frame
six weeks after intervention
Secondary Outcome Measure Information:
Title
General fatigue score
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.
Time Frame
Six weeks after intervention
Title
Number of participants that had adverse effects to intravenous iron
Description
Any adverse effects experienced by the participant arising from the administration of intravenous iron isomaltoside will be documented and managed as per protocol.
Time Frame
Up to six weeks after intervention
Title
Blood transfusion requirement
Description
Number of blood transfusions required after intervention
Time Frame
Up to six weeks after intervention
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
women who underwent spontaneous vaginal delivery with Post partum hemorrhage (PPH) ≥ 500ml OR women who underwent lower segment caesarean section with PPH ≥ 1000 ml
post PPH haemoglobin level ≤ 10.0 g/dl measured within 48hrs after delivery and stabilisation & resuscitation.
≥ 18 years of age
Proficient in Malaysian language or English language
Willingness to consent for blood taking and attending follow-up at 2 weeks and 6 weeks
Exclusion Criteria:
refused consent to participate in trial
history of hemolytic anemia, Thalassemia , and sickle cell anemia
women with signs of sepsis (clinical or laboratory evidence-intrapartum fever >38.5 degrees with abnormal vital signs, positive blood culture)
clinical or laboratory evidence of hepatic or renal, cardiovascular and hemolytic abnormalities
history of active severe acid peptic disorder, esophagitis or hiatus hernia and malabsorption syndrome.
Severe symptoms of anemia including dyspnoea at rest, angina pectoris, syncope or transient ischemic attacks.
history of severe asthma, eczema or other atopic allergy
known allergy to iron
patients with known immune or inflammatory conditions (e.g. systemic lupus erythematosus, rheumatoid arthritis).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carolyn Yim Chue Wai, MBBS
Phone
+603-79493133
Email
drcarolyim@um.edu.my
Facility Information:
Facility Name
University of Malaya Medical Centre
City
Petaling Jaya
State/Province
Wilayah Persekutuan Kuala Lumpur
ZIP/Postal Code
59100
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carolyn Yim Chue Wai, MBBS
Phone
+603-79493133
Email
drcarolyim@um.edu.my
12. IPD Sharing Statement
Learn more about this trial
Single Dose Intravenous Iron Isomaltoside in Combination With Oral Iron vs Oral Iron Monotherapy in Patients With Anemia After Postpartum Haemorrhage
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