Single Dose Intravenous Iron Isomaltoside in Combination With Oral Iron vs Oral Iron Monotherapy in Patients With Anemia After Postpartum Haemorrhage
NCT ID: NCT04505514
Last Updated: 2020-08-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
60 participants
INTERVENTIONAL
2020-08-01
2022-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Intravenous Iron Group
Iron Isomaltoside 1000
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
Iberet-Folic-500
once a day dose, to start 5 days after the intervention
Oral Iron Group
Placebo
100 ml of 0.9% sodium chloride, infused intravenously over ≥ 20 minutes.
\- infusion set will be covered for blinding
Iberet-Folic-500
once a day dose, to start 5 days after the intervention
Interventions
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Iron Isomaltoside 1000
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
Placebo
100 ml of 0.9% sodium chloride, infused intravenously over ≥ 20 minutes.
\- infusion set will be covered for blinding
Iberet-Folic-500
once a day dose, to start 5 days after the intervention
Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
18 Years
50 Years
FEMALE
No
Sponsors
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University of Malaya
OTHER
Responsible Party
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Dr Carolyn Yim Chue Wai
Consultant Anaesthesiologist
Locations
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University of Malaya Medical Centre
Petaling Jaya, Kuala Lumpur, Malaysia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2020121-8204
Identifier Type: -
Identifier Source: org_study_id
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