Status:
UNKNOWN
Single Dose Intravenous Iron Isomaltoside in Combination With Oral Iron vs Oral Iron Monotherapy in Patients With Anemia After Postpartum Haemorrhage
Lead Sponsor:
University of Malaya
Conditions:
Post Partum Hemorrhage
Anemia
Eligibility:
FEMALE
18-50 years
Phase:
PHASE4
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 ir...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
August 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2022
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04505514
Start Date
August 1 2020
End Date
December 31 2022
Last Update
August 12 2020
Active Locations (1)
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1
University of Malaya Medical Centre
Petaling Jaya, Kuala Lumpur, Malaysia, 59100