Status:
COMPLETED
Intravenous Versus Oral Iron in Late Pregnancy: Results of Treatment
Lead Sponsor:
Mahidol University
Collaborating Sponsors:
Vifor Pharma
Conditions:
Anemia
Pregnancy Complications
Eligibility:
FEMALE
18-45 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to compare the efficacy of body iron storage replenishment between low dose intravenous iron and oral iron in late pregnancy.
Detailed Description
Despite routine antenatal oral iron supplementation, the prevalence of iron deficiency anemia (IDA) in the 3rd trimester of pregnancy in developing countries remains high. Apparently, intravenous iron...
Eligibility Criteria
Inclusion
- Age 18-45 years old
- Singleton pregnancy at 32 weeks gestation
- Having anemia in the third trimester according to World Health Organization, namely, with a hemoglobin level of \< 11 g/dL or hematocrit of \< 33%
- Having no underlying disease such as hypertension, gestational diabetes mellitus, heart disease, peptic ulcer, etc.
- Having no history of allergy to iron containing medication
- Having no history or other allergic conditions or asthma
- Having no thalassemia disease, for examples: B thalassemia major, hemoglobin E/ B thalassemia, homozygous hemoglobin E, Hemoglobin H, AE Bart disease, and EF Bart disease. Pregnant women who have iron deficiency anemia and are thalassemia carriers such as A-thalassemia 1, B-thalassemia, or less severe Hb E/ B thalassemia are able to enter the study.
- Having no history of bleeding tendency
- Having no history of blood transfusion within the prior 120 days
- Having no history of delivery before 36 weeks gestation
- Giving consent and having signed the consent form for this study
Exclusion
- Stool exam revealed parasitic infestation
- C-reactive protein \> 3 mg/L
- Serum ferritin \> 15 mcg/L
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00746551
Start Date
September 1 2008
End Date
April 1 2010
Last Update
February 16 2015
Active Locations (1)
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1
Siriraj Hospital, Mahidol University
Bangkok, Bangkok, Thailand, 10700