Intravenous Versus Oral Iron in Late Pregnancy: Results of Treatment

• Status: Completed
• Trial end date: 2010-04-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Mahidol University
• Collaborators: Vifor Inc.; Vifor Pharma
• Treatments: Ferric Oxide, Saccharated; Ferrous fumarate; Iron

Criteria

Inclusion Criteria:

1. Age 18-45 years old

2. Singleton pregnancy at 32 weeks gestation

3. Having anemia in the third trimester according to World Health Organization, namely, with a hemoglobin level of < 11 g/dL or hematocrit of < 33%

4. Having no underlying disease such as hypertension, gestational diabetes mellitus, heart disease, peptic ulcer, etc.

5. Having no history of allergy to iron containing medication

6. Having no history or other allergic conditions or asthma

7. 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.

8. Having no history of bleeding tendency

9. Having no history of blood transfusion within the prior 120 days

10. Having no history of delivery before 36 weeks gestation

11. Giving consent and having signed the consent form for this study

Exclusion Criteria:

1. Stool exam revealed parasitic infestation

2. C-reactive protein > 3 mg/L

3. Serum ferritin > 15 mcg/L