Intravenous Versus Oral Iron in Late Pregnancy: Results of Treatment
Condition: Anemia; Pregnancy Complications
MeSH terms: Pregnancy Complications; Anemia
Intervention: Ferli-6® (Continental Pharm co., ltd.); Venofer® (Vifor AG, St. Gallen, Switzerland)
Intervention description: In the O-group, women had to take 3 ferrous fumarate tablets (Ferli-6®) everyday with a total of 200 mg of elemental iron per day from 33 weeks gestation until delivery. Emphasizing and monitoring for compliance to the treatment protocol were carried out.; Women in the IV-group received 500 mg iron sucrose (Venofer®, Vifor International AG, St. Gallen, Switzerland) divided into three weekly administrations. Two doses of 200 mg iron sucrose were given at 33 and 34 weeks gestation while the remaining (100 mg) was infused at gestation of 35 weeks. Thereafter, women in this group received no further iron therapy until delivery. In preparation, 200 mg of iron sucrose was diluted into 100 ml of 0.9% saline solution.
Intervention MeSH terms: Ferric Oxide, Saccharated
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 80.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: iron deficiency anemia; pregnancy; third trimester; intravenous iron; efficacy; a randomized trial; Female; Ferric Compounds/therapeutic use*; Infusions, Intravenous; Hematologic/therapy*

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.
    

Eligibility 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