Intravenous Versus Oral Iron for Treating Iron-Deficiency Anemia in Pregnancy
Trial Parameters
Brief Summary
Double blind, placebo controlled, multicenter randomized trial in pregnant women in the U.S. (N=300) to test the central hypothesis that IV iron in pregnant women with IDA (Hb\<11 g/dL and ferritin\<30 ng/mL) at 13 - 30 weeks will be effective, safe and cost-effective in reducing severe maternal morbidity-as measured by maternal anemia at delivery-and will also improve offspring neurodevelopment.
Eligibility Criteria
Inclusion Criteria: * Pregnant women between the ages of 18-45 * Singleton gestation * Iron-deficiency anemia (serum ferritin \<30ng/mL and Hb\<11 g/dL) * At 13-30 weeks gestation * Plan to deliver at participating hospital Exclusion Criteria: * Non-iron-deficiency anemia e.g thalassemia, sickle cell disease, B12 or folate deficiency, hypersplenism. * Malabsorptive syndrome, inflammatory bowel disease, gastric bypass, or sensitivity to oral or IV iron * Multiple gestation * Inability or unwillingness to provide informed consent * Inability to communicate with members of the study team, despite the presence of an interpreter * Planned delivery at a non-study affiliated hospital