Women and Infants Hospital of Rhode Island
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.
Iron-deficiency anemia (IDA) is a common, undertreated problem in pregnancy. According to data from the U.S. National Health and Nutrition Examination Survey (NHANES), 25% of pregnant women in the U.S. have iron deficiency, with rates of 7%, 24%, and 39% in the first, second, and third trimesters, respectively. The prevalence of IDA is estimated at 16.2% overall and up to 30% at delivery. Iron deficiency is associated with significant adverse maternal and fetal outcomes including blood transfusion, cesarean delivery, depression, preterm birth, and low birth weight. Moreover, iron-deficient mot…
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, desp…
Participants assigned to the IV iron group will receive a single IV infusion of 1000 mg ferric derisomaltose (Monoferric, Pharmacosmos Therapeutics Inc., Morristown, NJ) in 250 mL given over 20 minutes.
325mg ferrous sulfate tablets (65 mg of elemental iron), 1 to 3 orally per day.