Evaluation of safety and tolerability of iron amino acid chelate therapy in pregnant women

Abstract

Background: Anemia is a major health problem. Iron deficiency is the most common cause of anemia during pregnancy. It can be associated with increased preterm labor, preeclampsia, and maternal sepsis. It can also lead to fetal loss or even perinatal deaths. The aim of the study was to monitor the oral iron therapy [Iron Amino Acid Chelate (IAAC) equivalent to elemental iron 30 mg] administered according to hospital practice and to determine the safety, and tolerability of IAAC in pregnant women.Methods: The data of pregnant women attending the outpatient department of the hospital for antenatal care between March 2020 and February 2021 and prescribed IAAC was retrospectively analyzed. It was of interest to note the changes in the Hemoglobin (Hb) levels and serum ferritin levels. These parameters were considered as the primary efficacy parameter and were analyzed by the paired t-test.Results: The data indicated very well tolerance to IAAC preparation with increase in Hb levels. After 12 week of treatment, there were significant increases in hemoglobin levels with mean rise in Hb level was 7 to 9 gm/dL. A statistically significant difference was observed at the 4th, 8th, and 12th weeks from the baseline value to each evaluation in the Hb level due to the supplementation of oral iron. The change in the serum ferritin levels was found to be statistically significant at the 12th week from the baseline values. Most of the women tolerated the oral IAAC preparationConclusions: This retrospective analysis showcased a significant improvement in the Hb and serum ferritin levels of pregnant women after 12 weeks.