Comparison of injection Iron Isomaltoside with injection Iron Sucrose for treatment of iron deficiency anaemia in pregnancy - A randomized controlled trial

Anemia is a prevalent health issue in developing countries, including India, and is of particular concern during pregnancy due to its high occurrence and significant impact on maternal and fetal health.

According to the Centers for Disease Control and Prevention (1998), anemia in pregnant women is defined as hemoglobin levels below 11 g/dL in the first and third trimesters and below 10.5 g/dL in the second trimester, using the 5th percentile as the cutoff for iron-supplemented pregnancies.

In India, anemia is predominantly associated with iron deficiency. The National Family Health Survey (NFHS-5) reports that 52.2% of pregnant women aged 15-49 are anemic. Contributing factors include poor nutrition, increased demand from the fetoplacental unit, intestinal hookworm infection, malabsorption due to conditions like gastritis, celiac disease, and inflammatory bowel disease (IBD).

Iron deficiency anemia (IDA) can lead to a range of complications, from mild symptoms like fatigue and shortness of breath to severe, life-threatening outcomes. Adverse perinatal outcomes may include preeclampsia, infections, preterm labor, cardiac failure, and pregnancy loss. During labor, risks include shock, postpartum hemorrhage (PPH), uterine inertia, and cardiac failure. Postpartum complications may include puerperal sepsis, poor lactation, pulmonary embolism, subinvolution, and venous thrombosis. For the infant, intrauterine death (IUD) and low birth weight are potential consequences.

Recognizing IDA in pregnancy as a critical health issue, the scientific community has developed various iron formulations to address this problem, administered via oral or parenteral routes.

Despite the growing use of iron isomaltoside, there is a lack of research specifically focused on its efficacy and safety in the Indian obstetric population, where IDA is a major contributor to maternal morbidity and mortality. This study aims to compare iron isomaltoside with iron sucrose, evaluating their relative effectiveness and safety profiles.