Intravenous Iron Therapy for Iron Deficiency in Pregnancy

This trial aims to find the best way to treat iron deficiency anemia in pregnant women with severe iron deficiency, which can cause health problems for both mother and baby. By comparing two IV iron treatments, iron sucrose and iron isomaltoside (also known as Ferric Derisomaltose, Monoferric, or Monofer), the researchers hope to determine if iron stores can be replenished with fewer healthcare visits. This trial may suit pregnant women who are at least 13 weeks along and have been diagnosed with moderate to severe iron deficiency anemia. As a Phase 3 trial, it represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are currently being treated with IV iron products or have had a blood transfusion within 4 weeks prior to joining, you cannot participate.

Previous studies have shown that iron isomaltoside is safe for pregnant women. Research indicates that it can increase iron levels with just one visit and has a safety profile similar to other iron treatments. Another study found it effective without any serious side effects for both mothers and their babies.

For iron sucrose, studies have shown it to be generally safe and well-tolerated in pregnant women. In one study, only 9% of patients reported any negative side effects, which were mostly mild. Importantly, there were no negative effects on pregnancy outcomes.

Iron Isomaltoside and Iron Sucrose are unique treatments for iron deficiency in pregnancy because they offer faster replenishment of iron levels compared to oral iron supplements, which are the standard of care. Iron Isomaltoside can deliver up to 1000-1500 mg in one or two infusions, allowing for a quick and efficient boost of iron stores. This is particularly beneficial for pregnant women who need rapid correction of iron levels to support both their health and the baby's development. Iron Sucrose provides a flexible dosing schedule, with up to 1000 mg per week, making it adaptable to individual patient needs. Researchers are excited about these options because they could significantly improve the management of iron deficiency in pregnancy, ensuring better outcomes for both mothers and their babies.

Research has shown that iron isomaltoside, one of the treatments in this trial, effectively treats iron deficiency anemia in pregnant women by quickly boosting hemoglobin levels, which are crucial for oxygen transport in the blood, and reducing anemia symptoms. One study found that it allows for higher doses with fewer visits compared to other treatments, offering convenience for busy schedules. In contrast, iron sucrose, another treatment option in this trial, has improved hemoglobin levels more effectively than oral iron. Studies have indicated that women receiving iron intravenously, such as with iron sucrose, experience fewer side effects compared to taking iron pills. Both treatments are safe and effective for treating anemia during pregnancy, making them good options for improving health outcomes for both mothers and babies.¹²³⁴⁶