Early Antenatal Support for Iron Deficiency Anemia

Launched by THOMAS JEFFERSON UNIVERSITY · Feb 18, 2020

Keywords

ClinConnect Summary

This clinical trial is studying the best way to treat iron deficiency anemia in pregnant women, specifically looking at whether intravenous (IV) iron therapy is more effective than taking iron pills. Iron deficiency anemia can happen during pregnancy when a woman doesn't have enough iron in her blood, which can lead to fatigue and other health issues. The goal of this study is to see if starting IV iron treatment in the second trimester can help improve blood counts, enhance quality of life, and reduce side effects compared to oral iron supplements.

To be eligible for this trial, participants must be pregnant with a single baby and in their second trimester (under 24 weeks). They should have a hemoglobin level (a measure of blood health) between 9.0 and 11.0 and show signs of iron deficiency anemia, which is diagnosed with specific blood tests. Women with certain health conditions, like severe heart or kidney diseases, or those who have had previous IV iron treatments during this pregnancy, won’t be able to participate. If someone joins the study, they will receive either IV iron or oral iron and be monitored to see how well the treatment works and what effects it has. This trial is currently recruiting participants, and it aims to provide important insights into managing anemia during pregnancy to improve outcomes for mothers and their babies.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Singleton gestation
• • Gestational age \<24 weeks
• • Baseline Hb ≥9.0 and \<11.0 with evidence of iron deficiency anemia
• Iron deficiency anemia diagnosed (at any point in patient history) by:
• • Hb\<11.0
• • Ferritin\<30 and/or total iron saturation \<20
• Exclusion Criteria:
• • Sickle cell Disease (NOT sickle cell trait)
• • Evidence of acute anemia requiring transfusion or IV iron therapy
• • Major congenital or chromosomal anomaly
• • Previous use of IV iron in this pregnancy
• • Severe cardiac, renal, or liver disease
• • Autoimmune disease (ie Systemic Lupus Erythematosus (SLE)
• • Allergy or contraindication to either study drug
• • History of medication allergy, reaction to IV infusion, or reaction to Feraheme or other IV iron products