Intravenous Versus Oral Iron for Treating Iron-Deficiency Anemia in Pregnancy

• Status: Not yet recruiting
• Trial end date: 2027-04-30
• Target enrollment: 0
• Participant gender: Female

Summary

Double blind, placebo controlled, multicenter randomized trial in pregnant women in the U.S. (N=746) to test the central hypothesis that IV iron in pregnant women with moderate-to-severe IDA (Hb<10 g/dL and ferritin<30 ng/mL) at 24 - 28 weeks will be effective, safe and cost-effective in reducing severe maternal morbidity-as measured by peripartum blood transfusion-and will also improve offspring neurodevelopment.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Women and Infants Hospital of Rhode Island
• Collaborators: Hasbro Children's Hospital; University of Michigan; Washington University School of Medicine

Criteria

Inclusion Criteria:

• Pregnant women between the ages of 18-45

• Singleton gestation

• Iron-deficiency anemia (serum ferritin <30ng/mL and Hb<10 g/dL)

• At 24-28 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, despite the presence of an interpreter

• Planned delivery at a non-study affiliated hospital