Comparing IV and oral iron treatments for anemia in pregnant women

Double-blind Placebo-controlled Multicenter Randomized Trial of Intravenous Versus Oral Iron for Treating Iron-Deficiency Anemia in Pregnancy

This study is testing whether intravenous iron or oral iron supplements work better for pregnant women with anemia to improve their health and their baby's development.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 300 (estimated)
• Ages: 18 Years to 45 Years
• Sex: Female
• Sponsor: Women and Infants Hospital of Rhode Island (Academic / other)
• Locations: 8 sites (Birmingham, Alabama and 7 other locations)
• Trial ID: NCT05462704 on ClinicalTrials.gov

What this trial studies

This clinical trial is a double-blind, placebo-controlled, multicenter randomized trial involving 746 pregnant women in the U.S. who have moderate-to-severe iron-deficiency anemia. The study aims to compare the effectiveness, safety, and cost-effectiveness of intravenous iron versus oral iron supplementation in reducing severe maternal morbidity and improving offspring neurodevelopment. Participants will be monitored for outcomes such as the need for blood transfusions and the health of their newborns. The trial specifically targets women between 13 to 30 weeks of gestation with low hemoglobin and ferritin levels.

Who should consider this trial

Good fit: Ideal candidates for this study are pregnant women aged 18-45 with singleton gestation and diagnosed with moderate-to-severe iron-deficiency anemia.

Not a fit: Patients with non-iron-deficiency anemia or those with conditions that affect iron absorption may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective treatment option for iron-deficiency anemia in pregnant women, potentially reducing complications for both mothers and their babies.

How similar studies have performed: Previous studies have indicated that intravenous iron can be effective in treating iron-deficiency anemia, but this specific comparison in a pregnant population is novel.

Eligibility criteria

Inclusion Criteria:

* Pregnant women between the ages of 18-45
* Singleton gestation
* Iron-deficiency anemia (serum ferritin \<30ng/mL and Hb\<11 g/dL)
* At 13-30 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

Where this trial is running

Birmingham, Alabama and 7 other locations

• University of Alabama Medical Center — Birmingham, Alabama, United States (Recruiting)
• GNP Research at Heme-on-Call — Miami, Florida, United States (Recruiting)
• Michigan University Medical Center — Ann Arbor, Michigan, United States (Recruiting)
• Washington University Medical Center — St Louis, Missouri, United States (Recruiting)
• Oregon Health and Sciences Uiversity Medical Center — Portland, Oregon, United States (Recruiting)
• Hasbro Children's Hospital — Providence, Rhode Island, United States (Recruiting)
• Women & Infants Hospital of Rhode Island — Providence, Rhode Island, United States (Recruiting)
• University of Utah Hospital — Salt Lake City, Utah, United States (Recruiting)

Study contacts

• Principal investigator: Methodius Tuuli, MD, MPH, MBA — Women and Infants Hospital of Rhode Island
• Study coordinator: Crystal Ware, BSN, CCRP

Conditions Iron Deficiency Anemia; Pregnancy