Comparing IV and oral iron treatments for anemia in pregnant women

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Principal investigator: Methodius Tuuli, MD, MPH, MBA — Women and Infants Hospital of Rhode Island
• Study coordinator: Crystal Ware, BSN, CCRP
• Email: cware@wihri.org
• Phone: 401-274-1122

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.