Home › Iron-Deficiency Anemia › NCT05462704

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

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

Who can join

Ages 18 to 45 · Women

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

About the study

Double blind, placebo controlled, multicenter randomized trial in pregnant women in the U.S. (N=300) to test the central hypothesis that IV iron in pregnant women with IDA (Hb\<11 g/dL and ferritin\<30 ng/mL) at 13 - 30 weeks will be effective, safe and cost-effective in reducing severe maternal morbidity-as measured by maternal anemia at delivery-and will also improve offspring neurodevelopment.

What is being tested

• Ferric derisomaltose (drug)
• Ferrous sulfate (drug)

Sponsor: Women and Infants Hospital of Rhode Island · Participants: 300 · Started: Jan 17, 2023

Contact the study team

• Crystal Ware, BSN, CCRP · Phone: 401-274-1122

Official record on ClinicalTrials.gov — NCT05462704

Locations in the U.S.

Conditions

• Iron-Deficiency Anemia

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.