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

Description

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 13 - 30 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.

Conditions

Iron Deficiency Anemia, Pregnancy

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Study Overview

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Study Details

Study overview

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 13 - 30 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.

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

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

Condition
Iron Deficiency Anemia
Intervention / Treatment

-

Contacts and Locations

Birmingham

University of Alabama Medical Center, Birmingham, Alabama, United States, 35401

Miami

Heme-on-Call, Miami, Florida, United States, 33143

Ann Arbor

Michigan University Medical Center, Ann Arbor, Michigan, United States, 48109

Saint Louis

Washington University Medical Center, Saint Louis, Missouri, United States, 65105

Portland

Oregon Health and Sciences Uiversity Medical Center, Portland, Oregon, United States, 97239

Providence

Hasbro Children's Hospital, Providence, Rhode Island, United States, 02905

Providence

Women & Infants Hospital of Rhode Island, Providence, Rhode Island, United States, 02905

Salt Lake City

University of Utah Hospital, Salt Lake City, Utah, United States, 84132

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Pregnant women between the ages of 18-45
  • * Singleton gestation
  • * Iron-deficiency anemia (serum ferritin \<30ng/mL and Hb\<10 g/dL)
  • * At 13-30 weeks gestation
  • * Plan to deliver at participating hospital
  • * 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

Ages Eligible for Study

18 Years to 45 Years

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Women and Infants Hospital of Rhode Island,

Methodius Tuuli, MD, MPH, MBA, PRINCIPAL_INVESTIGATOR, Women and Infants Hospital of Rhode Island

Study Record Dates

2027-03-31