Actively Recruiting
Double-blind Placebo-controlled Multicenter Randomized Trial of Intravenous Versus Oral Iron for Treating Iron-Deficiency Anemia in Pregnancy
Led by Women and Infants Hospital of Rhode Island · Updated on 2025-06-10
300
Participants Needed
8
Research Sites
N/A
Total Duration
On this page
Sponsors
W
Women and Infants Hospital of Rhode Island
Lead Sponsor
H
Hasbro Children's Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate intravenous (IV) iron compared to oral iron in pregnant women with iron-deficiency anemia (IDA) between 13 to 30 weeks of pregnancy. The study focuses on women with low hemoglobin and ferritin levels, examining whether IV iron can reduce severe maternal anemia at delivery and improve the child's brain development. IDA during pregnancy is common and linked to negative outcomes such as blood transfusions, preterm birth, and low birth weight, with current oral treatments often causing side effects that reduce adherence. Participants are randomly assigned to receive either a single IV infusion of 1000 mg ferric derisomaltose or an IV placebo infusion with daily oral ferrous sulfate tablets until delivery. The trial is double-blind and placebo-controlled, conducted across multiple centers in the U.S. The study compares the safety, effectiveness, and cost of these two iron delivery methods in pregnant women with IDA. During the study, participants will be monitored through blood tests measuring hemoglobin, ferritin, and other maternal and neonatal health indicators around delivery and postpartum. Researchers will also assess maternal quality of life, depression scores, and infant neurodevelopment at 6 and 36 months. Safety events, delivery outcomes, and infant health will be closely tracked throughout the trial, which is expected to last until 2027.
CONDITIONS
Brief Title
Intravenous Versus Oral Iron for Treating Iron-Deficiency Anemia in Pregnancy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pregnant women between the ages of 18-45
- Singleton gestation (one baby)
- Iron-deficiency anemia with serum ferritin less than 30 ng/mL and hemoglobin less than 11 g/dL
- Between 13 and 30 weeks of pregnancy
- Plan to deliver at a participating hospital
You will not qualify if you...
- Non-iron-deficiency anemia such as thalassemia, sickle cell disease, vitamin B12 or folate deficiency, or hypersplenism
- Conditions affecting iron absorption like malabsorptive syndrome, inflammatory bowel disease, or gastric bypass
- Sensitivity or allergy to oral or intravenous iron
- Multiple pregnancy (twins or more)
- Unable or unwilling to provide informed consent
- Unable to communicate with the study team even with an interpreter
- Planned delivery at a hospital not affiliated with the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From enrollment until delivery (up to approximately 17 weeks depending on gestational age at enrollment)
Participants receive either a single intravenous infusion of 1000 mg ferric derisomaltose or daily oral ferrous sulfate tablets until delivery to treat iron-deficiency anemia during pregnancy.
1 infusion visit and daily oral medication until delivery
Duration - Up to 36 months postpartum
Participants are monitored for maternal and neonatal outcomes including anemia status at delivery, adverse events, and infant development up to 36 months of age.
Visits at delivery, postpartum (up to 6 weeks), and child assessments at about 6 and 36 months
Trial Site Locations
Total: 8 locations
1
University of Alabama Medical Center
Birmingham, Alabama, United States, 35401
Actively Recruiting
2
GNP Research at Heme-on-Call
Miami, Florida, United States, 33143
Actively Recruiting
3
Michigan University Medical Center
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
4
Washington University Medical Center
St Louis, Missouri, United States, 65105
Actively Recruiting
5
Oregon Health and Sciences Uiversity Medical Center
Portland, Oregon, United States, 97239
Actively Recruiting
6
Hasbro Children's Hospital
Providence, Rhode Island, United States, 02905
Actively Recruiting
7
Women & Infants Hospital of Rhode Island
Providence, Rhode Island, United States, 02905
Actively Recruiting
8
University of Utah Hospital
Salt Lake City, Utah, United States, 84132
Actively Recruiting
Research Team
C
Crystal Ware, BSN, CCRP
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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