Intravenous Versus Oral Iron for Treating Iron-Deficiency Anemia in Pregnancy
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorWomen and Infants Hospital of Rhode Island
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Ferric derisomaltose
- Ferrous sulfate
Treatment groups
300 Participants
are divided into 2 treatment groupsSponsors and collaborators
Women and Infants Hospital of Rhode Island
Lead sponsor
Hasbro Children's Hospital
Collaborator
University of Michigan
Collaborator
Washington University School of Medicine
Collaborator
University of Utah
Collaborator
University of Alabama at Birmingham
Collaborator
Oregon Health and Science University
Collaborator
GNP Research at Heme-on-Call
Collaborator
Source ClinicalTrials.gov