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
Women and Infants Hospital of Rhode Island
300 participants
Jan 17, 2023
INTERVENTIONAL
Summary
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
Inclusion Criteria5
- 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 Criteria6
- 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
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Participants assigned to the IV iron group will receive a single IV infusion of 1000 mg ferric derisomaltose (Monoferric, Pharmacosmos Therapeutics Inc., Morristown, NJ) in 250 mL given over 20 minutes.
325mg ferrous sulfate tablets (65 mg of elemental iron), 1 to 3 orally per day.
Locations(8)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05462704