Intravenous Versus Oral Iron for Treating Iron-Deficiency Anemia in Pregnancy
Key facts
- Who runs it
- Women and Infants Hospital of Rhode Island
- Where
- Ann Arbor, Birmingham, Miami, Portland, Providence, Salt Lake City, and St Louis, United StatesSee the 8 sites
- Trial code
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 300 people, planned
- Started
- 17 Jan 2023
- Expected to end
- 31 Mar 2027
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Ferric derisomaltose
- Ferrous sulfate
- Record updated
- 10 June 2025
Who can take part
- Age
- 18 years to 45 years
- Sex
- Women only
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 11 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 45 years old?
Where in United States
- Michigan University Medical CenterAnn Arbor, United StatesContact: Molly Stout, MD, MSCITaking people
- University of Alabama Medical CenterBirmingham, United StatesContact: Carolyn Webster, MDTaking people
- GNP Research at Heme-on-CallMiami, United StatesContact: Steven Fein, MDTaking people
- Oregon Health and Sciences Uiversity Medical CenterPortland, United StatesContact: Ashley Benson, MDTaking people
- Hasbro Children's HospitalProvidence, United StatesContact: Viren D'sa, MDTaking people
- Women & Infants Hospital of Rhode IslandProvidence, United StatesContact: Methodius Tuuli, MD, MPH, MBATaking people
- University of Utah HospitalSalt Lake City, United StatesContact: Ann Bruno, MDTaking people
- Washington University Medical CenterSt Louis, United StatesContact: Ebony Carter, MD, MPHTaking people
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- IV IronTreatment being tested
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 and daily placebo tablets until delivery.
Treatment: Ferric derisomaltose
- Oral IronExisting treatment, for comparison
Participants assigned to the oral iron group will receive a single 250 mL IV normal saline infusion given over 20 minutes and 325mg tablets of ferrous sulfate (65 mg of elemental iron) to be taken until delivery.
Treatment: Ferrous sulfate
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Double-blind Placebo-controlled Multicenter Randomized Trial of Intravenous Versus Oral Iron for Treating Iron-Deficiency Anemia in Pregnancy
- Fit questions
- Built from NCT05462704, who can take part
- Record updated
- 10 June 2025