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

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.

Conditions

• Iron Deficiency Anemia
• Pregnancy

Interventions

DRUG

Ferric derisomaltose

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.

DRUG

Ferrous sulfate

325mg ferrous sulfate tablets (65 mg of elemental iron), 1 to 3 orally per day.

Sponsors & Collaborators

• Hasbro Children's Hospital

  collaborator OTHER

• University of Michigan

  collaborator OTHER

• Washington University School of Medicine

  collaborator OTHER

• University of Utah

  collaborator OTHER

• University of Alabama at Birmingham

  collaborator OTHER

• Oregon Health and Science University

  collaborator OTHER

• GNP Research at Heme-on-Call

  collaborator UNKNOWN

• Women and Infants Hospital of Rhode Island

  lead OTHER

Principal Investigators

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

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

45 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-01-17

Primary Completion

2027-03-30

Completion

2027-03-31

FDA Drug

Yes

Countries

• United States

Study Locations