Recruiting
Phase 3

Intravenous & Oral Iron

Sponsor:

Women and Infants Hospital of Rhode Island

Code:

NCT05462704

Conditions

Iron Deficiency Anemia

Pregnancy

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Not accepted

Interventions

Ferric derisomaltose

Ferrous sulfate

Study Details

Brief 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

Study ID

NCT05462704

Start date

Jan 17, 2023

Status verified date

Jun, 2025

Completion date

Mar 31, 2027

Anticipated

Primary completion date

Mar 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: IV Iron

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.

active comparator: Oral Iron

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.

Interventions

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.

Ferrous sulfate

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

Primary outcome measure

  • Rate of maternal anemia (hgb<11mg/dL) at delivery [ Time Frame: Within 24 hours of admission to inpatient obstetrics unit for delivery of infant ]

Central Contacts and Locations

Central contacts

Crystal Ware, BSN, CCRP

401-274-1122cware@wihri.org

Locations

University of Alabama Medical Center

Recruiting

Birmingham, Alabama, United States, 35401

GNP Research at Heme-on-Call

Recruiting

Miami, Florida, United States, 33143

Michigan University Medical Center

Recruiting

Ann Arbor, Michigan, United States, 48109

Washington University Medical Center

Recruiting

St Louis, Missouri, United States, 65105

Oregon Health and Sciences Uiversity Medical Center

Recruiting

Portland, Oregon, United States, 97239

Hasbro Children's Hospital

Recruiting

Providence, Rhode Island, United States, 02905

Women & Infants Hospital of Rhode Island

Recruiting

Providence, Rhode Island, United States, 02905

University of Utah Hospital

Recruiting

Salt Lake City, Utah, United States, 84132

More Information

Sponsor

Women and Infants Hospital of Rhode Island

Last update posted

Jun 10, 2025

Last verified

Jun, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Women and Infants Hospital of Rhode Island on 2025-06-10.