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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Women and Infants Hospital of Rhode Island
Study ID
NCT05462704
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 45 Years
Healthy Volunteers
Not accepted

Interventions

  • Ferric derisomaltose — DRUG
    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 — DRUG
    325mg ferrous sulfate tablets (65 mg of elemental iron), 1 to 3 orally per day.

Study Details

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.

Key Dates

Start date
Jan 17, 2023
Status verified
Jun 2025
Primary completion
Mar 30, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

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

Locations (8)

FacilityCityStateZIPSite coordinators
University of Alabama Medical CenterBirminghamAlabama35401
Carolyn Webster, MD
GNP Research at Heme-on-CallMiamiFlorida33143
Steven Fein, MD
Michigan University Medical CenterAnn ArborMichigan48109
Molly Stout, MD, MSCI
Washington University Medical CenterSt LouisMissouri65105
Ebony Carter, MD, MPH
Oregon Health and Sciences Uiversity Medical CenterPortlandOregon97239
Ashley Benson, MD
Hasbro Children's HospitalProvidenceRhode Island02905
Viren D'sa, MD
Women & Infants Hospital of Rhode IslandProvidenceRhode Island02905
Methodius Tuuli, MD, MPH, MBA
University of Utah HospitalSalt Lake CityUtah84132
Ann Bruno, MD

Find similar trials in Birmingham, AL

By research site
University of Alabama Medical Center· Birmingham, ALGNP Research at Heme-on-Call· Miami, FLMichigan University Medical Center· Ann Arbor, MIWashington University Medical Center· St Louis, MOOregon Health and Sciences Uiversity Medical Center· Portland, ORHasbro Children's Hospital· Providence, RI

Related Studies