Intravenous Versus Oral Iron for Treating Iron-Deficiency Anemia in Pregnancy
IVIDA2
Double-blind Placebo-controlled Multicenter Randomized Trial of Intravenous Versus Oral Iron for Treating Iron-Deficiency Anemia in Pregnancy
1 other identifier
interventional
300
1 country
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jan 2023
Typical duration for phase_3
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 15, 2022
CompletedFirst Posted
Study publicly available on registry
July 18, 2022
CompletedStudy Start
First participant enrolled
January 17, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 31, 2027
June 10, 2025
June 1, 2025
4.2 years
May 15, 2022
June 5, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Rate of maternal anemia (hgb<11mg/dL) at delivery
Hemoglobin \<11mg/dL on admission to inpatient obstetrics unit for labor and delivery
Within 24 hours of admission to inpatient obstetrics unit for delivery of infant
Secondary Outcomes (25)
Concentration of maternal hemoglobin at delivery
Within 24 hours of admission to inpatient obstetrics unit for delivery of infant
Rate of maternal blood transfusion at delivery
Delivery to 7 days postpartum
Concentration of maternal ferritin at delivery
Within 24 hours of admission to inpatient obstetrics unit for delivery of infant
Concentration of maternal hemoglobin postpartum day 1
On day after participant delivered her infant; postpartum day 1
Rate of cesarean delivery
Once at infant delivery
- +20 more secondary outcomes
Study Arms (2)
IV Iron
EXPERIMENTALParticipants 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.
Oral Iron
ACTIVE COMPARATORParticipants 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
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Women and Infants Hospital of Rhode Islandlead
- Hasbro Children's Hospitalcollaborator
- University of Michigancollaborator
- Washington University School of Medicinecollaborator
- University of Utahcollaborator
- University of Alabama at Birminghamcollaborator
- Oregon Health and Science Universitycollaborator
- GNP Research at Heme-on-Callcollaborator
Study Sites (8)
University of Alabama Medical Center
Birmingham, Alabama, 35401, United States
GNP Research at Heme-on-Call
Miami, Florida, 33143, United States
Michigan University Medical Center
Ann Arbor, Michigan, 48109, United States
Washington University Medical Center
St Louis, Missouri, 65105, United States
Oregon Health and Sciences Uiversity Medical Center
Portland, Oregon, 97239, United States
Hasbro Children's Hospital
Providence, Rhode Island, 02905, United States
Women & Infants Hospital of Rhode Island
Providence, Rhode Island, 02905, United States
University of Utah Hospital
Salt Lake City, Utah, 84132, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Methodius Tuuli, MD, MPH, MBA
Women and Infants Hospital of Rhode Island
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Masking Details
- Participants will receive matching ferrous sulfate or placebo formulate to appear and taste similar. They will also each receive an infusion of 1000mg ferric derisomaltose in 250ml of normal saline or 250ml of normal saline only, camouflaged in an opaque intravenous bag and tubing covers.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor and Chair of Obstetrics and Gynecology
Study Record Dates
First Submitted
May 15, 2022
First Posted
July 18, 2022
Study Start
January 17, 2023
Primary Completion (Estimated)
March 30, 2027
Study Completion (Estimated)
March 31, 2027
Last Updated
June 10, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- 5 years after completion of study
- Access Criteria
- The investigators will make the data and associated documentation available to users under a data-sharing agreement that provides for commitment to: a) using the data only for research purposes and not to identify any individual participant; b) securing the data using appropriate computer technology; and c) destroying or returning the data after analyses are completed. Timelines for distribution of data will vary depending on any required restrictions as mentioned above. Data may be distributed by a number of electronic methods, including web-based databases, datasets, and spreadsheets, or via electronic media such as compact discs.
Data will be collected from human subjects and will be shared according to NIH guidelines. The investigators are committed to the sharing of final data, being mindful that the rights and privacy of people who participate in research must be protected at all times. The investigators will make a complete study dataset available for sharing. The investigators will have a description of study dataset, including code books, meta-data related to the dataset, and documented programming code used for creating the final study population, for creating variables, and for conducting all outcomes analyses. The investigators will remain HIPAA compliant, and therefore any datasets resulting from participants will be free of any identifiers that would permit linkages to individual research participants and variables that could lead to deductive disclosure of individual subjects.