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| ID | Type | Description | Link |
|---|---|---|---|
| K12HD103084 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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Evaluate the extent to which treatment of iron deficiency anemia beyond 24-34 weeks' gestation of pregnancy with intravenous iron increases hemoglobin compared to oral iron. The investigators will test the hypothesis that pregnant women who are anemic in the second and third trimester are more likely to significantly increase their hemoglobin with intravenous iron as opposed to the usual standard of care, oral iron.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravenous iron | Experimental | Participants will receive 510mg intravenous iron ferumoxytol, with a maximum of 2 doses based on the baseline hemoglobin level. The ferumoxytol is administered as an infusion for approximately 15 - 30 minutes. |
|
| Oral iron | Active Comparator | Participants will be prescribed 1-2 ferrous sulfate 325mg tablets by mouth (based on severity of anemia) until delivery. For standardization, the dosage is as follows based on severity: one ferrous sulfate tablet for women with baseline hemoglobin 9-11, and two ferrous sulfate tablets for hemoglobin < 9. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ferumoxytol Injection [Feraheme] | Drug | 510mg intravenous ferumoxytol |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Median Change in Hemoglobin Value Before and After Intervention | Hemoglobin is measured as g/dL at enrollment and after the study intervention | From enrollment to four weeks post-enrollment (may have been up to 6 weeks post-enrollment) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Discontinued Treatment | From enrollment to delivery or birth admission (average approximately 8 to 12 weeks) | |
| Number of Participants With Serious Adverse Events Associated With Treatment | From enrollment to delivery or birth admission (average approximately 8 to 12 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Median Change in Hemoglobin Value Before and After Intervention by Sex | NIH-required analysis. Hemoglobin is measured as g/dL at enrollment and after the study intervention | From enrollment to four weeks post-enrollment (may have been up to 6 weeks post-enrollment) |
| Median Change in Hemoglobin Value Before and After Intervention by Race / Ethnicity |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Deirdre Lyell | Stanford University | Principal Investigator |
| Irogue Igbinosa, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University School of Medicine/Lucile Packard Childrens Hospital | Stanford | California | 94305 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41860281 | Result | Igbinosa II, Leonard SA, Iwekaogwu I, Sherwin EB, Berube C, Lyell DJ. Intravenous Ferumoxytol Compared With Oral Ferrous Sulfate for Iron Deficiency Anemia in Pregnancy: A Randomized Controlled Trial. Obstet Gynecol. 2026 May 1;147(5):745-753. doi: 10.1097/AOG.0000000000006245. Epub 2026 Mar 19. |
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83 participants signed informed consent; 80 were allocated to treatment.
Can describe study design here, up to 500 characters with spaces
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| ID | Title | Description |
|---|---|---|
| FG000 | Oral Iron | Participants are prescribed 1-2 ferrous sulfate 325mg tablets by mouth (based on severity of anemia) until delivery. |
| FG001 | Intravenous Iron | Participants receive 510mg intravenous iron ferumoxytol, with a maximum of 2 doses based on the baseline hemoglobin level. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Intention to treat; all participants were analyzed according to the group to which they were randomized, regardless of treatment received.
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| ID | Title | Description |
|---|---|---|
| BG000 | Oral Iron | Participants are prescribed 1-2 ferrous sulfate 325mg tablets by mouth (based on severity of anemia) until delivery. |
| BG001 | Intravenous Iron | Participants receive 510mg intravenous iron ferumoxytol, with a maximum of 2 doses based on the baseline hemoglobin level. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Median Change in Hemoglobin Value Before and After Intervention | Hemoglobin is measured as g/dL at enrollment and after the study intervention | Participants analyzable for the primary outcome (had data through week 4) | Posted | Median | Inter-Quartile Range | g/dL | From enrollment to four weeks post-enrollment (may have been up to 6 weeks post-enrollment) |
|
Up to approximately 12 weeks
Participants reported adverse events (AEs) by survey using the terms listed. The week 4 survey asked participants to report AEs occurring from weeks 1 to 4 (may have been up to week 6; primary outcome analysis period) and the week 8 survey asked participants to report AEs occurring from weeks 5 to 8 (may have been up to week 12; secondary outcome analysis period).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Oral Iron - Weeks 1 to 4 | Adverse events occurring in the oral iron group during weeks 1 to 4 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea/ Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Deirdre J. Lyell, MD | Stanford University | (650) 498-4069 | dlyell@stanford.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 10, 2022 | Jun 6, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 28, 2023 | Mar 6, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D018798 | Anemia, Iron-Deficiency |
| ID | Term |
|---|---|
| D000747 | Anemia, Hypochromic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D052203 | Ferrosoferric Oxide |
| C020748 | ferrous sulfate |
| ID | Term |
|---|---|
| D005290 | Ferric Compounds |
| D058085 | Iron Compounds |
| D007287 | Inorganic Chemicals |
| D005296 | Ferrous Compounds |
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| Ferrous Sulfate |
| Drug |
325mg oral ferrous sulfate |
|
| Number of Participants Who Need Blood Transfusion Postpartum | From enrollment to delivery or birth admission (average approximately 8 to 12 weeks) |
| Change in Short Form (SF-)36 General Health Symptom Score | Score range: 0 to 100 (lower scores indicate more severe symptoms, higher scores correspond to fewer symptoms) | From enrollment to four weeks post-enrollment (may have been up to 6 weeks post-enrollment) |
| Change in Short Form (SF-)36 Physical Functioning Score | Score range: 0 to 100 (lower scores indicate less physical function, higher scores correspond to more physical function). | From enrollment to four weeks post-enrollment (may have been up to 6 weeks post-enrollment) |
| Change in Short Form (SF-)36 Role Limitations Due to Physical Health Score | Score range: 0 to 100 (lower scores indicate more limitations, higher scores correspond to fewer limitations). | From enrollment to four weeks post-enrollment (may have been up to 6 weeks post-enrollment) |
| Change in Short Form (SF-)36 Energy/Fatigue Score | Score range: 0 to 100 (lower scores indicate more fatigue, higher scores correspond to more energy). | From enrollment to four weeks post-enrollment (may have been up to 6 weeks post-enrollment) |
NIH-required analysis. Hemoglobin is measured as g/dL at enrollment and after the study intervention |
| From enrollment to four weeks post-enrollment (may have been up to 6 weeks post-enrollment) |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
|
| Hemoglobin | Median | Inter-Quartile Range | g/dL |
|
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| Secondary | Number of Participants Who Discontinued Treatment | Intention to treat; all participants were analyzed according to the group to which they were randomized, regardless of treatment received. | Posted | Count of Participants | Participants | From enrollment to delivery or birth admission (average approximately 8 to 12 weeks) |
|
|
|
| Secondary | Number of Participants With Serious Adverse Events Associated With Treatment | Intention to treat; all participants were analyzed according to the group to which they were randomized, regardless of treatment received. | Posted | Count of Participants | Participants | From enrollment to delivery or birth admission (average approximately 8 to 12 weeks) |
|
|
|
| Secondary | Number of Participants Who Need Blood Transfusion Postpartum | Intention to treat; all participants were analyzed according to the group to which they were randomized, regardless of treatment received. | Posted | Count of Participants | Participants | From enrollment to delivery or birth admission (average approximately 8 to 12 weeks) |
|
|
|
| Secondary | Change in Short Form (SF-)36 General Health Symptom Score | Score range: 0 to 100 (lower scores indicate more severe symptoms, higher scores correspond to fewer symptoms) | Participants with data at the respective time point | Posted | Median | Inter-Quartile Range | score on a scale | From enrollment to four weeks post-enrollment (may have been up to 6 weeks post-enrollment) |
|
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| Secondary | Change in Short Form (SF-)36 Physical Functioning Score | Score range: 0 to 100 (lower scores indicate less physical function, higher scores correspond to more physical function). | Participants with data at the respective time point | Posted | Median | Inter-Quartile Range | score on a scale | From enrollment to four weeks post-enrollment (may have been up to 6 weeks post-enrollment) |
|
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| Secondary | Change in Short Form (SF-)36 Role Limitations Due to Physical Health Score | Score range: 0 to 100 (lower scores indicate more limitations, higher scores correspond to fewer limitations). | Participants with data at the respective time point | Posted | Median | Inter-Quartile Range | score on a scale | From enrollment to four weeks post-enrollment (may have been up to 6 weeks post-enrollment) |
|
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| Secondary | Change in Short Form (SF-)36 Energy/Fatigue Score | Score range: 0 to 100 (lower scores indicate more fatigue, higher scores correspond to more energy). | Participants with data at the respective time point | Posted | Median | Inter-Quartile Range | score on a scale | From enrollment to four weeks post-enrollment (may have been up to 6 weeks post-enrollment) |
|
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| Other Pre-specified | Median Change in Hemoglobin Value Before and After Intervention by Sex | NIH-required analysis. Hemoglobin is measured as g/dL at enrollment and after the study intervention | Participants analyzable for the primary outcome (had data through week 4). Data were stratified by sex. | Posted | Median | Inter-Quartile Range | g/dL | From enrollment to four weeks post-enrollment (may have been up to 6 weeks post-enrollment) |
|
|
|
| Other Pre-specified | Median Change in Hemoglobin Value Before and After Intervention by Race / Ethnicity | NIH-required analysis. Hemoglobin is measured as g/dL at enrollment and after the study intervention | Participants analyzable for the primary outcome (had data through week 4). Data were stratified by race / ethnicity. | Posted | Median | Inter-Quartile Range | g/dL | From enrollment to four weeks post-enrollment (may have been up to 6 weeks post-enrollment) |
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| 0 |
| 40 |
| 0 |
| 40 |
| 17 |
| 40 |
| EG001 | Intravenous Iron - Weeks 1 to 4 | Adverse events occurring in the intravenous iron group during weeks 1 to 4 | 0 | 40 | 0 | 40 | 15 | 40 |
| EG002 | Oral Iron - Weeks 5 to 8 | Adverse events occurring in the oral iron group during weeks 5 to 8 | 0 | 40 | 0 | 40 | 13 | 40 |
| EG003 | Intravenous Iron - Weeks 5 to 8 | Adverse events occurring in the intravenous iron group during weeks 5 to 8 | 0 | 40 | 0 | 40 | 9 | 40 |
| Constipation | Gastrointestinal disorders | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
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| Gastrointestinal symptoms not listed | Gastrointestinal disorders | Systematic Assessment |
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| Dizziness | Nervous system disorders | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Edema/ Swelling of limbs | Blood and lymphatic system disorders | Systematic Assessment |
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| Itching | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Body aches/ pains | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| D000090463 |
| Iron Deficiencies |
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D008903 |
| Minerals |
| Change at week 4 |
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| Change at week 4 |
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| Change at week 4 |
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| Change at week 4 |
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| Change at Week 4 - Female |
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| Week 4 - Male |
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| Change at Week 4 - Male |
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| Change at Week 4 - Hispanic/Latine |
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| Week 4 - Non Hispanic Asian or Pacific Islander |
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| Change at Week 4 - Non Hispanic Asian or Pacific Islander |
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| Week 4 - Non Hispanic Black or African American |
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| Change at Week 4 - Non Hispanic Black or African American |
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| Week 4 - Non Hispanic White |
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| Change at Week 4 - Non Hispanic White |
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| Week 4 - Other/Unknown |
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| Change at Week 4 - Other/Unknown |
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