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This trial will be a comparative pragmatic open label feasibility randomized controlled trial of oral daily versus IV iron in anemic postpartum patients.
Two randomly assigned groups will be compared during the postpartum period:
Oral Iron group: Ferrous sulfate 325 mg (65 mg elemental iron) by mouth for a total of 6 weeks TID.
IV placebo in sodium chloride 0.9% 500mL IV infusion will be given before discharge home over 1 hour preceded by placebo test dose IV infusion of 100mL 0.9% sodium chloride.
IV Iron group: Low molecular weight iron dextran (infed) 1000mg in sodium chloride 0.9% 500mL IV infusion over 1 hour preceded by test dose 25 mg IV low molecular weight iron dextran infusion in 100mL 0.9% sodium chloride.
2.1 Oral placebo will be given by mouth for a total of 6 weeks TID.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral Iron group | Active Comparator | Ferrous sulfate 325 mg (65 mg elemental iron) by mouth for a total of 6 weeks three times daily. Intravenous placebo in sodium chloride 0.9% 500mL IV infusion will be given before discharge home over 1 hour preceded by placebo test dose IV infusion of 100mL 0.9% sodium chloride. |
|
| IV Iron group | Experimental | Low molecular weight iron dextran (infed) 1000mg in sodium chloride 0.9% 500mL IV infusion over 1 hour preceded by test dose 25 mg IV low molecular weight iron dextran infusion in 100mL 0.9% sodium chloride. Oral placebo will be given by mouth for a total of 6 weeks TID. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ferrous sulfate | Drug | one tablet 325 milligrams three times a day |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin Level | hemoglobin in grams per deciliters | 6 weeks after delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Nausea or Vomiting | feeling sick to vomit or vomit | up to 6 weeks after delivery |
| Myalgia | Generalized muscle pain |
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Inclusion Criteria:
Exclusion Criteria:
Participant eligibility is based on self-representation of gender identity.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ashley Salazar | Galveston | Texas | 77555 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37486650 | Derived | Saad AF, Stepanek R, Kothmann M, Wilson-Jimenez M, McCoy L, Aguillon B, Salazar A, Saade GR. Intravenous Iron Compared With Oral Iron Supplementation for the Treatment of Postpartum Anemia: A Randomized Controlled Trial. Obstet Gynecol. 2023 Jun 1;141(6):1052-1055. doi: 10.1097/AOG.0000000000005143. Epub 2023 May 3. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Oral Iron Group | Ferrous sulfate 325 mg (65 mg elemental iron) by mouth for a total of 6 weeks three times daily. Intravenous placebo in sodium chloride 0.9% 500mL IV infusion will be given before discharge home over 1 hour preceded by placebo test dose IV infusion of 100mL 0.9% sodium chloride. Ferrous sulfate: one tablet 325 milligrams three times a day |
| FG001 | IV Iron Group | Low molecular weight iron dextran (infed) 1000mg in sodium chloride 0.9% 500mL IV infusion over 1 hour preceded by test dose 25 mg IV low molecular weight iron dextran infusion in 100mL 0.9% sodium chloride. Oral placebo will be given by mouth for a total of 6 weeks TID. Iron dextran: 1000 mg intravenous infusion |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Oral Iron Group | Ferrous sulfate 325 mg (65 mg elemental iron) by mouth for a total of 6 weeks three times daily. Intravenous placebo in sodium chloride 0.9% 500mL IV infusion will be given before discharge home over 1 hour preceded by placebo test dose IV infusion of 100mL 0.9% sodium chloride. Ferrous sulfate: one tablet 325 milligrams three times a day |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Hemoglobin Level | hemoglobin in grams per deciliters | Posted | Median | Full Range | grams/deciliters | 6 weeks after delivery |
|
up to 6 weeks
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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 Group | Ferrous sulfate 325 mg (65 mg elemental iron) by mouth for a total of 6 weeks three times daily. Intravenous placebo in sodium chloride 0.9% 500mL IV infusion will be given before discharge home over 1 hour preceded by placebo test dose IV infusion of 100mL 0.9% sodium chloride. Ferrous sulfate: one tablet 325 milligrams three times a day |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Antonio Saad Director of PRD | UTMB Galveston | 4097721795 | antalar@me.com |
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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 | Nov 10, 2021 | Aug 4, 2023 | Prot_SAP_001.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 |
|---|---|
| C020748 | ferrous sulfate |
| D007505 | Iron-Dextran Complex |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D003911 | Dextrans |
| D005936 | Glucans |
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Randomized control trial
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Double blinded placebo controlled clinical trial. We will be using intravenous and oral placebos for each interventions
| Iron dextran |
| Drug |
1000 mg intravenous infusion |
|
| up to 6 weeks after delivery |
| BG001 |
| IV Iron Group |
Low molecular weight iron dextran (infed) 1000mg in sodium chloride 0.9% 500mL IV infusion over 1 hour preceded by test dose 25 mg IV low molecular weight iron dextran infusion in 100mL 0.9% sodium chloride. Oral placebo will be given by mouth for a total of 6 weeks TID. Iron dextran: 1000 mg intravenous infusion |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Number of Participants With Nausea or Vomiting | feeling sick to vomit or vomit | Posted | Count of Participants | Participants | up to 6 weeks after delivery |
|
|
|
| Secondary | Myalgia | Generalized muscle pain | Posted | Count of Participants | Participants | up to 6 weeks after delivery |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | IV Iron Group | Low molecular weight iron dextran (infed) 1000mg in sodium chloride 0.9% 500mL IV infusion over 1 hour preceded by test dose 25 mg IV low molecular weight iron dextran infusion in 100mL 0.9% sodium chloride. Oral placebo will be given by mouth for a total of 6 weeks TID. Iron dextran: 1000 mg intravenous infusion | 0 | 20 | 0 | 20 | 0 | 20 |
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| D000090463 |
| Iron Deficiencies |
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D011134 |
| Polysaccharides |
| D002241 | Carbohydrates |