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| ID | Type | Description | Link |
|---|---|---|---|
| Infed | Other Grant/Funding Number | pharmacosmos |
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| Name | Class |
|---|---|
| Pharmacosmos A/S | INDUSTRY |
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To determine the percentage of women who achieve anemia correction after a single dose of 1000mg of low molecular weight iron dextran(infed).
To determine the percentage of women who achieve anemia correction after a single dose of 1000mg of low molecular weight iron dextran(infed).
To determine whether IV iron supplementation has a higher satisfaction with treatment as compared to oral supplementation in a population previously intolerant of or unresponsive to oral iron.
To evaluate the safety of IV low molecular weight iron dextran in pregnant women.
To assess maternal and fetal outcomes-preterm delivery, low birth weight deliveries, ER visits and hospitalizations related to preterm labor, preterm contractions, ante-partum and post-partum transfusions, maternal hemoglobin at post-partum visit after IV iron supplementation groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IV iron | Other | Intravaneous iron(1000 mg low molecular weight iron dextran over 60 minutes) for moderate to severe iron deficient anemia of pregnancy in women intolerant of or unresponsive to oral iron. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravaneous iron(low molecular weight iron dextran) | Drug | 1000 mg of Iron dextran administered over one hour |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Women Who Achieve Anemia Correction After a Single Dose of 1000mg of Low Molecular Weight Iron Dextran(INfeD). | 4 weeks after infusion or post-partum |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Ferritin | 4 weeks post infusion or post-partum | |
| Percent Transferrin Saturation | 4 weeks post infusion or post-partum | |
| Safety as Measured by Number of Adverse Events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Auerbach, MD | Auerbach Hematology Oncology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Auerbach Hematology Oncology Assoc | Baltimore | Maryland | 21237 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28739199 | Result | Auerbach M, James SE, Nicoletti M, Lenowitz S, London N, Bahrain HF, Derman R, Smith S. Results of the First American Prospective Study of Intravenous Iron in Oral Iron-Intolerant Iron-Deficient Gravidas. Am J Med. 2017 Dec;130(12):1402-1407. doi: 10.1016/j.amjmed.2017.06.025. Epub 2017 Jul 21. |
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Oral iron intolerance plus iron deficiency anemia as defined by a serum ferritin of <20 ng/mL or transferrin saturation of <19% in the 2nd or 3rd trimester plus the ACOG guidelines of <10/.5 g/dL and 11.0 g/dl respectively. 73/74 enrolled received the planned dose.
Standard referrals from obstetricians and gynecologists
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| ID | Title | Description |
|---|---|---|
| FG000 | IV Iron | Intravaneous iron(1000 mg low molecular weight iron dextran over 60 minutes) for moderate to severe iron deficient anemia of pregnancy in women intolerant of or unresponsive to oral iron. Intravaneous iron(low molecular weight iron dextran): 1000 mg of Iron dextran administered over one hour |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Iron deficient gravidas in 2nd and 3rd trimesters
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| ID | Title | Description |
|---|---|---|
| BG000 | Intravenous Iron | As oral iron intolerant iron deficient 2nd and 3rd trimester gravidas defined by a ferritin of <20 ng/mL and TSAT ,19%. All were anemic by ACOG criteria of Hb <10.5 g/dL in 2nd trimester or, 11g/dL in 3rd, who received 1000 mg IV low molecular weight iron dextran in one hour |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Percentage of Women Who Achieve Anemia Correction After a Single Dose of 1000mg of Low Molecular Weight Iron Dextran(INfeD). | Of the 73 who received the infusion, 5 were lost to followup and 8 did not return for 4-week posttreatment bloodwork. Pretreatment (initial) and 4-week posttreatment laboratory studies are available for 60 | Posted | Count of Participants | Participants | 4 weeks after infusion or post-partum |
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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 | IV Iron | Intravaneous iron(1000 mg low molecular weight iron dextran over 60 minutes) for moderate to severe iron deficient anemia of pregnancy in women intolerant of or unresponsive to oral iron. Intravaneous iron(low molecular weight iron dextran): 1000 mg of Iron dextran administered over one hour |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Michael AUERBACH | AUERBACH HEMATOLOGY ONCOLOGY ASSOC | 410-780-4050 | MAUERBACHMD@ABHEMONC.COM |
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| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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To evaluate the safety of IV low molecular weight iron dextran in pregnant women. Also to asses maternal and fetal outcomes-preterm delivery, low-birth weight deliveries, ER visits and hospitalizations related to preterm labor, preterm contractions, ante-partum and post partum transfusions, maternal hemoglobin at post-partum visit after IV iron supplementation groups. A questionaire with a list of symptoms to include nausea, dizziness, hypotension, edema, headache, abdominal pain, chest pain, cough, itching, fever, back pain, muscle cramps and rash are asked immediately after administration and phone calls at 24, 48 hours and 7 days. |
| 4 weeks after infusion and 4 weeks post-partum |
| years |
|
| Sex/Gender, Customized | 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 |
|
| Pretreatment Hb | Mean | Standard Deviation | g/dL |
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| Iron Deficient Pregnant Gravidas | Count of Participants | Participants |
|
| Serum ferritin | Mean | Standard Deviation | ng/mL |
|
| Percent Transferrin Saturation | Mean | Standard Deviation | percent saturation (Fe/TIBC) |
|
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| Secondary | Serum Ferritin | Of the 73 who received the infusion, 5 were lost to followup and 8 did not return for 4-week posttreatment bloodwork. Pretreatment (initial) and 4-week posttreatment laboratory studies are available for 60 | Posted | Mean | Standard Deviation | ng/mL | 4 weeks post infusion or post-partum |
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|
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| Secondary | Percent Transferrin Saturation | Of the 73 who received the infusion, 5 were lost to followup and 8 did not return for 4-week posttreatment bloodwork. Pretreatment (initial) and 4-week posttreatment laboratory studies are available for 60 | Posted | Mean | Standard Deviation | percent saturation (Fe/TIBC) | 4 weeks post infusion or post-partum |
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|
|
| Secondary | Safety as Measured by Number of Adverse Events | To evaluate the safety of IV low molecular weight iron dextran in pregnant women. Also to asses maternal and fetal outcomes-preterm delivery, low-birth weight deliveries, ER visits and hospitalizations related to preterm labor, preterm contractions, ante-partum and post partum transfusions, maternal hemoglobin at post-partum visit after IV iron supplementation groups. A questionaire with a list of symptoms to include nausea, dizziness, hypotension, edema, headache, abdominal pain, chest pain, cough, itching, fever, back pain, muscle cramps and rash are asked immediately after administration and phone calls at 24, 48 hours and 7 days. | Posted | Number | minor adverse events | 4 weeks after infusion and 4 weeks post-partum |
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| 0 |
| 74 |
| 0 |
| 74 |
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