Intravenous Infusions of Ferumoxytol Compared to Oral Ferrous Sulfate for the Treatment of Anemia in Pregnancy
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Anemia, Anemia |
| Therapuetic Areas: | Hematology |
| Healthy: | No |
| Age Range: | 18 - 50 |
| Updated: | 9/8/2018 |
| Start Date: | September 1, 2018 |
| End Date: | September 30, 2019 |
| Contact: | Meghan G Hill, MBBS |
| Email: | meghanhill@obgyn.arizona.edu |
| Phone: | 502 626 6174 |
Intravenous Infusions of Ferumoxytol Compared to Oral Ferrous Sulfate for the Treatment of Anemia in Pregnancy: A Randomized Controlled Trial
This randomized controlled trial includes pregnant women with anemia. They are randomized to
IV iron infusions or to oral iron supplementation. Pregnancy outcomes are assessed.
IV iron infusions or to oral iron supplementation. Pregnancy outcomes are assessed.
This is a randomized controlled trial aimed at assessing whether IV Iron administration
(Ferumoxytol x 2 infusions) is superior to oral ferrous sulfate for the treatment of
iron-deficiency anemia in pregnancy.
140 patients will be randomized in a 1:1 ratio. Patients in the IV Iron group will receive
two infusions of Ferumoxytol, one week apart. Patients in the oral Ferrous Sulfate group will
receive medication to take at home during their pregnancy.
Patients will have iron studies performed at study entry, and again at presentation for
delivery. Cord blood will also be sampled for iron studies.
(Ferumoxytol x 2 infusions) is superior to oral ferrous sulfate for the treatment of
iron-deficiency anemia in pregnancy.
140 patients will be randomized in a 1:1 ratio. Patients in the IV Iron group will receive
two infusions of Ferumoxytol, one week apart. Patients in the oral Ferrous Sulfate group will
receive medication to take at home during their pregnancy.
Patients will have iron studies performed at study entry, and again at presentation for
delivery. Cord blood will also be sampled for iron studies.
Inclusion Criteria:
- Maternal age >/= 18
- Singleton gestation
- >/=20 weeks gestation, <37 weeks gestation
- Hemoglobin <11g/dL and/or hematocrit <33%
- Able to read/speak English or Spanish
Exclusion Criteria:
- Maternal age <18
- Multiple gestation
- <20 weeks gestation,
- Hemoglobin >/=11g/dL and/or hematocrit >/=33%
- Unable to read or speak English or Spanish
- Incarcerated patients
We found this trial at
1
site
Tucson, Arizona 85721
(520) 621-2211
Principal Investigator: Meghan G Hill, MBBS
Phone: 520-626-6174
University of Arizona The University of Arizona is a premier, public research university. Established in...
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