Iron Deficiency Anemia of Pregnancy
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTFerrous sulfate 325mg
Oral tablets supplied for home use
DRUGFerumoxytol
Ferumoxytol will be administered in two infusions, one week apart
Sponsors
AMAG Pharmaceuticals, Inc.
University of Arizona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomized Controlled Trial
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
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, \</= 37 weeks gestation * Hemoglobin \>/=11g/dL and/or hematocrit \>/=33% * Unable to read or speak English or Spanish * Incarcerated patients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in hemoglobin | 1 day - 22 weeks | We will assess the increase in maternal hemoglobin during the study timeframe |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood loss at delivery | 1 day - 22 weeks | Estimated or quantified blood loss at delivery |
| Hemoglobin change after delivery | 1 day - 22 weeks | Measured change in hemoglobin after delivery |
| Blood transfusion | 1 day - 22 weeks | Whether the mother requires a blood transfusion |
| Iron infusion | 1 day - 22 weeks | Whether the mother requires additional iron infusions |
| Change in other laboratory values | 1 day - 22 weeks | Including hematocrit, serum iron, transferrin saturation, ferritin |
| Preterm delivery | 1 day - 22 weeks | Whether the delivery occurs at less than 37 weeks of gestation |
| Indication for delivery | 1 day - 22 weeks | Indication for delivery if not spontaneous |
| Birth weight | 1 day - 22 weeks | Neonatal weight immediately after delivery |
| Concentration of substances in cord blood (iron studies) | 1 day - 22 weeks | Cord blood indices for iron, transferrin saturation and ferritin |
Countries
United States
Outcome results
None listed