Anemia, Iron Deficiency, Anemia of Pregnancy, Pregnancy Related
Conditions
Brief summary
This is a randomized, controlled multi-site trial of iron therapy in pregnancy. The purpose of this research is to see if second trimester initiation of intravenous (IV) iron therapy is better than oral iron therapy for treatment of anemia in pregnancy by improving blood count, quality of life and reducing side effects.
Detailed description
Pregnant singletons diagnosed with iron deficiency anemia will be enrolled between 14-24 weeks and will be randomized 1:1 to either a course of ferumoxytol (510mg x 2 doses 3-8 days apart) or oral iron (325mg) twice daily.
Interventions
DRUGFerumoxytol
510mg infusion x 2 doses 3-8 days apart
DRUGFerrous Sulfate
325mg oral twice daily
Sponsors
Auerbach Hematology and Oncology
Thomas Jefferson University
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 65 Years
Healthy volunteers
No
Inclusion criteria
* Singleton gestation * Gestational age \<24 weeks * Baseline Hb ≥9.0 and \<11.0 with evidence of iron deficiency anemia Iron deficiency anemia diagnosed (at any point in patient history) by: * Hb\<11.0 * Ferritin\<30 and/or total iron saturation \<20
Exclusion criteria
* Sickle cell Disease (NOT sickle cell trait) * Evidence of acute anemia requiring transfusion or IV iron therapy * Major congenital or chromosomal anomaly * Previous use of IV iron in this pregnancy * Severe cardiac, renal, or liver disease * Autoimmune disease (ie Systemic Lupus Erythematosus (SLE) * Allergy or contraindication to either study drug * History of medication allergy, reaction to IV infusion, or reaction to Feraheme or other IV iron products
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Hemoglobin | 90 days | Change in hemoglboin at day 90 following treatment initiation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anemia at Delivery | 9 months | Percent of participants in each group with Hb\>=11.0 at delivery |
| Need for additional therapy | 9 months | Percent of participants in each group requiring additional therapy for iron deficiency anemia after 28 weeks |
| Quality of life scale | 30, 60, 90 days | Linear Analogue Scale Assessment |
| Adherence | 90 days | adherence to assigned group. Measured by what % of IV infusions completed of the two required in IV iron group, and for oral iron group, what %pills taken/prescribed based on pill counts |
| Anemia resolution | 90 days | Percent of participants in each group with Hb\>=11.0 at day 90 |
| Neonatal outcomes: cord blood iron indices | 9 months | Hb, ferritin, total iron saturation |
| Neonatal outcomes: birth weight | 9 months | birth weight (grams) |
| Neonatal outcomes gestational age of delivery (weeks) | 9 months | gestational age of delivery (weeks) |
| Need for post partum transfusion | 9 months | Incidence of transfusion after delivery/post partum |
Countries
United States
Contacts
Primary ContactRupsa C Boelig, MD
Outcome results
None listed