Early Antenatal Support for Iron Deficiency Anemia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ferumoxytol, Ferrous Sulfate.
- Who it may be relevant to
- Registry conditions: Pregnancy Related, Anemia, Iron Deficiency, Anemia of Pregnancy. Basic parameters: 18 years — 65 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Early Antenatal Support for Iron Deficiency Anemia: A Randomized Controlled Trial of Early Initiation of Intravenous Versus Oral Iron Therapy for Treatment of Iron Deficiency Anemia in Pregnancy
Overview
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
- Drug Ferumoxytol
510mg infusion x 2 doses 3-8 days apart - Drug Ferrous Sulfate
325mg oral twice daily
Primary outcome measures
- Change in Hemoglobin [Time frame: 90 days]
Secondary outcome measures (9)
- Anemia resolution [Time frame: 90 days]
- Anemia at Delivery [Time frame: 9 months]
- Need for additional therapy [Time frame: 9 months]
- Quality of life scale [Time frame: 30, 60, 90 days]
- Adherence [Time frame: 90 days]
- Need for post partum transfusion [Time frame: 9 months]
- Neonatal outcomes: cord blood iron indices [Time frame: 9 months]
- Neonatal outcomes: birth weight [Time frame: 9 months]
- Neonatal outcomes gestational age of delivery (weeks) [Time frame: 9 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Thomas Jefferson University Hospital — Philadelphia
Identifiers
NCT: NCT04278651 · 19G.929