Early Antenatal Support for Iron Deficiency Anemia

Phase 4RecruitingNCT04278651

Thomas Jefferson University80 enrolled

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Interventions

FerumoxytolDRUG

510mg infusion x 2 doses 3-8 days apart

Ferrous SulfateDRUG

325mg oral twice daily

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

RECRUITING

Outcomes

Primary Outcomes

Change in Hemoglobin

Change in hemoglboin at day 90 following treatment initiation

Time frame: 90 days

Secondary Outcomes

Anemia resolution

Percent of participants in each group with Hb\>=11.0 at day 90

Time frame: 90 days

Anemia at Delivery

Percent of participants in each group with Hb\>=11.0 at delivery

Time frame: 9 months

Need for additional therapy

Percent of participants in each group requiring additional therapy for iron deficiency anemia after 28 weeks

Time frame: 9 months

Quality of life scale

Linear Analogue Scale Assessment

Time frame: 30, 60, 90 days

Adherence

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

Time frame: 90 days

Need for post partum transfusion

Incidence of transfusion after delivery/post partum

Time frame: 9 months

Neonatal outcomes: cord blood iron indices

Hb, ferritin, total iron saturation

Time frame: 9 months

Neonatal outcomes: birth weight

Central Contacts

Rupsa C Boelig, MD

CONTACT

215-955-9196 rupsa.boelig@jefferson.edu

Data from ClinicalTrials.gov

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