Early Antenatal Support for Iron Deficiency Anemia

Phase 4

Recruiting

• Conditions: Anemia, Iron Deficiency; Anemia of Pregnancy; Pregnancy Related
• Interventions: Drug: Ferrous Sulfate; Drug: Ferumoxytol

• Registration Number: NCT04278651
• Lead Sponsor: Thomas Jefferson University

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.

Study Timeline

• Study First Submitted: 2020-02-04
• Study First Submitted QC: 2020-02-18
• Study First Posted: 2020-02-20
• Study Start: 2021-09-29
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-17
• Last Update Posted: 2024-04-18
• Primary Completion: 2025-08-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral Iron	Ferrous Sulfate	325mg oral iron (ferrous sulfate) twice daily
Intravenous Iron	Ferumoxytol	510mg ferumoxytol intravenous infusion for two doses total; second dose 3-8 days after first dose.

Primary Outcome Measures

Name	Time	Method
Change in Hemoglobin	90 days	Change in hemoglboin at day 90 following treatment initiation

Secondary Outcome Measures

Name	Time	Method
Anemia resolution	90 days	Percent of participants in each group with Hb\>=11.0 at day 90
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 at Delivery	9 months	Percent of participants in each group with Hb\>=11.0 at delivery
Need for post partum transfusion	9 months	Incidence of transfusion after delivery/post partum
Neonatal outcomes: cord blood iron indices	9 months	Hb, ferritin, total iron saturation
Need for additional therapy	9 months	Percent of participants in each group requiring additional therapy for iron deficiency anemia after 28 weeks
Neonatal outcomes: birth weight	9 months	birth weight (grams)
Neonatal outcomes gestational age of delivery (weeks)	9 months	gestational age of delivery (weeks)

Trial Locations

Locations (1)

Thomas Jefferson University Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States