Early Antenatal Support for Iron Deficiency Anemia

NCT04278651 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: 19G.929
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy Related; Anemia, Iron Deficiency; Anemia of Pregnancy

Outcome Measures

Primary Outcomes (1)

• Change in Hemoglobin

  Change in hemoglboin at day 90 following treatment initiation

  90 days

Secondary Outcomes (9)

• Anemia resolution

  90 days

• Anemia at Delivery

  9 months

• Need for additional therapy

  9 months

• Quality of life scale

  30, 60, 90 days

• Adherence

  90 days

Study Arms (2)

Oral Iron

ACTIVE COMPARATOR

325mg oral iron (ferrous sulfate) twice daily

Drug: Ferrous Sulfate

Intravenous Iron

EXPERIMENTAL

510mg ferumoxytol intravenous infusion for two doses total; second dose 3-8 days after first dose.

Drug: Ferumoxytol

Interventions

Ferumoxytol DRUG

510mg infusion x 2 doses 3-8 days apart

Intravenous Iron

Ferrous Sulfate DRUG

325mg oral twice daily

Oral Iron

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Thomas Jefferson University: lead
• Auerbach Hematology and Oncology: collaborator

Study Sites (1)

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Interventions

Ferrosoferric Oxide; ferrous sulfate

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Ferric Compounds; Iron Compounds; Inorganic Chemicals; Ferrous Compounds; Minerals

Central Study Contacts

Rupsa C Boelig, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: February 4, 2020
• First Posted: February 20, 2020
• Study Start: September 29, 2021
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: December 2, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 1 year after publication of study results
• Access Criteria: After completion of planned primary and secondary analysis, IPD data may be available on request with completion of appropriate data sharing agreements

Locations

US (1)