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
Who is this study for? Patients with iron deficiency anemia in pregnancy
What treatments are being studied? Ferumoxytol
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:
• 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
Locations
United States
Pennsylvania
Thomas Jefferson University Hospital
RECRUITING
Philadelphia
Contact Information
Primary
Rupsa C Boelig, MD
rupsa.boelig@jefferson.edu
215-955-9196
Time Frame
Start Date: 2021-09-29
Estimated Completion Date: 2025-12-30
Participants
Target number of participants: 80
Treatments
Active_comparator: Oral Iron
325mg oral iron (ferrous sulfate) twice daily
Experimental: Intravenous Iron
510mg ferumoxytol intravenous infusion for two doses total; second dose 3-8 days after first dose.
Related Therapeutic Areas
Sponsors
Collaborators: Auerbach Hematology and Oncology
Leads: Thomas Jefferson University