RecruitingPhase 4NCT04278651

Early Antenatal Support for Iron Deficiency Anemia

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


Sponsor

Thomas Jefferson University

Enrollment

80 participants

Start Date

Sep 29, 2021

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating early antenatal (prenatal) support and treatment strategies for pregnant women with iron deficiency anemia — a common condition during pregnancy where the blood does not carry enough oxygen due to low iron levels. The study aims to find the most effective way to treat this condition early in pregnancy to protect both mother and baby. You may be eligible if: - You are at least 18 years old - You are pregnant with a single baby (not twins or more) - You are less than 24 weeks pregnant - Your hemoglobin (Hb) is between 9.0 and below 11.0, with evidence of iron deficiency anemia (ferritin below 30 and/or iron saturation below 20%) You may NOT be eligible if: - You have sickle cell disease (sickle cell trait is okay) - You have acute anemia that requires a blood transfusion or IV iron right away - Your baby has a known major birth defect or chromosomal problem - You have already received IV iron during this pregnancy - You have severe heart, kidney, or liver disease - You have an autoimmune disease such as lupus - You are allergic or have a contraindication to either study medication - You have had reactions to IV iron products in the past Talk to your obstetrician or midwife if you are pregnant and have been told you have iron deficiency anemia.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFerumoxytol

510mg infusion x 2 doses 3-8 days apart

DRUGFerrous Sulfate

325mg oral twice daily


Locations(1)

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

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NCT04278651


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