RecruitingPhase 3NCT06366698

Intravenous Iron Versus Oral Iron for the Treatment of Iron Deficiency Anemia

Randomized Control Trial: Intravenous Iron Versus Oral Iron for the Treatment of Iron Deficiency Anemia in Pregnancy


Sponsor

Arrowhead Regional Medical Center

Enrollment

900 participants

Start Date

Nov 21, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This study aims to assess whether administering intravenous iron early in pregnancy, compared to standard oral iron treatment, can enhance hemoglobin levels before delivery and reduce the need for blood transfusions in patients with iron deficiency anemia. Patients diagnosed with iron deficiency anemia were randomly assigned to receive either oral or intravenous iron. Before treatment initiation, patients completed a symptom questionnaire baseline hemoglobin, and ferritin levels were measured. Follow-up visits occurred four weeks later and at 24 to 28 weeks gestation, involving reassessment of symptoms, laboratory testing, and monitoring of treatment adherence. Final hemoglobin levels were determined before delivery, and data on the need for blood transfusion at delivery were recorded.


Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria5

  • Age \> 18 years of age
  • Ferritin level \< 30 ng/mL
  • Singe gestation
  • Gestational age up to 36 weeks as iron therapy after this has shown to be not beneficial at time of delivery. We will still plan to treat patients \> 36 weeks but not include them in the final analysis
  • Plan to delivery at Arrowhead Regional Medical Center (ARMC)

Exclusion Criteria9

  • Maternal age \< 18 years of age
  • Incarcerated patients
  • Multifetal gestation
  • Acute liver/kidney disease
  • Active infections
  • Known hematological malignancy
  • Other causes of anemia such as alpha/beta thalassemia, sickle cell disease, Folate/B12 deficiency, and anemia of chronic diseases
  • Known hypersensitivity with IV iron
  • Severe symptoms of anemia requiring blood transfusion

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Interventions

DRUGVenofer 200 MG Per 10 ML Injection

200 mg IV every 2 days until the targeted dose

DRUGFerrous sulfate

Take 1 tablet every other day with lemon/orange juice


Locations(1)

Arrowhead Regional Medical Center

Colton, California, United States

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NCT06366698


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