Intravenous Iron Versus Oral Iron for the Treatment of Iron Deficiency Anemia
Status unconfirmed · Phase 3
Conditions studied: Iron Deficiency Anemia of Pregnancy
In brief
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.
Key facts
- Study ID
- NCT06366698
- Run by
- Arrowhead Regional Medical Center
- People needed
- 900
- Starts
- 2023-11-21
- Expected to finish
- 2025-12-30
- Last updated by the study team
- 2024-04-16
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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
Where it is running
- Arrowhead Regional Medical Center — Colton, California, United States (enrolling)
Full record on ClinicalTrials.gov
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