Comparing intravenous iron to oral iron for treating anemia in pregnancy
Randomized Control Trial: Intravenous Iron Versus Oral Iron for the Treatment of Iron Deficiency Anemia in Pregnancy
PHASE3 · Arrowhead Regional Medical Center · NCT06366698
This study is testing whether giving pregnant women iron through an IV works better than taking it by mouth to improve their blood levels and reduce the need for blood transfusions during delivery.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 900 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Arrowhead Regional Medical Center (other) |
| Locations | 1 site (Colton, California) |
| Trial ID | NCT06366698 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of intravenous iron compared to standard oral iron treatment for improving hemoglobin levels in pregnant women with iron deficiency anemia. Participants diagnosed with this condition will be randomly assigned to receive either oral or intravenous iron, with their hemoglobin and ferritin levels measured before treatment and at follow-up visits. The study aims to determine if early intravenous iron administration can reduce the need for blood transfusions at delivery. The research addresses a significant health issue, as iron deficiency anemia can lead to serious complications for both mothers and infants.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women over 18 years old with low ferritin levels and single gestation up to 36 weeks.
Not a fit: Patients who may not benefit include those under 18, with multifetal gestation, or other specific medical conditions that cause anemia.
Why it matters
Potential benefit: If successful, this approach could significantly improve hemoglobin levels in pregnant women and reduce the need for blood transfusions during delivery.
How similar studies have performed: Previous studies have shown the safety and efficacy of intravenous iron, but this approach in early pregnancy is less commonly tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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 this trial is running
Colton, California
- Arrowhead Regional Medical Center — Colton, California, United States (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Iron Deficiency Anemia of Pregnancy, Anemia, Iron deficiency, Pregnancy, Intravenous iron