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

19G.929

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.

2021-09-29

2025-08-30

2025-12-30

Recruiting

Early phase I

80

Inclusion Criteria: * 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 Exclusion Criteria: * Sickle cell Disease (NOT sickle cell trait) * Evidence of acute anemia requiring transfusion or IV iron therapy * Major congenital or chromosomal anomaly * Previous use of IV iron in this pregnancy * Severe cardiac, renal, or liver disease * Autoimmune disease (ie Systemic Lupus Erythematosus (SLE) * Allergy or contraindication to either study drug * History of medication allergy, reaction to IV infusion, or reaction to Feraheme or other IV iron products

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized controlled trial', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 80, 'type': 'ESTIMATED'}}

2024-04-18