drugset / Trial / NCT03438227

Intravenous Iron for Iron-deficiency Anemia in Pregnancy: a Randomized Controlled Trial

NCT03438227

Phase 4 Completed 38 enrolled Indiana University
RandomizedParallel-groupDouble-blindTreatment

Summary

Iron deficiency is the most common cause of anemia in pregnancy worldwide, and, when severe, can have serious consequences for mothers and babies. While treatment of iron-deficiency anemia with iron supplementation is recommended, treatment strategies remain controversial: the American College of Obstetrics and Gynecology recommends oral iron supplementation with parental iron reserved for the rare patient who cannot tolerate or will not take oral iron, while United Kingdom professional organizations recommend a more liberal use of parenteral iron. The reason for these disparate recommendations is that few high-quality studies comparing oral to parenteral iron have been conducted in developed countries, and the potential impact of parental iron treatment on obstetric and perinatal outcomes remains unclear. We propose the first randomized-controlled trial in the United States describing the effectiveness and safety of treating pregnant women with iron-deficiency anemia with a protocol including parenteral iron compared with a protocol based on oral iron.

Timeline

Start
2018-04-15
Primary completion
2019-12-31
Completion
2019-12-31

Drugs

EvaluationDrugModalityDoseRoute
Comparator Ferrous Sulfate Diagnostic / imaging agent 325 mg Oral
Subject Iron dextran Unknown 1000 mg Intravenous