Intravenous Iron for Iron-deficiency Anemia in Pregnancy: a Randomized Controlled Trial
Status:
Completed
Trial end date:
2019-12-31
Target enrollment:
Participant gender:
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 UK 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.
Phase:
Phase 4
Details
Lead Sponsor:
Indiana University Washington University School of Medicine