CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 38 enrolled
Drug / intervention
Iron dextran +1 moredrug
Likely dose
Ferrous sulfate 325mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03438227
NCT03438227Phase 4Completed

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

Indiana University·interventional·Posted Feb 19, 2018·Updated Jun 11, 2024

In Brief

A Phase 4 clinical trial evaluating Iron dextran and Ferrous sulfate 325mg for Iron Deficiency Anemia of Pregnancy and Iron Malabsorption. Completed, enrolled 38 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
201820192020202120222023202420252026
First PostedFeb 19, 2018
Enrollment StartApr 15, 2018
Primary CompletionDec 31, 2019
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 8.4 years ago

Interventions

Iron dextrandrug

Single intravenous infusion of iron dextran 1000mg.

Ferrous sulfate 325mgdrug

Oral iron supplementation with ferrous sulfate 325mg one to three times daily