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

NCT03438227 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2024-06-11

Study results available
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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.

Conditions

  • Iron Deficiency Anemia of Pregnancy
  • Iron Malabsorption

Interventions

DRUG

Iron dextran

Single intravenous infusion of iron dextran 1000mg.

DRUG

Ferrous sulfate 325mg

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

Sponsors & Collaborators

  • Indiana University

    lead OTHER

Principal Investigators

  • Method Tuuli, MD · Indiana University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-15
Primary Completion
2019-12-31
Completion
2019-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03438227 on ClinicalTrials.gov