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OpenTrials
Completed

NCT Number: NCT05047211

Intravenous Iron vs. Oral Iron Supplementation for Postpartum Anemia

This trial will be a comparative pragmatic open label feasibility randomized controlled trial of oral daily versus IV iron in anemic postpartum patients.

Two randomly assigned groups will be compared during the postpartum period:

1. Oral Iron group: Ferrous sulfate 325 mg (65 mg elemental iron) by mouth for a total of 6 weeks TID.

IV placebo in sodium chloride 0.9% 500mL IV infusion will be given before discharge home over 1 hour preceded by placebo test dose IV infusion of 100mL 0.9% sodium chloride. 2. IV Iron group: Low molecular weight iron dextran (infed) 1000mg in sodium chloride 0.9% 500mL IV infusion over 1 hour preceded by test dose 25 mg IV low molecular weight iron dextran infusion in 100mL 0.9% sodium chloride.

2.1 Oral placebo will be given by mouth for a total of 6 weeks TID.

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Key information

Conditions

Anemia, Iron Deficiency Anemia Anemia, Hypochromic Anemia, Iron-Deficiency Delivery Complication Hematologic Diseases Hemic and Lymphatic Diseases Iron Deficiencies Iron Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Ashley Salazar

Galveston, Texas, 77555, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Delivery at our institution
  • Hemoglobin below 9 g/dl in postpartum day 1
  • Singleton gestation

Exclusion criteria

  • Diagnosis of malabsorptive disorder or history of gastric bypass procedure
  • Known diagnosis of anemia other than iron deficiency (thalassemia, macrocytic anemia, sickle cell, etc.)
  • Significant cardiovascular disease, including but not limited to myocardial infarction or unstable angina within 6 months prior to study inclusion or current history of NYHA Class III or IV congestive heart failure
  • Patient has received blood transfusion or there is a plan to transfuse
  • Lactose intolerance

Treatment and study plan

Ferrous Sulfate

Drug

one tablet 325 milligrams three times a day

Iron Dextran

Drug

1000 mg intravenous infusion

Primary outcomes

  1. Hemoglobin Level

    Time frame: 6 weeks after delivery

    hemoglobin in grams per deciliters

Secondary outcomes

  1. Number of Participants With Nausea or Vomiting

    Time frame: up to 6 weeks after delivery

    feeling sick to vomit or vomit

  2. Myalgia

    Time frame: up to 6 weeks after delivery

    Generalized muscle pain

Sponsors and collaborators

Lead sponsor

The University of Texas Medical Branch, Galveston

Other

Registry information

Official study title

A Feasibility Trial of Intravenous Iron vs. Oral Iron Supplementation for the Treatment of Postpartum Anemia (IVIRONMAN)

Acronym: IVIRONMAN

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Sep 17, 2021
Registry last updated
Aug 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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