Intravenous Iron vs. Oral Iron Supplementation for Postpartum Anemia

Anemia, Iron Deficiency Clinical Trial

— IVIRONMAN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05047211
• Other study ID #: 21-0127
• Status: Completed
• Phase: Phase 4
• Start date: October 7, 2021
• Est. completion date: April 15, 2023

Study information

• Verified date: August 2023
• Source: The University of Texas Medical Branch, Galveston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 15, 2023
• Est. primary completion date: March 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron Deficiency
• Anemia, Iron-Deficiency
• Delivery Complication

Intervention

Drug:
• Ferrous sulfate
one tablet 325 milligrams three times a day
• Iron dextran
1000 mg intravenous infusion

Locations

Country	Name	City	State
United States	Ashley Salazar	Galveston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Medical Branch, Galveston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin Level	hemoglobin in grams per deciliters	6 weeks after delivery
Secondary	Number of Participants With Nausea or Vomiting	feeling sick to vomit or vomit	up to 6 weeks after delivery
Secondary	Myalgia	Generalized muscle pain	up to 6 weeks after delivery