Phase 4 N=40 Randomized Quadruple-blind Treatment

Intravenous Iron vs. Oral Iron Supplementation for Postpartum Anemia

Anemia, Iron Deficiency · Delivery Complication

Bottom Line

View on ClinicalTrials.gov: NCT05047211 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2023

Primary outcome: Primary: Hemoglobin Level — 12; 12 grams/deciliters

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Ferrous sulfate (Drug); Iron dextran (Drug)
Age: Adult · 18+ yrs
Sex: Female
Sponsor: The University of Texas Medical Branch, Galveston
Primary completion: Mar 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Hemoglobin Level	12; 12	—
SECONDARY Number of Participants With Nausea or Vomiting	0; 0	—
SECONDARY Myalgia	1; 0	—

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.

Eligibility Criteria

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

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Data sourced from ClinicalTrials.gov (NCT05047211). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.