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Intravenous Iron vs. Oral Iron Supplementation for Postpartum Anemia

NCT05047211 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2023-08-29

Study results available
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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.

Conditions

  • Anemia, Iron Deficiency
  • Delivery Complication

Interventions

DRUG

Ferrous sulfate

one tablet 325 milligrams three times a day

DRUG

Iron dextran

1000 mg intravenous infusion

Sponsors & Collaborators

  • The University of Texas Medical Branch, Galveston

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-10-07
Primary Completion
2023-03-15
Completion
2023-04-15
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 NCT05047211 on ClinicalTrials.gov