Intravenous Iron vs. Oral Iron Supplementation for Postpartum Anemia
Completed · Phase 4 · Has a placebo group
Conditions studied: Anemia, Iron Deficiency, Delivery Complication
In brief
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.
Key facts
- Study ID
- NCT05047211
- Run by
- The University of Texas Medical Branch, Galveston
- People needed
- 40
- Starts
- 2021-10-07
- Expected to finish
- 2023-04-15
- Last updated by the study team
- 2023-08-29
Who can join
Age: 18 and older, up to 50. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- Delivery at our institution
- Hemoglobin below 9 g/dl in postpartum day 1
- Singleton gestation
You may not qualify if…
- 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
Where it is running
- Ashley Salazar — Galveston, Texas, United States
Full record on ClinicalTrials.gov
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