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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05047211
Other study ID # 21-0127
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


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
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