Intravenous Iron vs. Oral Iron Supplementation for Postpartum Anemia

Phase 4

Completed

• Conditions: Anemia, Iron Deficiency; Delivery Complication
• Interventions: Drug: Ferrous sulfate; Drug: Iron dextran

• Registration Number: NCT05047211
• Lead Sponsor: The University of Texas Medical Branch, Galveston

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-07
• Study First Submitted QC: 2021-09-07
• Study First Posted: 2021-09-17
• Study Start: 2021-10-07
• Primary Completion: 2023-03-15
• Study Completion: 2023-04-15
• Results First Submitted: 2023-07-18
• Status Verified: 2023-08
• Results First Submitted QC: 2023-08-04
• Last Update Submitted: 2023-08-04
• Results First Posted: 2023-08-29
• Last Update Posted: 2023-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral Iron group	Ferrous sulfate	Ferrous sulfate 325 mg (65 mg elemental iron) by mouth for a total of 6 weeks three times daily. Intravenous 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.
IV Iron group	Iron dextran	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. Oral placebo will be given by mouth for a total of 6 weeks TID.

Primary Outcome Measures

Name	Time	Method
Hemoglobin Level	6 weeks after delivery	hemoglobin in grams per deciliters

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Nausea or Vomiting	up to 6 weeks after delivery	feeling sick to vomit or vomit
Myalgia	up to 6 weeks after delivery	Generalized muscle pain

Trial Locations

Locations (1)

Ashley Salazar; 🇺🇸 Galveston, Texas, United States