Intravenous Iron vs. Oral Iron Supplementation for Postpartum Anemia

NCT05047211 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 21-0127
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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. 1.Oral Iron group: Ferrous sulfate 325 mg (65 mg elemental iron) by mouth for a total of 6 weeks TID.
2. 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.

Conditions

Anemia, Iron Deficiency; Delivery Complication

Keywords

Postpartum, iron deficiency anemia, intravenous iron

Outcome Measures

Primary Outcomes (1)

• Hemoglobin Level

  hemoglobin in grams per deciliters

  6 weeks after delivery

Secondary Outcomes (2)

• Number of Participants With Nausea or Vomiting

  up to 6 weeks after delivery

• Myalgia

  up to 6 weeks after delivery

Study Arms (2)

Oral Iron group

ACTIVE COMPARATOR

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.

Drug: Ferrous sulfate

IV Iron group

EXPERIMENTAL

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.

Drug: Iron dextran

Interventions

Ferrous sulfate DRUG

one tablet 325 milligrams three times a day

Oral Iron group

Iron dextran DRUG

1000 mg intravenous infusion

IV Iron group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Participant eligibility is based on self-representation of gender identity.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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.)
• Patient has received blood transfusion or there is a plan to transfuse
• Lactose intolerance

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead

Study Sites (1)

Ashley Salazar

Galveston, Texas, 77555, United States

Location

Related Publications (1)

• Saad AF, Stepanek R, Kothmann M, Wilson-Jimenez M, McCoy L, Aguillon B, Salazar A, Saade GR. Intravenous Iron Compared With Oral Iron Supplementation for the Treatment of Postpartum Anemia: A Randomized Controlled Trial. Obstet Gynecol. 2023 Jun 1;141(6):1052-1055. doi: 10.1097/AOG.0000000000005143. Epub 2023 May 3.

  PMID: 37486650 DERIVED

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Interventions

ferrous sulfate; Iron-Dextran Complex

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Dextrans; Glucans; Polysaccharides; Carbohydrates

Results Point of Contact

• Title: Dr Antonio Saad Director of PRD
• Organization: UTMB Galveston

antalar@me.com

4097721795

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double blinded placebo controlled clinical trial. We will be using intravenous and oral placebos for each interventions
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized control trial

Study Record Dates

• First Submitted: September 7, 2021
• First Posted: September 17, 2021
• Study Start: October 7, 2021
• Primary Completion: March 15, 2023
• Study Completion: April 15, 2023
• Last Updated: August 29, 2023
• Results First Posted: August 29, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)