Intravenous Iron for Iron-deficiency Anemia in Pregnancy: a Randomized Controlled Trial

NCT03438227 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: 1809251633
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 2

Brief Summary

Iron deficiency is the most common cause of anemia in pregnancy worldwide, and, when severe, can have serious consequences for mothers and babies. While treatment of iron-deficiency anemia with iron supplementation is recommended, treatment strategies remain controversial: the American College of Obstetrics and Gynecology recommends oral iron supplementation with parental iron reserved for the rare patient who cannot tolerate or will not take oral iron, while United Kingdom professional organizations recommend a more liberal use of parenteral iron. The reason for these disparate recommendations is that few high-quality studies comparing oral to parenteral iron have been conducted in developed countries, and the potential impact of parental iron treatment on obstetric and perinatal outcomes remains unclear. We propose the first randomized-controlled trial in the United States describing the effectiveness and safety of treating pregnant women with iron-deficiency anemia with a protocol including parenteral iron compared with a protocol based on oral iron.

Conditions

Iron Deficiency Anemia of Pregnancy; Iron Malabsorption

Keywords

Iron Deficiency Anemia of Pregnancy; oral iron supplementation; parenteral iron supplementation; maternal anemia

Outcome Measures

Primary Outcomes (1)

• Maternal Anemia at Delivery

  Number of participants with maternal hemoglobin \<11g/dl at delivery

  At delivery

Secondary Outcomes (13)

• Maternal Hemoglobin at Delivery

  On admission to inpatient obstetrics unit for delivery

• Number of Participants With Medication Adverse Events

  2 - 3 days after single intravenous iron infusion or initiation of oral iron

• Maternal Hemoglobin Below 10g/dl at Delivery

  At delivery

• Maternal Ferritin at Delivery

  At delivery

• Number of Participants Who Received Blood Transfusion

  During inpatient admission for delivery of neonate

Study Arms (2)

Intravenous iron dextran infusion

EXPERIMENTAL

Women randomized to receive intravenous iron infusion will receive a single infusion of dextran 1000mg IV as an inpatient on the antepartum or Labor \& Delivery Unit. They will receive continuous fetal monitoring for 30 minutes before and after the infusion as well for the duration of the infusion

Drug: Iron dextran

Oral ferrous sulfate supplementation

ACTIVE COMPARATOR

Women randomized to continue oral iron will continue to take ferrous sulfate 325mg one to three tablets daily, with the final dose at the discretion of the patient's obstetric provider.

Drug: Ferrous sulfate 325mg

Interventions

Iron dextran DRUG

Single intravenous infusion of iron dextran 1000mg.

Also known as: Experimental

Intravenous iron dextran infusion

Ferrous sulfate 325mg DRUG

Oral iron supplementation with ferrous sulfate 325mg one to three times daily

Also known as: Active comparator

Oral ferrous sulfate supplementation

Eligibility Criteria

• Gender Eligibility Details: Patients must be pregnant in order to participate
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Iron-deficiency anemia (serum ferritin \<30 micrograms, normal hemoglobin electrophoresis, and hemoglobin \<10 mg/dL), planned delivery at Barnes-Jewish Hospital

You may not qualify if:

• Non-iron-deficiency anemia, multiple gestation, prenatally diagnosed major fetal anomalies, known aneuploidy, planned delivery at other hospital, inability to obtain consent

Sponsors & Collaborators

• Indiana University: lead

Study Sites (2)

Indiana University School of Medicine

Indianapolis, Indiana, 46202, United States

Location

Center for Outpatient Health, Washington University in St. Louis

St Louis, Missouri, 63110, United States

Location

Related Publications (4)

• American College of Obstetricians and Gynecologists. ACOG Practice Bulletin No. 95: anemia in pregnancy. Obstet Gynecol. 2008 Jul;112(1):201-7. doi: 10.1097/AOG.0b013e3181809c0d. Erratum In: Obstet Gynecol. 2020 Jan;135(1):222. doi: 10.1097/AOG.0000000000003624.

  PMID: 18591330 BACKGROUND

• Pavord S, Myers B, Robinson S, Allard S, Strong J, Oppenheimer C; British Committee for Standards in Haematology. UK guidelines on the management of iron deficiency in pregnancy. Br J Haematol. 2012 Mar;156(5):588-600. doi: 10.1111/j.1365-2141.2011.09012.x.

  PMID: 22512001 BACKGROUND

• Reveiz L, Gyte GM, Cuervo LG, Casasbuenas A. Treatments for iron-deficiency anaemia in pregnancy. Cochrane Database Syst Rev. 2011 Oct 5;(10):CD003094. doi: 10.1002/14651858.CD003094.pub3.

  PMID: 21975735 BACKGROUND

• Lewkowitz AK, Stout MJ, Cooke E, Deoni SC, D'Sa V, Rouse DJ, Carter EB, Tuuli MG. Intravenous versus Oral Iron for Iron-Deficiency Anemia in Pregnancy (IVIDA): A Randomized Controlled Trial. Am J Perinatol. 2022 Jun;39(8):808-815. doi: 10.1055/s-0041-1740003. Epub 2021 Nov 28.

  PMID: 34839481 DERIVED

MeSH Terms

Interventions

Iron-Dextran Complex; ferrous sulfate

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Methodius Tuuli
• Organization: Brown University

MTuuli@wihri.org

401-430-1575

Study Officials

• Method Tuuli, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The research team will be blinded to the patients' treatment arm. A team of resident physicians who are unfamiliar with the study aims will provide standard obstetric care to all participants.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Obstetrics and Gynecology

Model Details: All participants at less than 28 weeks gestation will have an anemia evaluation and work up per standard prenatal care. Those who meet a clinical diagnosis of iron-deficiency anemia will initiate oral iron and have their Complete Blood Count rechecked between 24 and 28 weeks gestation. If their hemoglobin is less than 10 mg/dL, they will be randomized to either continue their oral iron supplementation or receive a single intravenous dextran iron transfusion. If the patient is enrolled after 28 weeks and receives a diagnosis of iron deficiency anemia, she will be randomized at that time.

Study Record Dates

• First Submitted: January 25, 2018
• First Posted: February 19, 2018
• Study Start: April 15, 2018
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: June 11, 2024
• Results First Posted: June 11, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)