A Comparison Between Intravenous Iron Sucrose to Its Combination With Oral Iron Supplements for the Treatment of Postpartum Anemia

NCT02458625 | Completed

• 1 other identifier: 0133-14
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 1

Brief Summary

This study is aimed to compare the efficacy of two mode of iron administration to treat post partum anemia - a single dose of intravenous iron sucrose versus a single dose of iron sucrose and 6 weeks of treatment with oral iron supplement.

Conditions

Postpartum Anemia

Outcome Measures

Primary Outcomes (1)

• The change between the hemoglobin level at randomization and the hemoglobin level after 6 weeks postpartum

  After 6 weeks post partum

Secondary Outcomes (6)

• Women's satisfaction from the protocol treatment according to the VAS (visual analog scale) after 6 weeks post partum

  Up to 6 weeks post partum

• The composite symptoms of anemia and functional capacity after 6 weeks postpartum as assessed by a questionnaire

  six weeks post partum

• Type and rate of adverse events

  Up to 6 weeks post partum

• The rate of patients who discontinued treatment

  Up to 6 weeks post partum

• The change in hemoglobin level, ferritin, serum iron, transferrin, MCV and iron saturation from randomization to 6 weeks post partum

  From randomization to 6 weeks post partum

Study Arms (2)

Iron sucrose 500 mg

ACTIVE COMPARATOR

One treatment arm will receive a single dose of I.V iron sucrose 500 mg.

Dietary Supplement: Iron sucrose 500 mg

Iron sucrose 500 mg+60 mg Iron bisglycinate

ACTIVE COMPARATOR

Second treatment arm will receive a single dose of I.V iron sucrose 500 mg and oral treatment with 60 mg Iron bisglycinate for 6 weeks after giving birth.

Dietary Supplement: Iron sucrose 500 mg; Dietary Supplement: Iron bisglycinate 60 mg

Interventions

Iron sucrose 500 mg DIETARY_SUPPLEMENT

Iron sucrose 500 mg; Iron sucrose 500 mg+60 mg Iron bisglycinate

Iron bisglycinate 60 mg DIETARY_SUPPLEMENT

Iron sucrose 500 mg+60 mg Iron bisglycinate

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women above 18 years old after giving birth

You may not qualify if:

• Women who suffer from known allergy for iron supplements
• Women who suffer from anemia not due to iron deficiency
• Women who suffer from acute infection
• Women who suffer from liver failure or viral hepatitis
• Women who suffer from thalassemia or hemoglobinopathies
• Women who suffer from renal failure
• Women who suffer from unbalanced thyroid disorder

Sponsors & Collaborators

• HaEmek Medical Center, Israel: lead

Study Sites (1)

Emek Medical Center

Afula, Israel

Location

Related Publications (1)

• Yefet E, Mruat Rabah S, Sela ND, Hosary Mhamed S, Yossef A, Nachum Z. Addition of oral iron bisglycinate to intravenous iron sucrose for the treatment of postpartum anemia-randomized controlled trial. Am J Obstet Gynecol. 2021 Dec;225(6):668.e1-668.e9. doi: 10.1016/j.ajog.2021.06.069. Epub 2021 Jun 23.

  PMID: 34171389 DERIVED

MeSH Terms

Interventions

Ferric Oxide, Saccharated

Intervention Hierarchy (Ancestors)

Ferric Compounds; Iron Compounds; Inorganic Chemicals; Glucaric Acid; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 28, 2015
• First Posted: June 1, 2015
• Study Start: April 1, 2016
• Primary Completion: June 7, 2020
• Study Completion: November 4, 2020
• Last Updated: November 6, 2020

Record last verified: 2020-11

Locations

IL (1)