Comparison Between Outcomes of Pregnant Women Treated With Ferinject vs. Venofer for Iron Deficiency Anemia

Comparison Between Outcomes of Pregnant Women Treated With Ferinject vs. Venofer for Iron Deficiency Anemia (Hb<9)

The purpose of this study is to compare maternal outcomes such as increased hemoglobin need for blood transfusion and hemoglobin level before and post partum in women with hemoglobin <9 gr/dl , treated with venofer and women treated with ferinject.

Study Overview

• Status: Recruiting
• Conditions: Pregnancy Anemia; Anemia, Iron Deficiency
• Intervention / Treatment: Drug: Venofer 200 MG Per 10 ML Injection; Drug: Ferinject

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: maya Wolf, MD; Phone Number: 972507887800; Email: mayaw@gmc.gov.il

Study Locations

• Israel
  • Nahariya, Israel
    • Recruiting
    • Galilee Medical Center
    • Contact: Maya Wolf, MD; Phone Number: 972-507887800

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

pregnancy>24 weeks of gestation anemia with Hb<9 anemia with Hb<9.5 if symptomatic anemia or previous postpartum hemorrhage

Exclusion Criteria:

• Allergy to one of the study's drugs
• IV iron treatment in the last month
• Underlying medical conditions associated with anemia, such as thalassemia Major, renal insufficiency, or spherocytosis
• Twin pregnancy
• non iron deficiency anemia

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: venofer; Women with iron def. anemia aith hemoglobin level <9 gr/dl who will be traeted with venofer	Drug: Venofer 200 MG Per 10 ML Injection; treat anemia with venofer up to 5 doses
Active Comparator: Ferinject; Women with iron def. anemia aith hemoglobin level <9 gr/dl who will be traeted with ferinject	Drug: Ferinject; ferinject 500 mg, once a week for 2 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ratio of women with Hb level >11 at delivery	Hb level	at delivery
postpartum Hb level	gr/dl	during 48 hours after delivery

Collaborators and Investigators

• Sponsor: Western Galilee Hospital-Nahariya

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2023
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: September 24, 2023
• First Submitted That Met QC Criteria: September 24, 2023
• First Posted (Actual): September 29, 2023

Study Record Updates

• Last Update Posted (Actual): September 11, 2026
• Last Update Submitted That Met QC Criteria: September 8, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Hematologic Diseases; Anemia; Iron Metabolism Disorders; Anemia, Hypochromic; Nutritional and Metabolic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Anemia, Iron-Deficiency; Organic Chemicals; Therapeutics; Drug Administration Routes; Drug Therapy; Carbohydrates; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Hydroxy Acids; Inorganic Chemicals; Ferric Compounds; Iron Compounds; Glucaric Acid; Ferric Oxide, Saccharated; Injections; ferric carboxymaltose
• Other Study ID Numbers: 0120-23-NHR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No