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: Not yet 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

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

pregnancy>24 weeks of gestation anemia with Hb<8 anemia with Hb<9 if symptomatic anemia of previous postpartum hemorrhage

Exclusion Criteria:

• Allergy to one of the study's drugs
• IV iron treatment in the last month
• chronic anemia- thalassemia, renal failure Twins 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 (Estimated): October 30, 2023
• Primary Completion (Estimated): September 20, 2025
• Study Completion (Estimated): September 20, 2025

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): October 6, 2023
• Last Update Submitted That Met QC Criteria: October 4, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Hematologic Diseases; Anemia, Hypochromic; Iron Metabolism Disorders; Anemia, Iron-Deficiency; Anemia; Iron Deficiencies; Hematinics; Ferric Oxide, Saccharated
• 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