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NCT06061393 Clinical Trial

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

Anemia, Iron Deficiency Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06061393
Other study ID # 0120-23-NHR
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received
Last updated
Start date October 30, 2023
Est. completion date September 20, 2025

Study information
Verified date October 2023
Source Western Galilee Hospital-Nahariya
Contact maya Wolf, MD
Phone 972507887800
Email mayaw@gmc.gov.il
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 200
Est. completion date September 20, 2025
Est. primary completion date September 20, 2025
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 50 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Venofer 200 MG Per 10 ML Injection
treat anemia with venofer up to 5 doses
• Ferinject
ferinject 500 mg, once a week for 2 weeks

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Western Galilee Hospital-Nahariya

Outcome
Type Measure Description Time frame Safety issue
Primary ratio of women with Hb level >11 at delivery Hb level at delivery
Primary postpartum Hb level gr/dl during 48 hours after delivery
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