Comparison Between Outcomes of Pregnant Women Treated With Ferinject vs. Venofer for Iron Deficiency Anemia
Primary Purpose
Anemia, Iron Deficiency, Pregnancy Anemia
Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Venofer 200 MG Per 10 ML Injection
Ferinject
Sponsored by
About this trial
This is an interventional treatment trial for Anemia, Iron Deficiency
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
venofer
Ferinject
Arm Description
Women with iron def. anemia aith hemoglobin level <9 gr/dl who will be traeted with venofer
Women with iron def. anemia aith hemoglobin level <9 gr/dl who will be traeted with ferinject
Outcomes
Primary Outcome Measures
ratio of women with Hb level >11 at delivery
Hb level
postpartum Hb level
gr/dl
Secondary Outcome Measures
Full Information
NCT ID
NCT06061393
First Posted
September 24, 2023
Last Updated
October 4, 2023
Sponsor
Western Galilee Hospital-Nahariya
1. Study Identification
Unique Protocol Identification Number
NCT06061393
Brief Title
Comparison Between Outcomes of Pregnant Women Treated With Ferinject vs. Venofer for Iron Deficiency Anemia
Official Title
Comparison Between Outcomes of Pregnant Women Treated With Ferinject vs. Venofer for Iron Deficiency Anemia (Hb<9)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 30, 2023 (Anticipated)
Primary Completion Date
September 20, 2025 (Anticipated)
Study Completion Date
September 20, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Western Galilee Hospital-Nahariya
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia, Iron Deficiency, Pregnancy Anemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
venofer
Arm Type
Active Comparator
Arm Description
Women with iron def. anemia aith hemoglobin level <9 gr/dl who will be traeted with venofer
Arm Title
Ferinject
Arm Type
Active Comparator
Arm Description
Women with iron def. anemia aith hemoglobin level <9 gr/dl who will be traeted with ferinject
Intervention Type
Drug
Intervention Name(s)
Venofer 200 MG Per 10 ML Injection
Intervention Description
treat anemia with venofer up to 5 doses
Intervention Type
Drug
Intervention Name(s)
Ferinject
Intervention Description
ferinject 500 mg, once a week for 2 weeks
Primary Outcome Measure Information:
Title
ratio of women with Hb level >11 at delivery
Description
Hb level
Time Frame
at delivery
Title
postpartum Hb level
Description
gr/dl
Time Frame
during 48 hours after delivery
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
pregnant women
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
maya Wolf, MD
Phone
972507887800
Email
mayaw@gmc.gov.il
12. IPD Sharing Statement
Learn more about this trial
Comparison Between Outcomes of Pregnant Women Treated With Ferinject vs. Venofer for Iron Deficiency Anemia
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