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

Sponsor

Western Galilee Hospital-Nahariya (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06061393

Collaborator

(none)

200

Enrollment

Arms

22.7

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Anemia, Iron Deficiency Pregnancy Anemia	Drug: Venofer 200 MG Per 10 ML Injection Drug: Ferinject	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Oct 30, 2023

Anticipated Primary Completion Date :

Sep 20, 2025

Anticipated Study Completion Date :

Sep 20, 2025

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

ratio of women with Hb level >11 at delivery [at delivery]
Hb level
postpartum Hb level [during 48 hours after delivery]
gr/dl

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Western Galilee Hospital-Nahariya

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dr. Maya Wolf, Principal Investigator., Western Galilee Hospital-Nahariya

ClinicalTrials.gov Identifier:

NCT06061393

Other Study ID Numbers:

0120-23-NHR

First Posted:

Sep 29, 2023

Last Update Posted:

Oct 6, 2023

Last Verified:

Oct 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Anemia

Anemia, Iron-Deficiency

Iron Deficiencies

Ferric Oxide, Saccharated

Study Results

No Results Posted as of Oct 6, 2023