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Clinical Trials/NCT06061393
NCT06061393
Not yet recruiting
Phase 4

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

Western Galilee Hospital-Nahariya0 sites200 target enrollmentOctober 30, 2023
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ConditionsAnemia, Iron DeficiencyPregnancy Anemia
InterventionsVenofer 200 MG Per 10 ML InjectionFerinject
DrugsVenofer 200 MG Per 10 ML InjectionFerinject

Overview

Phase
Phase 4
Intervention
Venofer 200 MG Per 10 ML Injection
Conditions
Anemia, Iron Deficiency
Sponsor
Western Galilee Hospital-Nahariya
Enrollment
200
Primary Endpoint
postpartum Hb level
Status
Not yet recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 30, 2023
End Date
September 20, 2025
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dr. Maya Wolf

Principal Investigator.

Western Galilee Hospital-Nahariya

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

Arms & Interventions

venofer

Women with iron def. anemia aith hemoglobin level \<9 gr/dl who will be traeted with venofer

Intervention: Venofer 200 MG Per 10 ML Injection

Ferinject

Women with iron def. anemia aith hemoglobin level \<9 gr/dl who will be traeted with ferinject

Intervention: Ferinject

Outcomes

Primary Outcomes

postpartum Hb level

Time Frame: during 48 hours after delivery

gr/dl

ratio of women with Hb level >11 at delivery

Time Frame: at delivery

Hb level

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