Comparison Between Outcomes of Pregnant Women Treated Wit... | NCT06061393

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

NCT06061393

Sponsor

Western Galilee Hospital-Nahariya

Status

Unknown status

Last Update Posted

Oct 6, 2023Actual

Enrollment

200Estimated

Phase

Phase 4

Conditions

Anemia, Iron Deficiency
Pregnancy Anemia

Interventions

Venofer 200 MG Per 10 ML Injection
Ferinject

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 30, 2023Estimated

Primary Completion Date

Sep 20, 2025Estimated

Completion Date

Sep 20, 2025Estimated

First Submitted Date

Sep 24, 2023

First Submission Date that Met QC Criteria

Sep 24, 2023

First Posted Date

Sep 29, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 4, 2023

Last Update Posted Date

Oct 6, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

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

Lead Sponsor

Western Galilee Hospital-NahariyaOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
venofer	Active Comparator	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
Ferinject	Active Comparator	Women with iron def. anemia aith hemoglobin level <9 gr/dl who will be traeted with ferinject	Drug: Ferinject

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Venofer 200 MG Per 10 ML Injection	Drug	treat anemia with venofer up to 5 doses	venofer

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

pregnant women

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
maya Wolf, MD	Contact	972507887800		mayaw@gmc.gov.il

Overall Officials

Not provided

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D018798	Anemia, Iron-Deficiency

Ancestor Terms

ID	Term
D000747	Anemia, Hypochromic
D000740	Anemia
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077605	Ferric Oxide, Saccharated
D007267	Injections
C522335	ferric carboxymaltose

Ancestor Terms

ID	Term
D005290	Ferric Compounds
D058085	Iron Compounds
D007287	Inorganic Chemicals
D005937	Glucaric Acid

Browse Leaves

Not provided

Browse Branches

Not provided