Phase 2 N=74 Treatment

Intravaneous Iron(1000 mg Low Molecular Weight Iron Dextran Over 60 Minutes) for Pregnant Women

Pregnancy

Bottom Line

View on ClinicalTrials.gov: NCT02038023 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2018

Primary outcome: Primary: Percentage of Women Who Achieve Anemia Correction After a Single Dose of 1000mg of Low Molecular Weight Iron Dextran(INfeD). — 35; 11 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Intravaneous iron(low molecular weight iron dextran) (Drug)
Age: Adult · 18+ yrs
Sex: Female
Sponsor: Auerbach Hematology Oncology Associates P C
Primary completion: Jul 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Women Who Achieve Anemia Correction After a Single Dose of 1000mg of Low Molecular Weight Iron Dextran(INfeD).	35; 11	—
SECONDARY Serum Ferritin	126.29	—
SECONDARY Percent Transferrin Saturation	22.64	—
SECONDARY Safety as Measured by Number of Adverse Events	6	—

Summary

To determine the percentage of women who achieve anemia correction after a single dose of 1000mg of low molecular weight iron dextran(infed).

Eligibility Criteria

Inclusion Criteria

pregnant women intolerable to oral iron. hbg 200 cc blood loss)prior to delivery. women with documented history of allergy to more than one class of drug clinically significant anemia requiring therapy in the opinion of the obstetrician, in the first trimester.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02038023). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.