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

Phase 2CompletedNCT02038023

Auerbach Hematology Oncology Associates P C74 enrolled

Overview

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

To determine the percentage of women who achieve anemia correction after a single dose of 1000mg of low molecular weight iron dextran(infed). To determine whether IV iron supplementation has a higher satisfaction with treatment as compared to oral supplementation in a population previously intolerant of or unresponsive to oral iron. To evaluate the safety of IV low molecular weight iron dextran in pregnant women. To assess maternal and fetal outcomes-preterm delivery, low birth weight deliveries, ER visits and hospitalizations related to preterm labor, preterm contractions, ante-partum and post-partum transfusions, maternal hemoglobin at post-partum visit after IV iron supplementation groups.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pregnancy

Interventions

Intravaneous iron(low molecular weight iron dextran)DRUG

1000 mg of Iron dextran administered over one hour

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

Inclusion Criteria: * pregnant women intolerable to oral iron. hbg \<10.9 g/dl during second or third trimester. Exclusion Criteria: * known sensitivity to IV iron. hemoglobinopathies. hemolytic anemia. women who have received or will receive blood transfusions. women with significant vaginal bleeding(\>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.

Locations (1)

Auerbach Hematology Oncology Assoc

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

Percentage of Women Who Achieve Anemia Correction After a Single Dose of 1000mg of Low Molecular Weight Iron Dextran(INfeD).

Time frame: 4 weeks after infusion or post-partum

Secondary Outcomes

Serum Ferritin

Time frame: 4 weeks post infusion or post-partum

Percent Transferrin Saturation

Time frame: 4 weeks post infusion or post-partum

Safety as Measured by Number of Adverse Events

To evaluate the safety of IV low molecular weight iron dextran in pregnant women. Also to asses maternal and fetal outcomes-preterm delivery, low-birth weight deliveries, ER visits and hospitalizations related to preterm labor, preterm contractions, ante-partum and post partum transfusions, maternal hemoglobin at post-partum visit after IV iron supplementation groups. A questionaire with a list of symptoms to include nausea, dizziness, hypotension, edema, headache, abdominal pain, chest pain, cough, itching, fever, back pain, muscle cramps and rash are asked immediately after administration and phone calls at 24, 48 hours and 7 days.

Time frame: 4 weeks after infusion and 4 weeks post-partum

Data from ClinicalTrials.gov

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