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

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

Detailed Description
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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.

Official Title
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Intravaneous Iron(1000 mg Low Molecular Weight Iron Dextran Over 60 Minutes) for Moderate to Severe Iron Deficient Anemia of Pregnancy in Women Intolerant of or Responsive to Oral Iron.

Conditions
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Pregnancy

Intervention / Treatment
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* Drug: Intravaneous iron(low molecular weight iron dextran)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: IV iron<br>Intravaneous iron(1000 mg low molecular weight iron dextran over 60 minutes) for moderate to severe iron deficient anemia of pregnancy in women intolerant of or unresponsive to oral iron. | Drug: Intravaneous iron(low molecular weight iron dextran)<br>* 1000 mg of Iron dextran administered over one hour<br>* Other names: Iron Dextran(InFed);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Women Who Achieve Anemia Correction After a Single Dose of 1000mg of Low Molecular Weight Iron Dextran(INfeD). |  | 4 weeks after infusion or post-partum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum Ferritin |  | 4 weeks post infusion or post-partum | 
| Percent Transferrin Saturation |  | 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. | 4 weeks after infusion and 4 weeks post-partum | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Iv iron in pregnant women, second and third trimester