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

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ClinicalTrials.gov Identifier: NCT02038023
Recruitment Status : Completed
First Posted : January 16, 2014
Results First Posted : June 28, 2018
Last Update Posted : June 28, 2018
Sponsor:
Collaborator:
Pharmacosmos A/S
Information provided by (Responsible Party):
Auerbach Hematology Oncology Associates P C

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

Condition or disease Intervention/treatment Phase
Pregnancy Drug: Intravaneous iron(low molecular weight iron dextran) Phase 2

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : July 2013
Actual Primary Completion Date : July 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
IV iron
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)
1000 mg of Iron dextran administered over one hour
Other Name: Iron Dextran(InFed)




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Serum Ferritin [ Time Frame: 4 weeks post infusion or post-partum ]
  2. Percent Transferrin Saturation [ Time Frame: 4 weeks post infusion or post-partum ]
  3. Safety as Measured by Number of Adverse Events [ Time Frame: 4 weeks after infusion and 4 weeks post-partum ]
    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.



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02038023


Locations
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United States, Maryland
Auerbach Hematology Oncology Assoc
Baltimore, Maryland, United States, 21237
Sponsors and Collaborators
Auerbach Hematology Oncology Associates P C
Pharmacosmos A/S
Investigators
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Principal Investigator: Michael Auerbach, MD Auerbach Hematology Oncology

Publications of Results:
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Responsible Party: Auerbach Hematology Oncology Associates P C
ClinicalTrials.gov Identifier: NCT02038023     History of Changes
Other Study ID Numbers: Intravaneous Iron in Pregnancy
Infed ( Other Grant/Funding Number: pharmacosmos )
First Posted: January 16, 2014    Key Record Dates
Results First Posted: June 28, 2018
Last Update Posted: June 28, 2018
Last Verified: January 2018
Keywords provided by Auerbach Hematology Oncology Associates P C:
Iv iron in pregnant women
second and third trimester
Additional relevant MeSH terms:
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Iron
Dextrans
Iron-Dextran Complex
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Anticoagulants
Plasma Substitutes
Blood Substitutes
Hematinics