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Completed

NCT Number: NCT02038023

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

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

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Key information

Conditions

Pregnancy Neoplasm Metastasis Neoplasms Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Auerbach Hematology Oncology Assoc

Baltimore, Maryland, 21237, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intravaneous iron(low molecular weight iron dextran)

Drug

1000 mg of Iron dextran administered over one hour

Other names: Iron Dextran(InFed)

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Auerbach Hematology Oncology Associates P C

Other

Collaborators

  • Pharmacosmos A/S

Registry information

Official study 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.

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jan 16, 2014
Registry last updated
Jun 28, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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