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OpenTrials
Completed

NCT Number: NCT03212781

Iron Dextran Versus Oral Iron for Treating Iron Deficiency Anemia in Pregnant Women

Iron deficiency is the most prevalent nutritional deficiency and the most common cause of anemia .It is characterized by a defect in hemoglobin synthesis, resulting in red blood cells that are abnormally small (microcytic) and contain a decreased amount of hemoglobin (hypochromic).

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Key information

Conditions

Anemia Hematologic Diseases Hemic and Lymphatic Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Assiut Faculty of Medicine

Asyut, Egypt

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Hemoglobin < 10 g/dL
  • Gestational age between 14-28 weeks.
  • Willingness to participate and signing the informed consent form.

Exclusion criteria

  • Iron overload or disturbances in utilization of iron
  • Decompensated liver cirrhosis and active hepatitis
  • Active acute or chronic infections
  • History of multiple allergies
  • Known hypersensitivity to parenteral iron or any recipients in the investigation drug products
  • Erythropoietin treatment within 8 weeks prior to the screening visit
  • Other iron treatment or blood transfusion within 4 weeks prior to the screening visit
  • Planned elective surgery during the study.

Treatment and study plan

Iron Dextran

Drug

total dose infusion

Ferrous fumarate

Drug

oral tablets

Primary outcomes

  1. The change in Hemoglobin concentration from baseline to 8 weeks therapy

    Time frame: 8 weeks

    measure hemoglobin level before and after treatment

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Total Dose Infusion of Iron Dextran Versus Oral Iron for Treating Iron Deficiency Anemia in Pregnant Women: a Randomized Controlled Trial

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jul 11, 2017
Registry last updated
Jul 11, 2017

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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