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OpenTrials
Completed

NCT Number: NCT03009578

Iron Sucrose Versus Ferrous Bis-glycinate for Treatment of Iron Deficiency Anemia

Iron deficiency may result from inadequate dietary intake, achlorhydria or excessive ingestion of proton pump inhibitors, parasitic infestations, chronic infections and repeated pregnancies. Iron supplementation of antenatal patients is a basic tenet of antenatal care programmes in numerous developing and underdeveloped nations.

Postpartum anemia is defined as hemoglobin of less than 11.5 gm% during the postpartum period. The prevalence of postpartum anemia varies from 4 - 27%. Chronic iron deficiency due to inadequate intake/ lack of iron supplementation during pregnancy, repeated pregnancies and postpartum hemorrhage are important causes of postpartum anemia

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Key information

Conditions

Anemia Hematologic Diseases Hemic and Lymphatic Diseases

Age range

18 year–35 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 level 7-11.5 gm/dl. No chronic diseases. Breastfeeding. Delivered at gestational age >38 weeks. Within 24-72 hours postpartum. Women who accept to participate in the study

Exclusion criteria

  • Severe anemia < 7 gm/dl.
  • Women received iron therapy during pregnancy.
  • Intolerance to iron preparations
  • Anemia due to other causes
  • Peripartum blood transfusion.

Treatment and study plan

Iron Sucrose Injection

Drug

iron Intramuscular injections

Ferrous Bisglycinate

Drug

oral iron tablets

Primary outcomes

  1. the percentage of patients achieving Hb rise 3 gm or more

    Time frame: 6 weeks

Secondary outcomes

  1. Mean rise of Hb from baseline to 6 weeks.

    Time frame: 6 weeks

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Intravenous Iron Sucrose Versus Oral Ferrous Bis-glycinate for Treatment of Postpartum Iron Deficiency Anemia: a Randomized Clinical Trial

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jan 4, 2017
Registry last updated
Jul 3, 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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