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Iron Supplementation Among Low-Income Postpartum Women

This study has been completed.
Sponsor:
Information provided by:
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT00207610
First received: September 16, 2005
Last updated: January 30, 2009
Last verified: January 2009
History of Changes

September 16, 2005
January 30, 2009
June 2003
September 2007   (final data collection date for primary outcome measure)
anemia [ Time Frame: 6 months postpartum ] [ Designated as safety issue: No ]
Anemia at 6 months postpartum
Complete list of historical versions of study NCT00207610 on ClinicalTrials.gov Archive Site
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Iron Supplementation Among Low-Income Postpartum Women
Phase 3 Study of the Prevention of Postpartum Anemia by Three Different Strategies

Anemia is common among low-income women after they have given birth. Anemia, or low hemoglobin in the blood cells, is usually caused by not having enough iron. Blood cells usually carry oxygen to other parts of the body. Without enough hemoglobin, the ability of blood cells to carry oxygen is decreased. Memory and work may be impaired. The purpose of this study is to evaluate three methods of giving iron to prevent anemia among low-income women after they have given birth.

Currently the Centers for Disease Control and Prevention recommendations to prevent iron deficiency advocate selective screening and treatment of anemia at about 6 weeks postpartum. However, among some groups, such as low income women, data suggest that anemia and iron deficiency are common. This study aims to evaluate the effectiveness of three stategies to prevent iron deficiency among low income postpartum women in Mississippi.

Comparisons: Clinics will be randomized to one of three strategies: 1)Selective anemia screening and treatment of anemic women, 2)universal anemia screening and treatment of anemic women, or 3)universal iron supplementation of 65 mg a day for three months.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Anemia
  • Behavioral: Daily iron supplements of 65 mg a day for 3 months
  • Behavioral: Universal anemia screening and treatment
  • Behavioral: Selective anemia screening and treatment
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
959
September 2007
September 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • postpartum girls and women, 2-6 weeks after birth
  • age 13 years or more
  • WIC certified

Exclusion Criteria:

  • sickle cell anemia
  • Hemoglobin < 7 g/dL
Female
13 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00207610
CDC-NCCDPHP-TS-0780
No
Not Provided
Centers for Disease Control and Prevention
Not Provided
Principal Investigator: Amal K Mitra, MD, DrPH University of Southern Mississippi
Centers for Disease Control and Prevention
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP