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Iron Supplementation Among Low-Income Postpartum Women

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00207610
First Posted: September 21, 2005
Last Update Posted: February 3, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Centers for Disease Control and Prevention
  Purpose
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.

Condition Intervention Phase
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 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Phase 3 Study of the Prevention of Postpartum Anemia by Three Different Strategies

Resource links provided by NLM:


Further study details as provided by Centers for Disease Control and Prevention:

Primary Outcome Measures:
  • anemia [ Time Frame: 6 months postpartum ]

Enrollment: 959
Study Start Date: June 2003
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
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): NCT00207610


Locations
United States, Mississippi
Center for Community Health, University of Southern Mississippi
Hattiesburg, Mississippi, United States, 39406-5122
Sponsors and Collaborators
Centers for Disease Control and Prevention
Investigators
Principal Investigator: Amal K Mitra, MD, DrPH University of Southern Mississippi
  More Information

ClinicalTrials.gov Identifier: NCT00207610     History of Changes
Other Study ID Numbers: CDC-NCCDPHP-TS-0780
First Submitted: September 16, 2005
First Posted: September 21, 2005
Last Update Posted: February 3, 2009
Last Verified: January 2009

Keywords provided by Centers for Disease Control and Prevention:
Anemia
Postpartum
iron
supplements

Additional relevant MeSH terms:
Anemia
Hematologic Diseases
Iron
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs