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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
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   13 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00207610

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

No publications provided

ClinicalTrials.gov Identifier: NCT00207610     History of Changes
Other Study ID Numbers: CDC-NCCDPHP-TS-0780
Study First Received: September 16, 2005
Last Updated: January 30, 2009
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Anemia
Hematologic Diseases

ClinicalTrials.gov processed this record on November 24, 2014