Iron Supplementation Among Low-Income Postpartum Women

Phase 3 Study of the Prevention of Postpartum Anemia by Three Different Strategies

Sponsors

Lead Sponsor: Centers for Disease Control and Prevention

Source Centers for Disease Control and Prevention
Brief Summary

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.

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.

Overall Status Completed
Start Date June 2003
Completion Date September 2007
Primary Completion Date September 2007
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
anemia 6 months postpartum
Enrollment 959
Condition
Intervention

Intervention Type: Behavioral

Intervention Name: Daily iron supplements of 65 mg a day for 3 months

Intervention Type: Behavioral

Intervention Name: Universal anemia screening and treatment

Intervention Type: Behavioral

Intervention Name: Selective anemia screening and treatment

Eligibility

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

Gender: Female

Minimum Age: 13 Years

Maximum Age: N/A

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Amal K Mitra, MD, DrPH Principal Investigator University of Southern Mississippi
Location
Facility: Center for Community Health, University of Southern Mississippi
Location Countries

United States

Verification Date

January 2009

Keywords
Has Expanded Access No
Condition Browse
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Prevention

Masking: None (Open Label)

Source: ClinicalTrials.gov