Iron Supplementation Among Low-Income Postpartum Women

Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00207610
• Other study ID #: CDC-NCCDPHP-TS-0780
• Status: Completed
• Phase: Phase 3
• First received: September 16, 2005
• Last updated: January 30, 2009
• Start date: June 2003
• Est. completion date: September 2007

Study information

• Verified date: January 2009
• Source: Centers for Disease Control and Prevention
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 959
• Est. completion date: September 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 13 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Anemia

Intervention

Behavioral:
• Daily iron supplements of 65 mg a day for 3 months

• Universal anemia screening and treatment

• Selective anemia screening and treatment

Locations

Country	Name	City	State
United States	Center for Community Health, University of Southern Mississippi	Hattiesburg	Mississippi

Sponsors (1)

Lead Sponsor	Collaborator
Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	anemia		6 months postpartum	No