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NCT00148629 Clinical Trial

Treatment and Prevention of Severe Anemia in Pregnant Zanzibari Women

Anemia Clinical Trial

Official title:
Preventing Unnecessary Blood Transfusions in Pregnant Women in Africa Through Effective Primary Health Care

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT00148629
Other study ID # UCHS 02-10-030
Secondary ID
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date April 2004

Study information
Verified date January 2022
Source Cornell University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this research is to compare the efficacy of two low-cost low intervention packages to prevent and treat severe anemia in pregnant women in Zanzibar, Tanzania. The two packages are Standard of Care as described by the WHO (presumptive treatment for malaria and helminths plus daily iron + folic acid supplements) and Enhanced Care (Standard of Care plus daily multivitamins and a 2nd dose of anthelminthic.)

Description:

This is a clinic-randomized trial involving 8 antenatal clinics and approximately 2500 women. The specific aims are: Aim 1: To evaluate the efficacy of the current internationally recommended standard of care, as described by the WHO, for the prevention of severe anemia among pregnant Zanzibari women. This aim will be achieved through a pre-post intervention comparison. Aim 2: To evaluate the efficacy of an enhanced treatment regimen in comparison to the current standard of care to prevent severe anemia among pregnant Zanzibari women. Aim 3: To evaluate the efficacy of the current internationally recommended standard of care, as described by the WHO, for the cure of severe anemia among pregnant Zanzibari women. Aim 4: To evaluate the efficacy of an enhanced treatment regimen in comparison to the current standard of care to cure severe anemia among pregnant Zanzibari women.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 2500
Est. completion date
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria: - Pregnant woman Exclusion Criteria: - Not a permanent resident of the community

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• multivitamin, mebendazole

Locations
Country Name City State
Tanzania Public Health Laboratory "Ivo de Carneri" Wawi Zanzibar

Sponsors (4)
Lead Sponsor Collaborator
Cornell University Bill and Melinda Gates Foundation, Johns Hopkins Bloomberg School of Public Health, UNICEF

Country where clinical trial is conducted

Tanzania, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of severe anemia (Hb < 7 g/dL)
Primary Cure of severe anemia
Secondary Infant birth weight
Secondary Neonatal mortality
Secondary Neonatal morbidity
Secondary Blood loss during delivery
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