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Treatment and Prevention of Severe Anemia in Pregnant Zanzibari Women

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00148629
Enrollment
2500
Registered
2005-09-08
Start date
2004-04-01
Completion date
2008-01-01
Last updated
2026-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia, Low Birth Weight, Neonatal Mortality

Keywords

Anemia, Birth weight, Neonatal Mortality, Tanzania, Pregnancy

Brief 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.)

Detailed 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.

Interventions

DRUGmultivitamin, mebendazole

Sponsors

Cornell University
Lead SponsorOTHER
Bill and Melinda Gates Foundation
CollaboratorOTHER
UNICEF
CollaboratorOTHER
Johns Hopkins Bloomberg School of Public Health
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
Yes

Inclusion criteria

* Pregnant woman

Exclusion criteria

* Not a permanent resident of the community

Design outcomes

Primary

MeasureTime frame
Incidence of severe anemia (Hb < 7 g/dL)
Cure of severe anemia

Secondary

MeasureTime frame
Infant birth weight
Neonatal mortality
Neonatal morbidity
Blood loss during delivery

Countries

Tanzania

Contacts

PRINCIPAL_INVESTIGATORRebecca J Stoltzfus, PhD

Cornell University

PRINCIPAL_INVESTIGATORJames M Tielsch, PhD

The Johns Hopkins Bloomberg School of Public Health

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026