Treatment and Prevention of Severe Anemia in Pregnant Zanzibari Women

Condition(s) targeted: Anemia; Low Birth Weight; Neonatal Mortality

Intervention: multivitamin, mebendazole (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Cornell University

Official(s) and/or principal investigator(s):
Rebecca J Stoltzfus, PhD, Principal Investigator, Affiliation: Cornell University
James M Tielsch, PhD, Principal Investigator, Affiliation: The Johns Hopkins Bloomberg School of Public Health

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.)

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

Study design: Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study

Primary outcome:

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

Cure of severe anemia

Secondary outcome:

Infant birth weight

Neonatal mortality

Neonatal morbidity

Blood loss during delivery

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.

Minimum age: N/A. Maximum age: N/A. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Pregnant woman

Exclusion Criteria:

- Not a permanent resident of the community

Public Health Laboratory "Ivo de Carneri", Wawi, Zanzibar, Tanzania

Starting date: April 2004
Last updated: November 16, 2005