Treatment and Prevention of Severe Anemia in Pregnant Zanzibari Women

Cornell University

Status and phase: Active, not recruiting; Phase 3

Conditions: Anemia; Neonatal Mortality; Low Birth Weight

Treatments: Drug: multivitamin, mebendazole

Study type: Interventional

Funder types: Other

Identifiers

NCT00148629

UCHS 02-10-030

Details and patient eligibility

About

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.)

Full 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.

Sex: Female

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Pregnant woman

Exclusion criteria

• Not a permanent resident of the community