Treatment and Prevention of Severe Anemia in Pregnant Zanzibari Women
Recruitment status was Active, not recruiting
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.)
Low Birth Weight
Drug: multivitamin, mebendazole
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||Preventing Unnecessary Blood Transfusions in Pregnant Women in Africa Through Effective Primary Health Care|
- Incidence of severe anemia (Hb < 7 g/dL)
- Cure of severe anemia
- Infant birth weight
- Neonatal mortality
- Neonatal morbidity
- Blood loss during delivery
|Study Start Date:||April 2004|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00148629
|Public Health Laboratory "Ivo de Carneri"|
|Wawi, Zanzibar, Tanzania|
|Principal Investigator:||Rebecca J Stoltzfus, PhD||Cornell University|
|Principal Investigator:||James M Tielsch, PhD||The Johns Hopkins Bloomberg School of Public Health|