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Sponsors and Collaborators: |
Cornell University Bill and Melinda Gates Foundation UNICEF Johns Hopkins Bloomberg School of Public Health |
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Information provided by: | Cornell University |
ClinicalTrials.gov Identifier: | NCT00148629 |
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.)
Condition | Intervention | Phase |
---|---|---|
Anemia Low Birth Weight Neonatal Mortality |
Drug: multivitamin, mebendazole |
Phase III |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Preventing Unnecessary Blood Transfusions in Pregnant Women in Africa Through Effective Primary Health Care |
Estimated Enrollment: | 2500 |
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.
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Tanzania, Zanzibar | |
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 |
Study ID Numbers: | UCHS 02-10-030 |
Study First Received: | September 6, 2005 |
Last Updated: | November 16, 2005 |
ClinicalTrials.gov Identifier: | NCT00148629 |
Health Authority: | United States: Institutional Review Board |
Anemia Birth weight Neonatal Mortality Tanzania Pregnancy |
Body Weight Birth Weight Signs and Symptoms |
Mebendazole Hematologic Diseases Anemia |
Anti-Infective Agents Antiparasitic Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses Mitosis Modulators |
Tubulin Modulators Anthelmintics Antimitotic Agents Pharmacologic Actions Antinematodal Agents |