Official Title: “Preventing Unnecessary Blood Transfusions in Pregnant Women in Africa Through Effective Primary Health Care”

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.)

Study Type: Interventional

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

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.

Intervention(s) in this Clinical Trial

• Drug: multivitamin, mebendazole

Primary Measures

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

Secondary Measures

• Infant birth weight
• Neonatal mortality
• Neonatal morbidity
• Blood loss during delivery

Inclusion Criteria:

• Pregnant woman

Exclusion Criteria:

• Not a permanent resident of the community

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Cornell University

Overall Clinical Trial Officials and Contacts

Rebecca J Stoltzfus, PhD Principal Investigator Cornell University  

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00148629

Study ID Number: UCHS 02-10-030

ClinicalTrials.gov Identifier: NCT00148629

Health Authority: United States: Institutional Review Board