Overview

This trial is active, not recruiting.

Conditions anemia, low birth weight, neonatal mortality
Treatment multivitamin, mebendazole
Phase phase 3
Sponsor Cornell University
Collaborator Bill and Melinda Gates Foundation
Start date April 2004
Trial size 2500 participants
Trial identifier NCT00148629, UCHS 02-10-030

Summary

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.)

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label

Primary Outcomes

Measure
Incidence of severe anemia (Hb < 7 g/dL)
time frame:
Cure of severe anemia
time frame:

Secondary Outcomes

Measure
Infant birth weight
time frame:
Neonatal mortality
time frame:
Neonatal morbidity
time frame:
Blood loss during delivery
time frame:

Eligibility Criteria

Female participants of any age.

Inclusion Criteria: - Pregnant woman Exclusion Criteria: - Not a permanent resident of the community

Additional Information

Official title Preventing Unnecessary Blood Transfusions in Pregnant Women in Africa Through Effective Primary Health Care
Principal investigator Rebecca J Stoltzfus, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2005.
Information provided to ClinicalTrials.gov by Cornell University.