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Treatment and Prevention of Severe Anemia in Pregnant Zanzibari Women

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by Cornell University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Bill and Melinda Gates Foundation
UNICEF
Johns Hopkins Bloomberg School of Public Health
Information provided by:
Cornell University
ClinicalTrials.gov Identifier:
NCT00148629
First received: September 6, 2005
Last updated: November 16, 2005
Last verified: September 2005
History of Changes

September 6, 2005
November 16, 2005
April 2004
Not Provided
  • Incidence of severe anemia (Hb < 7 g/dL)
  • Cure of severe anemia
Same as current
Complete list of historical versions of study NCT00148629 on ClinicalTrials.gov Archive Site
  • Infant birth weight
  • Neonatal mortality
  • Neonatal morbidity
  • Blood loss during delivery
Same as current
Not Provided
Not Provided
 
Treatment and Prevention of Severe Anemia in Pregnant Zanzibari Women
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.)

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.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
  • Anemia
  • Low Birth Weight
  • Neonatal Mortality
Drug: multivitamin, mebendazole
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
2500
Not Provided
Not Provided

Inclusion Criteria:

  • Pregnant woman

Exclusion Criteria:

  • Not a permanent resident of the community
Female
Not Provided
Yes
Contact information is only displayed when the study is recruiting subjects
Tanzania
 
NCT00148629
UCHS 02-10-030
Not Provided
Not Provided
Cornell University
  • Bill and Melinda Gates Foundation
  • UNICEF
  • Johns Hopkins Bloomberg School of Public Health
Principal Investigator: Rebecca J Stoltzfus, PhD Cornell University
Principal Investigator: James M Tielsch, PhD The Johns Hopkins Bloomberg School of Public Health
Cornell University
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP