Treatment and Prevention of Severe Anemia in Pregnant Zanzibari Women - Full Text View

Sponsor:	Cornell University
Collaborators:	Bill and Melinda Gates Foundation UNICEF Johns Hopkins Bloomberg School of Public Health
Information provided by:	Cornell University
ClinicalTrials.gov Identifier:	NCT00148629

Purpose

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

Resource links provided by NLM:

MedlinePlus related topics: Anemia

Drug Information available for: Mebendazole

U.S. FDA Resources

Further study details as provided by Cornell University:

Primary Outcome Measures:

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

Secondary Outcome Measures:

Infant birth weight
Neonatal mortality
Neonatal morbidity
Blood loss during delivery

Estimated Enrollment:	2500
Study Start Date:	April 2004

Detailed 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.

Eligibility

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Pregnant woman

Exclusion Criteria:

Not a permanent resident of the community

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00148629

Locations

Tanzania, Zanzibar
Public Health Laboratory "Ivo de Carneri"
Wawi, Zanzibar, Tanzania

Sponsors and Collaborators

Cornell University

Bill and Melinda Gates Foundation

UNICEF

Johns Hopkins Bloomberg School of Public Health

Investigators

Principal Investigator:	Rebecca J Stoltzfus, PhD	Cornell University
Principal Investigator:	James M Tielsch, PhD	The Johns Hopkins Bloomberg School of Public Health

More Information

No publications provided

Study ID Numbers:	UCHS 02-10-030
Study First Received:	September 6, 2005
Last Updated:	November 16, 2005
ClinicalTrials.gov Identifier:	NCT00148629 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Cornell University:

Anemia
Birth weight
Neonatal Mortality
Tanzania
Pregnancy

Additional relevant MeSH terms:

Birth Weight
Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Hematologic Diseases
Mitosis Modulators
Anemia
Anthelmintics
Antimitotic Agents

Pharmacologic Actions
Body Weight
Signs and Symptoms
Mebendazole
Antiparasitic Agents
Therapeutic Uses
Tubulin Modulators
Antinematodal Agents

ClinicalTrials.gov processed this record on February 08, 2010