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
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Preventing Unnecessary Blood Transfusions in Pregnant Women in Africa Through Effective Primary Health Care

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Tanzania
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

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

Keywords provided by Cornell University:
Anemia
Birth weight
Neonatal Mortality
Tanzania
Pregnancy

Additional relevant MeSH terms:
Anemia
Birth Weight
Hematologic Diseases
Body Weight
Signs and Symptoms
Mebendazole
Piperazine
Piperazine citrate
Antinematodal Agents
Anthelmintics
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

ClinicalTrials.gov processed this record on July 22, 2014