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NCT Number: NCT00148629

Treatment and Prevention of Severe Anemia in Pregnant Zanzibari Women

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.)

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Key information

Conditions

Anemia Birth Weight Body Weight Hematologic Diseases Hemic and Lymphatic Diseases Low Birth Weight Neonatal Mortality Pathological Conditions, Signs and Symptoms Signs and Symptoms

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Public Health Laboratory "Ivo de Carneri"

Wawi, Zanzibar, Tanzania

About this 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pregnant woman

Exclusion criteria

  • Not a permanent resident of the community

Treatment and study plan

multivitamin, mebendazole

Drug

Primary outcomes

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

  2. Cure of severe anemia

Secondary outcomes

  1. Infant birth weight

  2. Neonatal mortality

  3. Neonatal morbidity

  4. Blood loss during delivery

Sponsors and collaborators

Lead sponsor

Cornell University

Other

Collaborators

  • Bill and Melinda Gates Foundation
  • Johns Hopkins Bloomberg School of Public Health
  • UNICEF

Registry information

Official study title

Preventing Unnecessary Blood Transfusions in Pregnant Women in Africa Through Effective Primary Health Care

Important dates

Study start
2004
Primary completion
2008
Study completion
2008
First posted
Sep 8, 2005
Registry last updated
Feb 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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