Treatment and Prevention of Severe Anemia in Pregnant Zanzibari Women

January 24, 2022 updated by: Cornell University

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.)

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

2500

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Pregnant woman

Exclusion Criteria:

  • Not a permanent resident of the community

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Neonatal morbidity
Neonatal mortality
Infant birth weight
Blood loss during delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cornell University

Collaborators

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

Investigators

  • Principal Investigator: James M Tielsch, PhD, The Johns Hopkins Bloomberg School of Public Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2004

Study Registration Dates

First Submitted

September 6, 2005

First Submitted That Met QC Criteria

September 6, 2005

First Posted (ESTIMATE)

September 8, 2005

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2022

Last Update Submitted That Met QC Criteria

January 24, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UCHS 02-10-030

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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