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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00730366 |
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Date of registration:
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05/08/2008 |
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Primary sponsor: |
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Public title:
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New Approaches to Improve Coverage and Compliance of Antimalarial Treatment for Pregnant Women in Rural Africa
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Scientific title:
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New Approaches to Improve Coverage and Compliance of Antimalarial Treatment for Pregnant Women in Rural Africa. |
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Date of first enrolment:
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March 2004 |
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Target sample size:
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2766 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00730366 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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Countries of recruitment
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Burkina Faso
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Contacts
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Name:
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Sheick Coulibaly Oumar Coulibaly, MD PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Directeur de la Biologie Médicale du Laboratoire National de Santé Publique |
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Name:
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Umberto D'Alessandro, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Institute of Tropical Medicine |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Female
- First or second trimester of pregnancy
- First or second pregnancy
- Resident in the study area
Exclusion Criteria:
- Refuse to give informed consent
Age minimum:
N/A
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Malaria in Pregnancy
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Intervention(s)
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Drug: Chloroquine
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Drug: sulfadoxine-pyrimethamine
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Primary Outcome(s)
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Birth weight
[Time Frame: At delivery]
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Secondary Outcome(s)
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Anemia
[Time Frame: At 32 weeks gestation and at delivery]
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Gestational age
[Time Frame: At first antenatal visit]
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Peripheral and placental parasitaemia
[Time Frame: At 32 weeks gestation (peripheral) and at delivery (both)]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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