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Main
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Note: This record shows only 22 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 2016 |
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Main ID: |
NCT01941264 |
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Date of registration:
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10/09/2013 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Community-based Screening and Treatment of Malaria in Pregnancy: a Cluster-randomized Trial
COSMIC |
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Scientific title:
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Community-based Scheduled Screening and Treatment of Malaria in Pregnancy for Improved Maternal and Infant Health: a Cluster-randomized Trial in The Gambia, Burkina Faso and Benin |
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Date of first enrolment:
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October 2013 |
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Target sample size:
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4265 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01941264 |
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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: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Prevention
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Phase:
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N/A
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Countries of recruitment
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Benin
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Burkina Faso
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Gambia
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Contacts
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Name:
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Henk Schallig, Dr |
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Address:
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Telephone:
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Email:
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Affiliation:
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Royal Tropical Institute (KIT) |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Residence in the study area and intention to stay in the area for the duration of the
pregnancy and for delivery.
- Aged at least 16 years (pregnant adolescents younger than 16 years will be considered
only if they are accompanied by a responsible adult (in the Gambia) or married
(considered an adult by marriage in Burkina Faso and Benin.)
- Willing to provide biological samples as and when required during the study period
(blood and placental biopsy)
- Informed consent
Exclusion Criteria:
- A history of sensitivity to sulphonamides.
- Already participating in another research study
Age minimum:
16 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Maternal Malaria During Pregnancy - Baby Not Yet Delivered
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Small for Gestational Age (Disorder)
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Malaria, Antepartum
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Intervention(s)
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Other: community based screening and treatment
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Primary Outcome(s)
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Placental malaria
[Time Frame: After delivery]
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Secondary Outcome(s)
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Birth weight
[Time Frame: After delivery]
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Secondary ID(s)
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ISRCTN37259296
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6800110
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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