Status:
COMPLETED
Immune Parameters in the Cord Blood of Newborns Exposed to Malaria in the Womb
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Malaria
Eligibility:
FEMALE
18-99 years
Brief Summary
This study, conducted by the Malaria Research and Training Center at the University of Bamako, Mali, and the NIAID, will examine how exposure to the malaria parasite in the womb affects the developing...
Detailed Description
In malaria endemic areas the fetus is at risk for in utero exposure to Plasmodium falciparum or its soluble products. Little is known about how this exposure modulates the developing fetal immune syst...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Age greater than or equal to 18 years
- Healthy female in 3rd trimester of pregnancy
- Resident of Bancoumana
- Willingness to allow cord and placental blood samples to be stored and used for future studies of the immune response to malaria
- Ability to give informed consent and willingness to comply with study requirements and procedures
- EXCLUSION CRITERIA:
- Currently taking corticosteroids or other immunosuppressants
- Underlying heart disease, bleeding disorder, or other condition that in the judgment of the Principal Investigator (PI) could increase the risk to the volunteer
- Fever greater than or equal to 37.5 degree C or evidence of an acute infection
- Anemia (hemoglobin less than 9 g/dL)
- Participation in another clinical protocol that requires the administration of an experimental vaccine or experimental treatment.
Exclusion
Key Trial Info
Start Date :
October 8 2008
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 10 2010
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00772642
Start Date
October 8 2008
End Date
September 10 2010
Last Update
July 2 2017
Active Locations (1)
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1
Malaria Research and Training Center
Bamako, Mali