Collection of Biological Material From Pregnant Women in a Malarial Region
- Malaria is a disease caused by a parasite that infects the blood. It affects millions of people every year and frequently harms or kills pregnant woman and infants. Researchers are looking for treatments that may help pregnant women in areas of the world where malaria is common. To do so, they want to collect blood and other samples from pregnant women in south-central Uganda. They will also collect samples from newborn babies if the mother agrees to it.
- To collect biological material such as blood samples from pregnant women and newborns.
- Women between 14 and 45 years of age who are pregnant or are in labor.
- Participants will be from the Kalisizio area of south-central Uganda.
- Women who are pregnant will provide blood and urine samples.
- Women who are in labor will allow researchers to collect samples from their baby after the delivery. Samples will be taken of placenta tissue and umbilical cord blood. The baby will also be weighed and measured. Researchers will look at the baby's physical appearance and muscle strength.
- Treatment will not be offered as part of this study.
|Study Design:||Time Perspective: Prospective|
|Official Title:||In-Vitro Evaluation of Anti-Adhesion Activity by Antibodies to Pregnancy Malaria Vaccine Candidates|
- Samples collected from the women will be used in in-vitro assays to assess the functional activity of antisera raised against pregnancy malaria vaccine candidates as the primary outcome of this study. [ Time Frame: ongoing ] [ Designated as safety issue: No ]
|Study Start Date:||February 2013|
|Study Completion Date:||March 2016|
|Primary Completion Date:||October 2015 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01862783
|Rakai District, Uganda|
|Principal Investigator:||Michal Fried, Ph.D.||National Institute of Allergy and Infectious Diseases (NIAID)|