Congenital transmission of Trypanosoma cruzi in Argentina, Honduras, and Mexico: Study protocol
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Background: Trypanosoma cruzi has been divided into Discrete Typing Units I and non-I (II-VI). T. cruzi I is predominant in Mexico and Central America, while non-I is predominant in most of South America, including Argentina. Little is known about congenital transmission of T. cruzi I. The specific aim of this study is to determine the rate of congenital transmission of T. cruzi I compared to non-I. Methods/design. We are conducting a prospective study to enroll at delivery, 10,000 women in Argentina, 7,500 women in Honduras, and 13,000 women in Mexico. We are measuring transmitted maternal T. cruzi antibodies by performing two rapid tests in cord blood (Stat-Pak, Chembio, Medford, New York, and Trypanosoma Detect, InBios, Seattle, Washington). If at least one of the results is positive, we are identifying infants who are congenitally infected by performing parasitological examinations on cord blood and at 4-8 weeks, and serological follow-up at 10 months. Serological confirmation by ELISA (Wiener, Rosario, Argentina) is performed in cord and maternal blood, and at 10 months. We also are performing T. cruzi standard PCR, real-time quantitative PCR and genotyping on maternal venous blood and on cord blood, and serological examinations on siblings. Data are managed by a Data Center in Montevideo, Uruguay. Data are entered online at the sites in an OpenClinica data management system, and digital pictures of data forms are sent to the Data Center for quality control. Weekly reports allow for rapid feedback to the sites. Trial registration. Observational study with ClinicalTrials.gov Identifier NCT01787968. © 2013 Buekens et al.; licensee BioMed Central Ltd.
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Chagas disease; Congenital transmission; Latin America; Trypanosoma cruzi adult; Argentina; article; Chagas disease; controlled study; enzyme linked immunosorbent assay; female; follow up; genotype; Honduras; human; major clinical study; maternal blood; Mexico; observational study; parasite transmission; prospective study; quality control; rapid test; real time polymerase chain reaction; serology; Trypanosoma cruzi; umbilical cord blood; Uruguay; venous blood; Adult; Antibodies, Protozoan; Argentina; Chagas Disease; Female; Fetal Blood; Honduras; Humans; Infant; Infant, Newborn; Infectious Disease Transmission, Vertical; Mexico; Pregnancy; Pregnancy Complications, Parasitic; Prospective Studies; Trypanosoma cruzi
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