title: Congenital transmission of Trypanosoma cruzi in Argentina, Honduras, and Mexico: study protocol.
abstract: 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
  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.
authors.affiliation: School of Public Health and Tropical Medicine, Tulane University, 1440 Canal Street, Ste, 2430, New Orleans, Louisiana LA 70112, USA. pbuekens@tulane.edu.
authors.forename: Pierre
authors.initials: P
authors.lastname: Buekens
authors.forename: Maria-Luisa
authors.initials: ML
authors.lastname: Cafferata
authors.forename: Jackeline
authors.initials: J
authors.lastname: Alger
authors.forename: Fernando
authors.initials: F
authors.lastname: Althabe
authors.forename: José M
authors.initials: JM
authors.lastname: Belizán
authors.forename: Yves
authors.initials: Y
authors.lastname: Carlier
authors.forename: Alvaro
authors.initials: A
authors.lastname: Ciganda
authors.forename: Eric
authors.initials: E
authors.lastname: Dumonteil
authors.forename: Rubi
authors.initials: R
authors.lastname: Gamboa-Leon
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Howard
authors.forename: Maria Luisa
authors.initials: ML
authors.lastname: Matute
authors.forename: Sergio
authors.initials: S
authors.lastname: Sosa-Estani
authors.forename: Carine
authors.initials: C
authors.lastname: Truyens
authors.forename: Dawn
authors.initials: D
authors.lastname: Wesson
authors.forename: Concepcion
authors.initials: C
authors.lastname: Zuniga
mesh_terms: D000328:Adult; D000913:Antibodies, Protozoan / Q000097:blood*; D001118:Argentina; D014355:Chagas Disease / Q000151:congenital / Q000175:diagnosis / Q000517:prevention & control / Q000635:transmission*; D005260:Female; D005312:Fetal Blood / Q000276:immunology; D006721:Honduras; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D018445:Infectious Disease Transmission, Vertical / Q000517:prevention & control*; D008800:Mexico; D011247:Pregnancy; D015597:Pregnancy Complications, Parasitic / Q000097:blood / Q000175:diagnosis; D011446:Prospective Studies; D014349:Trypanosoma cruzi / Q000235:genetics / Q000276:immunology*
chemical_list: D000913:Antibodies, Protozoan