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Congenital transmission of Trypanosoma cruzi in Argentina, Honduras, and Mexico: study protocol
Autor/es
Buekens MD, MPH, PhD, Pierre ;Truyens, Carine;Matute, Maria Luisa;Howard , Elizabeth;Gamboa León – Rubi, ;Dumonteil, Eric;Carlier, Yves;Alger, Jackeline;Sosa-Estani, Sergio;Ciganda, Alvaro;Belizán, José ;Althabe, Fernando;Cafferata, María Luisa;Wesson, Dawn;
Fecha de última actualización: 10/2013
Buekens P, Cafferata ML, Alger J, Althabe F, Belizan JM, Carlier Y, Ciganda A, Dumonteil E, Gamboa-Leon R, Howard E, Matute ML, Sosa-Estani S, Truyens C, Wesson D, Zuniga C. Congenital transmission of Trypanosoma cruzi in Argentina, Honduras, and Mexico: study protocol. Reprod Health. 2013 Oct 11;10(1):55
Buekens P, Cafferata ML, Alger J, Althabe F, Belizan JM, Carlier Y, Ciganda A, Dumonteil E, Gamboa-Leon R, Howard E, Matute ML, Sosa-Estani S, Truyens C, Wesson D, Zuniga C. Reprod Health. 2013 Oct 11;10(1):55. -Texto completo-
Resumen
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.
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.