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Reproductive Health
Published in: Reproductive Health 1/2013

Open Access 01-12-2013 | Study protocol

Congenital transmission of Trypanosoma cruzi in Argentina, Honduras, and Mexico: study protocol

Authors: Pierre Buekens, Maria-Luisa Cafferata, Jackeline Alger, Fernando Althabe, José M Belizán, Yves Carlier, Alvaro Ciganda, Eric Dumonteil, Rubi Gamboa-Leon, Elizabeth Howard, Maria Luisa Matute, Sergio Sosa-Estani, Carine Truyens, Dawn Wesson, Concepcion Zuniga

Published in: Reproductive Health | Issue 1/2013

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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/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
Appendix
Available only for authorised users
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Metadata
Title
Congenital transmission of Trypanosoma cruzi in Argentina, Honduras, and Mexico: study protocol
Authors
Pierre Buekens
Maria-Luisa Cafferata
Jackeline Alger
Fernando Althabe
José M Belizán
Yves Carlier
Alvaro Ciganda
Eric Dumonteil
Rubi Gamboa-Leon
Elizabeth Howard
Maria Luisa Matute
Sergio Sosa-Estani
Carine Truyens
Dawn Wesson
Concepcion Zuniga
Publication date
01-12-2013
Publisher
BioMed Central
Published in
Reproductive Health / Issue 1/2013
Electronic ISSN: 1742-4755
DOI
https://doi.org/10.1186/1742-4755-10-55

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