Clinical trial NCT01787968: Congenital Transmission of Lineages I and II of Trypanosoma Cruzi
Official title: Congenital Transmission of Lineages I and II of Trypanosoma Cruzi
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chagas Disease
Keywords: Congenital transmission
Trypanosoma cruzi
Chagas disease
Lead sponsor: Tulane University
Sponsor class: OTHER
Collaborators: name: Institute for Clinical Effectiveness and Health Policy
name: Laboratory of Parasitology Universite Libre de Bruxelles
name: Instituto de Enfermedades Infecciosas y Parasitol Antonio Vidal
name: Lab de Parasitologia Universidad Autonoma de Yucatan
First posted: 2013-02-11
Enrollment: 28348
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women delivering in participating hospitals.

Brief summary: T. cruzi has been divided into two main lineages: T. cruzi I (TcI) and T. cruzi II (TcII, including all non-TcI). TcI is predominant in Mexico and Central America, while TcII (non-TcI) is predominant in most of South America, including Argentina. In recent studies from Argentina, the risk of congenital transmission has been estimated to vary between 2.6 percent and 7.9 percent. By contrast, we know very little about the congenital transmission of TcI. It has been suggested that congenital transmission of T. cruzi is strain related, and there is an urgent need to know if TcI transmits differently than TcII (non-TcI). Our primary hypothesis is that congenital transmission rates are different for TcI versus TcII. Our secondary hypothesis is that the characteristics of T. cruzi infected mothers (e.g., age, parity, transmission in previous pregnancies) and their exposure to vectors are different in regions where TcI is predominant versus regions where TcII (non-TcI) is predominant. To test these hypotheses, we propose to conduct a prospective study to enroll at delivery 13,000 women in Mexico, 7,500 women in Honduras, and 10,000 women in Argentina. We will measure transmitted maternal T. cruzi antibodies in cord blood, and, if the results are positive, we will identify infants who are congenitally infected by performing parasitological examinations on cord blood and at 4-8 weeks, and serological follow-up at 10 months. We will also perform standard PCR, real-time quantitative PCR, and T. cruzi genotyping on maternal blood, standard PCR and T. cruzi genotyping on the cord blood of congenitally infected newborns, and serological examinations on siblings. We will estimate the exposure to vectors in the household. In addition, we will measure prenatal outcomes among infected and uninfected infants with seropositive mothers, and the birth weight of their siblings. The specific aims of this study are: 1) To determine the rate of congenital transmission of TcI compared to TcII (non-TcI); 2) To compare the T. cruzi infected mothers' characteristics and exposure to vectors in regions where TcI is predominant and regions where TcII (non-TcI) is predominant; and 3) To describe the birth outcomes of infected and uninfected infants born to TcI and TcII seropositive women.


Eligibility criteria: Inclusion Criteria:

* Women 18 years old or more, informed consent, live birth.

Exclusion Criteria:

* Women residing outside of the follow-up area.

Primary outcomes:
measure: Congenital transmission of Trypanosoma cruzi
timeFrame: Two years
Secondary outcomes:
measure: Birth outcomes
timeFrame: Two years
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: Tulane School of Public Health and Tropical Medicine
state: Louisiana
city: Buenos Aires
country: Argentina
facility: Institute for Clinical Effectiveness and Health Policy
city: Brussels
country: Belgium
facility: Laboratory of Parasitology, Universite Libre de Bruxelles
city: Tegucigalpa
country: Honduras
facility: Inst. de Enfermedades Infecciosas y Parasitol Antonio Vidal
city: Merida
country: Mexico
facility: Lab. de Parasitologia, Universidad Autonoma de Yucatan
Study officials:
affiliation: Tulane SPHTM
name: Pierre Buekens, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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;10:55. doi: 10.1186/1742-4755-10-55.