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NCT01787968 · ClinicalTrials.gov registry record
Congenital Transmission of Lineages I and II of Trypanosoma Cruzi
A clinical trial, sponsored by Tulane University School of Public Health and Tropical Medicine.
- Completed
- Registry status
- 28,348
- Enrollment target
NCT01787968: Completed study, sponsored by Tulane University School of Public Health and Tropical Medicine.
NCT01787968 is a clinical trial that has completed, run by Tulane University School of Public Health and Tropical Medicine. The registered enrollment target is 28,348 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01787968 has completed, sponsored by Tulane University School of Public Health and Tropical Medicine.
- COMPLETED
- Registry status
- 28,348 participants
- Enrollment target
Study 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
Primary Outcome
We will identify infants who are congenitally infected by performing parasitological examinations on cord blood, on venous blood at 4-8 weeks, and serological follow-up at 10 months. Standard PCR, quantitative real-time PCR (qPCR), and T. cruzi genotyping will be performed on maternal blood and cord blood.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28,348 participants |
| Start Date | 2011-04 |
| Est. Completion | 2013-12 |
What the finished NCT01787968 record still lists
NCT01787968 is an observational study that tracks outcomes without assigning an intervention. Its 28,348 participants enrollment target places it among the larger protocols in the corpus.
The record links to 0 conditions, and to 0 interventions.
NCT01787968 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01787968 about?
NCT01787968 is a clinical study titled "Congenital Transmission of Lineages I and II of Trypanosoma Cruzi". 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 congeni...
What is the current status of trial NCT01787968?
This trial is currently completed. The enrollment target is 28,348 participants. The study started on 2011-04. Estimated completion is 2013-12.
Who is sponsoring clinical trial NCT01787968?
This trial is sponsored by Tulane University School of Public Health and Tropical Medicine, which has 6 total clinical trials registered on ClinicalTrials.gov.
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