An observational study in Chagas Disease and Lactation, sponsored by Hospital de Niños R. Gutierrez de Buenos Aires. Completed at 1 site in Argentina. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2015-03-18.
Sponsored by Hospital de Niños R. Gutierrez de Buenos Aires · Observational
The investigators propose to study the transfer of benznidazole into breastmilk from the blood of lactating women who receive the drug for the treatment of Chagas disease. Breastmilk and blood samples will be obtained from these patients at given times after they take the clinically indicated medication, and the concentrations in both matrices will be compared to estimate degree of transfer, which in turn will be used to evaluate potential degree of exposure of infants breastfed by these women. This study will help clarify safety of continuing breastfeeding while receiving treatment with benznidazole for Chagas disease.
69 studies on the registry are indexed under Chagas Disease; 4 are open to participants now.
This study's enrollment of 10 is below the median of 95 across 20 observational studies indexed under Chagas Disease.
Browse Chagas Disease studies →Hospital de Niños R. Gutierrez de Buenos Aires is the lead sponsor of 15 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
population of young women with Chagas disease referred to our center for evaluation and treatment
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Exclusion Criteria:
Women with Chagas disease who fulfill clinical criteria for treatment with benznidazole, and who are also lactating
Benznidazole concentration in breastmilk and in plasma
Randomly obtained breastmilk samples will be obtained to both evaluate the breastmilk / plasma concentration ratio of the drug, and to develop a population pharmacokinetics model of drug trasfer into breastmilk, if possible. Breastmilk concentrations will be used to calculate potential infant exposure through breastmilk to the medication (benznidazole) taken by the mother
Time frame: at randomly selected time points during the 30 days of treatment
incidence of adverse drug reactions in women treated with benznidazole during lactation
Women receiving treatment with benznidazole while lactating, enrolled in the study will be followed according to current clinical guidelines, and monitored during the 60 days of the treatment (as per Chagas disease treatment guidelines), and monthly for 3 months after treatment completion.
Time frame: throughout the 30 days of treatment
The record gives a start of Aug 2011, a primary completion of Jun 2013 and a completion of Dec 2013. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.
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Hospital de Niños R. Gutierrez de Buenos Aires