An observational study in Hepatitis C Virus, HIV Infections and Pregnancy, sponsored by Centre Hospitalier Universitaire de Nice. Completed at 3 sites in France. Open to female participants aged 15 Years to 55 Years. Per ClinicalTrials.gov, last updated 2023-11-13.
Sponsored by Centre Hospitalier Universitaire de Nice · Observational
According to the centres taking part in the ALHICE survey, the number of HIV-HCV co-infected women is currently decreasing. This drop was first noted in 2006 and persisted in 2007. What might have been considered a chance phenomenon during the first year (2006) was confirmed in the beginning of 2008. In view of this information, the investigators wished to ascertain the reality of this trend and to investigate its causes, by attempting to answer the following questions: - Has the prevalence of risk factors for HCV infection changed among the general population over the past 10 years?
The objectives are to study trends in numbers of deliveries among HCV/HIV co-infected women as well as trends in risk factors for HCV infection among women of child bearing age and lastly to create a cohort of HCV infected children.
Materials and Methods:
This multi-centre epidemiological study (CHU Nice, CHU Toulouse, CHU Montpellier, H Clinic Barcelona, H Mar Barcelona) consists in two parts. Our study does not interfere with the usual management of mother and child as laboratory data (virology, immunology, and liver function) are already included in the medical files. Data collection will be conducted via an anonymous questionnaire by an only one clinical research assistant who will travel to each participating centre. These data are contained in the mother's and child's medical files. The data concerning the socio-demographic characteristics of mother, the characteristics of HIV and HCV infection with special attention for infection risk factors, and the circumstances of the delivery. The questionnaire among children include laboratory results at birth, M6, and M12, as well as assessment of hepatic fibrosis.
Data were analysed using SPSS software. Qualitative variables were tested by Chi-square and Fisher's exact test. For quantitative variables, the non-parametric Mann-Whitney test was used (median, 25th and 75th quartile). A p-value inferior than 0.05 was considered statistically significant.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 142 is below the median of 240 across 2,136 observational studies indexed under Infections.
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HCV/HIV infected pregnant women
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This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier Universitaire de Nice