|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Centre Hospitalier Universitaire de Nice |
|---|---|
| Information provided by: | Centre Hospitalier Universitaire de Nice |
| ClinicalTrials.gov Identifier: | NCT00894257 |
Purpose
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:
Furthermore, follow-up data from HCV-infected children born during this period will provide information concerning the course of HCV infection.
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 consists of two parts. The first is a retrospective survey which will include HIV/HCV co-infected pregnant women, diagnosed prior to or during their pregnancy, who gave birth in one of the participating centres between 1999 and 2008. The second part is a cross-sectional study conducted on a given week each semester between 1999 and 2008 which will include all the women who gave birth in one of the centres included in the study. The study is foreseen to last one year.
These data are contained in the mother's and child's medical files. Data will be stored at the coordinating centre. Recorded variables include socio-demographic characteristics, obstetrical history, details of HIV and HCV infection, co-morbidities and circumstances of delivery, and among children, laboratory results at birth, M6, and M12, as well as assessment of hepatic fibrosis.
| Condition |
|---|
|
Hepatitis C Virus HIV Infections Pregnancy |
| Study Type: | Observational |
| Study Design: | Cohort, Retrospective |
| Official Title: | Trends in Risk of Mother-to-Child Transmission of Hepatitis C Through Analysis of Prevalence of Risk Factors for Maternal Infection Among a Southern European Population |
| Study Start Date: | May 2009 |
| Groups/Cohorts |
|---|
| HCV/HIV infected pregnant women |
Introduction:
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, we wished to ascertain the reality of this trend and to investigate its causes,
Main Objectives:
Specific objectives:
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.
Eligibility| Ages Eligible for Study: | 15 Years to 55 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
HCV/HIV infected pregnant women
Inclusion Criteria:
Contacts and Locations| Contact: Eugènia MARINE-BARJOAN, MD | 04.92.03.56.34 | marine-barjoan.e@chu-nice.fr |
| Contact: sylvie MALERBA | 04 92 03 42 57 | malerba.s@chu-nice.fr |
| France | |
| CHU Nice | |
| Nice, France, 06000 | |
| CHU Toulouse | |
| toulouse, France, 31000 | |
| CHU Montpellier | |
| Montpellier, France, 34000 | |
More Information
| Responsible Party: | CHU Nice ( Marine Barjoan Eugenia ) |
| Study ID Numbers: | 07-PP-06 |
| Study First Received: | May 5, 2009 |
| Last Updated: | May 5, 2009 |
| ClinicalTrials.gov Identifier: | NCT00894257 History of Changes |
| Health Authority: | France: French Data Protection Authority |
|
HCV infected pregnant women |
|
Communicable Diseases Liver Diseases RNA Virus Infections Sexually Transmitted Diseases, Viral Slow Virus Diseases Flaviviridae Infections Immune System Diseases Acquired Immunodeficiency Syndrome Hepatitis, Viral, Human Infection |
Immunologic Deficiency Syndromes Hepatitis Virus Diseases Digestive System Diseases HIV Infections Sexually Transmitted Diseases Lentivirus Infections Hepatitis C Retroviridae Infections |