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Trends in Risk Factors for Mother-to-Child Transmission of Hepatitis C Among a Southern European Population (EPI ALHICE B)
This study is not yet open for participant recruitment.
Verified by Centre Hospitalier Universitaire de Nice, May 2009
First Received: May 5, 2009   No Changes Posted
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:

  • Has the prevalence of risk factors for HCV infection changed among the general population over the past 10 years?
  • Has the prevalence of risk factors for HCV infection changed among HIV/HCV co-infected women over the past 10 years?
  • Is the change in the number of co-infected women who gave birth during the past 10 years related to the prevalence of certain risk factors among this population?
  • Is the change in the number of co-infected women who gave birth during the past 10 years related to a decrease in certain risk factors for HCV infection among the general population?
  • Have changes in addictive behaviour among women of child-bearing age played a role in the decreasing number of HCV-contaminated children?

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

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Nice:

Biospecimen Retention:   None Retained

Biospecimen Description:

Study Start Date: May 2009
Groups/Cohorts
HCV/HIV infected pregnant women

Detailed Description:

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:

  • To study the trends of risk factors of HCV infection in mothers.
  • To study the trends of the number of deliveries among HCV/HIV coinfected women.
  • To create a cohort of HCV infected children.

Specific objectives:

  • To identify the modifications of HCV infection risks factors prevalence in a HIV/HCV co-infected mothers, HCV infected mothers and negative HIV and HCV mothers.
  • To compare the characteristics of delivery in a HIV/HCV coinfected population, HCV or HIV infected population with a seronegative population.
  • To analyze the differences in the follow-up of 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.

  Eligibility

Ages Eligible for Study:   15 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Study Population

HCV/HIV infected pregnant women

Criteria

Inclusion Criteria:

  • Infected HIV/HCV pregnant women
  • All women to give birth in 1 randomized week each 6 months
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00894257

Contacts
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

Locations
France
CHU Nice
Nice, France, 06000
CHU Toulouse
toulouse, France, 31000
CHU Montpellier
Montpellier, France, 34000
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
  More Information

No publications provided

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

Keywords provided by Centre Hospitalier Universitaire de Nice:
HCV infected pregnant women

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on February 08, 2010