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Trends in Risk Factors for Mother-to-Child Transmission of Hepatitis C Among a Southern European Population (EPIALHICE B)

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ClinicalTrials.gov Identifier: NCT00894257
Recruitment Status : Unknown
Verified March 2010 by Centre Hospitalier Universitaire de Nice.
Recruitment status was:  Recruiting
First Posted : May 6, 2009
Last Update Posted : April 5, 2010
Information provided by:

Study Description
Brief Summary:

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.

Condition or disease
Hepatitis C Virus HIV Infections Pregnancy

Detailed Description:

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.

Study Design

Study Type : Observational
Estimated Enrollment : 128 participants
Observational Model: Cohort
Time Perspective: 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
Estimated Primary Completion Date : May 2010
Estimated Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

HCV/HIV infected pregnant women

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 55 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
HCV/HIV infected pregnant women

Inclusion Criteria:

  • Infected HIV/HCV pregnant women
  • All women to give birth in 1 randomized week each 6 months
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00894257

Contact: Eugènia MARINE-BARJOAN, MD marine-barjoan.e@chu-nice.fr
Contact: sylvie MALERBA 04 92 03 42 57 malerba.s@chu-nice.fr

CHU Montpellier Recruiting
Montpellier, France, 34000
Principal Investigator: alain BEREBI, MD         
CHU Nice Recruiting
Nice, France, 06000
Principal Investigator: eugenia marine barjoan, MD         
CHU Toulouse Recruiting
Toulouse, France, 31000
Principal Investigator: Pierre BOULOT, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
Principal Investigator: Eugénia MARINE-BARJOAN, MD CHU de Nice
More Information

Responsible Party: Marine Barjoan Eugenia, CHU Nice
ClinicalTrials.gov Identifier: NCT00894257     History of Changes
Other Study ID Numbers: 07-PP-06
First Posted: May 6, 2009    Key Record Dates
Last Update Posted: April 5, 2010
Last Verified: March 2010

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

Additional relevant MeSH terms:
Hepatitis A
Hepatitis C
HIV Infections
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Lentivirus Infections
Retroviridae Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases