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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by Centre Hospitalier Universitaire de Nice.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier:
NCT00894257
First received: May 5, 2009
Last updated: April 2, 2010
Last verified: March 2010
  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.


Condition
Hepatitis C Virus
HIV Infections
Pregnancy

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


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

Estimated Enrollment: 128
Study Start Date: May 2009
Estimated Study Completion Date: May 2010
Estimated Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
HCV/HIV infected pregnant women

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.

  Eligibility

Ages Eligible for Study:   15 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 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
Investigators
Principal Investigator: Eugénia MARINE-BARJOAN, MD CHU de Nice
  More Information

No publications provided

Responsible Party: Marine Barjoan Eugenia, CHU Nice
ClinicalTrials.gov Identifier: NCT00894257     History of Changes
Other Study ID Numbers: 07-PP-06
Study First Received: May 5, 2009
Last Updated: April 2, 2010
Health Authority: France: French Data Protection Authority

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

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

ClinicalTrials.gov processed this record on September 14, 2014