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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
Sponsor:
Information provided by:
Centre Hospitalier Universitaire de Nice

Tracking Information
First Submitted Date May 5, 2009
First Posted Date May 6, 2009
Last Update Posted Date April 5, 2010
Study Start Date May 2009
Estimated Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT00894257 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Trends in Risk Factors for Mother-to-Child Transmission of Hepatitis C Among a Southern European Population
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
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.

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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population HCV/HIV infected pregnant women
Condition
  • Hepatitis C Virus
  • HIV Infections
  • Pregnancy
Intervention Not Provided
Study Groups/Cohorts HCV/HIV infected pregnant women
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: April¬†2,¬†2010)
128
Original Enrollment Not Provided
Estimated Study Completion Date May 2010
Estimated Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Infected HIV/HCV pregnant women
  • All women to give birth in 1 randomized week each 6 months
Sex/Gender
Sexes Eligible for Study: Female
Ages 15 Years to 55 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT00894257
Other Study ID Numbers 07-PP-06
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Marine Barjoan Eugenia, CHU Nice
Study Sponsor Centre Hospitalier Universitaire de Nice
Collaborators Not Provided
Investigators
Principal Investigator: Eugénia MARINE-BARJOAN, MD Centre Hospitalier Universitaire de Nice
PRS Account Centre Hospitalier Universitaire de Nice
Verification Date March 2010