Ignite Creation Date:
2025-12-24 @ 6:50 PM
Ignite Modification Date:
2025-12-26 @ 8:04 AM
Study NCT ID:
NCT00894257
Status:
COMPLETED
Last Update Posted:
2023-11-13
First Post:
2009-05-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trends in Risk Factors for Mother-to-Child Transmission of Hepatitis C Among a Southern European Population
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006526', 'term': 'Hepatitis C'}, {'id': 'D015658', 'term': 'HIV Infections'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 142}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-05-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2014-04-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-09', 'studyFirstSubmitDate': '2009-05-05', 'studyFirstSubmitQcDate': '2009-05-05', 'lastUpdatePostDateStruct': {'date': '2023-11-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-05-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04-15', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['HCV infected pregnant women'], 'conditions': ['Hepatitis C Virus', 'HIV Infections', 'Pregnancy']}, 'descriptionModule': {'briefSummary': '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?\n\n* Has the prevalence of risk factors for HCV infection changed among HIV/HCV co-infected women over the past 10 years?\n* 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?\n* 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?\n* 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.\n\nThe 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.', 'detailedDescription': "Materials and Methods:\n\nThis 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.\n\nData 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."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '55 Years', 'minimumAge': '15 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'HCV/HIV infected pregnant women', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Infected HIV/HCV pregnant women\n* All women to give birth in 1 randomized week each 6 months'}, 'identificationModule': {'nctId': 'NCT00894257', 'acronym': 'EPIALHICE B', 'briefTitle': 'Trends in Risk Factors for Mother-to-Child Transmission of Hepatitis C Among a Southern European Population', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nice'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '07-PP-06'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'HCV/HIV infected pregnant women'}]}, 'contactsLocationsModule': {'locations': [{'zip': '34000', 'city': 'Montpellier', 'country': 'France', 'facility': 'CHU Montpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '06000', 'city': 'Nice', 'country': 'France', 'facility': 'CHU Nice', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '31000', 'city': 'Toulouse', 'country': 'France', 'facility': 'CHU Toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'overallOfficials': [{'name': 'Eugénia MARINE-BARJOAN, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hospitalier Universitaire de Nice'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nice', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Marine Barjoan Eugenia', 'oldOrganization': 'CHU Nice'}}}}