Zika Virus Infection Clinical Trial
— ZITOPExOfficial title:
Evaluation of Viral Replication by Tonate Virus (TONV) and Zika Virus (ZIKV), Within an ex Vivo Trophoblast and Placental Model
Prospective, non-interventional study carried out after culturing placental trophoblastic tissue ex vivo and infection with Zika and Tonate
Status | Not yet recruiting |
Enrollment | 8 |
Est. completion date | April 1, 2024 |
Est. primary completion date | April 1, 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patient over 18 years old - Singleton pregnancy of normal course, at term, birth by caesarean section OR - Trophoblast from Voluntary Termination of Pregnancy (IVG), after endo-uterine aspiration Exclusion Criteria: - Need for pathological, genetic or bacteriological examination of the placenta - Multiple pregnancy - HBV+ (Hepatitis B positive), HCV+ (Hepatitis C positive) , known CMV seroconversion during pregnancy (CytoMégaloVirus) - Immunosuppression (drugs, corticosteroids, etc.) - Diabetes - Pre eclampsia - Intrauterine growth retardation (IUGR), - Vascular or placental pathology. - Refusal to participate - Patient under guardianship / curatorship / security measure - Patient under AME (state medical aid) |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Assistance Publique - Hôpitaux de Paris |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To assess the replication potential of TONV and ZIKV after placenta infection ex vivo. | Determine the viral load (RT-qtPCR) of TONV and ZIKV after placenta infection, ex vivo in RNA copies/mL | inclusion | |
Secondary | Validate the ex vivo placental model for TONV. | Analysis of viral load in placental explants for TONV in RNA copies/mL | Inclusion | |
Secondary | Compare viral infection of the placenta at different terms of pregnancy (first trimester and term). | Analysis of the viral load according to the term in RNA copies/mL | first trimester | |
Secondary | Compare viral infection of the placenta at different terms of pregnancy (first trimester and term). | Analysis of gene expression of the different cytokines according to the term in RNA copies/mL | first trimester | |
Secondary | Compare viral infection of the placenta at different terms of pregnancy (first trimester and term). | Analysis of the histological lesions according to the term in RNA copies/mL | first trimester | |
Secondary | Compare viral infection of the placenta at different terms of pregnancy (first trimester and term). | Analysis of the viral load according to the term in RNA copies/mL | term | |
Secondary | Compare the placental infection of TONV versus ZIKV. | Analysis of viral load depending on the virus (ZIKV vs TONV) in RNA copies/mL | inclusion | |
Secondary | Compare the placental infection of TONV versus ZIKV. | Analysis of gene expression of different cytokines depending on the virus (ZIKV vs TONV) in RNA copies/mL | inclusion | |
Secondary | Compare the placental infection of TONV versus ZIKV. | Analysis of histological lesions depending on the virus (ZIKV vs TONV) in RNA copies/mL | inclusion | |
Secondary | Highlight the cellular targets of TONV. | Histological analysis and labeling of TONV cells in RNA copies/mL | inclusion | |
Secondary | Highlight the cellular targets of TONV. | Histological analysis and labeling of placental cells in RNA copies/mL | inclusion |
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