Evaluation of Viral Replication by Tonate Virus (TONV) and Zika Virus (ZIKV), Within an ex Vivo Trophoblast and Placental Model
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 8
- 主要终点
- To assess the replication potential of TONV and ZIKV after placenta infection ex vivo.
研究概览
简要总结
Prospective, non-interventional study carried out after culturing placental trophoblastic tissue ex vivo and infection with Zika and Tonate
详细描述
The analysis will relate for each virus studied + control + favipiravir to 1 placenta in the 1st trimester and 1 placenta at term.
2 experiments per virus will be planned.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.)
- •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)
研究组 & 干预措施
Human placentas and trophoblasts (biological waste) from uncomplicated pregnancies.
The placentas will be collected following a birth by caesarean section after oral and written information by delivery of the information note for women who have had a normal singleton pregnancy at term.
Similarly, trophoblasts are collected following endo-uterine aspiration in the context of voluntary termination of pregnancy.
- Cell line and virus
- Infection of human placental culture explants
- Determination of viral load in tissues by qRT-PCR
干预措施: Cell line and virus (Biological)
Human placentas and trophoblasts (biological waste) from uncomplicated pregnancies.
The placentas will be collected following a birth by caesarean section after oral and written information by delivery of the information note for women who have had a normal singleton pregnancy at term.
Similarly, trophoblasts are collected following endo-uterine aspiration in the context of voluntary termination of pregnancy.
- Cell line and virus
- Infection of human placental culture explants
- Determination of viral load in tissues by qRT-PCR
干预措施: Infection of human placental culture explants (Biological)
Human placentas and trophoblasts (biological waste) from uncomplicated pregnancies.
The placentas will be collected following a birth by caesarean section after oral and written information by delivery of the information note for women who have had a normal singleton pregnancy at term.
Similarly, trophoblasts are collected following endo-uterine aspiration in the context of voluntary termination of pregnancy.
- Cell line and virus
- Infection of human placental culture explants
- Determination of viral load in tissues by qRT-PCR
干预措施: Determination of viral load in tissues by qRT-PCR (Biological)
结局指标
主要结局
To assess the replication potential of TONV and ZIKV after placenta infection ex vivo.
时间窗: inclusion
Determine the viral load (RT-qtPCR) of TONV and ZIKV after placenta infection, ex vivo in RNA copies/mL
次要结局
- Compare the placental infection of TONV versus ZIKV.(inclusion)
- Highlight the cellular targets of TONV.(inclusion)
- Compare viral infection of the placenta at different terms of pregnancy (first trimester and term).(first trimester)
- Validate the ex vivo placental model for TONV.(Inclusion)
- Compare viral infection of the placenta at different terms of pregnancy (first trimester and term).(term)