Études Observationnelles Des conséquences de l'Infection à Virus Zika au Cours de la Grossesse Pendant l'épidémie Des départements français d'Amérique de l'année 2016
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 26,980
- 试验地点
- 4
- 主要终点
- Incidence of ZIKV infection during pregnancy
研究概览
简要总结
The Zika (ZIKV) epidemic has spread into the three French Overseas Departments in the Caribbean (DFAs). It is therefore urgent to set up tools to collect clinical and paraclinical data for the evaluation of potential complications due to having ZIKV infection during pregnancy. This study is meant to collect, within usual care practices, clinical and paraclinical information which will allow the precise description of the consequences of ZIKV infection occurring during pregnancy.
详细描述
This is a prospective observational, non-interventional study that has been integrated into the usual standard of care practices. All information and biological samples collected during the course of this project will be done through the new medical standard of care which has been put in place during the ZIKV epidemic in the DFAs; this new standard of care is a result of existing recommendations from medical professionals and/or public health authorities. Outside of these recommendations, no invasive procedure will be done simply to satisfy an objective of this study.
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 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •On-going pregnancy regardless the presumed date of birth
- •Clinical signs suggestive of ZIKV infection
- •Whatever the RT-PCR analysis
排除标准
- •No consent
- •Inclusion Criteria:
- •Head circumference < 5th percentile
- •Other brain morphological abnormality
- •Hydramnios
- •Intrauterine growth restriction (IUGR)
- •Exclusion Criteria:
- •No consent
- •Inclusion Criteria:
- •Pregnant woman during epidemic period of ZIKV
- •Exclusion Criteria:
- •Opposition
- •Inclusion Criteria:
- •Delivery during epidemic period of ZIKV
- •Exclusion Criteria:
- •No consent
- •Inclusion Criteria:
- •Spontaneous abortion or fetal death in utero during epidemic period of ZIKV
- •Exclusion Criteria:
- •No consent
结局指标
主要结局
Incidence of ZIKV infection during pregnancy
时间窗: 12 months
次要结局
- Incidence of microcephaly and other fetal abnormalities(12 month)