Zika Virus Infection's Pregnancy Consequences in French Department of America (ZIKA-DFA-FE)
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
研究概览
详细说明
研究类型
注册 (预期的)
联系人和位置
学习地点
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Cayenne Cedex、法国、97306
- CH Andrée Rosemon (CHAR)
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FORT DE France Cedex、法国、97261
- CHU de Martinique
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Pointe A Pitre、法国、97139
- CHU de Pointe à Pitre/Les Abymes
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Saint-laurent-du-maroni、法国、97320
- CH de l'Ouest Guyanais Franck Joly (CHOG)
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
The population of this study is women who have been pregnant during the 2016 ZIKV Epidemic in the DFAs. Five study arms (hereafter called 'modules') have been defined with various inclusion criteria for each module.
M1: Pregnant women with clinical signs of acute ZIKV infection
Module 2: Pregnant women for which an abnormality has been detected in the fetus.
Module 3: Bio-bank of serum, collected once per trimester, from all pregnant women.
Module 4: Bio-bank of maternal blood and infant cord blood, taken the day of birth in all mothers and their babies in the 3 DFAs.
Module 5: Bio-bank of maternal blood and fetal tissues from women in whom the pregnancy was terminated due to miscarriage, abortion on medical grounds, or a fetal death in-utero.
描述
M1:
Inclusion Criteria:
- On-going pregnancy regardless the presumed date of birth
- Clinical signs suggestive of ZIKV infection
- Whatever the RT-PCR analysis
Exclusion Criteria:
- Minor
- No consent
M2:
Inclusion Criteria:
- Head circumference < 5th percentile
- Other brain morphological abnormality
- Hydramnios
- Intrauterine growth restriction (IUGR)
Exclusion Criteria:
- Minor
- No consent
M3:
Inclusion Criteria:
- Pregnant woman during epidemic period of ZIKV
Exclusion Criteria:
- Minor
- Opposition
M4:
Inclusion Criteria:
- Delivery during epidemic period of ZIKV
Exclusion Criteria:
- Minor
- No consent
M5:
Inclusion Criteria:
- Spontaneous abortion or fetal death in utero during epidemic period of ZIKV
Exclusion Criteria:
- Minor
- No consent
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
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Module 1
Identification and monitoring of pregnant women who develop clinical signs of acute infection due to ZIKV (standard monitoring report)
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Module 2
Monitoring of pregnant women with a suspected embryofetopathy (standard monitoring report)
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Module 3
Trimester biological collection of all pregnant women during the outbreak of Zika (standard monitoring report)
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Module 4
Biological collection of maternal blood and cord blood collected during the delivery
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Module 5
Biological collection of maternal blood and fetal tissues of pregnant women whose pregnancies started during the outbreak of Zika , ends in an spontaneous abortion, Induced abortion or intrauterine fetal demise
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
Incidence of ZIKV infection during pregnancy
大体时间:12 months
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12 months
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次要结果测量
结果测量 |
大体时间 |
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Incidence of microcephaly and other fetal abnormalities
大体时间:12 month
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12 month
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其他结果措施
结果测量 |
大体时间 |
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Analysis of risk factor for the occurence of congenital abnormalities
大体时间:12 month
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12 month
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合作者和调查者
出版物和有用的链接
一般刊物
- Funk AL, Hoen B, Vingdassalom I, Ryan C, Kadhel P, Schepers K, Gaete S, Tressieres B, Fontanet A. Reassessment of the risk of birth defects due to Zika virus in Guadeloupe, 2016. PLoS Negl Trop Dis. 2021 Mar 3;15(3):e0009048. doi: 10.1371/journal.pntd.0009048. eCollection 2021 Mar.
- Hoen B, Schaub B, Funk AL, Ardillon V, Boullard M, Cabie A, Callier C, Carles G, Cassadou S, Cesaire R, Douine M, Herrmann-Storck C, Kadhel P, Laouenan C, Madec Y, Monthieux A, Nacher M, Najioullah F, Rousset D, Ryan C, Schepers K, Stegmann-Planchard S, Tressieres B, Volumenie JL, Yassinguezo S, Janky E, Fontanet A. Pregnancy Outcomes after ZIKV Infection in French Territories in the Americas. N Engl J Med. 2018 Mar 15;378(11):985-994. doi: 10.1056/NEJMoa1709481.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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