Rash Accompanied by Three or More Dengue-like Symptoms During Pregnancy and Microcephaly: Case-control Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Zika virus infection clinical outcomes during pregnancy
研究概览
简要总结
It is suspected that zika virus infection during pregnancy is associated with microcephaly. The objective of this study is to investigate the occurrence of rash accompanied by three or more dengue-like signs and symptoms during pregnancy is related to the microcephaly using the case-control design.
详细描述
The investigators will carry out a case-control study among mothers who delivered their babies at Nossa Senhora de Lourdes maternity hospital located in Aracaju, state of Sergipe, Brazil from September 1, 2015 through January 5, 2016. Data sources for the phase I of the study will consist of medical records review and a standard questionnaire applied by telephone to collect information about demographic features, clinical signs and symptoms, and the duration and severity of the illness. Phase II will include dengue, chikungunya and dengue serologic test results as secondary outcome, if available. The objective of this study is to investigate the occurrence of rash accompanied by three or more dengue-like signs and symptoms during pregnancy is related to the microcephaly using the case-control design
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Delivered a baby at nossa senhora de lourdes maternity from September 1, 2015 through january 5, 2016.
排除标准
- •Syphilis during pregnancy, toxoplasmosis during pregnancy, consanguinity, other genetics disorder, alcohol or abuse drug consumption during pregnancy.
结局指标
主要结局
Zika virus infection clinical outcomes during pregnancy
时间窗: From September 1, 2015 through January 5, 2016
acute onset of generalized rash together with three of the following symptoms: Conjunctivitis, arthralgia, mild-fever or periarticular edema.
次要结局
- Dengue virus serology(march, 2016 through July 5, 2016)
- zika virus serology(march, 2016 through July 5, 2016)
- Chikungunya virus serology(march, 2016 through July 5, 2016)
研究者
Gustavo Barcelos Barra
Pharm.D Ph.D
Laboratório Sabin