International Prospective Observational Cohort Study of Zika in Infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6,461
- 试验地点
- 10
- 主要终点
- Incidence of adverse fetal outcomes for ZIKV infected participants
研究概览
简要总结
The overall objective of this multisite, multicountry Zika in Infants and Pregnancy (ZIP) study is to assess the strength of the association between Zika virus infection (ZIKV) during pregnancy and adverse maternal/fetal outcomes and the risk of vertical transmission. The study will prospectively enroll a cohort of pregnant women up to 17 weeks and 6 days gestation and subjects at any gestational age with acute Zika infection, confirmed by serology or PCR (polymerase chain reaction) test. The study will follow these women through their pregnancy to identify for clinical evidence of acute ZIKV, while controlling for potential confounders. Outcomes in the women, the developing fetus, and infants will be assessed. All protocol-specified data will be recorded and entered in a central data management system for the purposes of analysis of composite data from the study.
详细描述
The overall objective of this multisite, multicountry Zika in Infants and Pregnancy (ZIP) study is to assess the strength of the association between Zika virus infection (ZIKV) during pregnancy and adverse maternal/fetal outcomes and the risk of vertical transmission. The study will prospectively enroll a cohort of pregnant women up to 17 weeks and 6 days gestation and subjects at any gestational age with acute Zika infection, confirmed by serology or PCR (polymerase chain reaction) test. The study will follow these women through their pregnancy to identify for clinical evidence of acute ZIKV, while controlling for potential confounders. Outcomes in the women, the developing fetus, and infants will be assessed. All protocol-specified data will be recorded and entered in a central data management system for the purposes of analysis of composite data from the study.
The study will recruit up to10,000 pregnant women in their first trimester from ZIKV-endemic regions and follow them longitudinally to study the impact of incident ZIKV during pregnancy on maternal, fetal, and newborn outcomes. Researchers will identify cases of incident ZIKV among pregnant women by monitoring for symptoms of Zika-like illness and performing serial laboratory sampling for diagnosis of seroconversion and viral shedding. After delivery, infants born with evidence of ZIKV or born to mothers diagnosed with incident virus infection will be followed in a prospective longitudinal cohort for at least 1 year. In addition, a control group of infants born to mothers without evidence of ZIKV during pregnancy will be followed.
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
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Informed consent
- •Age >15 years
- •Assent and consent as required per local country regulations
- •Confirmation of pregnancy by beta human chorionic gonadotropin (hCG) measurement in blood/urine or ultrasound confirmation of pregnancy with fetal heart tones present
- •Pregnant women up to 17 weeks and 6 days gestation and subjects at any gestational age with acute Zika infection, confirmed by serology or PCR (polymerase chain reaction) test.
排除标准
- •Pregnant Women
- •Women who cannot adhere to proposed testing schedule
- •Pregnant women enrolled in other research including other ZIKV research
- •Inclusion Criteria (newborn)
- •All infants born to women enrolled in the observational cohort are eligible for enrollment
- •Exclusion Criteria (newborn)
- •Mother or custodial parent does not consent to have child participate
- •Infants born to mothers that are not part of the ZIP cohort study
结局指标
主要结局
Incidence of adverse fetal outcomes for ZIKV infected participants
时间窗: 12 months of age
To measure the incidence of adverse fetal outcomes (including microcephaly, fetal demise, neonatal death, central nervous system (CNS) malformations, hydrops, and ocular abnormalities) in fetuses/infants.
Incidence of congenital malformations for ZIKV infected participants
时间窗: 12 months of age
To measure the incidence of congenital malformations in fetuses/infants.
Incidence of congenital malformations for ZIKV symptomatic participants
时间窗: 12 months of age
To measure the incidence of congenital malformations in fetuses/infants.
Incidence of adverse fetal outcomes for ZIKV symptomatic participants
时间窗: 12 months of age
To measure the incidence of adverse fetal outcomes (including microcephaly, fetal demise, neonatal death, CNS malformations, hydrops, and ocular abnormalities) in fetuses/infants.
次要结局
未报告次要终点