ZP04 Trimester Form, Raw Dataset in International Prospective Observational Cohort Study of Zika in Infants and Pregnancy

Trimester Form, raw dataset, SAS. Raw data for the trimester form.
Study Description
The overall objective of this study was 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. At research sites in ZIKV endemic regions pregnant women were recruited and consented in the first and early second trimesters of pregnancy and then followed through delivery up to 6 weeks post-partum; their infants were followed until at least 1 year of age. Pregnant women with symptomatic ZIKV infection confirmed by presence of ZIKV RNA and/or IgM for ZIKV were also enrolled, regardless of gestational age. Maternal participants were tested monthly for ZIKV infection; additional demographic, clinical, laboratory and environmental data were collected to assess the potential interaction of these variables with ZIKV infection. Delivery outcomes and detailed infant assessments, including physical and neurological outcomes, were obtained. Pregnant women in their first or early second trimester from ZIKV-endemic regions and infants from the women's pregnancies. Ethnicity and race information provided below is on mothers only.

妊娠分期表原始数据集（SAS格式），即用于该妊娠分期表的原始采集数据。
研究概况
本研究的总体目标为评估妊娠期寨卡病毒（Zika virus, ZIKV）感染与不良母婴结局的关联强度，以及病毒垂直传播风险。研究在寨卡病毒流行地区的科研站点开展，招募于妊娠首三月及妊娠早中三月签署知情同意书的孕妇，随访至分娩后6周；其所诞新生儿则被随访至至少1周岁。对于经寨卡病毒核糖核酸（ZIKV RNA）和/或寨卡病毒IgM抗体检测确认存在症状性寨卡病毒感染的孕妇，无论孕周均纳入研究。入组孕妇每月接受寨卡病毒感染检测；同时收集人口学、临床、实验室及环境相关数据，以评估这些变量与寨卡病毒感染的潜在交互作用。研究获取了分娩结局及详细的婴儿评估数据，包括体格与神经系统发育结局。本研究的研究对象为寨卡病毒流行地区妊娠首三月或早中三月的孕妇，以及该类孕妇所孕育的胎儿与新生儿。下述提供的种族与民族信息仅针对孕妇本人。