The Safe Passage Study: Design, Methods, Recruitment, and Follow-Up Approach
The Safe Passage Study: Design, Methods, Recruitment, and Follow-Up Approach
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DOI：
10.1111/ppe.12136
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发表时间：
2014-09-01
影响因子：
2.8
通讯作者：
Kinney, Hannah C.
中科院分区：
文献类型：
--
作者：
Dukes, Kimberly A.;Burd, Larry;Kinney, Hannah C.
背景安全通道研究是一项大型、前瞻性、多学科研究，旨在（1）调查产前酒精暴露、婴儿猝死综合征（SIDS）和死产之间的关系，（2）确定暴露后表型结果谱的生物学基础，这些表型结果受环境和遗传因素的影响，增加死产、SIDS和存活儿童的风险，提供的结果是基于一个中期评估的6004名妇女登记，从北方平原，美国，和开普敦，南非，地区已知的高风险的母亲在怀孕期间饮酒的12000预计。研究目的，研究设计，和描述性统计，包括同意，招聘和保留信息，provided.ResultsOverall访问的遵守率为87%，并包括产前，分娩/新生儿，产后接触，通过1年产后。在病历审查之前，妊娠结局的确定率为98%;不到2%的妇女退出。同意使用DNA和胎盘组织超过94%，同意参加尸检部分的研究是71%.ConclusionsThe安全通道研究是第一个多站点的研究，SIDS和死产整合前瞻性收集的暴露信息与多学科的生物学信息，在同一个母亲和胎儿/婴儿二分体使用一个共同的协议。研究设计及其成功的重要组成部分是与社区的密切联系以及严格的系统和流程，以确保遵守研究方案和程序。
BackgroundThe Safe Passage Study is a large, prospective, multidisciplinary study designed to (1) investigate the association between prenatal alcohol exposure, sudden infant death syndrome (SIDS), and stillbirth, and (2) determine the biological basis of the spectrum of phenotypic outcomes from exposure, as modified by environmental and genetic factors that increase the risk of stillbirth, SIDS, and in surviving children, fetal alcohol spectrum disorders.MethodsThe results provided are based on an interim assessment of 6004 women enrolled, out of the 12000 projected, from the Northern Plains, US, and Cape Town, South Africa, areas known to be of high risk for maternal drinking during pregnancy. Research objectives, study design, and descriptive statistics, including consent, recruitment, and retention information, are provided.ResultsOverall visit compliance is 87%, and includes prenatal, delivery/newborn, and postnatal contacts through 1 year post-delivery. Pregnancy outcome ascertainment is 98% prior to medical chart review; less than 2% of women withdraw. Consent for the use of DNA and placental tissue exceed 94%, and consent to participate in the autopsy portion of the study is 71%.ConclusionsThe Safe Passage Study is the first multi-site study of SIDS and stillbirth to integrate prospectively collected exposure information with multidisciplinary biological information in the same maternal and fetal/infant dyad using a common protocol. Essential components of the study design and its success are close ties to the community and rigorous systems and processes to ensure compliance with the study protocol and procedures.