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规划、实施和运行巴西具有生物库资源的多中心早产研究:早产 SAMBA 研究。

Planning, Implementing, and Running a Multicentre Preterm Birth Study with Biobank Resources in Brazil: The Preterm SAMBA Study.

机构信息

Department of Obstetrics and Gynecology, University of Campinas (UNICAMP), School of Medical Sciences, Campinas, SP, Brazil.

LNBio-Brazilian National Laboratory of Biosciences and University of Campinas (UNICAMP) School of Medical Sciences, University of Campinas (UNICAMP), Campinas, SP, Brazil.

出版信息

Biomed Res Int. 2019 Jan 16;2019:5476350. doi: 10.1155/2019/5476350. eCollection 2019.

Abstract

BACKGROUND

Our aim was to describe the steps in planning, implementing, and running a multicentre cohort study of maternal and perinatal health using a high-quality biobank comprised of maternal serum, plasma, and hair samples collected from five sites in Brazil. The Preterm SAMBA study, conducted by the Brazilian Network for Studies on Reproductive and Perinatal Health, was an innovative approach used to identify women at higher risk for preterm birth. It is also of great importance in the study of other maternal and perinatal complications in the context of Brazil, which is a middle-income country.

METHODS

We described phases of planning, implementing, and running the Preterm SAMBA study, a multicentre Brazilian cohort study of low-risk nulliparous pregnant women, to validate a set of metabolite biomarkers for preterm birth identified in an external cohort. Procedures and strategies used to plan, implement, and maintain this multicentre preterm birth study are described in detail. Barriers and experience cited in the current narrative are not usually discussed in the scientific literature or published study protocols.

RESULTS

Several barriers and strategies were identified in different phases of the Preterm SAMBA study at different levels of the study framework (steering committee; coordinating and local centres). Strategies implemented and resources used in the study are a legacy of the Brazilian Network, aimed at training collaborators in such complex settings.

CONCLUSION

The Brazilian Network for Studies on Reproductive and Perinatal Health has gained some experience in conducting a multicentre cohort study using a resourceful biobank which may be helpful to other research groups and maternal/perinatal health networks that plan on employing a similar approach to a similar background.

摘要

背景

本研究旨在描述一项多中心队列研究的规划、实施和运行步骤,该研究以一个高质量的生物库为基础,该生物库由来自巴西 5 个地点的孕产妇血清、血浆和头发样本组成。由巴西生殖和围产健康研究网络开展的 Preterm SAMBA 研究,是一种用于识别早产风险较高的女性的创新方法。对于研究巴西等中等收入国家的其他孕产妇和围产并发症也非常重要。

方法

我们描述了 Preterm SAMBA 研究的规划、实施和运行阶段,该研究是一项多中心巴西队列研究,纳入低危初产妇,以验证在外部队列中确定的一组早产代谢物生物标志物。详细描述了用于规划、实施和维持这项多中心早产研究的程序和策略。本研究报告中提到的当前叙述中的障碍和经验在科学文献或已发表的研究方案中通常没有讨论。

结果

在 Preterm SAMBA 研究的不同阶段,在研究框架的不同层面(指导委员会、协调和地方中心)都确定了一些障碍和策略。该研究中实施的策略和使用的资源是巴西网络的遗产,旨在培训在这种复杂环境下的合作者。

结论

巴西生殖和围产健康研究网络在使用资源丰富的生物库进行多中心队列研究方面积累了一些经验,这可能对其他计划采用类似方法和背景的研究小组和孕产妇/围产健康网络有所帮助。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0d97/6354138/e79624a7a7a0/BMRI2019-5476350.001.jpg

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