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

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journal contribution
posted on 10.09.2019, 13:22 by RT Souza, JG Cecatti, ML Costa, J Mayrink, RC Pacagnella, R Passini, KG Franchini, FE Feitosa, IM Calderon, EA Rocha Filho, DF Leite, J Vettorazzi, LC Kenny, PN Baker, MA Parpinelli, KG Fernandes, JP Guida, D Santana, RM Barbosa, RBF Galvao, BF Cassettari, L Pfitscher, DL de Feitosa
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.

Funding

The Preterm SAMBA study group also included Mary A. Parpinelli, Karayna G Fernandes, José P Guida, Danielly Santana, Ricardo M Barbosa, and Rafael B F Galvao, School of Medical Sciences, University of Campinas, Brazil; Bianca F. Cassettari, School of Medicine of Botucatu, UNESP, Brazil; Lucia Pfitscher, School of Medicine, Federal University of Rio Grande do Sul, Porto Alegre, Brazil; Daisy Lucena de Feitosa, School of Medicine, Federal University of Ceará, Fortaleza, Brazil. The authors also acknowledge the following research assistants, collaborators, and staff members of the institution who made a remarkable contribution to run the Preterm SAMBA study: Elias de Melo Ferreira Júnior, and Danilo Anacleto, School of Medicine, Federal University of Pernambuco, Recife, Brazil; Vilma Zotareli and Marcia Alice Silva, from Cemicamp, who provided administrative and financial support for the study. The authors also acknowledge Global Health Strategies and FioCruz (Oswaldo Cruz Foundation, Rio de Janeiro), the institutions responsible for financial and clinical advisory on behalf of BMGF, which made a remarkable contribution to the identification of barriers for study sustainability, disruptiveness, and potentiality to scale.

History

Citation

BioMed Research International Volume, 2019, Article ID 5476350, 8 pages

Author affiliation

/Organisation/COLLEGE OF LIFE SCIENCES

Version

VoR (Version of Record)

Published in

BioMed Research International Volume

Publisher

Hindawi

issn

2314-6133

eissn

2314-6141

Acceptance date

27/12/2018

Copyright date

2019

Available date

10/09/2019

Publisher version

https://www.hindawi.com/journals/bmri/2019/5476350/

Notes

The current manuscript describes several topics related to methodological aspect and the implementation of a multicentre cohort study and does not involve data to be available.

Language

en