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Methodological issues on planning and running the Brazilian Multicenter Study on Preterm Birth.

Lajos GJ, Tedesco RP, Passini R, Dias TZ, Nomura ML, Rehder PM, Haddad SM, Sousa MH, Cecatti JG, Brazilian Multicenter Study on Preterm Birth Study Gro - ScientificWorldJournal (2015)

Bottom Line: A multicenter cross-sectional study on preterm births in Brazilian facilities plus a nested case-control study to assess their associated factors.A description of all steps of planning and implementing such a nationwide study, including strategies for dealing with problems arising during the process, is presented. 20 referral hospitals in different regions of Brazil participated in the study.Finally, we got information on 4,150 preterm births and 1,146 term births.

View Article: PubMed Central - PubMed

Affiliation: Department of Obstetrics and Gynecology, School of Medical Sciences, University of Campinas, 13083-881 Campinas, SP, Brazil.

ABSTRACT

Objectives: Assuming that the occurrence of preterm births and their maternal and neonatal associated conditions in Brazil are not completely known, a multicenter study was proposed. The purpose of this paper is to describe the methods used, its processes, achievements, and challenges.

Study design: A multicenter cross-sectional study on preterm births in Brazilian facilities plus a nested case-control study to assess their associated factors. A description of all steps of planning and implementing such a nationwide study, including strategies for dealing with problems arising during the process, is presented.

Results: 20 referral hospitals in different regions of Brazil participated in the study. A detailed questionnaire for data collection, an electronic platform for data transcription and monitoring, research materials, and specific monitoring tools were developed; then data management and analyses were performed. Finally, we got information on 4,150 preterm births and 1,146 term births.

Conclusions: This study represented the first step of a planned comprehensive assessment of preterm birth in Brazil, with detailed information that will lead to several analyses and further studies, bringing the knowledge to improve screening, diagnosis, and treatment practices in maternal and perinatal health with the final purpose of reducing the burden of this condition in the country.

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Related in: MedlinePlus

Sample screens from the online data entry and management system: (a) Coversheet for the study in OpenClinica. (b) Build study page of EMIP at OpenClinica.
© Copyright Policy - open-access
Related In: Results  -  Collection


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fig1: Sample screens from the online data entry and management system: (a) Coversheet for the study in OpenClinica. (b) Build study page of EMIP at OpenClinica.

Mentions: The successful experience of the Brazilian Network for Surveillance of Severe Maternal Morbidity [23] using OpenClinica allowed us to select the same software. This internet-based system consists of an electronic platform for data entry and management of data, which is designed to support all types of clinical studies in a variety of locations [24]. We choose the free version of the system that allows forms creation, analysis and data storage, and stratification of the right of access to be granted to users working in the same study (Figure 1).


Methodological issues on planning and running the Brazilian Multicenter Study on Preterm Birth.

Lajos GJ, Tedesco RP, Passini R, Dias TZ, Nomura ML, Rehder PM, Haddad SM, Sousa MH, Cecatti JG, Brazilian Multicenter Study on Preterm Birth Study Gro - ScientificWorldJournal (2015)

Sample screens from the online data entry and management system: (a) Coversheet for the study in OpenClinica. (b) Build study page of EMIP at OpenClinica.
© Copyright Policy - open-access
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC4338388&req=5

fig1: Sample screens from the online data entry and management system: (a) Coversheet for the study in OpenClinica. (b) Build study page of EMIP at OpenClinica.
Mentions: The successful experience of the Brazilian Network for Surveillance of Severe Maternal Morbidity [23] using OpenClinica allowed us to select the same software. This internet-based system consists of an electronic platform for data entry and management of data, which is designed to support all types of clinical studies in a variety of locations [24]. We choose the free version of the system that allows forms creation, analysis and data storage, and stratification of the right of access to be granted to users working in the same study (Figure 1).

Bottom Line: A multicenter cross-sectional study on preterm births in Brazilian facilities plus a nested case-control study to assess their associated factors.A description of all steps of planning and implementing such a nationwide study, including strategies for dealing with problems arising during the process, is presented. 20 referral hospitals in different regions of Brazil participated in the study.Finally, we got information on 4,150 preterm births and 1,146 term births.

View Article: PubMed Central - PubMed

Affiliation: Department of Obstetrics and Gynecology, School of Medical Sciences, University of Campinas, 13083-881 Campinas, SP, Brazil.

ABSTRACT

Objectives: Assuming that the occurrence of preterm births and their maternal and neonatal associated conditions in Brazil are not completely known, a multicenter study was proposed. The purpose of this paper is to describe the methods used, its processes, achievements, and challenges.

Study design: A multicenter cross-sectional study on preterm births in Brazilian facilities plus a nested case-control study to assess their associated factors. A description of all steps of planning and implementing such a nationwide study, including strategies for dealing with problems arising during the process, is presented.

Results: 20 referral hospitals in different regions of Brazil participated in the study. A detailed questionnaire for data collection, an electronic platform for data transcription and monitoring, research materials, and specific monitoring tools were developed; then data management and analyses were performed. Finally, we got information on 4,150 preterm births and 1,146 term births.

Conclusions: This study represented the first step of a planned comprehensive assessment of preterm birth in Brazil, with detailed information that will lead to several analyses and further studies, bringing the knowledge to improve screening, diagnosis, and treatment practices in maternal and perinatal health with the final purpose of reducing the burden of this condition in the country.

Show MeSH
Related in: MedlinePlus