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Identification of earlier predictors of pregnancy complications through wearable technologies in a Brazilian multicentre cohort: Maternal Actigraphy Exploratory Study I (MAES-I) study protocol
  1. Renato T Souza1,
  2. Jose Guilherme Cecatti1,
  3. Jussara Mayrink2,
  4. Rafael Bessa Galvão1,
  5. Maria Laura Costa1,
  6. Francisco Feitosa3,
  7. Edilberto Rocha Filho4,
  8. Debora F Leite4,
  9. Janete Vettorazzi5,
  10. Ricardo P Tedesco6,
  11. Danielly S Santana1,
  12. Joao Paulo Souza7
  13. on behalf of the MAES-I Study Group
    1. 1Obstetrics and Gynecology, Universidade Estadual de Campinas, Campinas, Brazil
    2. 2Faculdade de Ciencias Medicas, Universidade Estadual de Campinas, Campinas, Brazil
    3. 3Maternidade Escola, Universidade Federal do Ceara, Fortaleza, Brazil
    4. 4Obstetrics and Gynecology, Universidade Federal de Pernambuco, Recife, Brazil
    5. 5Obstetrics and Gynecology, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil
    6. 6Obstetrics and Gynecology, School of Medicine of Jundiai, Campinas, Brazil
    7. 7Social Medicine, Faculdade de Medicina de Ribeirao Preto, Universidade de Sao Paulo, Ribeirao Preto, Brazil
    1. Correspondence to Professor Jose Guilherme Cecatti; cecatti{at}unicamp.br

    Abstract

    Introduction Non-invasive tools capable of identifying predictors of maternal complications would be a step forward for improving maternal and perinatal health. There is an association between modification in physical activity (PA) and sleep–wake patterns and the occurrence of inflammatory, metabolic, pathological conditions related to chronic diseases. The actigraphy device is validated to estimate PA and sleep–wake patterns among pregnant women. In order to extend the window of opportunity to prevent, diagnose and treat specific maternal conditions, would it be possible to use actigraphy data to identify risk factors for the development of adverse maternal outcomes during pregnancy?

    Methods and analysis A cohort will be held in five centres from the Brazilian Network for Studies on Reproductive and Perinatal Health. Maternal Actigraphy Exploratory Study I (MAES-I) will enrol 400 low-risk nulliparous women who will wear the actigraphy device on their wrists day and night (24 hours/day) uninterruptedly from 19 to 21 weeks until childbirth. Changes in PA and sleep–wake patterns will be analysed throughout pregnancy, considering ranges in gestational age in women with and without maternal complications such as pre-eclampsia, preterm birth (spontaneous or provider-initiated), gestational diabetes, maternal haemorrhage during pregnancy, in addition to perinatal outcomes. The plan is to design a predictive model using actigraphy data for screening pregnant women at risk of developing specific adverse maternal and perinatal outcomes.

    Ethics and dissemination MAES-I has been reviewed and approved by each institutional review board and also by the National Council for Ethics in Research. Detailed information about the study is provided in the Brazilian Cohort website (www.medscinet.com/samba) and findings will be published in the scientific literature and institutional webpages.

    • wearable technologies
    • actigraphy
    • physical activity
    • sleep patterns
    • sleep-wake cycle
    • prediction
    • pregnancy complications

    This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.

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    Footnotes

    • Contributors All authors contributed to the overall study design and specific methodologies. RTS, JGC, JM, MLC and JPS conceived the study design and wrote the first version of the study protocol. In a first meeting, the protocol was discussed and incorporated suggestions from RBG, FF, ERF, DFL, JV, RPT and DSS. RTS, JGC, JM and RBG planned the implementation of the study and developed the necessary material. RTS, JM, MLC and JGC drafted the manuscript that was afterwards revised by all other authors who gave suggestions. All authors discussed and made important contributions to the manuscript, read and approved the final version for submission.

    • Funding This study was funded by The Bill and Melinda Gates Foundation through the Grand Challenge Exploration program, call 19 (research grant OPP1182749).

    • Competing interests None declared.

    • Ethics approval MAES-I study has been reviewed and approved by the National Committee for Ethics in Research of Brazil (CONEP) and by the Institutional Review Board (IRB) of the coordinating centre (Letter of approval 1.834.116 issued on 24thth November 2016) and of all other Brazilian participating centres.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Collaborators The MAES-I Study Group also includes: Carina B Luiz; Luiza C Brust; Danilo Anacleto; Lívia C Nascimento; Daisy Lucena; Denise E F Cordeiro; Mariana B Rogerio.

    • Patient consent for publication Obtained.

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