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
- physical activity
- sleep patterns
- sleep-wake cycle
- 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/.
Statistics from Altmetric.com
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.
If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.