Identification of earlier predictors of pregnancy complications through wearable technologies in a Brazilian multicentre cohort: Maternal Actigraphy Exploratory Study I (MAES-I) study protocol

Abstract

IntroductionNon-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 analysisA 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 disseminationMAES-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.

Data-Driven Modeling of Pregnancy-Related Complications

“…The use of sensors and actigraphy to monitor sleep quality, activity patterns, and movement in patients is a novel approach to the quantification of lifestyle-related behaviors that might affect health [135,136]. Although this strategy has been underexplored, altered sleep patterns during pregnancy have been shown to lead to differential gene expression in mothers [137].…”

Agreement between the short and long versions of the Resilience Scale: A validation among the obstetric population according to vulnerability status

“…The Maternal Actigraphy Exploratory Study I (MAES‐I) project is a prospective cohort study that included nulliparous singleton pregnant women from mid‐pregnancy to childbirth in four Brazilian centers from March 2018 to March 2020. The study protocol has been previously published 18 . Briefly, the study was designed to explore predictors of gestational complications, including clinical conditions and patterns of physical activity and sleep, based on actigraphy data by means of a wearable wrist actigraphy device used 24 hours/day uninterruptedly, from 19 to 21 weeks until childbirth.…”

“…The study protocol has been previously published. 18 Briefly, the study was designed to explore predictors of gestational complications, including clinical conditions and patterns of physical activity and sleep, based on actigraphy data by means of a wearable wrist actigraphy device used 24 hours/day uninterruptedly, from 19 to 21 weeks until childbirth. Singleton pregnant women were considered eligible until 21 weeks of pregnancy.…”

Wearable sensors for prediction of intraamniotic infection in women with preterm premature rupture of membranes: a prospective proof of principle study

“…Despite the clinical relevance of early infection detection, encouraging results from previous studies as well as successful use of wearables in pregnant women for other indications [24,[27][28][29][30], to our knowledge, no study on the usability of wearable sensors for prediction of intraamniotic infection has been performed yet. We therefore evaluate the detection of infection in women with PPROM using noninvasive parameters measured by a wearable device within a prospective proof of principle study.…”