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通过巴西多中心队列中的可穿戴技术识别妊娠并发症的早期预测指标:母体活动监测探索性研究 I(MAES-I)研究方案。

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

机构信息

Obstetrics and Gynecology, Universidade Estadual de Campinas, Campinas, Brazil.

Faculdade de Ciencias Medicas, Universidade Estadual de Campinas, Campinas, Brazil.

出版信息

BMJ Open. 2019 Apr 20;9(4):e023101. doi: 10.1136/bmjopen-2018-023101.

DOI:10.1136/bmjopen-2018-023101
PMID:31005906
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6500316/
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.

摘要

简介

能够识别产妇并发症预测因素的非侵入性工具将是改善母婴健康的一大进步。体力活动(PA)和睡眠-觉醒模式的改变与与慢性疾病相关的炎症、代谢和病理状况的发生有关。活动记录仪已被验证可用于估计孕妇的 PA 和睡眠-觉醒模式。为了扩大预防、诊断和治疗特定产妇疾病的机会窗口,是否可以使用活动记录仪数据来识别妊娠期间发生不良产妇结局的危险因素?

方法和分析

该队列将在巴西生殖与围产健康研究网络的五个中心进行。产妇活动记录仪探索性研究 I(MAES-I)将招募 400 名低风险初产妇,这些产妇将在 19 至 21 周直至分娩期间,不间断地在手腕上佩戴活动记录仪 24 小时/天。将分析整个孕期的 PA 和睡眠-觉醒模式变化,考虑到有和无产妇并发症(如子痫前期、早产(自发性或由医生发起)、妊娠期糖尿病、妊娠期间出血)的孕妇的妊娠年龄范围,以及围产期结局。计划使用活动记录仪数据设计一个预测模型,以筛选有发生特定不良产妇和围产期结局风险的孕妇。

伦理和传播

MAES-I 已由每个机构审查委员会和国家伦理研究委员会审查和批准。有关研究的详细信息在巴西队列网站(www.medscinet.com/samba)上提供,研究结果将在科学文献和机构网页上发表。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9c98/6500316/efad41b96ecb/bmjopen-2018-023101f02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9c98/6500316/95e2cdf621c5/bmjopen-2018-023101f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9c98/6500316/efad41b96ecb/bmjopen-2018-023101f02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9c98/6500316/95e2cdf621c5/bmjopen-2018-023101f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9c98/6500316/efad41b96ecb/bmjopen-2018-023101f02.jpg

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