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在非洲人群中,SARS-CoV-2 感染对母婴健康的流行情况和影响:一项多中心前瞻性队列研究(MA-CoV 项目)的方案。

Prevalence and impact of SARS-CoV-2 infection on maternal and infant health in African populations: protocol of a multicentre prospective cohort study (MA-CoV project).

机构信息

Maternal, Child and Reproductive Health Initiative, Barcelona Institute for Global Health, Barcelona, Spain.

CIBERESP, Madrid, Spain.

出版信息

BMJ Open. 2023 May 22;13(5):e067083. doi: 10.1136/bmjopen-2022-067083.

Abstract

INTRODUCTION

Pregnant women are currently considered a vulnerable population to SARS-CoV-2 infection, with increased risk of severe COVID-19, preterm birth and maternal mortality. There is, however, a paucity of data on the burden of maternal SARS-CoV-2 infection in sub-Saharan countries. The objective of this study is to determine the prevalence and health effects of maternal SARS-CoV-2 infection in selected sites from Gabon and Mozambique.

METHODS AND ANALYSIS

MA-CoV (MAternal CoVid) is an observational, multicentre prospective cohort study where 1000 pregnant women (500 per country) will be enrolled at the antenatal clinic visits. Participants will undergo monthly follow-up at each antenatal care visit, delivery and postpartum visit. The primary study outcome is the prevalence of SARS-CoV-2 infection during pregnancy. The clinical presentation of COVID-19 in pregnancy will also be characterised, and incidence of infection during pregnancy will be evaluated, as well as the risk factors of maternal and neonatal morbidity and mortality associated with SARS-CoV-2 infection and the risk of mother to child transmission of SARS-CoV-2. SARS-CoV-2 infection screening will be performed through PCR diagnosis.

ETHICS AND DISSEMINATION

The protocol was reviewed and approved by the , and the Ethics Committee of the Hospital Clinic of Barcelona (Spain). Project results will be presented to all stakeholders and published in open access journals.

TRIAL REGISTRATION NUMBER

NCT05303168.

摘要

简介

孕妇目前被认为是 SARS-CoV-2 感染的脆弱人群,COVID-19 重症、早产和孕产妇死亡的风险增加。然而,撒哈拉以南非洲国家孕产妇 SARS-CoV-2 感染负担的数据很少。本研究的目的是确定加蓬和莫桑比克选定地点孕产妇 SARS-CoV-2 感染的流行率和健康影响。

方法和分析

MA-CoV(孕产妇新冠病毒)是一项观察性、多中心前瞻性队列研究,将在产前诊所就诊时招募 1000 名孕妇(每个国家 500 名)。参与者将在每次产前保健就诊、分娩和产后就诊时进行每月随访。主要研究结果是妊娠期间 SARS-CoV-2 感染的流行率。还将描述 COVID-19 在妊娠中的临床表现,并评估妊娠期间感染的发生率,以及与 SARS-CoV-2 感染相关的孕产妇和新生儿发病率和死亡率的危险因素,以及 SARS-CoV-2 从母亲到孩子的传播风险。SARS-CoV-2 感染筛查将通过 PCR 诊断进行。

伦理和传播

该方案已由 、 和巴塞罗那临床医院伦理委员会(西班牙)审查和批准。项目结果将提交给所有利益相关者,并在开放获取期刊上发表。

试验注册编号

NCT05303168。

相似文献

本文引用的文献

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Pregnancy and COVID-19.妊娠与 COVID-19。
Physiol Rev. 2021 Jan 1;101(1):303-318. doi: 10.1152/physrev.00024.2020. Epub 2020 Sep 24.

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