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抗药性管控措施以改善妊娠、分娩和婴幼儿期抗生素使用(CAREChild):老挝人民民主共和国一项前瞻性、准实验性干预研究方案。

Containment of Antibiotic REsistance-measures to improve antibiotic use in pregnancy, childbirth and young children (CAREChild): a protocol of a prospective, quasiexperimental interventional study in Lao PDR.

机构信息

Department of Global Public Health, Karolinska Institute, Stockholm, Stockholm County, Sweden

Vientiane Capital Health Department, Lao Ministry of Health, Vientiane, Lao People's Democratic Republic.

出版信息

BMJ Open. 2020 Nov 19;10(11):e040334. doi: 10.1136/bmjopen-2020-040334.

Abstract

INTRODUCTION

Antibiotics are essential to treat infections during pregnancy and to reduce both maternal and infant mortality. Overall use, but especially non-indicated use, and misuse of antibiotics are drivers of antibiotic resistance (ABR). High non-indicated use of antibiotics for uncomplicated vaginal deliveries is widespread in many parts of the world. Similarly, irrational use of antibiotics is reported for children. There is scarcity of evidence regarding antibiotic use and ABR in Lao PDR (Laos). The overarching aim of this project is to fill those knowledge gaps and to evaluate a quality improvement intervention. The primary objective is to estimate the proportion of uncomplicated vaginal deliveries where antibiotics are used and to compare its trend before and after the intervention.

METHODS AND ANALYSIS

This 3-year, prospective, quasiexperimental study without comparison group includes a formative and interventional phase. Data on antibiotic use during delivery will be collected from medical records. Knowledge, attitudes and reported practices on antibiotic use in pregnancy, during delivery and for children, will be collected from women through questionnaires. Healthcare providers' knowledge, attitudes and practices of antibiotics administration for pregnant women, during delivery and for children, will be collected via adapted questionnaires. Perceptions regarding antibiotics will be explored through focus group discussions with women and individual interviews with key stakeholders. Faecal samples for culturing of and spp. and antibiotic susceptibility testing will be taken before, during and 6 months after delivery to determine colonisation of resistant strains. The planned intervention will comprise training workshops, educational materials and social media campaign and will be evaluated using interrupted time series analysis.

ETHICS AND DISSEMINATION

The project received ethical approval from the National Ethics Committee for Health Research, Ministry of Health, Laos. The results will be disseminated via scientific publications, conference presentations and communication with stakeholders.

TRAIL REGISTRATION NUMBER

ISRCTN16217522; Pre-results.

摘要

简介

抗生素对于治疗孕妇感染以及降低母婴死亡率至关重要。抗生素的总体使用情况,尤其是不适当使用和滥用,是抗生素耐药性(ABR)的驱动因素。在世界许多地区,对于无并发症的阴道分娩,抗生素的不适当使用非常普遍。同样,儿童抗生素的不合理使用也有报道。关于老挝人民民主共和国(老挝)抗生素使用和 ABR 的证据稀缺。该项目的总体目标是填补这些知识空白并评估质量改进干预措施。主要目标是估计使用抗生素的无并发症阴道分娩比例,并比较干预前后的趋势。

方法和分析

这是一项为期 3 年的前瞻性准实验研究,没有对照组,包括形成期和干预期。将从病历中收集分娩期间使用抗生素的数据。通过问卷调查收集妇女在怀孕期间、分娩期间和儿童时期使用抗生素的知识、态度和报告做法。通过改编后的问卷收集医疗保健提供者在怀孕期间、分娩期间和儿童时期使用抗生素的知识、态度和实践。通过与妇女进行焦点小组讨论和与利益相关者进行个别访谈,探讨对抗生素的看法。在分娩前、分娩期间和分娩后 6 个月,将采集粪便样本进行 和 spp. 的培养和抗生素药敏试验,以确定耐药菌株的定植情况。计划的干预措施包括培训研讨会、教育材料和社交媒体活动,并将使用中断时间序列分析进行评估。

伦理和传播

该项目已获得老挝卫生部国家卫生研究伦理委员会的伦理批准。结果将通过科学出版物、会议演讲和与利益相关者的沟通进行传播。

试验注册号

ISRCTN85541502;预结果。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9e70/7678367/91a92130648b/bmjopen-2020-040334f01.jpg

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