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加纳随机空气污染与健康研究(GRAPHS)中的孕周评估:超声能力建设、胎儿生物测量方案制定及持续质量控制

Gestational Age Assessment in the Ghana Randomized Air Pollution and Health Study (GRAPHS): Ultrasound Capacity Building, Fetal Biometry Protocol Development, and Ongoing Quality Control.

作者信息

Boamah Ellen A, Asante Kp, Ae-Ngibise Ka, Kinney Patrick L, Jack Darby W, Manu Grace, Azindow Irene T, Owusu-Agyei Seth, Wylie Blair J

机构信息

Kintampo Health Research Centre, Brong Ahafo Region, Kintampo, Ghana.

出版信息

JMIR Res Protoc. 2014 Dec 18;3(4):e77. doi: 10.2196/resprot.3797.

DOI:10.2196/resprot.3797
PMID:25525828
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4376157/
Abstract

BACKGROUND

Four million premature deaths occur yearly as a result of smoke from cooking fires. The Ghana Randomized Air Pollution and Health Study (GRAPHS) is underway in the Kintampo North municipality and South district of rural Ghana to evaluate the impact of improved cook stoves introduced during pregnancy on birth weight and childhood pneumonia. These hypotheses are being tested in a cluster-randomized intervention trial among 1415 maternal-infant pairs within 35 communities assigned to a control arm (traditional cooking) or one of two intervention arms (cooking with an improved biomass stove; cooking with liquefied petroleum gas stoves).

OBJECTIVE

The trial is designed to ensure delivery of the stove intervention prior to the period of maximal fetal growth. To answer questions about the impact of household air pollution on pregnancy outcome, accurate gestational age assessment is critical. This manuscript describes in detail the development of the gestational dating protocol, intensive ultrasound training involved, ultrasound capacity building, and ultrasound quality control program.

METHODS

Ultrasound training occurred in several phases over the course of 2 years. Training included a basic obstetric ultrasound course offered to all midwives performing antenatal care at the two study hospitals, followed by a more intense period of hands-on training focused on fetal biometry for a select group of providers demonstrating aptitude in the basic course. A standard operating procedure was developed describing how to obtain all fetal biometric measurements. Consensus was obtained on how biometric images are used in the trial to establish gestational age and estimate the delivery date. An ongoing ultrasound quality control program including the use of an image scorecard was also designed.

RESULTS

Publication of trial results is anticipated in late 2016.

CONCLUSIONS

Use of ultrasound should be strongly considered in field-based trials involving pregnant women to accurately establish gestational age, as menstrual dates may be incorrect or unknown. The inclusion of ultrasound in areas where ultrasound capacity does not previously exist requires a significant investment of time and resources. Such investment ensures appropriate training, high quality images, and accurate dating pregnancies. We outline our ultrasound training, image acquisition, quality control, and dating protocols in detail.

TRIAL REGISTRATION

Clinicaltrials.gov NCT01335490; http://clinicaltrials.gov/ct2/show/NCT01335490 (Archived by WebCite at http://www.webcitation.org/6UbERJNO6).

摘要

背景

每年有400万人因烹饪用火产生的烟雾而过早死亡。加纳随机空气污染与健康研究(GRAPHS)正在加纳农村的金坦波北市和南区开展,以评估孕期引入改良炉灶对出生体重和儿童肺炎的影响。这些假设正在一项整群随机干预试验中进行检验,该试验涉及35个社区的1415对母婴,这些社区被分配到一个对照组(传统烹饪)或两个干预组之一(使用改良生物质炉灶烹饪;使用液化石油气炉灶烹饪)。

目的

该试验旨在确保在胎儿生长最快的时期之前提供炉灶干预。为了回答有关家庭空气污染对妊娠结局影响的问题,准确评估孕周至关重要。本文详细描述了孕周确定方案的制定、所涉及的强化超声培训、超声能力建设以及超声质量控制计划。

方法

超声培训在2年的时间里分几个阶段进行。培训包括为在两家研究医院提供产前护理的所有助产士开设的基础产科超声课程,随后是一段更密集的实践培训,重点是为在基础课程中表现出能力的一组特定提供者进行胎儿生物测量。制定了一个标准操作程序,描述如何获取所有胎儿生物测量数据。就如何在试验中使用生物测量图像来确定孕周和估计分娩日期达成了共识。还设计了一个正在进行的超声质量控制计划,包括使用图像记分卡。

结果

预计试验结果将于2016年底公布。

结论

在涉及孕妇的现场试验中,应强烈考虑使用超声来准确确定孕周,因为月经日期可能不正确或未知。在以前没有超声能力的地区引入超声需要大量的时间和资源投入。这种投入可确保进行适当的培训、获得高质量的图像并准确确定妊娠日期。我们详细概述了我们的超声培训、图像采集、质量控制和孕周确定方案。

试验注册

Clinicaltrials.gov NCT01335490;http://clinicaltrials.gov/ct2/show/NCT01335490(由WebCite存档于http://www.webcitation.org/6UbERJNO6)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/514c/4376157/74c83ef55971/resprot_v3i4e77_fig4.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/514c/4376157/d519d498e0d5/resprot_v3i4e77_fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/514c/4376157/1198cf5d081a/resprot_v3i4e77_fig2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/514c/4376157/77a444de6dd9/resprot_v3i4e77_fig3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/514c/4376157/74c83ef55971/resprot_v3i4e77_fig4.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/514c/4376157/d519d498e0d5/resprot_v3i4e77_fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/514c/4376157/1198cf5d081a/resprot_v3i4e77_fig2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/514c/4376157/77a444de6dd9/resprot_v3i4e77_fig3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/514c/4376157/74c83ef55971/resprot_v3i4e77_fig4.jpg

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