Hospital-based birth defects surveillance in Kampala, Uganda

摘要 据估计，每年有790万名儿童出生时就有严重的出生缺陷，其中330万 五岁以下儿童死于与其出生缺陷有关的因素。全面、可靠 大多数发展中国家没有关于出生缺陷的数据。在许多资源匮乏的环境中， 出生缺陷的基线患病率尚不清楚，系统地监测出生缺陷是困难的或非系统的 存在。孕期抗逆转录病毒治疗(ART)可以最大限度地降低母婴垂直传播的风险。 因此，建议所有携带艾滋病毒的孕妇接受有效的抗逆转录病毒治疗方案，以 防止艾滋病毒传播给他们的婴儿。然而，人们一直担心， 接受抗逆转录病毒治疗的妇女在怀孕或怀孕前三个月分娩婴儿的风险增加 先天缺陷。该提案的目标是建立一个以出生缺陷医院为基础的监测计划 在乌干达坎帕拉，并确定主要外部出生缺陷的流行率以及与 母亲的危险因素包括对这些缺陷进行抗逆转录病毒治疗。乌干达坎帕拉的四家医院 将被纳入监测系统，每年约有48,000次交付。信息量大的出生(活产 和死产)，无论胎龄如何，在四家医院出生的人将被纳入监测范围 该项目为期五年。信息丰富的出生是指新生儿发育良好，足以 确定是否有出生缺陷。每名新生儿出生后都将尽快接受检查。 将获得婴儿的尺寸(体重、头围和身长)，所有新生儿将 由训练有素的助产士检查主要的外部出生缺陷。有重大外部出生缺陷的新生儿将 在获得同意后被拍照，照片将被用来对诊断进行分类。根据需要， 照片和逐字描述将被发送给出生缺陷专家以确认诊断和 采用ICD-10疾病分类标准对出生缺陷进行编码。人口统计信息、艾滋病毒状况和 产科信息(产次状况、以前的活产和死产、以前出生的婴儿是否存在身体缺陷 (儿童)将为所有母亲收集。每一个婴儿的母亲被确认为严重的外部出生缺陷 有兴趣的人将被邀请参加一项病例对照研究。将为每个案例选择三个控件 与医院接生的情况相符。在同意之后，每一位母亲将被要求回答关于， 怀孕期间服用的药物类型，包括抗逆转录病毒药物和复方新诺明，病史 和更详细的人口统计信息。该监视项目将提供有关 乌干达出生缺陷的基线患病率，而病例对照研究将允许检查可能的 抗逆转录病毒治疗对婴儿结局的影响，同时也筛查其他常见的已知原因 先天缺陷。

ABSTRACT Every year there are an estimated 7.9 million children born with a serious birth defect and 3.3 million of these are children under five years of age who die from factors related to their birth defect. Comprehensive, reliable data on birth defects are not available for most developing countries. In many resource-poor settings, the baseline prevalence of birth defects is not known and systematic monitoring for birth defects is difficult or non- existent. Antiretroviral treatment (ART) in pregnancy can maximally reduce the risk of vertical transmission of HIV, and therefore it is recommended that all pregnant women with HIV receive effective ART regimens to prevent the transmission of HIV to their infants. However, there have been concerns about the possibility of women on ART at conception or during the first trimester having an increased risk of delivering an infant with a birth defect. The goal of this proposal is to establish a birth defect hospital based surveillance program in Kampala, Uganda and to determine the prevalence of major external birth defects and association of maternal risk factors including antiretroviral therapy to these defects. Four hospitals in Kampala, Uganda will be included in the surveillance system with approximately 48,000 deliveries per year. Informative births (live and stillborn) regardless of gestational age that are born at the four hospitals will be included in the surveillance project for a duration of five years. Informative births are those in which the newborn is formed well enough to ascertain whether or not there is a birth defect. Each newborn will be examined as soon as possible after birth. Infant measurements (weight, head circumference and length) will be obtained and all newborns will be examined for major external birth defects by trained midwives. Newborns with major external birth defects will be photographed after obtaining consent and the photographs will be used to classify the diagnosis. As needed, the photos and verbatim descriptions will be sent to birth defect experts for confirmation of diagnoses and for coding of the birth defect using ICD-10 disease classification criteria. Demographic information, HIV status and obstetric information (parity status, previous live and still births, presence of physical defects of births of previous children) will be collected for all mothers. Every mother of an infant identified with a major external birth defect of interest will be asked to participate in a case-control study. Three controls will be selected for each case matched on hospital of delivery. After consenting, each mother will be asked to respond to questions regarding, types of medications taken during pregnancy including antiretroviral drugs and cotrimoxazole, medical history and more detailed demographic information. The surveillance program will provide crucial current data on the baseline prevalence of birth defects in Uganda while the case-control study will allow examination of the possible effects of antiretroviral treatment on infant outcomes while also screening for other common known causes of birth defects.