Hospital-based birth defects surveillance in Kampala, Uganda

摘要 每年估计有790万儿童出生时有严重的出生缺陷，其中330万人 五岁以下儿童死于与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。在许多资源贫乏的环境中， 出生缺陷的基线患病率尚不清楚，对出生缺陷的系统监测是困难的或不可能的。 存在的妊娠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，建议所有感染艾滋病毒的孕妇接受有效的抗逆转录病毒疗法， 防止艾滋病毒传染给婴儿。然而，有人担心， 在怀孕时或在头三个月期间接受抗逆转录病毒治疗的妇女， 先天缺陷该提案的目标是建立一个以医院为基础的出生缺陷监测项目 在乌干达的坎帕拉，并确定主要外部出生缺陷的流行率和 包括抗逆转录病毒治疗的母亲的风险因素，这些缺陷。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次分娩。有资料的出生（活产 和死产），无论胎龄，在四家医院出生的婴儿将被纳入监测范围。 项目为期五年。信息性分娩是指新生儿发育良好， 确定是否存在出生缺陷。新生儿出生后将尽快接受检查。 将获得婴儿测量结果（体重、头围和身长），并对所有新生儿进行 由受过训练的助产士检查是否有重大的外部出生缺陷。新生儿与重大外部出生缺陷将 在获得同意后拍照，照片将用于诊断分类。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， 使用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、以前的分娩是否存在身体缺陷） 孩子们）将为所有母亲收集。每一位婴儿的母亲都被确定患有严重的外部出生缺陷 将要求感兴趣的患者参加病例对照研究。每个病例将选择三个对照组 与分娩的医院吻合同意后，每位母亲将被要求回答以下问题， 妊娠期间使用的药物类型，包括抗逆转录病毒药物和复方新诺明，病史 更详细的人口统计信息。该监测计划将提供关键的当前数据， 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，同时还筛查其他常见的已知原因， 出生缺陷

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.