Do Cesarean Deliveries Reduce Mortality in Infants with Birth Defects?

剖腹产会降低出生缺陷婴儿的死亡率吗？

• 批准号: 9175062
• 负责人: A.J. Agopian
• 金额: $ 19.17万
• 依托单位: UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-09-01 至 2018-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9175062
• 关键词: 1 year old; Accounting; Address; Age; Birth; Birth Weight; Breech Presentation; Case-Control Studies; Cesarean section; Cessation of life; Characteristics; Clinical; Congenital Abnormality; Congenital omphalocele; Data; Defect; Discipline of obstetrics; Epidemiologic Studies; Ethnic Origin; Exposure to; Forcep; Gastroschisis; General Population; Gestational Age; Human; Individual; Infant; Infant Mortality; Infection; Ischemia; Lesion; Life; Light; Logistic Regressions; Methods; Modification; Neonatal; Neonatal Mortality; Obstetric Labor; Outcome; Patients; Pattern; Perception; Policies; Population; Procedures; Public Health; Race; Randomized Clinical Trials; Randomized Controlled Trials; Registries; Reporting; Research; Research Design; Risk; Sample Size; Sampling; Sampling Studies; Selection Bias; Spinal Dysraphism; Statistical Data Interpretation; Subgroup; Texas; Time; Trauma; Vacuum; Vagina; Vaginal delivery procedure; Vulnerable Populations; clinical practice; evidence base; follow-up; high risk; human subject; improved; improved outcome; infant death; interest; meetings; mortality; population based; prevent; theories

PROJECT SUMMARY In the U.S., infants with open birth defects (spina bifida, gastroschisis, omphalocele) are more likely to have cesarean section (CS) deliveries than infants with any other type of birth defect. It has been proposed that CS may reduce the high risk of early death infants (e.g., by limiting trauma on the lesion and risk of infection). However, there is a lack of evidence to support or refute this theory in humans, and it is also not clear which other procedures or conditions influence mortality risk in infants with open birth defects. Therefore, a well-designed study is urgently needed to identify the optimal delivery procedures and conditions for these infants. A randomized control trial would be difficult to coordinate for relatively rare outcomes and would be difficult to justify in the absence of empirical evidence suggesting a benefit to CS. Therefore, an observational epidemiologic study design should be conducted, using a very large, population-based study sample to address differences in clinical referral patterns (i.e., selection bias); considering sufficiently homogenous and appropriate case-definitions (e.g., evaluating gastroschisis and omphalocele separately); addressing the potential for confounding; following-up during a long period (e.g., 1 year); and accounting for follow-up time in statistical analysis. We propose a two year study that meets these criteria using data from the Texas Birth Defects Registry for thousands of infants with open birth defects delivered between 1999-2011. We will use multivariable logistic regression to separately evaluate CS and several other obstetric procedures/conditions (forceps use, vacuum extraction, breech presentation, induction of labor, and prolonged labor) and risk for death by 28 days and age one for each of the three open birth defects. We will also consider the potential for effect modification by race/ethnicity, gestational age, and birth weight and the potential for confounding for several variables. Our findings will help determine the best clinical practices during labor and delivery for these infants and may ultimately reduce unnecessary invasive maternal procedures, and prevent infant deaths in this high-risk population.

项目摘要 在美国，患有开放性出生缺陷的婴儿（脊柱裂，胃肠道，omphalocele）更多 可能比具有任何其他类型的先天缺陷的婴儿进行剖宫产（CS）。 已经提出，CS可能会降低早期死亡婴儿的高风险（例如，通过限制 病变和感染风险的创伤）。但是，缺乏支持或 在人类中反驳这一理论，也不清楚哪些其他程序或条件 影响开放性出生缺陷的婴儿的死亡风险。因此，精心设计的研究是 迫切需要确定这些婴儿的最佳分娩程序和条件。一个 随机对照试验很难为相对罕见的结果进行协调，并且 在没有经验证据的情况下，很难证明对CS有好处。 因此，应该使用非常的观察性流行病学研究设计 基于人群的大型研究样本，以解决临床转诊模式的差异（即 选择偏见）；考虑到足够均匀且适当的病例定义（例如， 分别评估胃静脉曲张和杂钙膨出）；解决潜力 混淆；在长期内进行后续（例如，1年）；并考虑后续时间 在统计分析中。我们提出了一项为期两年的研究，该研究使用来自 得克萨斯州的出生缺陷为成千上万的婴儿出生缺陷的婴儿注册表 在1999-2011之间。我们将使用多变量逻辑回归分别评估CS 以及其他几种产科程序/条件（使用镊子，真空提取，臀位 介绍，劳动力和延长劳动）和死亡的风险降到28天的年龄 三个开放的先天缺陷中的每一个。我们还将考虑效果的潜力 通过种族/种族，胎龄和出生体重进行修改，并有可能 混淆了几个变量。我们的发现将有助于确定最佳的临床实践 在这些婴儿的分娩和分娩期间，最终可能会减少不必要的侵入性 孕产妇程序，并防止这种高风险人群的婴儿死亡。