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: 9333411
• 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 2019-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9333411
• 关键词: 1 year old; Accounting; Address; Age; Birth Weight; Breech Presentation; Case-Control Studies; Cesarean section; Cessation of life; Characteristics; Clinical; Congenital Abnormality; Congenital omphalocele; Data; Defect; Discipline of obstetrics; Ethnic Origin; Exposure to; Forcep; Gastroschisis; General Population; Gestational Age; Human; Individual; Infant; Infant Mortality; Infection; Ischemia; Lesion; Life; Light; Logistic Regressions; Medical; Methods; Modification; Neonatal; Neonatal Mortality; Obstetric Labor; Outcome; Patients; Pattern; Perception; Policies; Population Study; Procedures; Prolonged labor; 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; Syndrome; Texas; Time; Trauma; Vacuum; Vagina; Vaginal delivery procedure; Vulnerable Populations; clinical practice; epidemiology study; evidence base; follow-up; high risk; high risk population; human data; human subject; improved; improved outcome; infant death; interest; 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.

项目概要 在美国，患有开放性出生缺陷（脊柱裂、腹裂、脐膨出）的婴儿更多 与任何其他类型出生缺陷的婴儿相比，剖腹产 (CS) 分娩的可能性更高。 有人提出，CS 可以降低婴儿早期死亡的高风险（例如，通过限制 病灶外伤和感染风险）。然而，缺乏证据支持或 在人类身上反驳这一理论，也不清楚还有哪些其他程序或条件 影响具有开放性出生缺陷的婴儿的死亡风险。因此，一项精心设计的研究 迫切需要确定这些婴儿的最佳分娩程序和条件。一个 随机对照试验很难协调相对罕见的结果，并且会 在缺乏表明对 CS 有益的经验证据的情况下，很难证明其合理性。 因此，应该进行观察性流行病学研究设计，使用非常广泛的方法 大量基于人群的研究样本，以解决临床转诊模式的差异（即 选择偏差）；考虑足够同质和适当的案例定义（例如， 分别评估腹裂和脐膨出）；解决潜力 混淆；长期（例如1年）随访；并考虑后续时间 在统计分析中。我们提出一项为期两年的研究，使用来自以下数据的数据来满足这些标准： 德克萨斯州出生缺陷登记处，登记了数千名患有开放性出生缺陷的婴儿 1999 年至 2011 年间。我们将使用多变量逻辑回归来单独评估CS 以及其他几种产科手术/条件（产钳的使用、真空吸引术、臀位术） 分娩、引产和延长产程）以及 28 天和年龄的死亡风险 三种开放性出生缺陷各一种。我们还将考虑潜在的影响 种族/民族、胎龄和出生体重的改变以及潜在的 多个变量的混杂。我们的研究结果将有助于确定最佳临床实践 在这些婴儿的分娩过程中，可能最终会减少不必要的侵入性 产妇手术，并防止这一高危人群中的婴儿死亡。