Do Cesarean Deliveries Reduce Mortality in Infants with Birth Defects?

项目总结 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 与任何其他类型的出生缺陷婴儿相比，剖腹产婴儿更有可能进行剖腹产。 已经提出，CS可以降低婴儿过早死亡的高风险(例如，通过限制 病变上的创伤和感染风险)。然而，缺乏证据来支持或 在人类身上反驳这一理论，也不清楚还有哪些程序或条件 影响开放性出生缺陷婴儿的死亡风险。因此，一个设计良好的研究是 迫切需要确定这些婴儿的最佳分娩程序和条件。一个 随机对照试验将难以协调以获得相对罕见的结果，并将 在没有经验证据表明对CS有好处的情况下，很难证明这是合理的。 因此，应该进行一项观察性流行病学研究设计，使用非常 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)；处理潜在的 混杂；长期(如1年)的跟踪；以及考虑后续时间 在统计分析中。我们建议进行一项为期两年的研究，使用以下数据来满足这些标准 德克萨斯州出生缺陷登记处数千名开放性出生缺陷婴儿的登记 1999-2011年间。我们将使用多变量Logistic回归来单独评估CS 以及其他几种产科手术/条件(产钳使用、真空抽出、臀部手术 临产、引产和延长分娩)和28天及以下死亡风险 三种公开的出生缺陷各一种。我们还将考虑潜在的影响 根据种族/民族、胎龄和出生体重的改变，以及 混淆了几个变量。我们的发现将有助于确定最佳临床实践 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 产妇程序，并防止这一高危人群中的婴儿死亡。

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.