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.

项目摘要 在美国，有开放性出生缺陷的婴儿（脊柱裂、腹裂、脐膨出） 可能有剖宫产（CS）分娩的婴儿比任何其他类型的出生缺陷。 已经提出CS可以降低早期死亡婴儿的高风险（例如，通过限制 损伤和感染风险）。然而，缺乏证据支持或 在人类中反驳这一理论，也不清楚其他程序或条件 影响开放性出生缺陷婴儿死亡风险。因此，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 随机对照试验将难以协调相对罕见的结果， 在没有经验证据表明CS有益的情况下，难以证明。 因此，应进行观察性流行病学研究设计， 大的，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）;考虑充分同质和适当的病例定义（例如， 分别评价腹裂和脐膨出）;解决 混杂;长期随访（例如，1年）;并考虑随访时间 在统计分析中。我们建议进行一项为期两年的研究，使用以下数据满足这些标准： 德克萨斯州出生缺陷登记处为数千名患有开放性出生缺陷的婴儿提供了 在1999年到2011年之间。我们将使用多变量逻辑回归单独评估CS 以及其他几种产科手术/状况（产钳使用、真空抽吸、臀位 分娩、引产和产程延长）以及28天和年龄时的死亡风险 三种开放性出生缺陷各一种。我们也会考虑潜在的影响 根据人种/种族、胎龄和出生体重以及 几个变量的混淆。我们的研究结果将有助于确定最佳的临床实践 在这些婴儿的分娩和分娩过程中， 产妇手术，并防止这一高风险人群的婴儿死亡。