Effect Of Iatrogenic Delivery at 34-38 Weeks' Gestation on Pregnancy Outcome

描述（由申请人提供）：孕妇及其提供者面临的最关键的决定之一是是否干预分娩或允许怀孕继续，试图优化母亲和婴儿的结果。未能通过引产或产前剖腹产进行干预可能会导致对母亲和婴儿的不良健康后果，而干预则会导致伴随健康问题的早产。我们建议使用设计和数据分析方法，有效地模拟了一系列每周的干预试验，对大量符合早期分娩干预条件的妊娠人群进行观察性研究。我们建议从2002年至2012年期间在罗得岛妇女和婴儿医院发生的96，000例单胎分娩记录开始评估干预的风险和益处。我们将队列限制为约13，500例妊娠，这些妊娠具有三种最常见的潜在干预适应症之一：胎儿生长受限、母体糖尿病疾病和母体高血压疾病。对于每例妊娠，我们将提取与正在进行的干预决策（时间、严重程度等）相关的关键临床数据，根据行政数据进行初步鉴定 对诊断进行分析，然后审查产前和住院病历，以确认诊断并确定干预的决定因素。对于每位患者怀孕34至38周的每周，我们将确定他们是否患有使他们面临分娩干预风险的疾病，以及干预是否实际上已经完成。将审查这一周决定的后果，以及随后几周为那些仍有干预风险的人所作的决定。待评估的关键婴儿结局包括新生儿重症监护室入院、不良呼吸结局、住院时间和新生儿发病率指数;对于母亲，我们将评估计划外剖宫产和住院时间。该分析将使用倾向评分和多重插补，以均衡在妊娠34 - 38周每周接受和未接受干预的患者以及早产和早期总体的给定胎龄下的协变量。受非随机化导致的固有局限性的影响，该方法将通过解释每次妊娠的临床细节来控制适应症的混杂，并考虑干预决策的纵向性质及其健康后果，从而非常接近试验。获得的见解将有直接相关的临床决策经常遇到的妊娠并发症。

DESCRIPTION (provided by applicant): Among the most critical decisions faced by pregnant women and their providers is whether to intervene to deliver or allow the pregnancy to continue, trying to optimize the outcome for mothers and infants. Failure to intervene by labor induction or prelabor Cesarean delivery can lead to adverse health consequences for the mother and infant, whereas intervention results in early delivery with attendant health concerns. We propose to conduct an observational study of a large population of pregnancies eligible for early delivery intervention using a design and data analysis approach that effectively simulates a series of week-by-week intervention trials. We propose to evaluate the risks and benefits of intervention starting with records from 96,000 singleton deliveries that occurred at Women and Infants hospital in Rhode Island over the period 2002-2012. We will restrict the cohort to the ~13,500 pregnancies with one of the three most common potential indications for intervention: fetal growth restriction, maternal diabetic disorders, and maternal hypertensive disorders. For each of these pregnancies, we will abstract key clinical data relevant to the ongoing decision regarding intervention (timing, severity, etc.), with preliminary identification based on administrative data on diagnoses followed by review of prenatal and inpatient medical records to confirm diagnoses and identify determinants of intervention. For each week of each patient's pregnancy between 34 and 38 weeks, we will determine whether they had the condition that put them at risk of intervention for delivery and whether or not the intervention was, in fact, done. The consequences of that weeks' decision will be examined, as will the decisions made in subsequent weeks for those still at risk of intervention. Key infant outcomes to be evaluated are admission to the neonatal intensive care unit, adverse respiratory outcomes, length of hospital stay, and an index of neonatal morbidity; for the mothers, we will assess unplanned Cesarean delivery and duration of hospitalization. The analysis will use propensity scores with multiple imputation to equalize covariates at a given gestational age for those who did and did not receive interventions in each week of gestation from 34 to 38, as well as for the preterm and early term period overall. Subject to the inherent limitations resulting from non-randomization, this approach will closely approximate a trial by accounting for the clinical details of each pregnancy to control for confounding by indication and considering the longitudinal nature of the intervention decisions and their health consequences. Insights gained will have direct relevance to clinical decision-making regarding frequently encountered complications of pregnancy.