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

描述(由申请人提供)：孕妇和她们的提供者面临的最关键的决定之一是，是干预分娩还是允许怀孕继续，试图优化母亲和婴儿的结局。未能通过引产或产前剖腹产进行干预可能会对母亲和婴儿造成不利的健康后果，而干预会导致早产并伴随着健康问题。我们建议使用设计和数据分析方法对符合早产干预条件的大量妊娠人群进行观察性研究，该方法有效地模拟了一系列逐周干预试验。我们建议从2002-2012年间罗德岛州妇幼医院发生的96,000例单胎分娩的记录开始，评估干预的风险和好处。我们将把队列限制在有三个最常见的潜在干预指征之一的13,500名孕妇：胎儿生长受限、母亲糖尿病和母亲高血压疾病。对于每一次怀孕，我们将提取与正在进行的干预决策(时机、严重性等)相关的关键临床数据，并根据管理数据进行初步识别 关于诊断，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。对于每个患者怀孕34到38周之间的每一周，我们将确定他们是否患有使其面临分娩干预风险的状况，以及干预是否实际上已经完成。将审查这几周决定的后果，以及随后几周对那些仍面临干预风险的人所做的决定。要评估的关键婴儿结局包括进入新生儿重症监护病房、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腹产和住院时间。这项分析将使用带有多重归因的倾向评分，以使34至38周内接受干预和未接受干预的孕妇在给定孕龄时的协变量相等，以及整个早产期和早产期的协变量相等。受制于非随机化的固有局限性，这种方法将接近于一项试验，方法是考虑每一次妊娠的临床细节，以按适应症控制混淆，并考虑干预决定的纵向性质及其对健康的影响。所获得的洞察力将与妊娠常见并发症的临床决策直接相关。

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.