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

妊娠 34-38 周医源分娩对妊娠结局的影响

• 批准号: 9064185
• 负责人: David A Savitz
• 金额: $ 51.37万
• 依托单位: WOMEN AND INFANTS HOSPITAL-RHODE ISLAND
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-05-15 至 2018-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9064185
• 关键词: Accounting; Address; Admission activity; Affect; Benefits and Risks; Birth; Caring; Categories; Cesarean section; Characteristics; Child; Clinical; Clinical Data; Communities; Complex; Computerized Medical Record; Data; Data Analyses; Decision Making; Development; Diagnosis; Disease; Equilibrium; Ethics; Event; Failure; Fetal Growth; Fetal Growth Retardation; Gestational Age; Health; Health Services; Hospitalization; Hospitals; Infant; Infant Health; Inpatients; Intervention; Intervention Trial; Judgment; Lead; Length of Stay; Maternal Health; Medical Records; Methods; Mothers; Nature; Neonatal Intensive Care Units; Newborn Infant; Observational Study; Outcome; Patients; Population; Pregnancy; Pregnancy Complications; Pregnancy Outcome; Pregnant Women; Provider; Records; Research; Rhode Island; Risk; Series; Severities; Statistical Methods; Time; Uncertainty; Ursidae Family; Variant; Woman; abstracting; adverse outcome; base; clinical decision-making; clinical practice; cohort; design; diabetic; indexing; infant outcome; insight; neonatal morbidity; preference; prenatal; randomized trial; respiratory; stillbirth

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.

描述（由申请人提供）：在孕妇及其提供者面临的最关键决定中，是否要干预或允许怀孕继续，试图优化母亲和婴儿的结果。不通过劳动归纳或剖宫产前分娩进行干预会对母亲和婴儿造成不利的健康后果，而干预会导致早期分娩和随之而来的健康问题。我们建议使用设计和数据分析方法有效地模拟一系列每周的干预试验，对有资格进行早期分娩干预的大量怀孕进行观察研究。我们建议评估从2002 - 2012年期间在罗德岛州妇女和婴儿医院发生的96,000个单顿分娩的记录开始的干预风险和好处。我们将将队列限制在约13,500例怀孕中，其中三个最常见的干预症状之一是：胎儿生长限制，母体糖尿病疾病和母性高血压疾病。对于这些怀孕中的每一个，我们将通过基于管理数据的初步识别来抽象与正在进行的有关干预措施（时机，严重性等）的决定有关的关键临床数据 关于诊断，然后对产前和住院病历进行审查，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周之间的每个星期，我们将确定他们是否有使他们有干预措施的风险，并且实际上是否已经完成了干预措施。这几周决定的后果将被检查，随后几周对仍有干预风险的决定的决定也将进行。待评估的关键婴儿结果是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，我们将评估计划外的剖宫产和住院时间。该分析将使用具有多个插补的倾向得分来在给定的妊娠年龄均衡协变量，以供那些妊娠每周接受干预的人，从34到38，以及整个早产和早期期。受非随机化产生的固有局限性的约束，这种方法将通过考虑每种怀孕的临床细节来密切近似试验，以控制通过指示和考虑干预决定的纵向性质及其健康后果的纵向性质。获得的洞察力将与临床决策有关经常遇到怀孕并发症的直接相关。