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: 9270055
• 负责人: David A Savitz
• 金额: $ 35.67万
• 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 2019-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9270055
• 关键词: Accounting; Address; Admission activity; Affect; Benefits and Risks; Birth; Caring; Categories; Cesarean section; Characteristics; Child; Clinical; Clinical Data; Clinical Services; Communities; Complex; Computerized Medical Record; Data; Data Analyses; Development; Diagnosis; Disease; Eligibility Determination; Equilibrium; Ethics; Event; Failure; Fetal Growth; Fetal Growth Retardation; Gestational Age; Health; Health Services; Hospitalization; Hospitals; Iatrogenesis; Infant; Infant Health; Inpatients; Intervention; Intervention Trial; Judgment; Lead; Length of Stay; Logistics; 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; Uncertainty; Ursidae Family; Variant; Woman; adverse outcome; base; clinical decision-making; clinical practice; cohort; design; diabetic; health of the mother; indexing; infant outcome; insight; neonatal morbidity; preference; prenatal; public health relevance; 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）：孕妇及其提供者面临的最关键的决定是是否干预分娩或允许继续妊娠，以努力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的健康造成不良后果，而干预会导致早产并带来随之而来的健康问题。我们建议使用有效模拟一系列每周干预试验的设计和数据分析方法，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 年期间罗德岛州妇婴医院 96,000 例单胎分娩的记录开始评估干预的风险和益处。我们将队列限制在大约 13,500 名妊娠中，这些妊娠具有三种最常见的潜在干预指征之一：胎儿生长受限、孕产妇糖尿病和孕产妇高血压。对于每次妊娠，我们将提取与正在进行的干预决策相关的关键临床数据（时间、严重程度等），并根据管理数据进行初步识别 诊断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 至 38 周期间的每一周，我们将确定他们是否患有使他们面临分娩干预风险的状况，以及是否确实进行了干预。将审查该周决定的后果，以及随后几周为仍面临干预风险的人做出的决定。需要评估的关键婴儿结局包括入住新生儿重症监护病房、不良呼吸系统结局、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。该分析将使用多重插补的倾向评分来均衡给定胎龄下 34 至 38 周期间接受和未接受干预的人群以及整个早产期和早产期的协变量。受非随机化带来的固有局限性的影响，这种方法将通过考虑每次妊娠的临床细节来控制适应症的混杂因素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。获得的见解将与有关常见妊娠并发症的临床决策直接相关。

项目成果

Predicting primary cesarean delivery in pregnancies complicated by gestational diabetes mellitus.

预测妊娠合并妊娠糖尿病的初次剖宫产。

• DOI: 10.1016/j.ajog.2023.06.002
• 发表时间: 2023
• 期刊: American journal of obstetrics and gynecology
• 影响因子: 9.8
• 作者: Ramos,SebastianZ;Lewkowitz,AdamK;Lord,MeganG;Has,Phinnara;Danilack,ValeryA;Savitz,DavidA;Werner,ErikaF
• 通讯作者: Werner,ErikaF

Neonatal Outcomes are Similar between Patients with Resolved and Those with Persistent Oligohydramnios.

羊水过少得到缓解的患者和持续性羊水过少的患者的新生儿结局相似。

• DOI: 10.1055/a-2278-8948
• 发表时间: 2024
• 期刊: American journal of perinatology
• 影响因子: 2
• 作者: Whelan,AnnaR;Has,Phinnara;Savitz,DavidA;Danilack,ValeryA;Lewkowitz,AdamK
• 通讯作者: Lewkowitz,AdamK

Outcomes among Neonates after a Diagnosis of Persistent or Transient Fetal Growth Restriction Delivered at Term.

诊断出持续性或暂时性足月胎儿生长受限后新生儿的结果。

• DOI: 10.1055/a-2051-3859
• 发表时间: 2023
• 期刊: American journal of perinatology
• 影响因子: 2
• 作者: Ramos,SebastianZ;Has,Phinnara;Gimovsky,AlexisC;Danilack,ValeryA;Savitz,DavidA;Lewkowitz,AdamK
• 通讯作者: Lewkowitz,AdamK

Risk factors for respiratory distress syndrome among high-risk early-term and full-term deliveries.

• DOI: 10.1080/14767058.2022.2128657
• 发表时间: 2022-12
• 期刊: JOURNAL OF MATERNAL-FETAL & NEONATAL MEDICINE
• 影响因子: 1.8
• 作者: Gould, Alexander J.;Ding, Jia Jennifer;Recabo, Olivia;Has, Phinnara;Savitz, David A.;Danilack, Valery A.;Lewkowitz, Adam K.
• 通讯作者: Lewkowitz, Adam K.

Health Outcomes Associated With Clinician-initiated Delivery for Hypertensive Disorders at 34-38 Weeks' Gestation.

• DOI: 10.1097/ede.0000000000001442
• 发表时间: 2022-03-01
• 期刊: Epidemiology (Cambridge, Mass.)
• 作者: Savitz DA;Danilack VA;Cochancela J;Hughes BL;Rouse DJ;Gutmann R
• 通讯作者: Gutmann R