Elective Induction of Labor and Pregnancy Outcomes

选择性引产和妊娠结果

• 批准号: 8887237
• 负责人: SASCHA DUBLIN
• 金额: $ 76.92万
• 依托单位: KAISER FOUNDATION HEALTH PLAN OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-09-01 至 2016-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8887237
• 关键词: Address; Affect; Algorithms; Apgar Score; Birth; Birth Certificates; California; Childbirth; Clinical; Clinical Trials; Computerized Medical Record; Data; Data Collection; Discipline of obstetrics; Dystocia; Electronics; Ethnic Origin; Event; Fetus; Foundations; Future; Gestational Age; Goals; Health; Health Planning; Health Services Research; Infant Health; Integrated Health Care Systems; Intensive Care Units; Intervention; Knowledge; Medical; Medical Records; Meta-Analysis; Methods; Mothers; Natural Language Processing; Neonatal; Neonatal Intensive Care Units; Obesity; Observational Study; Outcome; Phase; Physician' s Practice Patterns; Policy Making; Population; Population Heterogeneity; Postpartum Hemorrhage; Practice Guidelines; Pregnancy; Pregnancy Outcome; Pregnant Women; Provider; Race; Randomized Clinical Trials; Records; Research; Research Design; Research Personnel; Retrospective Studies; Risk; Risk Estimate; Risk Factors; Shapes; Shoulder; Solid; System; Uncertainty; Washington; Wing; Woman; adverse outcome; base; clinical practice; clinically relevant; design; electronic data; fetal; health care delivery; improved; intraamniotic infection; neonatal death; parity; pregnant; stillbirth; tool; trend

DESCRIPTION (provided by investigator): Background and goals: Each year in the US, up to 490,000 pregnant women undergo elective induction, an intervention to bring on labor without a medical reason. Whether this causes risks to the woman or fetus is unclear. Only one recent clinical trial studied elective induction before 41 weeks of fetal gestation, and it found no difference in outcomes compared to letting the pregnancy continue (expectant management). Observational studies have found more cesarean delivery after induction, but most compared induction to spontaneous labor at the same gestational age, which is not the genuine clinical alternative. Instead, elective induction should be compared to the true alternative, expectant management. Most studies were too small to study uncommon but important outcomes, and none looked at whether risks differ by the mother's race/ethnicity or obesity. Our goal is to compare outcomes for elective induction at 38, 39 or 40 weeks' gestation versus expectant management, to help pregnant women and their providers make more informed decisions. Methods: A multiphase retrospective study of births from 2001 to 2011 will be conducted in two integrated health care systems. In Phase 1, the eligible population (206,000 singleton births) will be identified and classified by their apparent induction and outcome status based on electronic health plan and birth certificate data. In Phase 2, we will conduct 8000 brief medical record reviews to determine true exposure status (elective induction vs. expectant management). In Phase 3, we will review 3500 records in depth for true outcome status and risk factors. Phases 2 and 3 will oversample women with elective induction or rare outcomes, improving our power to address these specific aims: Aim 1: Compare the risk of the following outcomes after elective induction at 38, 39 or 40 weeks' gestation versus expectant management: cesarean delivery, postpartum hemorrhage, chorioamnionitis, neonatal intensive care unit stay, shoulder dystocia, low Apgar score, stillbirth, and neonatal death; and Aim 2: Examine how risks vary by the mother's race/ethnicity, parity, and pre-pregnancy obesity. Secondary analyses will develop an algorithm to more accurately identify elective inductions from electronic data. Impact: This research will compare elective labor induction at 38, 39 or 40 weeks' gestation to expectant management to provide new information about its risks or benefits for the mother and fetus. Our results could immediately affect clinical practice by helping women and providers make more informed choices together. They will also provide a solid foundation for practice guidelines and policy making.

描述（由研究者提供）： 背景和目标：在美国，每年有多达 490,000 名孕妇接受选择性引产，这是一种在没有医学原因的情况下进行分娩的干预措施。目前尚不清楚这是否会对女性或胎儿造成风险。最近只有一项临床试验研究了胎儿妊娠 41 周前的选择性引产，结果发现与继续妊娠（期待管理）相比，结果没有差异。观察性研究发现引产后剖宫产的情况较多，但大多数将引产与同胎龄的自然分娩进行比较，这并不是真正的临床替代方案。相反，选择性引产应与真正的替代方案、期待治疗进行比较。大多数研究规模太小，无法研究不常见但重要的结果，也没有一项研究关注风险是否因母亲的种族/民族或肥胖而不同。我们的目标是比较妊娠 38、39 或 40 周时选择性引产与期待治疗的结果，以帮助孕妇及其提供者做出更明智的决定。方法：将对两个综合医疗保健系统 2001 年至 2011 年的出生情况进行多阶段回顾性研究。在第一阶段，符合条件的人口（206,000 名单胎出生者）将 根据电子健康计划和出生证明数据，根据其明显的诱导和结果状态进行识别和分类。在第二阶段，我们将进行 8000 份简短的医疗记录审查，以确定真实的暴露状态（选择性诱导与期待治疗）。在第 3 阶段，我们将深入审查 3500 条记录，了解真实的结果状态和风险因素。第 2 和第 3 阶段将对选择性引产或罕见结果的女性进行过度抽样，提高我们实现这些特定目标的能力： 目标 1：比较妊娠 38、39 或 40 周选择性引产与期待治疗后出现以下结果的风险：剖宫产、产后出血、绒毛膜羊膜炎、新生儿重症监护病房住院、肩难产、低阿普加评分、死产和 新生儿死亡；目标 2：检查风险如何因母亲的种族/民族、胎次和孕前肥胖而变化。二次分析将开发一种算法，以更准确地从电子数据中识别选择性诱导。影响：本研究将妊娠 38、39 或 40 周时的选择性引产与期待治疗进行比较，以提供有关其对母亲和胎儿的风险或益处的新信息。我们的结果可以帮助女性和提供者共同做出更明智的选择，从而立即影响临床实践。它们还将为实践指南和政策制定提供坚实的基础。