Elective Induction of Labor and Pregnancy Outcomes

选择性引产和妊娠结果

基本信息

批准号：
8701182
负责人：
SASCHA DUBLIN
金额：
$ 78.69万
依托单位：
KAISER FOUNDATION HEALTH PLAN OF WASHINGTON
依托单位国家：
美国
项目类别：
财政年份：
2013
资助国家：
美国
起止时间：
2013-09-01 至 2017-05-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8701182
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 Infection of amniotic sac and membranes 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&apos 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 neonatal death parity pregnant public health relevance stillbirth tool trend

项目摘要

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（调查员提供）：背景和目标：每年在美国，多达490,000名孕妇会进行选修课，这是一种干预措施，无需医疗原因即可进行劳动。这是否会给妇女还是胎儿造成风险。最近只有一项临床试验研究了胎儿妊娠41周之前的选修课，并且发现与让怀孕继续进行的结局没有差异（预期管理）。观察性研究发现，诱导后更多的剖宫产分娩，但大多数在同一胎龄将诱导与自发性劳动相提并论，这不是真正的临床选择。相反，应将选修课与真正的替代方案进行比较。大多数研究太小了，无法研究罕见，但重要的结果，没有人看着母亲的种族/种族或肥胖的风险是否有所不同。我们的目标是比较38、39或40周妊娠与预期管理的选修成果，以帮助孕妇及其提供者做出更明智的决定。方法：从2001年到2011年的出生研究将在两个综合的卫生保健系统中进行。在第1阶段，符合条件的人口（206,000个单身人士）将根据电子健康计划和出生证明数据，可以通过其明显的诱导和结果状态来识别和分类。在第2阶段，我们将进行8000次简短的病历审查，以确定真正的接触状态（选举归纳与预期管理）。在第3阶段，我们将深入审查3500个记录，以了解真实结果状况和风险因素。第2和第3段将以选举的入选或罕见结局的范围超出女性，提高我们解决这些特定目标的能力：目标1：比较在38、39或40周的选举诱导后与预期管理相比的风险：胸部出血，后脑炎，杂症静态炎，伴有胸腔炎的评分，伴有胸腔炎和预期管理。新生儿死亡；和目标2：检查风险如何因母亲的种族/种族，奇偶校验和怀孕前的肥胖而异。次级分析将开发一种算法，以更准确地从电子数据中识别选修课。影响：这项研究将比较38、39或40周妊娠的选修劳动力与预期管理，以提供有关母亲和胎儿的风险或福利的新信息。我们的结果可能会通过帮助妇女和提供者一起做出更明智的选择来立即影响临床实践。他们还将为实践指南和政策制定提供坚实的基础。