MATERNAL MONITORING FOR FETAL LUNG MATURATION

描述(改编自《调查者摘要》)：产前类固醇 已经在临床上应用了25年，以降低呼吸道疾病的风险 窘迫综合征(RDS)，新生儿死亡的主要原因。 然而，这种疗法被严重低估，因为它只有50 在降低RDS风险方面的有效率，使其成为 通过治疗来控制。本实验室发现母体血清 雌三醇(E3)表示胎儿是否对药物有反应 在出生之前，提供了一种客观的手段来管理这些高风险 第一次怀孕。在第一阶段，这项观察性研究将 在马里兰大学和其他5个地区推广 全国围产期中心验证这项测试的临床应用 使用标准放射免疫分析(RIA)技术。母体雌三醇 由RIA测定的雌三醇随后将用于验证由 定量酶联免疫吸附试验(EIA)，这是一种更 可获得且具有成本效益的技术。使用以下工具验证此测试 环境影响评估将有助于将其转化为实践和商业化。在……里面 此外，这项测试的生物学验证将通过关联提供 孕期激素对胎儿肾上腺DHA的影响 脐血和肺表面活性物质在羊水和新生儿RDS中的表达。在……里面 第二阶段将收集更多关于这名复杂患者的患者数据 为了制定专门的“床边”定性环境影响评估 为了这个目的。这项新的检查可能会为产科提供一个突破 产前应用类固醇治疗早孕的管理。

DESCRIPTION (Adapted from the Investigator's Abstract): Antenatal steroids have been clinically for 25 years to reduce the risk of respiratory distress syndrome (RDS), the major cause of death among newborn infants. However, this therapy is grossly underutilized because it is only 50 percent effective in reducing the risk of RDS, making it a difficult therapy to control. This laboratory has discovered that maternal serum estriol (E3) indicates whether or not the fetus has responded to the drug before birth, providing an objective means of managing these high risk pregnancies for the first time. In Phase I this observational study will be expanded at the University of Maryland and at 5 other regional perinatal centers nationally to validate the clinical use of this test using standard radioimmunoassay (RIA) technology. Maternal estriol determined by RIA will then be used to validate estriol measured by a quantitative enzyme-linked immunosorbent assay (EIA), which is a more accessible and cost-effective technology. Validation of this test using EIA will facilitate its reduction to practice and commercialization. In addition, biologic validation of this test will be provided by correlating it with the effects of antenatal steroids on both fetal adrenal DHA in cord blood and on lung surfactant in amniotic fluid and neonatal RDS. In Phase II more patient data will be collected on this complex patient population in order to develop a "bedside" qualitative EIA specifically for this purpose. This new test may provide a breakthrough for obstetric management of preterm pregnancies treated with antenatal steroids.