MATERNAL MONITORING FOR FETAL LUNG MATURATION

描述（改编自研究者摘要）：类固醇 25年来一直在临床上减少呼吸道疾病的风险， 窘迫综合征（RDS）是新生儿死亡的主要原因。 然而，这种疗法是严重利用不足，因为它只有50 降低RDS风险的有效性百分比，使其难以 治疗控制。 实验室发现母体血清 雌三醇（E3）表明胎儿是否对药物有反应 在出生前，提供一个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 将在马里兰州大学和其他5个地区扩大 全国围产期中心，以验证该测试的临床使用 使用标准放射免疫测定（RIA）技术。 母体雌三醇 然后将使用RIA测定的雌三醇来验证通过 定量酶联免疫吸附测定（EIA），这是一个更 可获得且具有成本效益的技术。 使用以下方法验证本试验 环境影响评估将促进其减少到实践和商业化。 在 此外，本试验的生物学验证将通过以下方式提供： 它与产前类固醇对胎儿肾上腺DHA的影响， 对羊水和新生儿RDS中肺表面活性物质的影响。 在 II期将收集更多关于该复杂患者的患者数据 人口，以制定一个“床边”定性环评具体 以实现此目的。 这项新的测试可能会为产科提供一个突破， 使用产前类固醇治疗的早产管理。

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.