IMMUNODETECTION OF WOMEN AT RISK FOR PRETERM DELIVERY

描述(改编自申请人的摘要)：这是 研究人员将开发一种新的怀孕期间使用的诊断测试 以确定早产(PTD)风险升高的妇女。一个 应用抗癌胚单抗进行免疫分析 纤维连接蛋白(FFN)是一种起源于胎盘的妊娠相关蛋白，在 为了这个目的，羊水已经标准化。初步 研究表明，FFN在人体内的含量超过50 ng/ml 81%的妇女在23-36周龄时宫颈阴道分泌物 因怀疑胎膜破裂而寻求医疗救治的妊娠患者 而在267名女性中，只有20%(p不到0.001) 并不复杂的足月妊娠。这种差异不可能是 由取样时胎龄差异、宫颈扩张 或分泌物中有血迹。第一阶段的主要目标 将描述宫颈阴道fFN之间的关系 PTD在100例高危人群中的表达和发病率 怀孕。在第一阶段，调查人员将设计一种 一项临床试验，以彻底评估一种抗病毒药物的诊断效果 商业应用的FFN检测。

DESCRIPTION (Adapted from the applicant's abstract): It is the intent of the investigators to develop a new diagnostic test for use during pregnancy to identify women at elevated risk for preterm delivery (PTD). An immunoassay using a monoclonal antibody directed against oncofetal fibronectin (fFN), a pregnancy-related protein of placental origin found in the amniotic fluid, has been standardized for this purpose. Preliminary studies have shown that greater than 50 ng/ml of fFN was present in the cervicovaginal secretions of 81 percent of women at 23 to 36 weeks of gestation who sought medical attention for suspected rupture of membranes of PTD, in contrast to only 20 percent (p less than 0.001) of 267 women with uncomplicated term pregnancies. This difference could not be explained by differences in gestational age at sampling, cervical dilation or presence of blood in the secretions. The primary objective of Phase I will be to characterize the relationship between cervicovaginal fFN expression and incidence of PTD in a longitudinal study of 100 high risk pregnancies.In Phase I, the investigators will design a prospective clinical trial to thoroughly evaluate the diagnostic efficacy of an anti- fFN assay for commercial application.