RANDOMIZED TRIAL OF 11-14 WEEK AMNIOCENTESIS AND TA CVS

描述：这是一个修订后的建议，用于随机比较 安全性和准确性的经腹腹腔穿刺术和经腹CVS， 每一项均在相同的77-104天的改良胎龄窗内完成 与末次月经后105-125天相比， CVS的穿刺术和LMP后63-76天。 12个财团 成立了经验丰富的产前诊断中心， 患者及时获取和完成拟议项目 时尚. 该小组包括主要研究人员， 产科、医学遗传学、细胞遗传学、儿科、 流行病学、生物统计学和合作临床试验的开展。 该研究的具体目的是比较经腹穿刺术 和CVS在妊娠77-104天，关于：早产或胎儿 细胞遗传学正常妊娠的损失，少于28个完成 妊娠周数;总胎儿丢失，包括 羊水流失导致囊袋小于1 cm; 分娩时胎龄;围产期发病率：宫内生长 发育迟缓（IUGR）、新生儿呼吸问题和其他并发症; 新生儿的肢体缺陷和其他先天性异常;未能 获得诊断样本;未能获得诊断;细胞遗传学 异常核型诊断的准确性（通过标准培养方法）; 荧光原位诊断的准确性和适用性 在CVS和羊水样本中，与 标准方法;羊水甲胎蛋白和 妊娠77-104天乙酰胆碱酯酶测定诊断神经管畸形 缺陷

DESCRIPTION: This is a revised proposal for a randomized comparison of the safety and accuracy of transabdominal amniocentesis and transabdominal CVS, each done during the same modified gestational age window of 77-104 days post last menstrual period (LMP) in contrast to 105-125 days post LMP for amniocentesis and 63-76 days post LMP for CVS. A consortium of 12 experienced prenatal diagnostic centers has been formed to facilitate patient acquisition and completion of the proposed project in a timely fashion. The group includes as principal investigators researchers with expertise in obstetrics, medical genetics, cytogenetics, pediatrics, epidemiology, biostatistics, and the conduct of cooperative clinical trials. The specific aims for the study are to compare transabdominal amniocentesis and CVS at 77-104 days gestation with respect to: Preterm delivery or fetal loss from cytogenetically normal pregnancies, at less than 28 completed gestational weeks; total fetal loss including neonatal death before discharge; Amniotic fluid loss resulting in a pocket of less than 1 cm; gestational age at delivery; perinatal morbidity: intrauterine growth retardation (IUGR), neonatal respiratory problems and other complications; limb defects and other congenital anomalies of the newborn; failure to obtain a sample for diagnosis; failure to obtain a diagnosis; cytogenetic accuracy for diagnosis of abnormal karyotype (by standard culture methods); the diagnostic accuracy and applicability of fluorescence in situ hybridization (FISH) in CVS and amniotic fluid samples, as compared with standard methods; the accuracy of amniotic fluid alphafetoprotein and acetylcholinesterase at 77-104 days gestation for diagnosis of neural tube defects.