RANDOMIZED TRIAL OF 11-14 WEEK AMNIOCENTESIS AND TA CVS

描述：这是一项修订后的建议，用于随机比较 经腹羊膜腔穿刺术和经腹脑血管痉挛的安全性和准确性 每一次都是在相同的77-104天的修改孕周窗口内完成的 末次月经后(LMP)与LMP后105-125天 羊水穿刺术和LMP治疗CVS后63~76天。由12人组成的财团 成立了经验丰富的产前诊断中心，以方便 耐心地获取并及时完成拟议的项目 时尚。该小组包括作为主要调查人员的研究员 具备产科、医学遗传学、细胞遗传学、儿科学等专业知识， 流行病学、生物统计学和合作临床试验的开展。 这项研究的具体目的是比较经腹羊膜穿刺术 和妊娠77-104天的CVS：早产或胎儿 细胞遗传学正常的妊娠丢失，完成不到28次 妊娠周；包括新生儿死亡在内的全部胎儿丢失 排泄物；羊水丢失导致口袋小于1厘米； 分娩时的胎龄；围产期发病率：宫内发育 胎儿发育迟缓(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畸形；不能 获得诊断样本；未能获得诊断；细胞遗传学 诊断异常核型的准确性(通过标准培养方法)； 原位荧光诊断的准确性和适用性 CVS和羊水标本的杂交(FISH)与 标准方法；羊水甲胎蛋白和甲胎蛋白的准确性 妊娠77~104日龄乙酰胆碱酯酶诊断神经管畸形 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.