JAMA. 1976 Sep 27;236(13):1471-6. doi: 10.1001/jama.1976.03270140023016.
This prospective study of the safety and accuracy of midtrimester amniocentesis involved 1,040 subjects and 992 controls. Immediate complications of amniocentesis (vaginal bleeding or amniotic fluid leakage) occurred in approximately 2% of the women. There was no statistically significant difference between the two groups in rate of fetal loss (3.5% for the subjects, 3.2% for the controls) or incidence of complications of pregnancy of delivery. Newborn examination indicated no significant differences between the two groups in incidence of congenital anomalies and no evidence of physical injury resulting from amniocentesis. The two groups did not differ significantly in physical, neurological, or developmental status at one year of age. Diagnostic accuracy was 99.4%. Midtrimester amniocentesis is a highly accurate and safe procedure that does not significantly increase the risk of fetal loss or injury.
这项关于孕中期羊膜穿刺术安全性和准确性的前瞻性研究涉及1040名受试者和992名对照者。羊膜穿刺术的即刻并发症(阴道出血或羊水渗漏)发生在约2%的女性中。两组在胎儿丢失率(受试者为3.5%,对照者为3.2%)或分娩妊娠并发症发生率方面无统计学显著差异。新生儿检查表明,两组在先天性异常发生率方面无显著差异,也没有羊膜穿刺术导致身体损伤的证据。两组在一岁时的身体、神经或发育状况方面无显著差异。诊断准确率为99.4%。孕中期羊膜穿刺术是一种高度准确且安全的操作,不会显著增加胎儿丢失或受伤的风险。