美国胎儿pH监测的多中心临床试验

Multicenter clinical trials of fetal pH monitoring in the U.S.A.

作者信息

Hochberg H M

出版信息

Arch Gynecol. 1978 Sep 1;226(1-2):93-9. doi: 10.1007/BF02116733.

Abstract

A multicenter collaborative study of the safety and clinical efficacy of the ROCHE fetal pH monitor has been started. A common protocol and reporting forms are used. As of April, 1978, 115 case reports have been received describing results with the latest hardware. The tissue pH monitor can be relied upon to monitor pH if the values are in the normal range. Comparison of tissue pH (tpH) with 146 capillary pH samples revealed 98% accuracy of tpH in classifying normal (greater than or equal to 7.20), but false tpH acidosis occurred in 6% of normals. Therefore, acidotic tpH values must be verified. Although six infants had some degree of trauma (small lacerations), there were no serious or permanent injuries.

摘要

一项关于罗氏胎儿pH监测仪安全性和临床疗效的多中心合作研究已经启动。使用了通用方案和报告表格。截至1978年4月，已收到115份病例报告，描述了使用最新硬件的结果。如果组织pH值在正常范围内，组织pH监测仪可用于监测pH值。将组织pH（tpH）与146份毛细血管pH样本进行比较，结果显示tpH对正常pH值（大于或等于7.20）分类的准确率为98%，但6%的正常样本出现了tpH酸中毒的假阳性结果。因此，酸中毒的tpH值必须得到验证。虽然有6名婴儿有一定程度的创伤（小裂伤），但没有严重或永久性损伤。